cap_458 preamble—medicinesact

MT

MEDICINES ACT (preamble—medicinesact)

125 Articles / Provisions · Malta

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Table of Provisions (125)

Preamble Art. 1 Short title. First Schedule Art. 2 Interpretation. Second Schedule Art. 3 Functions of the Licensing Authority. Third Schedule Art. 4 Establishment of the Medicines Authority. Art. 5 Legal personality of the Medicines Authority. Art. 6 Functions of the Medicines Authority. Art. 7 Organisation of the Medicines Authority. Art. 8 The Chief Executive Officer of the Medicines Authority. Art. 9 Employees of the Medicines Authority. Art. 10 Accounts of the Medicines Authority. Art. 11 Procurement by the Medicines Authority. Art. 12 Applicability of the Code of Ethics. Art. 13 Exemption from tax, etc. Art. 14 Establishment of Medicines Review Board. Art. 15 Medicines Review Board may appoint advisors. Art. 16 Functions of the Medicines Review Board. Art. 17 Procedure of appeal. Art. 18 Public hearing. Art. 19 Applicability of certain provisions. Art. 20 Authorisation to place medicinal products on the market. Art. 21 Review or appeal. Art. 22 Granting of marketing authorisation. Art. 23 Notification of marketing authorisation. Art. 24 Validity of market authorisation. Art. 25 Application of renewal. Art. 26 Notification of refusal. Art. 27 Refusal to renew marketing authorisation. Art. 28 Suspension or revocation of marketing authorisation. Art. 29 Classification of medicinal products. Art. 30 List of medicinal products having a marketing authorisation. Art. 31 Advertising of medicinal products. Art. 31A Marketing authorisation holders to abide by standards. Art. 32 Homeopathic medicinal products. Art. 33 Products derived from human blood or human plasma. Art. 34 Radio- pharmaceutical medicinal product. Art. 35 Immunological medicinal products. Art. 36 Herbal medicinal products. Art. 37 Manufacturer’s licence. Art. 38 Application for manufacturer’s licence. Art. 39 Granting of manufacturer’s licence. Art. 40 Notice for further information. Art. 41 Suspension or revocation of manufacturer’s licence. Art. 42 Inspection in relation to manufacturers, etc. Art. 43 Duration and renewal of manufacturer's licence. Art. 44 Responsibilities of manufacturer’s licence holder. Art. 45 Responsibilities of the qualified person. Art. 46 Suspension of activity of a qualified person. Art. 47 Change in conditions of manufacturer’s licence. Art. 48 Obligations of Licensing Authority. Art. 49 Manufacture of homeopathic medicinal products. Art. 50 Manufacture of medicinal products derived from human blood and human plasma, etc. Art. 51 Manufacture of radio- pharmaceuticals. Art. 52 Immunological medicinal product. Art. 53 Herbal medicinal products. Art. 54 Wholesale dealing. Art. 54A Brokering. Art. 55 Application for a wholesale dealer’s licence. Art. 56 Granting of a wholesale dealer’s licence. Art. 57 Notice for further information. Art. 58 Duration and renewal of wholesale dealer’s licence. Art. 59 Obligations of holder of wholesale dealer’s licence. Art. 60 Responsibilities of the responsible person. Art. 60A Suspension of responsible person. Art. 61 Suspension or revocation of wholesale dealer’s licence. Art. 62 Change in conditions of a wholesale dealer’s licence. Art. 63 Obligations of Licensing Authority. Art. 64 Inspecting in relation to wholesale. Art. 65 Special provisions. Art. 66 Licence to open a pharmacy. Art. 67 Application for a pharmacy licence. Art. 68 Grant of a pharmacy licence. Art. 69 Notice for further information. Art. 70 Duration and renewal of pharmacy licence. Art. 71 Transfer of a pharmacy licence. Art. 72 Suspension or revocation of pharmacy licence. Art. 73 Temporary closure of pharmacy. Art. 74 Obligations of the holder of a pharmacy licence. Art. 75 Managing pharmacist. Art. 75A Suspension of managing pharmacist. Art. 76 Duties of pharmacist. Art. 77 Interest in a pharmacy. Art. 78 Licensee may employ one or more pharmacists. Art. 79 Medicinal products to be sold from a pharmacy. Art. 80 Dispensing of a medicinal product. Art. 81 Dispensing against prescription. Art. 82 Presentation of a prescription. Art. 83 Labelling of dispensed products. Art. 84 Disposal of expired, deteriorated or imperfect products. Art. 85 Storage of medicinal products in pharmacy. Art. 86 Premises, etc., in accordance with requirements and standards. Art. 87 Pharmacist to be guided by set standards. Art. 88 Inspections of pharmacies. Art. 89 Opening of pharmacies. Art. 90 Definition of poisons. Art. 91 Keeping, etc., of poisons. Art. 92 Licence for sale of poisons. Art. 93 Keeping of poisonous substances in a safe place. Art. 94 Sale of poisonous substances. Art. 95 Power of inspection. Art. 96 Poisoned grain, seed etc., Art. 97 Special restrictions on persons to be supplied with medicinal products. Art. 98 Adulteration of medicinal products. Art. 99 Offences and penalties. Art. 100 Special procedure. Art. 101 Dritt ta’ dħul. Emendat: XI. 2007.18. Art. 101A Art. 102 Art. 103 Art. 104 Dispożizzjonijiet supplimentari dwar id-dritt ta’ dħul. Art. 104A Art. 104B Proof of controls carried out. Art. 104C Recalls and rapid alerts. Art. 105 Recognition of equivalent standards. Art. 106 Power of Minister to make regulations. Art. 107 Transitory provision. Art. 108 Amendment of Medical and Kindred Professions Ordinance. Art. 109 Saving. Art. 109A Designation of competent authority. Art. 110 Saving provisions. Art. 111 Medical devices and in vitro diagnostic medical devices. Art. 112 Language.

Statutory Text (125 Articles)

Laws of Malta — Chapter 458 — MEDICINES ACT

Preamble — MEDICINES ACT Open official source

ME DICINE S

CHAPTER 458

MEDICINES ACT

To make provision for matters connected with the manufacture, preparation and assembly,

wholesale distribution, storage, destruction, disposal, advertising and authorisation of

medicinal products and any activity connected therewith and the regulation of the sale of

medicinal products, pharmacies and related pharmaceutical activities and for any other

matters ancillary thereto or connected therewith.

21st November, 2003;

1st December, 2003

ACT III of 2003 , as amended by Acts III of 2004 and XI of 2007 ; Legal Notice 427 of

2007 ; and Acts XXIX of 2007 , V of 2013 , VII and XXXV of 2020 and XX of 2025.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 1 Short title. — MEDICINES ACT Open official source

The short title of this Act is the Medicines Act.

PART I

PRELIMINARY

Laws of Malta — Chapter 458 — MEDICINES ACT

First Schedule — MEDICINES ACT Open official source

(Deleted by Act III.2004.45)

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 2 Interpretation. — MEDICINES ACT Open official source

In this Act, unless the context otherwise requires -

"adverse reaction" means a response to a medicinal product which

is noxious and unintended;

"advertising" in relation to medicinal products includes any form

of door-to-door information, canvassing activity or inducement

designed to promote the prescription, supply, sale or consumption

of medicinal products and without prejudice to the generality of the

foregoing in particular includes

(a) the advertising of medicinal products to the general

public;

(b) the advertising of medicinal products to persons

qualified to prescribe or supply them;

(c) visits by medical or sales representatives to persons

qualified to prescribe medicinal products;

(d) the supply of samples;

(e) the provision of inducements to prescribe or supply

medicinal products, by way of a gift, offer or promise

of any benefit or bonus, whether in money or in kind,

except when the intrinsic value of such an inducement

is minimal;

(f)

sponsorship of promotional meetings attended by

persons qualified to prescribe or supply medicinal

products;

(g) sponsorship of any scientific congress attended by

persons qualified to prescribe or supply medicinal

products and in particular where payment of their

travelling and accommodation expenses is offered in

connection therewith;

but shall exclude

(i)

the labelling and the accompanying package

leaflets, as may be specified in accordance with

the provisions of Part III, Title I of this Act;

(ii) correspondence, even if accompanied by

material of a non-promotional nature, which is

in reply to a specific question about a particular

medicinal product;

(iii) factual, informative, announcement or reference

material relating to pack changes, adverse-

reaction warnings as part of general drug

precautions, trade catalogues, price lists and

other material of a similar nature provided that

such material does not include any product

claim;

(iv) any statement relating to human health or

disease, provided there is no reference, whether

direct or indirect, to a medicinal product;

"active substance" means any substance or mixture of substances

intended to be used in the manufacture of a medicinal product and that,

when used in its production, becomes an active ingredient of that

product intended to exert a pharmacological, immunological or

metabolic action with a view to restoring, correcting or modifying

physiological functions or to make a medical diagnosis;

"analysis" includes testing of a medicinal product or any of its

constituents, both active or inactive, in respect of their chemical,

physical, pharmaceutical, biological, toxicological or

pharmacological properties;

"assemble", in relation to a medicinal product, means to enclose

the product in a container which is labelled before the product is

sold or supplied, or, where the product is already enclosed in the

container in which it is to be sold or supplied, labelling the

container before the product is sold or supplied in it, and shall also

include the act of introducing approved information in or on the

container and "assembly" shall be construed accordingly;

"authorised officer" in relation to the Medicines Authority means

any officer or employee of the Authority or any other person

authorised by the Authority to act on its behalf and in relation to

the Licensing Authority means any officer or employee of the

Department as referred to in article 5 of the Department of Health

(Constitution) Ordinance authorised by the Licensing Authority to

act on its behalf;

"brokering of medicinal products" means all activities in relation to

the sale or purchase of medicinal products, except for wholesale

distribution, that do not include physical handling and that consist of

negotiating independently and on behalf of another legal or natural

person;

"business" means any economic activity whether carried out by

the individual or by a body of persons, whether corporate or

unincorporate and includes the exercise of a profession;

"clinical trial" means any investigation in human subjects

intended to discover or verify, the clinical, pharmacological and, or

other pharmacodynamic effects of one or more investigational

medicinal products, and, or to identify any adverse reactions to one

or more investigational medicinal products, and, or to study the

absorption, distribution, metabolism and excretion of one or more

investigational products with the object of ascertaining their safety

and, or efficacy. This includes clinical trials carried out in either

one site or multiple sties, whether in one or more than one Member

State;

"common name" means the international non-proprietary name

recommended by the World Health Organization, or, if one does not

exist, the usual common name;

"composition" in relation to a medicinal product, means the

ingredients constituting it and the proportions, and the degrees of

strength, quality and purity, in which those ingredients are

respectively contained in it and as m ay be established in a

recognised pharmacopoeia;

"container" in relation to a medicinal product, means the

immediate packaging or outer packaging;

"cosmetic product" shall have the same definition as found under

the Product Safety Act;

"dental practitioner" means a person who is authorised to

exercise such profession under the Medical and Kindred

Professions Ordinance or any other law replacing the same;

"designated Minister" means the Minister who is designated by the

Prime Minister as being responsible for the Medicines Authority;

"disease" includes any injury, ailment or adverse condition,

whether of body or mind;

"dispensing" means the sale or supply of medicinal products from a

pharmacy;

"excipient" means any constituent of a medicinal product other than

the active substance and the packaging material;

"falsified medicinal product" means any medicinal product with

a false representation of

(a) its identity, including its packaging and labelling, its

name or its composition as regards any of the

ingredients including excipients and the strength of

those ingredients;

(b) its source, including its manufacturer, its country of

manufacturing, its country of origin or its marketing

authorisation holder; or

(c) its history, including the records and documents

relating to the distribution channels used,

but excludes unintentional quality defects and is without prejudice

to infringements of intellectual property rights;

"foodstuff" shall have the same meaning as that under the Food

Safety Act;

"good practice" in relation to manufacturing practice, laboratory

practice, distribution practice, clinical practice and dispensing

practice means the standards for the proper execution of the

relative activity as established by or under this Act;

"herbal medicinal product" means any medicinal product,

exclusively containing as active ingredients one or more herbal

substances or one or more herbal preparations, or one or more such

herbal substances in combination with one or more such herbal

preparations;

"herbal preparations" means preparations obtained by subjecting

herbal substances to treatments such as extraction, distillation,

expression, fractionation, purification, concentration or

fermentation. These include comminuted or powdered herbal

substances, tinctures, extracts, essential oils, expressed juices and

processed exudates;

"herbal substances" means all mainly whole, fragmented or cut

plants, plant parts, algae, fungi, lichen in an unprocessed, usually

dried, form, but sometimes fresh. Certain exudates that have not

been subjected to a specific treatment are also considered to be

herbal substances. Herbal substances are precisely defined by the

plant part used and the botanical name according to the binomial

system (genus, species, variety and author);

"homeopathic medicinal product" means any medicinal product

prepared form substances called homeopathic stocks in accordance

with a homeopathic manufacturing procedure described by the

European Pharmacopoeia or, in the absence thereof, by the

pharmacopoeias currently used officially in the Member States. A

homeopathic medicinal product may contian a number of

principles;

"immediate packaging" means the container or other form of

packaging immediately in contact with the medicinal product;

"immunological medicinal product" means any medicinal

product consisting of vaccines, toxins, serums or allergen products,

where -

(a) vaccines, toxins and serums shall cover in particular

(i)

agents used to produce active immunity, such as

cholera vaccine, BCG, polio vaccines, smallpox

vaccine;

(ii) agents used to diagnose the state of immunity,

including in particular tuberculin and tuberculin

PPD, toxins for the Schick and Dick Tests,

brucellin;

(iii) agents used to produce passive immunity, such

as diphtheria antitoxin, anti-smallpox globulin,

antilymphocytic globulin;

(b) "allergen product" shall mean any medicinal product

which is intended to identify or induce a specific

acquired alteration in the immunological response to

an allergizing agent;

"importation" means any one or more of the following activities

procuring, holding, selling and release of imported medicinal products

in any part of Malta notwithstanding any provisions in any other Act,

but does not include imported medicinal products that are in transit

where the whole consignment of the said products remains fully intact

and its status is not changed for free circulation;

"ingredient" in relation to the manufacture or the preparation of a

substance, includes anything which is the sole active ingredient of

the substance as manufactured or prepared;

"investigational medicinal product" means a pharmaceutical

form of an active substance or placebo being tested or used as a

reference in a clinical trial, including products already with a

marketing authorization but used or assembled (formulated or

packaged) in a way different from the authorised form, or when

used for an unauthorised indication, or when used to gain further

information about the authorised form;

"kit" means any preparation to be reconstituted or combined with

radionuclides in the final radiopharmaceutical, usually prior to its

administration;

"labelling" means any information on the immediate or outer

packaging;

"licence" means a licence issued under the provisions of this Act;

"licensee" means any person who is the holder of a licence for a

particular activity granted under this Act;

"magistral formula" means any medicinal product prepared in a

pharmacy in accordance with a medical prescription for an

individual patient;

"manufacture", in relation to a medicinal product, includes any

process carried out in the course of manufacturing the product, but

does not include dissolving or dispersing the product in, or diluting

or mixing it with, some other substance used as a vehicle for the

purpose of administering it;

"medical practitioner" means a person who is authorised to

exercise such profession under the Medical and Kindred

Professions Ordinance or any other law replacing same;

"medicinal prescription" means any medicinal prescription

issued by a professional person qualified to prescribe medicinal

products by or under this Act;

"medicinal product" means any substance or combination of

substances -

(a) presented as having properties for

treating

or

preventing disease in human beings; or

(b) which may be used in or administered to human beings

either with a view to restoring, correcting or

modifying physiological functions by exerting a

pharmacological, immunological or metabolic action,

or to making a medical diagnosis;

"medicinal products derived from human blood or human

plasma" means medicinal products based on blood constituents

which are prepared industrially by public or private establishments,

s uc h m e d ic i na l p r o du c ts i n c l u d in g , i n p a r t i c u l a r, a l bu m i n ,

coagulating factors and immunoglobulins of human origin;

"medicinal purpose" includes any one or more of the following

purposes

(a) the treating or preventing disease;

(b) the diagnosing of disease or ascertaining the existence,

degree or extent of a physiological condition;

(c) contraception;

(d) inducing anaesthesia;

(e) the prevention or interference with the normal

operation of a physiological function, whether

permanently or temporarily, and whether by way of

terminating, reducing or postponing or increasing or

accelerating the operation of that function or in any

other way.

"Medicines Authority" means the Authority established under

article 4;

"Medicines Review Board" means the Board established under

article 14;

"Minister" means the Minister responsible for public health;

"name of the medicinal product" means the name, which may be

either an invented name not liable to confusion with the common

name, or a common or scientific name accompanied by a trade

mark or the name of the marketing authorisation holder;

"officinal formula" means any medicinal product which is

prepared in a pharmacy in accordance with the prescriptions of a

pharmacopoeia and is intended to be supplied directly to the

patients served by such pharmacy;

"outer packaging" means the packaging into which the

immediate packaging is placed;

"package", in relation to any medicinal product, means any box,

packet or other article in which one or more container of the

product are, or are intended to be, enclosed, and, where any such

box, packet or other article is, or is to be itself enclosed in one or

more other boxes, packets or articles, includes any of the said

boxes, packets or articles;

"package leaflet" means a leaflet containing information for the

user which accompanies the medicinal product;

"pharmacist" means a person who is authorised to exercise such

profession under the Medical and Kindred Professions Ordinance,

or any other law replacing the same;

"pharmacy technician" means a person authorised to act as such

under the Medical Kindred and Profession Ordinance or any other

law replacing the same;

"post-authorisation safety study" means any study relating to an

authorised medicinal product conducted with the aim of identifying,

characterising or quantifying a safety hazard, confirming the safety

profile of the medicinal product, or of measuring the effectiveness of

risk management measures;

"prescribed" means prescribed by regulations made by the

Minister under this Act;

"qualified person" means any person who is a qualified person in

relation to a manufacturer’s licence as provided in article 38 (1)(e);

"radionuclide generator" means any system incorporating a fixed

parent radionuclide from which is produced a daughter

radionuclide which is to be obtained by elution or by any other

method and used in a radiopharmaceutical;

"radionuclide precursor" means any radionuclide not being a

radiopharmaceutical, radionuclide generator or kit which is

produced for the radio-labelling of another substance prior to

administration;

"radiopharmaceutical" means any medicinal product which,

when ready for use, contains one or more radionuclides

(radioactive isotopes) included for a medicinal purpose;

"recognised laboratory" means any laboratory recognised as such

by the Licensing Authority for the purposes of this Act;

"recognised pharmacopeia" means a pharmacopeia recognised by

rules for the purpose of this Act;

"responsible person" means any person who is a responsible

person in relation to a wholesale dealer's licence as provided in

article 55(1)(d);

"risk-benefit balance" means an evaluation of the positive

therapeutic effects of the medicinal product in relation to the risks

as defined in paragraph (a) of the definition "risks related to use of

the medicinal product";

"risks related to use of the medicinal product” means -

(a) any risk relating to the quality, safety or efficacy of the

medicinal product as regards patients’ health or public

health;

(b) any risk of undesirable effects on the environment

"rules" means rules made by the Licensing Authority under the

provisions of this Act;

"serious adverse reaction" means an adverse reaction which

results in death, is life-threatening, requires inpatient

hospitalisation or prolongation of existing hospitalisation, results

i n pe rs i s te n t or sig ni fi c a n t di s a b il it y or i nc a pac it y, or i s a

congenital anomaly or birth defect

"strength of the medicinal product" means the content of the

active substances expressed quantitatively per dosage unit, per unit

of volume or weight according to the dosage form;

"substance" means any matter irrespective of origin be it human

(including human blood and human blood products), animal

(including micro-organisms, whole animals, parts of organs, animal

secretions, toxins, extracts, blood products), vegetable (including

micro-organisms, plants, parts of plants, vegetable secretions,

extracts), or chemical (including elements, naturally occurring

chemical materials and chemical products obtained by chemical

change or synthesis);

"Superintendent of Public Health" has the same meaning as is

assigned to it by article 4 of the Department of Health

(Constitution) Ordinance;

"unexpected adverse reaction" means an adverse reaction, the

nature, severity or outcome of which is not consistent with the

summary of product characteristics;

"veterinary surgeon" means a person who is authorised to

exercise such profession under the Veterinary Services Act, or any

other law replacing the same;

"wholesale distribution", in relation to a medicinal product and

active substances, includes any one or all activities consisting of

procuring, holding, supplying or exporting medicinal products and

active substances, apart from supplying medicinal products to the

public.

PART II

ADMINISTRATION

Title I - The Licensing Authority

Laws of Malta — Chapter 458 — MEDICINES ACT

Second Schedule — MEDICINES ACT Open official source

Proceedings of the Medicines Review Board

1. All members of the Medicines Review Board shall be

present for a hearing of an appeal or the development of a second

opinion.

2. All members of the Board shall have a vote and the opinion

of the Board shall reflect the opinion of the majority of members

Provided that a dissenting member may also request that

his opinion be attached to the Board's opinion report as a minority

report.

3. The appellant shall appear before the Board either in

person or through an agent on the day and at the time fixed for the

hearing, make his submissions and produce such evidence as the

Board may allow

Provided that the Board may postpone the hearing of the

appeal if it is satisfied that the appellant was prevented from

appearing before it owing to illness or absence from Malta or other

similar reasonable cause.

4. The Board shall give the Medicines Authority an

opportunity to make its submissions in justification of its opinion/s,

and bring such evidence as the Board may consider necessary.

5. The Board shall have the power to summon witnesses and

to administer the oath to any person appearing before it.

6. The Board shall have power to confirm or issue a different

opinion to that appealed against, as it may deem appropriate.

7. The opinion of the Board shall be final albeit not binding to

the decision of the Licensing Authority and no appeal shall lie

therefrom except on a question of law only.

8. Subject to the foregoing provisions and to the provisions of

this Act, the Board shall regulate its own procedure.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 3 Functions of the Licensing Authority. — MEDICINES ACT Open official source

(1) The Superintendent of Public Health shall be the

Licensing Authority for the purposes of this Act.

(2)

The Licensing Authority shall have the following functions

(a) to establish standards to ensure the quality, safety and

efficacy of medicinal products;

(b) to establish standards for the operation of pharmacies;

(c) to establish standards for the manufacture, preparation,

assembly, packing, packaging or re-packing and

labelling of medicinal products or any substance which

is used or is intended to be used in such products;

(d) to establish standards for the operation of wholesale

distribution;

(e) to establish standards for the testing or analysis of

medicinal products or any substance which is used or

is intended to be used therein;

(f)

to establish standards for the carrying out of clinical

trials;

(g) to establish standards for the reporting of adverse

reactions, serious adverse reactions or suspected

unexpected adverse reactions and make provision for

the collection or submission of related information

from any person or activity regulated by or under this

Act;

(h) to establish standards in relation to the advertising of

medicinal products;

(i)

to advise the Minister in the making of regulations in

respect of the classification of medicinal products;

(j)

to issue, renew, amend, vary, suspend or revoke

marketing authorisations for medicinal products;

(k) to withdraw or recall medicinal products from the

market in the interest of public health; and

(l)

to ensure compliance with international obligations

entered into by the Government of Malta in relation to

any matter regulated by or under this Act;

(m) to issue, renew, amend, vary, suspend or revoke any

authorisation or licence that may be required by or

under this Act;

(n) to carry out inspections of any activity, service or

procedures in relation to medicinal products and to do

all such things as may be necessary for the purpose of

ensuring compliance with any provisions of this Act,

or made thereunder v;

(o) to authorise the advertising

and

promotion

of

medicinal products;

(p) to carry out any other activity as may be prescribed;

(q) to advise the Minister on any matter connected with its

functions or any other provision of this Act.

(3) The Licensing Authority may by rules delegate any of its

functions referred to in subarticle (2)(l), (m), (n) and (o) to the

Medicines Authority.

(4) The Licensing Authority shall levy such fees as may be

prescribed for the purpose of this Act

Provided that such regulations may provide for the waiving

of such fees in such circumstances as may be prescribed.

(5) For the proper exercise of its functions, the Licensing

Authority may establish advisory committees as it may deem

necessary.

Title II - The Medicines Authority

Laws of Malta — Chapter 458 — MEDICINES ACT

Third Schedule — MEDICINES ACT Open official source

(Deleted by Act XI.2007.24)

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 4 Establishment of the Medicines Authority. — MEDICINES ACT Open official source

There shall be established a Medicines Authority, or such

other authority as the Prime Minister may, after consultation with

the Minister and the designated Minister, designate in terms of article

109A.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 5 Legal personality of the Medicines Authority. — MEDICINES ACT Open official source

(1) The Medicines Authority shall be a body corporate

having a separate and distinct legal personality and shall be

capable, subject only to the provisions of this Act, of entering into

any contract, of acquiring, holding and disposing of any kind of

property both movable and immovable, of employing personnel for

the purposes of its operations; and of suing and being sued, and to

which any function or operation of government are or may be

assigned under this or any other law.

(2) The legal and judicial representation of the Medicines

Authority shall vest in the Chief Executive Officer

Provided that the Medicines Authority may appoint one or

more of its officers or employees to appear in its name and on its

b eh a l f i n a n y j u d i c i a l p r o ce e d i n g s o r i n a n y a ct , co n t r a ct ,

instrument or other document whatsoever.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 6 Functions of the Medicines Authority. — MEDICINES ACT Open official source

(1) The Medicines Authority shall have the following

functions

(a) to carry out those such functions as may be delegated

to it by the Licensing Authority in terms of article

3(3);

(b) to assist and advise the Licensing Authority on any

matter relating to the regulation of medicinal products

and related activities;

(c) to undertake such activities and projects as may be

necessary or expedient for the proper exercise of its

functions;

(d) to establish such procedures as may be necessary for

obtaining and assessing information as regards the

safety, quality and efficacy of medicinal products to be

placed on the market in Malta;

(e) to establish such procedures as may be necessary to

make such assessments of medicinal product safety,

quality and efficacy as it may deem necessary for those

products to be placed on the market in Malta;

(f)

to establish such procedures as may be necessary for

monitoring and obtaining reports on the quality, safety

or efficacy of medicinal products;

(g) to make recommendations to the Licensing Authority

in relation to standards and licensing;

(h) to advise the Licensing Authority on the precautions or

restrictions to which medicinal products may be

subjected for their marketing or continued use in

Malta;

(i)

to furnish, whenever it so thinks fit or is so requested

by the Licensing Authority, advice or make

recommendations to the Licensing Authority in

relation to any matter connected with its functions; and

(j)

to notify the EU Commission of non-prescription

medicinal products which in its judgement are at risk of

falsification and may inform the EU Commission of

medicinal products which may be deemed not to be at

risk according to the criteria set out in Article 54a(2b) of

Directive 2001/83/EC as amended.

(2) For the proper exercise of its functions, the Medicines

Authority may require the production of such information or

documents as may be necessary for any of its functions and may

seek expert advice from any person, who is not a member of the

Medicines Review Board, possessing the necessary qualifications

and experience, and may also establish such advisory committees

as it may deem necessary, either for general or specific purposes.

(3) The Medicines Authority shall levy such fees as may be

prescribed for the purposes of this Act

Provided that such regulations may provide for the waiving

of such fees in such exceptional circumstances as may be

prescribed.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 7 Organisation of the Medicines Authority. — MEDICINES ACT Open official source

The Authority shall establish such Directorates as may be

necessary, and shall assign to each such Directorate those functions

which it may deem expedient for the proper exercise of its

functions.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 8 The Chief Executive Officer of the Medicines Authority. — MEDICINES ACT Open official source

(1) The Chief Executive Officer shall be appointed by the

Minister from amongst persons who are suitably qualified and

experienced in the medical, pharmaceutical or medical science

sector.

(2) The Chief Executive Officer shall be responsible for the

overall management and performance of the Authority including

the management of the day-to-day operations of the Authority.

(3) A person shall not be eligible to be appointed or to hold

office as Director or Chief Executive Officer of the Authority if he

(i)

is a member of the House of Representatives; or

(ii)

is a Judge or a Magistrate; or

(iii)

is legally incapacitated; or

(iv)

has been declared bankrupt or has made a

composition or arrangement with his creditors;

or

(v)

has been convicted of fraud or any other offence

against public trust, or has otherwise been

sentenced to a term of imprisonment for a term

not less than three months; or

(vi)

has a financial or other interest whether direct or

indirect, in any enterprise or activity which is

likely to affect the discharge of his functions as a

member of the Authority.

(4) (a) The Chief Executive Officer of the Authority shall

hold office for a period not exceeding five years and

shall be eligible for re-appointment for further periods

each not exceeding five years.

(b) The Chief Executive Officer of the Authority may be

relieved from office by the designated Minister prior to

the expiry of his term of office where, in the opinion of

t h e d e s i g n a t e d M i n i s t e r, h e h a s b e e n g u i l t y o f

misconduct or on the ground of inability to continue to

perform the functions of his office, whether due to

infirmity of mind or of body, or to any other cause, or

of misbehaviour.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 9 Employees of the Medicines Authority. — MEDICINES ACT Open official source

(1) Subject to the provisions of the Constitution and of any

other enactment applicable thereto, and without prejudice to the

other provisions of this Act, the appointment of officers or

employees of the Authority shall be made by the Authority. The

terms and conditions of employment shall be established by the

Authority with the concurrence of the designated Minister, given

after consultation with the Minister responsible for finance.

(2) The Prime Minister may, at the request of the Authority

after it consults with the designated Minister, from time to time and

by direction detail a public officer for duty with the Authority in

such a capacity and for such term and under such conditions as may

be established in relation to the officer so detailed.

(3) The Prime Minister may at any time revoke any such

direction given under subarticle (2).

(4) Where an officer is detailed for duty with the Authority

such officer shall, during the time in which such a direction is in

force, be under the administrative direction and control of the Chief

Executive Officer and shall otherwise remain and retain all rights

and duties as a public officer and for the purposes of any law

relating to government service pension, service with the Authority

shall be deemed to be service with the Government

Provided that no account shall be taken in assessing the

pensionable emoluments of such officer for the purposes of any law

relating to government service pensions of any allowances, bonuses

or gratuities paid to such officer by the Authority in excess to what

he is entitled as a public officer

Provided further that during the time in respect of which he

is so detailed to perform duties with the Authority the terms and

conditions of his service shall not be less favourable than those

which are attached to his appointment under the Government

during the period aforesaid. Such terms and conditions shall not be

deemed to be less favourable merely because they are not in all

respects identical with or superior to those enjoyed by the officer

concerned at the date of such offer, if such terms and conditions,

taken as a whole, in the opinion of the Prime Minister offer

substantially equivalent or greater benefits.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 10 Accounts of the Medicines Authority. — MEDICINES ACT Open official source

(1) The Authority shall keep proper books of account in

such manner as the Minister of Finance may from time to time

direct. Such accounts shall be audited by an auditor appointed for

the purpose by the Authority and shall moreover be subject to audit

by the Auditor General.

(2) The Authority shall, not later than fourteen weeks after the

end of each financial year, present to the designated Minister and

the permanent secretary the audited accounts together with a report

on the workings of the Authority which report shall state the

manner in which the Authority has operated to fulfil its functions

and its plans in the future.

(3) The reports referred to in subarticle (2) shall be laid on the

Table of the House of Representatives by the designated Minister

not later than six weeks after its receipt, or where the House is

during the period not in session not later than the second week after

the House resumes its sittings.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 11 Procurement by the Medicines Authority. — MEDICINES ACT Open official source

Except with the approval of the designated Minister, the

Authority shall not enter into any contract for the supply of goods

or materials or for the execution of work or for the rendering of

services, to or for the benefit of the Authority, which is estimated

by the Authority to involve an expenditure exceeding two hundred

and thirty-two thousand and nine hundred and thirty-seven euro

and thirty-four cents (232,937.34) or such other amount as the

designated Minister may from time to time direct in writing, except

after notice of the intention of the Authority to enter into such

contract has been published and competitive tenders have been

issued.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 12 Applicability of the Code of Ethics. — MEDICINES ACT Open official source

The Chief Executive Officer and all other executive

officers and employees of the Authority shall conform with and

abide by any public service values and Code of Ethics that may be

in force from time to time in relation to public officers.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 13 Exemption from tax, etc. — MEDICINES ACT Open official source

The Authority shall be exempt from any liability for the

payment of any tax on income or duty on documents for the time

being in force in Malta.

Title III - Medicines Review Board

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 14 Establishment of Medicines Review Board. — MEDICINES ACT Open official source

(1) There shall be a Medicines Review Board which shall

be composed of three members and three substitute members

appointed by the Minister, as follows

(a) a person who shall be a legal practitioner having at

least seven years’ legal experience who shall act as the

chairperson; and

(b) two other persons who possess the technical and

scientific qualifications and experience in the field of

regulation of medicinals.

(2) The Minister shall designate a public officer to act as

secretary for the Medicines Review Board.

(3) The members of the Medicines Review Board shall be

appointed by the Minister for a term of three years under such

terms and conditions as may be specified in their appointment.

Members so appointed may be re-appointed on the expiration of

their term of office.

(4) Where any member of the Medicines Review Board is

unable to act, the substitute member having the same qualifications

shall act in his stead.

(5) A person shall not be qualified to hold office as a member

or substitute member of the Medicines Review Board if he

(i)

is a member of the House of Representatives, or

(ii)

is a Judge or a Magistrate; or

(iii)

is legally incapacitated; or

(iv)

has been declared bankrupt or has made a

composition or arrangement with his creditors;

or

(v)

has been convicted of fraud or any other offence

against public trust, or has otherwise been

sentenced to a term of imprisonment for a term

not less than three months; or

(vi)

has a financial or other interest, whether direct

or indirect, in any enterprise or activity which is

likely to affect the discharge of his functions as a

member of the Board.

(6) The provisions of Sub-title II of Title II of Book Third of

the Code of Organization and Civil Procedure shall, mutatis

mutandis, apply to members of the Medicines Review Board who

may be challenged or may abstain from sitting on that Board during

the hearing of an appeal.

(7) A person shall cease to be a member of the Medicines

Review Board at the expiration of his term of office, or if any

circumstances arise that, if he were not a member of the Medicines

Review Board, he would cease to be qualified for such

appointment.

(8) A member of the Medicines Review Board may be removed

from office by the Minister if, in his opinion, such member is no

longer fit to continue in office or has become incapable of properly

performing his duties as a member.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 15 Medicines Review Board may appoint advisors. — MEDICINES ACT Open official source

(1) In the execution of its functions, the Medicines

Review Board may seek the advice of any knowledgeable person

on any matter which is the subject of an appeal being heard.

(2) The Board may also require any government department

and, or authority to provide it with such information or advice it

may deem necessary for the proper exercise of its functions.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 16 Functions of the Medicines Review Board. — MEDICINES ACT Open official source

(1) It shall be the function of the Medicines Review Board to

hear an appeal submitted by the applicant of a marketing authorisation

on any recommendation of the Medicines Authority in relation to the

safety, quality and efficacy of a medicinal product and to provide

advice and make its recommendations to the Licensing Authority in

this regard.

(2) Concurrently with the submission of its recommendations

to the Licensing Authority, the Board shall also submit a copy of

such recommendations to the appellant and to the Medicines

Authority.

(3) Any administrative and financial support required by the

Medicines Review Board for the performance of its functions shall

be provided by the Licensing Authority.

(4) Subject to the foregoing provisions the business of the

Medicines Review Board shall be conducted in accordance with the

rules contained in the Second Schedule and otherwise the Board

may regulate its own procedure.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 17 Procedure of appeal. — MEDICINES ACT Open official source

(1) Where an applicant for a marketing authorisation feels

aggrieved by the findings and recommendations made by the

Medicines Authority to the Licensing Authority, he may, within

fourteen days of the receipt of a copy of such findings and

recommendations, file an appeal with the Medicines Review Board.

(2) The Licensing Authority may, if it deems it necessary,

within fourteen days of the receipt of the findings and

recommendations of the Medicines Authority on the safety, quality

and efficacy of a medicinal product, request the Medicines Review

Board to provide it with a second opinion on the case.

(3) Any appeal or request for review shall be made in writing

and shall be accompanied by the prescribed fee.

(4)

The application for an appeal or request for review shall

clearly and comprehensively state the grounds for the appeal or

review and shall provide all evidence and documentation to sustain

any claim made and which may be necessary to enable the Board to

decide on the case

Provided that the Medicines Review Board may require the

submission of such further information or documentation as it may

deem necessary

Provided further that the Medicines Review Board shall

after obtaining all the relevant information, process the application

within a time limit specified in regulations made under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 18 Public hearing. — MEDICINES ACT Open official source

(1) The Medicines Review Board shall appoint the matter

for public hearing within thirty days of the day of filing of the

appeal or request for review and shall decide the matter as

expeditiously as possible.

(2) The Medicines Review Board will inform the appellant, the

Licensing Authority and the Medicines Authority of its opinion in

writing as soon as is practicable.

PART III

GENERAL PROVISIONS

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 19 Applicability of certain provisions. — MEDICINES ACT Open official source

(1) The provisions of Titles I, II and III shall apply

(a) to medicinal products for human use intended to be

placed on the market in Member States and either

prepared industrially or manufactured by a method

involving an industrial process;

(b) in cases of doubt, where, taking into account all its

characteristics, a product may fall within the definition

of a medicinal product and within the definition of a

product covered by other Community legislation.

(2)

Titles I, II and III of this Act shall not apply to -

(a) any medicinal product prepared in accordance with a

magistral formula;

(b) any medicinal product prepared in accordance with an

officinal formula;

(c) medicinal products intended for research and

development trials, but without prejudice to the

provisions of the Clinical Trials Regulations;

(d) radionuclides in the form of sealed sources;

(e) whole blood, plasma or blood cells of human origin,

except for plasma prepared by a method involving an

industrial process;

(f)

intermediate products intended for further processing

by an authorised manufacturer.

(3)

(a) The Authority may, in accordance with legislation in

force and to fulfil special needs, exclude from the

provisions of this Act medicinal products supplied in

response to a bona fide unsolicited order, formulated

in accordance with the specifications of an authorised

health-care professional and for use by an individual

patient under his direct personal responsibility.

(b) The Authority may temporarily authorise the

distribution of an unauthorised medicinal product in

response to the suspected or confirmed spread of

pathogenic agents, toxins, chemical agents or nuclear

radiation any of which could cause harm

Provided that marketing authorisation holders,

manufacturers and health professionals are not subject

to civil or administrative liability for any

consequences resulting from the use of a medicinal

product otherwise than for the authorised indications

or from the use of an unauthorised medicinal product,

when such use is recommended or required by the

Authority in response to the suspected or confirmed

spread of pathogenic agents, toxins, chemical agents

or nuclear radiation any of which could cause harm.

This shall apply irrespective of whether or not national

or Community authorisation has been granted

Provided further that liability for defective products,

as provided for by Council Directive 85/374/EEC of

25 July, 1985 on the approximation of the laws,

regulations and administrative provisions of the

Member States, concerning liability for defective

products shall not be affected by the preceding

proviso.

Title I - Marketing Authorisation Relating to Medicinal Products

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 20 Authorisation to place medicinal products on the market. — MEDICINES ACT Open official source

(1) No person shall place a medicinal product on the

market in Malta unless he is in possession of a marketing

authorisation from the Licensing Authority, in accordance with the

provisions of this Act or any regulations or rules made thereunder

Provided that the Licensing Authority may, in exceptional

cases, allow the use of a medicinal product without a marketing

authorisation subject to such conditions as it may attach to it

Provided further that a medicinal product that is essentially

identical to a medicinal product for which a marketing

authorisation has already been granted shall only be subject to

conditions as may be determined by the Licensing Authority.

(2) Any application for the grant of a marketing authorisation

shall be made to the Licensing Authority and shall be accompanied

by the prescribed fee.

(3) The application shall contain all the information and

documents necessary for the assessment of the safety, quality and

efficacy of the medicinal product and shall be submitted in such

form and manner as the Licensing Authority may by rules require.

(4) The Licensing Authority shall forward the application

submitted to it to the Medicines Authority as soon as possible.

(5) Where an application for the issue of a marketing

authorisation is received by the Medicines Authority, the Authority

may -

(a) refuse to process the application if such application is

not submitted in accordance with the provisions of this

Act;

(b)

request the applicant to furnish it with such further

information relating to the application as it may

consider necessary; and where any such request has

been made, the Medicines Authority shall not be

required to determine the application until the

information as requested has been submitted to it;

(c) assess the application in respect of medicinal product

safety, quality and efficacy in such a manner and

within such period as may be prescribed by or under

this Act; and

(d) carry out any other activity as may be prescribed by

the Minister from time to time.

(6) The Medicines Authority shall report its findings and make

its recommendations to the Licensing Authority, and shall submit a

copy thereof to the applicant, in such a manner and within such

period as may be prescribed.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 21 Review or appeal. — MEDICINES ACT Open official source

Where the Licensing Authority or the applicant disagree

with the findings or recommendations of the Medicines Authority,

either party may lodge an appeal to the Medicines Review Board in

the manner established under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 22 Granting of marketing authorisation. — MEDICINES ACT Open official source

(1) On receipt of the findings and recommendations of the

Medicines Authority, or following an appeal or a request for a

review by the Medicines Review Board, the Licensing Authority

may refuse or otherwise issue a marketing authorisation either as

recommended by the Medicines Authority or subject to any such

condition or obligation as it may deem necessary.

(2) The decision of the Licensing Authority shall be final and

together with the detailed reasons for such decision shall be

communicated to the Medicines Review Board, the Medicines

Authority and the applicant as necessary.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 23 Notification of marketing authorisation. — MEDICINES ACT Open official source

(1) In granting or refusing a marketing authorisation, the

Licensing Authority shall also inform the Medicines Authority of

such a decision.

(2)

A marketing authorisation shall specify

(a) the summary of product characteristics as approved;

(b) the approved labelling and packaging;

(c) any conditions that may be attached to the granting of

the marketing authorisation;

(d) the classification of the medicinal product;

(e) the term of validity of the marketing authorisation;

(f)

any other specification that the Licensing Authority

may deem necessary.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 24 Validity of market authorisation. — MEDICINES ACT Open official source

(1) Every marketing authorisation granted under this Act,

shall unless previously revoked, expire at the end of its validity.

(2) Every marketing authorisation so granted under this Act

shall unless previously revoked, be renewable upon an application

by the holder made at least three months before the expiry of the

period of validity.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 25 Application of renewal. — MEDICINES ACT Open official source

(1) Where an application for the renewal of a marketing

authorisation under this Act has been duly made, the validity of the

marketing authorisation shall be deemed to continue to have effect

until such time as the Licensing Authority has determined the

application.

(2) Notwithstanding the provisions of any other law, no court

may issue a warrant of prohibitory injunction restraining the

Licensing Authority from determining any such application.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 26 Notification of refusal. — MEDICINES ACT Open official source

The Licensing Authority shall refer an application for

renewal of a marketing authorisation to the Medicines Authority,

and in such case the provisions of article 20(4), (5) and (6) and of

article 21 shall, mutatis mutandis apply.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 27 Refusal to renew marketing authorisation. — MEDICINES ACT Open official source

(1) The Licensing Authority may refuse to grant or renew

the marketing authorisation on the basis of poor quality, safety and

efficacy of the medicinal product or in the interest of public health

or any other reason that would normally be a valid reason for the

suspension, revocation or refusal of a marketing authorisation

Provided that the Licensing Authority shall notify the

Medicines Authority and the applicant of the decision giving

detailed reasons for such decision.

(2)

A renewal of a marketing authorisation shall specify -

(a) the summary of product characteristics as approved;

(b) the approved labelling and packaging;

(c) any conditions that may be attached to the granting of

the marketing authorisation;

(d) the classification of the medicinal product;

(e) the term of validity of the marketing authorisation;

(f)

any other specification that the Licensing Authority

may deem necessary.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 28 Suspension or revocation of marketing authorisation. — MEDICINES ACT Open official source

(1) The Licensing Authority shall suspend, revoke,

withdraw or vary the marketing authorization for a medicinal

product, ensure that the supply of the medicinal product is

prohibited and order its withdrawal from the market if

(a) the medicinal product is harmful; or

(b) it lacks therapeutic efficacy, where such lack of

therapeutic efficacy shall be deemed as occurring

when it is concluded that therapeutic results cannot be

obtained from the medicinal product; or

(c) the risk benefit balance is not favourable; or

(d) its qualitative and quantitative composition is not as

declared; or

(e) the controls on the medicinal product and, or on the

ingredients and the controls at an intermediate stage of

the manufacturing process have not been carried out,

or if the requirement or obligation relating to the grant

of the manufacturing authorisation has not been

fulfilled

Provided that the Licensing Authority may limit the

prohibition to supply the medicinal product, or its withdrawal from

the market, to those batches which are the subject of dispute.

(2) An authorisation shall also be suspended, revoked,

withdrawn or varied where the particulars supporting the

application as provided for in this Act are found to be incorrect or

have been amended without authorisation or when the requisite

controls required by or under this Act have not been carried out.

This provision also applies in cases where the manufacture of the

medicinal product is not carried out in compliance with the particulars

provided pursuant to the description of the manufacturing method

submitted in the application for a marketing authorisation, or where

controls employed by the manufacturer are not carried out in

compliance with the control methods described in the application for a

marketing authorisation.

(3) When the packaging, labelling or the package leaflet of the

medicinal product in question do not comply with the requirements

as specified by or under this Act, the Licensing Authority may

suspend the marketing authorisation by notice served on the holder

of the marketing authorisation concerned and the suspension shall

continue to have effect until the Licensing Authority is satisfied

that the requirements have been fulfilled.

(4) If the Licensing Authority suspends or revokes a marketing

authorisation, it shall notify the holder of the marketing

authorisation and the Medicines Authority of such decision stating

in detail the reasons on which such a decision is based.

(5) The holder of the marketing authorisation may, within

fourteen days of such notification, request the Medicines Review

Board to examine the circumstances leading to the suspension or

the revocation of the marketing authorisation, and the Medicines

Review Board shall make its recommendations on the matter to the

Licensing Authority

Provided that the request shall not suspend the effects of the

decision of the Licensing Authority and that the L icensing

Authority shall not be bound by the recommendations made by the

Medical Review Board.

(6) The Licensing Authority shall suspend or revoke the

marketing authorization for a category of preparations or all

preparations where the provisions of Title II are not complied with.

(7) The provisions of this article and of articles 99 to 104, shall

apply to homeopathic medicinal products.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 29 Classification of medicinal products. — MEDICINES ACT Open official source

(1) When a marketing authorisation is granted or renewed,

the Licensing Authority shall specify the classification of the

medicinal product in accordance with the provisions of this Act,

but in general into

(a) a medicinal product

subject

to

a

medicinal

prescription; or

(b) a medicinal product not subject to a medicinal

prescription, where such medicinal product is

considered that with reasonable safety it can be sold or

supplied by or under the supervision of a pharmacist

unless otherwise provided for by this Act that a

medicinal product under subarticle (1)(b) is classified

under subarticle (1)(a).

(2) The Licensing Authority may by rules determine the type,

content and presentation or otherwise of a prescription and who is

authorised to issue the said prescription that may be needed for a

medicinal product or class of medicinal products.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 30 List of medicinal products having a marketing authorisation. — MEDICINES ACT Open official source

(1) The Licensing Authority shall, at least annually,

publish in the Gazette a list specifying -

(a) the medicinal products that have a valid marketing

authorisation;

(b) the medicinal products which may only be sold by

prescription; and

(c) where applicable, the type of prescription required and

the person or persons authorised to issue the said

prescription.

(2) Whenever a marketing authorisation has been issued in

relation to a medicinal product the Licensing Authority shall

publish in the Gazette the information specified in subarticle (1)(a),

(b) and (c) and such publication shall be deemed to amend the list

of medicinal products issued under subarticle (1).

(3) The Licensing Authority shall publish in the Gazette, as

soon as is practical, the list of medicinal products for which the

marketing authorisation has been suspended or revoked and such

publication shall be deemed to amend the list of medicinal products

issued under subarticle (1).

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 31 Advertising of medicinal products. — MEDICINES ACT Open official source

A medicinal product may only be advertised in accordance

with such conditions as may be established by or under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 31A Marketing authorisation holders to abide by standards. — MEDICINES ACT Open official source

Marketing authorisation holders shall abide by the

standards on pharmacovigilance, marketing authorisations as well

as labelling and packaging as may be established by or under this

Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 32 Homeopathic medicinal products. — MEDICINES ACT Open official source

(1) Without prejudice to article 28, homeopathic

medicinal products which satisfy the conditions in paragraphs (a)

to (c) shall be subject to special simplified procedures as provided

in subarticle (2) to (4). The products to which this subarticle

applies are products which -

(a) are administered orally and externally, subject to such

regulations as may be made by the Minister in respect

thereof;

(b) have no specific therapeutic indication appearing on

the labelling of the medicinal product or in any

information relating thereto; and

(c) have a sufficient degree of dilution to guarantee the

safety of the medicinal product, in particular, the

medicinal product may not contain either more than

one part per 10,000 of the mother tincture or more than

1/100 th of the smallest dose used in allopathy with

regard to active principles whose presence in an

allopathic medicinal product results in the obligation

to submit a medicinal prescription.

(2) The criteria and rules applicable to the granting of a

marketing authorization shall also apply to the special simplified

procedure with the exception of the proof of therapeutic efficacy.

(3) Any application for the registration of a homeopathic

medicinal product shall contain such documents and information as

may be prescribed by regulations made under this Act and such

application may cover a series of medicinal products derived from

the same homeopathic stock or stocks.

(4) Homeopathic medicinal products which do not satisfy the

conditions prescribed in subarticle (1) shall be authorized and

labelled in accordance with the provisions of this Act applicable to

medicinal products, and shall also be subject to the requirements of

pharmacovigilance as established by regulations under this Act.

(5) The Minister may by regulations under this Act prescribe

rules for the toxicological and pharmacological tests and clinical

trials of homeophathic medicinal products.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 33 Products derived from human blood or human plasma. — MEDICINES ACT Open official source

The provisions of this Part shall apply to medicinal

products based on blood constituents which are prepared

industrially by a private or a public establishment but shall not

apply to blood, plasma or blood cells of human origin.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 34 Radio- pharmaceutical medicinal product. — MEDICINES ACT Open official source

The marketing authorisation referred to in article 20 shall

be required for generators, kits, precursor radiopharmaceuticals and

industrially prepared radiopharmaceuticals other than

radiopharmaceuticals prepared at the time of use by a person or by

an establishment authorised, under this Act, to use such medicinal

products in an approved health care establishment exclusively from

authorised generators, kits or precursor radiopharmaceuticals in

accordance with the manufacturer’s instructions.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 35 Immunological medicinal products. — MEDICINES ACT Open official source

(1) The provisions of this

Part

shall

apply

to

immunological medicinal products.

(2) The Licensing Authority may prescribe rules regulating the

issue or otherwise of a marketing authorisation for immunological

medicinal products.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 36 Herbal medicinal products. — MEDICINES ACT Open official source

The Licensing Authority may prescribe rules regulating the

issue or otherwise of a marketing authorisation for herbal medicinal

products.

Title II - Manufacture of Medicinal Products for Human Use

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 37 Manufacturer’s licence. — MEDICINES ACT Open official source

Without prejudice to any exemption that may be granted

under this Act, no person shall import from countries which are

outside the European Union or European Economic Area,

manufacture, assemble or in any way modify any medicinal product

except in accordance with a manufacturer ’s licence issued in

accordance with the provisions of this Act or any regulations or

rules made thereunder

Provided that such a licence shall not be required for the

preparation, division, changes in packaging or presentation where

these processes are carried out for the purpose of dispensing or

administering as provided under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 38 Application for manufacturer’s licence. — MEDICINES ACT Open official source

(1) Any application for the grant of a licence to

manufacture, assemble or modify a medicinal product shall be

made to the Licensing Authority and shall contain such

information, documents, samples and other material as provided by

or under this Act

Provided that such application shall indicate the following

(a) the name of the medicinal product and pharmaceutical

form or forms, which is to be manufactured, assembled

or in any way modified;

(b) the place where such activity is to take place, and such

information and documentation as may be required in

order to show that such place is suitable and sufficient

for that purpose;

(c) the equipment and control facilities as may be required

by or under this Act;

(d) the name and address of the applicant;

(e) the name of at least one qualified person who shall be

professionally responsible for the activity, such person

having such qualifications as may be prescribed

Provided that when more than one qualified person

is nominated, the application will clearly delineate the

specific responsibilities of each person;

(f)

any other information, documentation or evidence as

may be requested by the Licensing Authority in

accordance with or under this Act.

(2) The Licensing Authority shall determine the application in

the period of time as may be established under this Act

Provided that such time may be suspended until the relevant

information is provided.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 39 Granting of manufacturer’s licence. — MEDICINES ACT Open official source

(1) The Licensing Authority shall, before determining an

application, inspect the premises indicated in the application and

shall not issue a licence until it is satisfied that such premises

conform with the requirements established by or under this Act

Provided that a licence may be made conditional to the

carrying out of such obligations as may be imposed therein.

(2) The manufacturer's licence shall specify the premises and

the medicinal products and pharmaceutical form or forms to which

it applies.

(3) The licence holder shall ensure that the activity is carried

out in accordance to the provisions of this Act and any regulations

made thereunder.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 40 Notice for further information. — MEDICINES ACT Open official source

Where the Licensing Authority considers that

circumstances may exist which would render necessary the

consideration of whether the licence should be varied, suspended or

revoked, the Licensing Authority may serve on the holder of a

manufacturer's licence a notice requiring him, within such time as

may be specified in the notice, to furnish it with any information

specified in the notice.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 41 Suspension or revocation of manufacturer’s licence. — MEDICINES ACT Open official source

(1) The

Licensing

Authority

may

suspend

a

manufacturer’s licence for such period as it may determine, or may

revoke, or vary the provisions of, any such licence.

(2) The powers vested in subarticle (1) shall only be

exercisable in any of the following circumstances, where

(a) the matters stated in the application on which the

licence was granted were false or incomplete in a

material particular;

(b) a material change of circumstances has occurred in

relation to any of those matters;

(c) any of the conditions of the licence has been

contravened;

(d) the requirements in relation to the licences as

established by or under this Act have not been

complied with;

(e)

the processes of manufacture or assembly of a

medicinal product are carried out in a manner that is

not in compliance with the provisions of the marketing

authorisation of that medicinal product;

(f)

the conditions for good manufacturing practice are not

being complied with; and

(g) in any other circumstance as is established by or under

this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 42 Inspection in relation to manufacturers, etc. — MEDICINES ACT Open official source

(1) The Licensing Authority shall carry out regular

inspections to ensure that the requirements established by or under

this Act in relation to the manufacture, assembly or modification of

a medicinal product are complied with.

(2) The Licensing Authority or any person carrying out an

inspection shall

(a) inspect the manufacturing establishment and any other

location he may deem necessary;

(b) examine any relevant documents;

(c) take any samples he may deem necessary;

(d) draw up a report of the findings and communicate the

contents of such report to the licensee or the applicant

for a licence in relation to such inspection and to the

qualified person;

(e) carry out any other activity he may deem appropriate

for the proper execution of his duties and

responsibilities as provided for by or under this Act.

(3) Except in urgent cases an inspection shall be carried out in

the presence of a qualified person or his representative, if any.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 43 Duration and renewal of manufacturer's licence. — MEDICINES ACT Open official source

(1) Subject to the provisions of this Act, every licence

granted under this Part shall, unless previously renewed or revoked,

continue to be valid until such time as it is renewed by the

Licensing Authority following an inspection.

(2) The Licensing Authority shall establish the period of

validity of any licence issued under this Part.

(3) Following the inspection mentioned in sub-article (1), the

Licensing Authority

(a) may renew the licence, with or without modifications,

for such a further period as specified; or

(b) if, having regard to the provisions of this Act, it

considers it necessary or expedient to do so, may

refuse to renew the licence.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 44 Responsibilities of manufacturer’s licence holder. — MEDICINES ACT Open official source

It shall be the duty of the holder of a manufacturer's

licence -

(a) to immediately inform the Licensing Authority of any

change of the qualified person;

(b) to provide authorised officers access to his premises at

any reasonable time;

(c) to enable the qualified person to carry out his duties

established by or under this Act;

(d) to maintain such records for any transaction in

medicinal products as may be established by or under

this Act and have such records available for inspection

by any authorised officer for such period of time as

may be required by or under this Act;

(e) to have at his disposal the services of staff to satisfy

the requirements specified by or under this Act in

relation to the manufacture, assembly or modification

of medicinal products;

(f)

to apply in writing to the Licensing Authority of any

change proposed or modification required in relation

to the licence;

(g) to comply with the regulations or Orders relating to

good practice in manufacture as may be established by

or under this Act or under any other Act;

(h) to dispose of medicinal products as established by or

under this Act or under any other Act;

(i)

other responsibilities as may be established from time

to time by or under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 45 Responsibilities of the qualified person. — MEDICINES ACT Open official source

(1) The responsibilities of a qualified person shall be

(a) to ensure that standards of good practice

in

manufacturing are complied with at all times;

(b) to ensure that each batch of medicinal products has

been manufactured, tested and complies in all respects

with any requirement established by or under this Act;

and

(c) to ensure that each batch of medicinal products has

been manufactured in accordance with the

requirements of the marketing authorisation.

(2) The qualified person shall be permanently and continuously

at the disposal of the holder of the manufacturer’s licence

Provided that the qualified persons may nominate another

person similarly qualified to act as his representative.

(3) When the qualified person has nominated a representative

as aforesaid he shall immediately inform the Licensing Authority

of such nomination.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 46 Suspension of activity of a qualified person. — MEDICINES ACT Open official source

The Licensing Authority, may if it has reasonable suspicion

to believe that any qualified person is acting in contravention of

any of the provisions of this Act, suspend the activity of such

qualified person by notice in writing specifying the reasons for

such suspension until such person has complied with any

requirement of the Licensing Authority to remedy the non-

compliance.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 47 Change in conditions of manufacturer’s licence. — MEDICINES ACT Open official source

The Licensing Authority may upon an application made by

the holder of licence in request thereof, vary the conditions of the

licence if it is satisfied that such variation will not adversely affect

standards of good practice in manufacture as may be prescribed.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 48 Obligations of Licensing Authority. — MEDICINES ACT Open official source

The Licensing Authority may vary, suspend, revoke or

refuse to renew a manufacturer's licence, or it may refer the matter

to the Medicines Authority, and in such case the provisions of

article 20(4), (5) and (6) and of article 21 shall, mutatis mutandis

apply.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 49 Manufacture of homeopathic medicinal products. — MEDICINES ACT Open official source

The provisions of articles 37 to 48 shall apply to the

manufacture and assembly of homeopathic medicinal products.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 50 Manufacture of medicinal products derived from human blood and human plasma, etc. — MEDICINES ACT Open official source

Without prejudice to article 33, the provisions of articles

37 to 48 and any regulations made thereunder shall apply to the

manufacture and assembly of medicinal products derived from

human blood and human plasma.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 51 Manufacture of radio- pharmaceuticals. — MEDICINES ACT Open official source

Without prejudice to article 34, the provisions of articles

37 to 48 and any regulations made thereunder shall apply to the

manufacture and assembly of radiopharmaceutical medicinal

products.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 52 Immunological medicinal product. — MEDICINES ACT Open official source

Without prejudice to article 35, the provisions of articles

37 to 48 and any regulations made thereunder shall apply to the

manufacture and assembly of immunological medicinal products.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 53 Herbal medicinal products. — MEDICINES ACT Open official source

Without prejudice to article 36, the provisions of articles

37 to 48 and any regulations made thereunder shall apply to the

manufacture and assembly of herbal medicinal products.

Title III - Wholesale Distribution and Brokering of Medicinal

Products for Human Use

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 54 Wholesale dealing. — MEDICINES ACT Open official source

(1) Without prejudice to any exemptions that may be

granted by or under this Act, no person shall engage in the

wholesale distribution of any medicinal product unless he is the

holder of a wholesale dealer's licence issued in accordance with the

provisions of this Act. and unless the medicinal product has been

granted a marketing authorisation by the Licensing Authority.

(2) The wholesale distribution of a medicinal product by way

of wholesale dealing shall only be carried out from the place

specified in, and in accordance with the conditions of, the licence.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 54A Brokering. — MEDICINES ACT Open official source

(1) Persons may only broker medicinal products if they

a r e e s t a bl i s h e d i n M a l t a w it h a p e r m a ne nt a d d r e s s a n d a r e

registered with the Licensing Authority. Those persons shall

submit, at least, their name, corporate name and permanent address

in order to register. They shall notify the Licensing Authority of

any changes thereof without unnecessary delay. Persons brokering

medicinal products who have commenced their activity on the date

of coming into force of this Act * shall register with the Licensing

Authority by the 2 March, 2013.

(2) The Licensing Authority shall enter the information

referred to in sub-article (1) in a register that shall be publicly

accessible.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 55 Application for a wholesale dealer’s licence. — MEDICINES ACT Open official source

(1) Any application for the grant of a wholesaler's licence

shall be made to the Licensing Authority and shall contain such

information, documents, and other material as provided by or under

*the reference is to Act V of 2013 which came into force on 1st October, 2013 - see

Legal Notice 289 of 2013.

this Act

Provided that such application shall indicate the following

(a) the name and address of the applicant;

(b) the address of the premises that are to be used for the

purpose of wholesale distribution;

(c) the equipment and control facilities as may be required

by or under this Act;

(d) information, documentation or evidence to prove that

the premises is suitable and adequate, and that there

are suitable facilities, installations and equipment so

as to ensure proper conservation and distribution of

medicinal products;

(e) the name of at least one responsible or qualified person

who shall be professionally responsible for the

activity, such person having such qualifications as may

be prescribed

Provided that when more than one qualified or

responsible person is nominated, the application will

clearly delineate the specific responsibilities of each

person;

(f) any other information, documentation or evidence as

may be requested by the Licensing Authority in

accordance with or under this Act.

(2) The Licensing Authority shall determine the application in

the period of time as may be established under this Act

Provided that such time may be suspended until the relevant

information is provided.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 56 Granting of a wholesale dealer’s licence. — MEDICINES ACT Open official source

(1) The Licensing Authority shall, before determining an

application, inspect the premises indicated in the application and

shall not issue a licence until it is satisfied that such premises

conform with the requirements established by or under this Act

Provided that a licence may be made conditional to the

carrying out of such obligations as may be imposed therein.

(2) The wholesale dealer’s licence shall specify the premises

and the activities to which it applies.

(3) The licence holder shall ensure that the activity is carried

out in accordance to the provisions of this Act and any regulations

made thereunder.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 57 Notice for further information. — MEDICINES ACT Open official source

Where the Licensing Authority considers that

circumstances may exist which would render necessary the

consideration of whether the licence should be varied, suspended or

revoked, the Licensing Authority may serve on the holder of a

wholesale dealer’s licence a notice requiring him, within such time

as may be specified in the notice, to furnish it with any information

specified in the notice.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 58 Duration and renewal of wholesale dealer’s licence. — MEDICINES ACT Open official source

(1) Subject to the provisions of this Act, every licence

granted under this Part shall, unless previously renewed or revoked,

continue to be valid until such time as it is renewed by the

Licensing Authority following an inspection.

(2) The Licensing Authority shall establish the period of

validity of any licence issued under this Part.

(3) Following the inspection mentioned in sub-article (1), the

Licensing Authority

(a) may renew the licence, with or without modifications,

for such a further period as specified; or

(b) if, having regard to the provisions of this Act, it considers

it necessary or expedient to do so, may refuse to renew

the licence.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 59 Obligations of holder of wholesale dealer’s licence. — MEDICINES ACT Open official source

It shall be the duty of the holder of a wholesale dealer's

licence -

(a) to immediately inform the Licensing Authority of any

change of the qualified or responsible person;

(b) to provide authorised officers access to his premises at

any reasonable time;

(c) to enable the Licensing Authority to carry out its

duties established by or under this Act;

(d) to maintain such records for any transaction in

medicinal products as may be established by or under

this Act and have such records available for inspection

by any authorised officer for such period of time as

may be required by or under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 60 Responsibilities of the responsible person. — MEDICINES ACT Open official source

(1) The responsible person shall ensure that standards of

good practice in wholesale distribution as may be prescribed are

complied with at all times.

(2) The qualified person or responsible person shall be

permanently and continuously at the disposal of the holder of the

wholesale dealer’s licence

Provided that the qualified or responsible person may

nominate another person to act as his representative.

(3) When the qualified or responsible person has nominated a

representative as aforesaid he shall immediately inform the

Licensing Authority of such nomination.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 60A Suspension of responsible person. — MEDICINES ACT Open official source

The Licensing Authority may, if it has reasonable suspicion

to believe that any responsible person is acting in contravention of

any of the provisions of this Act, suspend the activity of such

responsible person by notice in writing specifying the reasons for

such suspension until such person has complied with any

requirement of the Licensing Authority to remedy the non-

compliance.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 61 Suspension or revocation of wholesale dealer’s licence. — MEDICINES ACT Open official source

The Licensing Authority may suspend a wholesale dealers'

licence granted under this Act for such period as it may determine,

or may revoke, or vary the provisions of, any such licence in any of

the following cases

(a) where the matters stated in the application on which

the licence was issued were false or incomplete in a

material particular;

(b) where a material change of circumstances has occurred

in relation to any of those matters;

(c) where any of the conditions of the licence has been

contravened;

(d) where the requirements in relation to the licence as

established by or under this Act have not been

complied with;

(e) where conditions of good practice in wholesale

distribution are not being complied with; and

(f)

in any other circumstance as may be established by or

under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 62 Change in conditions of a wholesale dealer’s licence. — MEDICINES ACT Open official source

The Licensing Authority may, upon an application made by

the holder of a licence in respect thereof, vary the conditions of the

licence, if it is satisfied that such variation will not adversely affect

the standards of good practice in wholesale distribution.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 63 Obligations of Licensing Authority. — MEDICINES ACT Open official source

The Licensing Authority may vary, suspend, revoke or

refuse to renew a wholesale dealer’s licence, or it may refer the

matter to the Medicines Authority, and in such case the provisions

of article 20(4), (5) and (6) and of article 21 shall, mutatis mutandis

apply.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 64 Inspecting in relation to wholesale. — MEDICINES ACT Open official source

(1) The Licensing Authority shall ensure that the

requirements established by or under this Act in relation to the

wholesale dealing of a medicinal product are complied with.

(2)

The Licensing Authority shall

(a) inspect the wholesale dealing establishment and any

other location it may deem necessary;

(b) examine any documents relating to the inspection;

(c) take any samples it may deem necessary;

(d) draw up a report of the findings, which shall be

communicated to the licensee or the applicant for a

licence in relation to such inspection and to the

responsible person;

(e) carry out any other activity it may deem appropriate

for the proper execution of its duties and

responsibilities as provided for by or under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 65 Special provisions. — MEDICINES ACT Open official source

Without prejudice to the provisions of this Part, the

Licensing Authority may by rules establish additional requirements

for the wholesale distribution of

(a) narcotic or psychotropic substances;

(b) medicinal products derived from blood;

(c) immunological medicinal products;

(d) radiopharmaceuticals;

(e) such other medicinal products or class or classes of

medicinal products as the Minister may prescribe.

Title IV - Pharmacies and Related Pharmaceutical Activity

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 66 Licence to open a pharmacy. — MEDICINES ACT Open official source

(1) It shall not be lawful for any person to open or keep a

pharmacy unless he is in possession of a pharmacy licence issued in

accordance with the provisions of this Act or any regulations made

thereunder.

(2) Licences are to be issued in accordance with geo-

demographic criteria as may be established by regulations made

under this Act.

(3) Regulations under this article shall not be made unless the

Minister shall have first published a draft thereof in the

Government Gazette allowing any person a period of at least four

weeks to make representations to the Minister.

(4) The Minister shall request the Licensing Authority to report

on any representation made to him after hearing such person or

taking such expert advice as it considers expedient, together with

any views it may have and the Minister may, upon receipt of the

report by the Licensing Authority proceed to revise the draft

regulations and to promulgate such regulations in accordance with

such revision.

(5) Without prejudice to any exemption that may be granted by

or under this Act, no person shall sell by retail any medicinal

product expect in accordance with a pharmacy licence issued in

accordance with the provisions of this Act or any regulations or

rules made thereunder.

(6) The licensee shall be responsible for complying with the

conditions of the licence as may be established by or under this

Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 67 Application for a pharmacy licence. — MEDICINES ACT Open official source

(1) Any application for the grant of a pharmacy licence

shall be made to the Licensing Authority and shall contain such

information, documents, samples and other material as provided by

or under this Act

Provided that such application shall indicate the following

(a) the name and address of the applicant;

(b) the address of the premises that are to be used for the

purpose of the retail sale of the medicinal products;

(c) the equipment and control facilities as may be required

by or under this Act;

(d) the name of a managing pharmacist who shall be

professionally responsible for all activities;

(e) any other information, documentation or evidence as

may be requested by the Licensing Authority in

accordance with or under this Act.

(2) The Licensing Authority shall determine the application in

the period of time as may be established under this Act

Provided that such time may be suspended until the relevant

information is provided.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 68 Grant of a pharmacy licence. — MEDICINES ACT Open official source

(1) The Licensing Authority shall, before determining an

application, inspect the premises indicated in the application and

shall not issue a licence until it is satisfied that such premises are

suitable and adequate, and that there are suitable facilities,

installations, and equipment so as to ensure proper conservation

and dispensing of medicinal products

Provided that a licence may be made conditional to the

carrying out of such obligations as may be imposed therein.

(2) The pharmacy licence shall specify the premises and the

activities to which it applies

Provided that the Licensing Authority may, upon

application, grant an additional licence for the use of identified

premises to be used as a store for the purpose of the pharmacy after

it is satisfied that such premises comply with any requirements

established by or under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 69 Notice for further information. — MEDICINES ACT Open official source

Where the Licensing Authority considers that

circumstances may exist which would render necessary the

consideration of whether the licence should be varied, suspended or

revoked, the Licensing Authority may serve on the holder of a

pharmacy licence a notice requiring him, within such time as may

be specified in the notice, to furnish it with any information

specified in the notice.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 70 Duration and renewal of pharmacy licence. — MEDICINES ACT Open official source

(1) Subject to the provisions of this Act, every licence

granted under this Part shall, unless previously renewed or revoked,

continue to be valid until such time as it is renewed by the

Licensing Authority following an inspection.

(2) The Licensing Authority shall establish the period of

validity of any licence issued under this Part.

(3) Following the inspection mentioned in sub-article (1), the

Licensing Authority

(a) may renew the licence, with or without modifications,

for such a further period as specified; or

(b) if, having regard to the provisions of this Act, it considers

it necessary or expedient to do so, may refuse to renew

the licence.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 71 Transfer of a pharmacy licence. — MEDICINES ACT Open official source

No person may transfer a licence unless authorised by the

Licensing Authority which authorisation shall not be issued unless

the Licensing Authority is satisfied that the new licensee complies

with any requirement established by or under this Act, and on

payment of the prescribed fee.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 72 Suspension or revocation of pharmacy licence. — MEDICINES ACT Open official source

The Licensing Authority may suspend a pharmacy licence

granted under this Act for such period as it may determine or may

revoke, or vary the provisions of any such licence in any of the

following circumstances

(a) where any matter stated in the application on which

the licence was issued is false or incomplete

(b) where a material change of circumstances has occurred

in relation to any of those matters;

(c) where the provisions of the licence have been

contravened by the licensee; or

(d) in any other circumstance as may be established by or

under this Act

Provided that the Licensing Authority shall notify the

licensee of the decision giving detailed reasons for such decision.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 73 Temporary closure of pharmacy. — MEDICINES ACT Open official source

(1) The licensee of a pharmacy shall not close a pharmacy,

temporarily or otherwise, unless he has given at least twenty-four

hours notice to, and such closure has been authorised by, the

Licensing Authority

Provided that the temporary closure shall not be construed

to include the closure of a pharmacy resulting from the unforeseen

or unexpected absence of a pharmacist, force majeure resulting in

the inability to open the premises, or closure outside the business

hours established for pharmacies by rules made the Licensing

Authority.

(2) Subject to the provisions of subarticle (1), the licence in

relation to a pharmacy which has remained closed for a period of

five consecutive working days without the authorisation of the

Licensing Authority shall be deemed to have been automatically

revoked.

(3) The Licensing Authority may, on receipt of a notice as is

referred to in subarticle (1), or where it has come to its knowledge

that a pharmacy has been closed, seal all the medicinal products,

wherever kept by the licensee in terms of the provisions of this Act,

and take charge of any register required to be kept by the licensee

under this or any other law.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 74 Obligations of the holder of a pharmacy licence. — MEDICINES ACT Open official source

It shall be the duty of the holder of a pharmacy licence -

(a) to inform the Licensing Authority of any change of the

managing pharmacist, prior to such change;

(b) to provide authorised officers access to his premises at

any reasonable time;

(c) to enable the Licensing Authority to carry out its

duties established by or under this Act;

(d) to maintain such records for any transaction in

medicinal products as may be established by or under

this Act and have such records available for inspection

by any authorised officer for such period of time as

may be required by or under this Act;

MEDICINES

(e) to comply with regulations or Orders relating to good

practice in retail sale of medicinal products as may be

established by or under this Act;

(f)

to dispose of medicinal products as established by or

under this Act or any other law;

(g) ensure that a pharmacist is present at all times during the

time when the pharmacy is open;

(h) other responsibilities as may be established from time

to time by or under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 75 Managing pharmacist. — MEDICINES ACT Open official source

(1) Every pharmacy shall be managed by a pharmacist

hereinafter referred to as the "managing pharmacist".

(2)

The managing pharmacist shall

(a) act as the managing pharmacist of a licensed pharmacy

including any other premises used as a store by the

said pharmacy in terms of article 68(2);

(b) ensure that he or another pharmacist is present in the

pharmacy at all times in order to sell or supervise the sale

of medicinal products and to keep records of the

pharmacist who was present while the pharmacy was

open;

(c) keep any documents, information or evidence in the

manner as may be required to be kept by or under this

Act;

(d) carry out such obligations pertaining to a managing

pharmacist as may be established by or under this Act;

(e) nominate a substitute managing pharmacist when he

cannot carry out his duties for a period of five or more

consecutive days and shall notify the Licensing

Authority of this substitution

Provided that in exceptional cases the licensee may

nominate a replacement and notify the Licensing

Authority;

(f)

comply with regulations or rules relating to good

practice in the dispensing of medicinal products as

may be established by or under this Act;

(g) dispose of medicinal products as established by or

under this Act or any other law.

(3) No pharmacist may, without the authority in writing of the

Licensing Authority, act as a managing pharmacist of two or more

pharmacies

Provided that the Licensing Authority shall not give such

authority unless it is satisfied that such pharmacist can reasonably

carry out the duties of a managing pharmacist for more than one

pharmacy.

(4) No pharmacist shall take up or abandon his duties as a

managing pharmacist of any pharmacy without giving prior notice

in writing to that effect to the Licensing Authority.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 75A Suspension of managing pharmacist. — MEDICINES ACT Open official source

The Licensing Authority may, if it has reasonable

suspicion to believe that any managing pharmacist is acting in

contravention of any of the provisions of this Act, suspend the

a c t iv i t y o f s u c h m a na g i ng p h a r m a c is t by n o t i c e i n w r i t i ng

specifying the reasons for such suspension until such person has

complied with any requirement of the Licensing Authority to

remedy the non-compliance.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 76 Duties of pharmacist. — MEDICINES ACT Open official source

(1) Unless otherwise provided by or under this Act, a

medicinal product shall only be prepared or dispensed from a

pharmacy and by a pharmasist

Provided that a pharmacist may permit medicinal products

to be prepared or dispensed by a pharmacy technician under his

personal supervision as regulated by or under this Act.

(2) In carrying out his functions in the preparation and

dispensing of medicinal products from a pharmacy, a pharmacist

shall act in accordance with such standards as may be established

by or under this Act or any other Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 77 Interest in a pharmacy. — MEDICINES ACT Open official source

The conditions and criteria where any person can have or

not have a direct or indirect interest in a pharmacy shall be

prescribed under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 78 Licensee may employ one or more pharmacists. — MEDICINES ACT Open official source

The licensee shall employ a pharmacist to carry out the

responsibilities of a managing pharmacist and shall provide all the

support and in no way interfere with the managing pharmacist’s or

a pharmacist's professional responsibilities in the performance of

his duties as defined in by or under this Act or under any other law.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 79 Medicinal products to be sold from a pharmacy. — MEDICINES ACT Open official source

(1) A pharmacy shall only dispense in medicinal products

and trade in products or groups or classes of products that may

from time to time be established by rules made by the Licensing

Authority.

(2) Unless otherwise provided by or under this Act, a medicinal

product shall only be sold from a pharmacy

Provided that the Licensing Authority may, in special

circumstances relating to the provision of services to the public, by

rules prescribe that a medicinal product or class or classes of

medicinal products therein specified may be sold from a premises

other than a pharmacy such premises not being a general retail

outlet

Provided further that the Licensing Authority may with

same circumstances by rules prescribe that a medicinal product of

class or classes of medicinal products therein specified may be

sold, prepared or provided to a patient by a person, other than a

pharmacist, who is suitably qualified for such purpose

Provided also that such rules shall provide for the

circumstances under which such a sale, preparation or provision

may occur and impose such restrictions as may be provided.

(3) The Licensing Authority may by rules establish a list of

medicinal products that as a minimum must be available at a

pharmacy at all times

Provided that this requirement may be temporarily waived

in relation to a particular medicinal product or class of medicinal

product in exceptional circumstances, if the Licensing Authority is

satisfied that the unavailability of such a medicinal product or class

of medicinal product from a pharmacy is beyond the control of the

managing pharmacist.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 80 Dispensing of a medicinal product. — MEDICINES ACT Open official source

(1) A pharmacist shall prepare or dispense any medicinal

product required by any person presenting a prescription unless he

has a justified reason of concern that the prescription is false, that

the person is misusing the prescribed medicinal product, or that the

medicinal product is not available or if he has professional reasons

for not preparing or dispensing the prescription.

(2) Upon presentation of a prescription for a medicinal product,

unless the prescriber specifically requests a particular branded

product by writing "branded" or "®" on the prescription, a

pharmacist can dispense the medicinal product prescribed or an

equivalent medicinal product having the same chemical entity,

dose, dosage form and dosage frequency as the medicinal product

indicated on the prescription.

(3) When, in dispensing any medicinal product, a pharmacist

discovers that there are reasons why the medicinal product should

not be dispensed to the patient or that the dosage regimen indicated

on the prescription goes beyond what can be considered a safe

therapeutic dose, the pharmacist is bound to draw the attention

thereto of the person prescribing the same and may require such

person to write out in ink or in other indelible manner on the

prescription a statement assuming responsibility for the

prescription.

(4) The pharmacist shall assume full responsibility for the

dispensing of medicinal products which do not need a prescription

for dispensing to patients.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 81 Dispensing against prescription. — MEDICINES ACT Open official source

(1) It shall not be lawful for any pharmacist to dispense

any medicinal product except on the prescription of a medical or

dental practitioner, veterinary surgeon or other person authorized to

prescribe under this or any other Act, unless the medicinal product

is deemed not to require a medicinal prescription by the Licensing

Authority.

(2) The provisions of subarticle (1) shall also apply to products

or substances not classified as medicinal products but which have

been deemed to require a medicinal prescription for their use by the

relevant competent authority.

(3) It shall be lawful for a pharmacist to dispense any medicinal

product on the prescription of a medical practitioner, dentist or

veterinary surgeon from an EU member state provided that the

pharmacist can ascertain that such medical practitioner, dentist or

veterinary surgeon is licensed to practice his profession in the member

state of origin.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 82 Presentation of a prescription. — MEDICINES ACT Open official source

The Licensing Authority may by rules prescribe the format,

content and presentation of a prescription required by or under this

Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 83 Labelling of dispensed products. — MEDICINES ACT Open official source

The pharmacist shall label each medicinal product or

magistral formula or officinal formula dispensed in accordance

with such regulations or rules made under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 84 Disposal of expired, deteriorated or imperfect products. — MEDICINES ACT Open official source

It shall not be lawful for any managing pharmacist to sell,

allow the sale, dispensing or supply in any other way of -

(a) any imperfect, deteriorated or harmful substance;

(b) any medicinal product bearing an expiry date which

has expired;

(c) food not in accordance with the provisions of the Food

Safety Act, or any regulations made thereunder

Provided that such imperfect, deteriorated or expired

substances or medicinal products shall only be kept in such place

and in such a manner as the Licensing Authority may from time to

time by rules establish.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 85 Storage of medicinal products in pharmacy. — MEDICINES ACT Open official source

(1) It shall not be lawful for any managing pharmacist to

keep anywhere within the pharmacy any medicinal product in any

container or under such conditions which are not suitable to the

nature thereof and which are not such as to protect it from

alteration, deterioration or contamination.

(2) It shall not be lawful for any managing pharmacist to permit

any medicinal product under his charge to be kept or stored outside

the pharmacy under his management, and it shall be his duty to

ensure that the pharmacy has the facilities to ensure that medicinal

products are stored in accordance with storage recommendations

Provided that in the case where the Licensing Authority has

granted a licence for the keeping or storage of medicinal products

in any premises other than the pharmacy, the responsibilities of the

managing pharmacist shall also apply to such premises.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 86 Premises, etc., in accordance with requirements and standards. — MEDICINES ACT Open official source

Premises, facilities, records and equipment used for the

storage, preparation and dispensing of medicinal products are to be

kept in accordance with the requirements and standards established

by or under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 87 Pharmacist to be guided by set standards. — MEDICINES ACT Open official source

The preparation of magistral and officinal formulas, and

the division of authorised packs into smaller units, reconstitution,

dispensing and administration of medicinal products and any other

activity related to medicinal products and their use shall be in

accordance with such standards as may be established under this

Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 88 Inspections of pharmacies. — MEDICINES ACT Open official source

(1) The Licensing Authority shall have the right to inspect

pharmacies and any premises licensed for use as stores under

article 68(2) whenever it deems necessary.

(2) Any inspection as aforesaid shall be carried out in the

presence of the managing pharmacist or of the pharmacist for the

time being in charge of the pharmacy.

(3)

At the time of the inspection, the inspecting officer shall

draw up a list of deficiencies that may have been identified at the

time of the inspection and shall sign this list, and such list shall be

countersigned by the managing pharmacist or by the pharmacist for

the time being in charge of the pharmacy

Provided that the inspecting officer shall draw up a report

of the inspection within seven working days of the inspection and

shall forward a copy of such report to the Licensing Authority, the

licensee and the managing pharmacist

Provided also that the managing pharmacist or pharmacist

for the time being in charge of the pharmacy may make comments

or otherwise make reservations in respect of the contents of the said

list.

(4)

(a) If in the course of the inspection, any article is found to

be in breach of the provisions of this Act or any

regulation made thereunder, the inspecting officer shall

forthwith seize the said article.

(b) The wrapper or receptacle containing the article so

seized shall be sealed and the signature of the

inspecting officer and the managing pharmacist shall

be appended to the seal

Provided that if the managing pharmacist so

requests, the article in question shall be divided, by the

inspecting officer, in two equal parts, sealed and signed

in the manner as aforesaid, and one part be given to the

managing pharmacist

Provided further that the inspecting officer shall

send the seized article, sealed and signed in the manner

aforesaid to the Licensing Authority together with the

inspection report as described in subarticle (3).

(5) If the managing pharmacist or the pharmacist for the time

being in charge of the pharmacy refuses to countersign the list

referred to in subarticle (3), the inspecting officer shall record such

fact on the said list together with the reason given, if any, for such

refusal.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 89 Opening of pharmacies. — MEDICINES ACT Open official source

The Licensing Authority may by notice in the Gazette

establish the business hours of pharmacies and may also require

pharmacies in specified localities or districts to open for the

serving of customers on such days and for such times as may be

specified in such notice.

PART IV

POISONOUS SUBSTANCES

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 90 Definition of poisons. — MEDICINES ACT Open official source

For the purposes of the provisions contained in this Part,

"poison" means -

(a) all those substances which, taken even in a very small

dose, may cause the death or serious injury to any

person,

(b) all those substances which the Minister may, on the

advice of the Licensing Authority, prescribe,

but does not include any similar substance which is used, or is

intended to be used, for day to day domestic purposes, which latter

substance, however shall be deemed to be a poison for the purpose

of article 94.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 91 Keeping, etc., of poisons. — MEDICINES ACT Open official source

It shall not be lawful for any person to keep for sale,

manufacture, sell or otherwise distribute or deal in any poison

without a licence from the Licensing Authority.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 92 Licence for sale of poisons. — MEDICINES ACT Open official source

(1) The licence mentioned in article 91 shall only be

granted to manufacturers of, and dealers in chemical products,

colorists and such other persons as require to make use of poisons

in the exercise of their trade or profession.

(2) Such licence shall show the name and surname of the

licensee, his trade or profession, and the place in which he intends

to carry on such trade or profession and any other information as

may be established from time to time by rules made by the

Licensing Authority.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 93 Keeping of poisonous substances in a safe place. — MEDICINES ACT Open official source

Every person granted a licence under article 91 shall keep

all poisonous substances in a separate and safe place the key

whereof shall be always kept by the licence holder.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 94 Sale of poisonous substances. — MEDICINES ACT Open official source

(1) No person granted a licence under article 91 shall sell

or deliver any poisonous substance, either by wholesale or retail, to

any person not being a pharmacist, except on production of a

prescription or for purposes of disinfection or industry or for any

other purpose as may be authorised by the Licensing Authority.

(2) Every person granted a licence under article 91 shall keep,

maintain, update, store and make available to the Licensing

Authority or any authorised person any information as may from

time to time be required by the Licensing Authority and in any such

manner as may be form time to time be required by the Licensing

Authority.

(3) Poisonous substances shall be labelled in such a manner the

Licensing Authority may from time to time by rules establish.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 95 Power of inspection. — MEDICINES ACT Open official source

The Licensing Authority or any authorised officer, may in

the interest of public health, pay surprise visits to the business

premises of manufacturers of and dealers in chemical products and

of the other persons referred to in article 91.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 96 Poisoned grain, seed etc., — MEDICINES ACT Open official source

Without prejudice to the provisions of the Pesticides

Control Act, it is prohibited to sow, cast, put or place, or cause to

be sown, cast, put or placed in or upon any land or other exposed

place any grain, seed, meal, or flesh which has been so dipped or

steeped in poison, or has been so mixed with poison or other

ingredient or preparation as to be rendered poisonous and

calculated to destroy life.

PART V

OTHER DEALINGS WITH MEDICINAL PRODUCTS

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 97 Special restrictions on persons to be supplied with medicinal products. — MEDICINES ACT Open official source

The Licensing Authority may by rules provide, either in

respect of medicinal products generally or in respect of medicinal

products of a description or falling within a class specified in the

rules that, subject to such exceptions as may be so specified, no

person -

(a) being the holder of a marketing authorisation, or

(b) in the course of business carried by him and

consisting, in whole or in part, of manufacturing

medicinal products or of selling medicinal products by

way of wholesale dealing,

shall sell or supply any medicinal product to which the rules apply

to any person who does not fall within a class specified in those

rules.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 98 Adulteration of medicinal products. — MEDICINES ACT Open official source

No person shall -

(a) add any substance to, or abstract any substance from, a

medicinal product so as to affect injuriously the

composition of the product, with the intent that the

product shall be sold or supplied in that state; or

(b) knowingly or unknowingly sell or supply, or offer or

expose for sale or supply, or have in his possession for

the purpose of sale or supply

(i)

any medicinal product whose composition has

been injuriously affected by the addition or

abstraction of any substance;

(ii)

any medicinal product which is deliberately and

fraudulently mislabeled with respect to identity

and, or source including products with the correct

ingredients, with the wrong ingredients, without

active ingredients, in an insufficient quantity or

excessive quantity of active ingredients or with

fake packaging.

PART VI

OFFENCES AND PENALTIES

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 99 Offences and penalties. — MEDICINES ACT Open official source

(1) Without prejudice to any other liability under any

o t h e r l a w, a ny p e r s on w h o f a il s t o co m p l y w i t h a n y o f t he

provisions of this Act or any regulations or rules made thereunder

shall be guilty of an offence and shall, on conviction, be liable, in

the case of an offence against

(a) the provisions of articles 20(1), 37, 54, 54A, 98 and

104A, to a fine (multa) of not less than eleven

thousand and six hundred and forty-six euro and eighty

seven cents (11,646.87) and not exceeding one

hundred and sixteen thousand and four hundred and

sixty-eight euro and sixty-seven cents (116,468.67) or

to imprisonment for a term not exceeding two years, or

both such fine and imprisonment;

(b) the provisions of articles 31A, 44 and 56(3), to a fine

(multa) of not less than five thousand eight hundred

and twenty-three euro and seventy-five cents

(5,823.75) and not exceeding sixty-nine thousand and

eight hundred and eighty-one euro and twenty cents

(69,881.20) or to imprisonment for a term not

exceeding six months, or both such fine and

imprisonment;

(c) the provisions of articles 32(4), 45, 66(1), 66(5),

66(6), 66A, 71, 75(3), 75(4), 76(1), 81(1) and 91, to a

fine (multa) of not less than two thousand and three

hundred and twenty-nine euro and thirty-eight cents

(2,329.38) and not exceeding forty-six thousand and

five hundred and eighty-seven euro and forty-seven

cents (46,587.47) or to imprisonment for a term not

exceeding three months, or to both such fine and

imprisonment;

(d) the provisions of articles 59, 60, 74, 75(1), 75(2), 84,

93, 94(1) and 96, to a fine (multa) of not less than one

thousand and one hundred and sixty-four euro and

sixty-nine cents (1,164.69) and not exceeding twenty-

three thousand and two hundred and ninety-three euro

and seventy-three cents (23,293.73);

(e) the provisions of articles 78, 83, 85(1), 85(2), 86, 87

and 94(2), to a fine (multa) of not less than four

hundred and sixty-five euro and eighty-seven cents

(465.87) and not exceeding eleven thousand and six

hundred and forty-six euro and eighty-seven cents

(11,646.87);

(f)

the provisions of articles 31, 73(1), 79(1), 79(2),

80(1), 80(2) and 94(3), to a fine (multa) of not less

than two hundred and thirty-two euro and ninety-four

cents (232.94) and not exceeding two thousand and

three hundred and twenty-nine euro and thirty-seven

cents (2,329.37).

(2) Without prejudice to the powers of the Licensing Authority

under this Act, where any person who has committed an offence is the

holder of a licence or an authorisation under this Act, the Court shall,

at the request of the prosecution, order the revocation or suspension of

the aforesaid licence or authorisation.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 100 Special procedure. — MEDICINES ACT Open official source

(1) Notwithstanding any other law providing for the trial

of offences, where the Licensing Authority believes that a person

has committed an offence against this Act or any regulations or

rules made thereunder, the Authority shall give notice in writing to

such person describing the offence of which the person is accused,

indicating the steps to be taken to remedy the offence and the

penalty which he is required to pay in respect of that offence.

(2) The provisions of sub-article (1) shall not apply in offences

where there is a breach of articles 20(1), 37, 44, 54, 56(3), 98 and

Liġijiet ta' Malta — Kapitolu 458 — ATT DWAR IL-MEDIĊINI

Art. 101 Dritt ta’ dħul. Emendat: XI. 2007.18. — ATT DWAR IL-MEDIĊINI Open official source

(1) Bla ħsara għad-dispożizzjonijiet ta’ dan l-artikolu, u

mingħajr preġudizzju għad-dispożizzjonijiet l-oħra ta’ dan l-Att,

persuna li tkun awtorizzata bil-miktub kif imiss mill-Awtorità dwar

il-Liċenzjar għandu jkollha dritt, meta turi l-awtorizzazzjoni jew il-

k r e d e n z j a l i t a g ħ h a , f ’ k u l l ħ i n r a ġ o n e v o l i t i d ħ o l u t a għ m e l

spezzjonijiet ripetuti u mhux mgħarrfin f’xi fond

(a) bil-għan li taċċerta ruħha jekk ikunx hemm jew kienx

hemm, jew x’aktarx li jkun hemm xi ksur ta’ xi

dispożizzjoni ta’ dan l-Att jew ta’ xi regolamenti jew

regoli magħmulin taħtu;

(b) ġeneralment għall-finijiet tal-eżerċizzju mill-Awtorità

dwar il-Liċenzjar tal-funzjonijiet tagħha taħt dan l-Att

jew taħt regolamenti jew regoli magħmulin taħtu.

Għall-fini ta’ din it-Taqsima, fond jiftiehem bħala li

jinkludi bini, struttura, xi post ieħor li jkun jew kwalunkwe mezz

ta’ trasport.

(2) Uffiċjal awtorizzat ikollu d-dritt, meta juri l-

awtorizzazzjoni tiegħu, f ’kull ħin raġonevoli jitla’ abbord kull

bastiment jew inġenju tal-ajru għall-fini li jaċċerta ruħu jekk ikunx

hemm f ’xi bastiment jew inġenju tal-ajru xi sustanza jew oġġett

importat bi ksur ta’ xi dispożizzjoni ta’ dan l-Att jew ta’ xi

regolamenti jew regoli magħmulin taħtu jew jekk l-imsemmi

inġenju jkunx qed iwettaq xi attività bi ksur ta’ xi waħda mill-

imsemmija dispożizzjonijiet.

Liġijiet ta' Malta — Kapitolu 458 — ATT DWAR IL-MEDIĊINI

Art. 101A — ATT DWAR IL-MEDIĊINI Open official source

(1) L-Awtorità dwar il-Liċenzjar għandha, b’koperazzjoni

mal-Aġenzija tal-Mediċini Ewropea, tiżgura li jitħarsu l-ħtiġiet

legali li jirregolaw prodotti mediċinali, permezz ta’ spezzjonijiet,

jekk ikun hekk meħtieġ li ma jitħabbrux minn qabel, u, fejn ikun

adatt, billi jintalab xi Laboratorju ta’ Kontroll tal-Mediċini

Uffiċjali jew laboratorju li jagħmel dak ix-xogħol biex jagħmel

testijiet fuq kampjuni. Din il-koperazzjoni tkun tikkonsisti fil-qsim

ta’ informazzjoni mal-Aġenzija tal-Mediċini Ewropea kemm dwar

spezzjonijiet li jkunu ġew ippjanati u li jkun saru kemm fil-

kordinazzjoni ta’ spezzjonijiet f’pajjiżi terzi.

(2) L-ispezzjonijiet għandhom jinkludu imma ma jkunux

limitati għal dawk imsemmija fil-paragrafi (a) u (b) kif ġejjin

(a) manufatturi, li jkunu jinsabu fl-Unjoni Ewropea jew

f’pajjiżi terzi, u distributuri bl-ingrossa ta’ prodotti

mediċinali jkunu soġġetti għal spezzjonijiet ripetuti;

(b) l-Awtorità dwar il-Liċenzjar għandu jkollha sistema ta’

superviżjoni inkluż permezz ta’ spezzjonijiet li jsiru bi

frekwenza adatta bbażata fuq ir-riskju, fil-fond tal-

manufatturi, importaturi, jew distributuri ta’ sustanzi

attivi, li jkunu jinsabu f’territorju Malti, u l-

prosegwiment effettiv tagħhom.

(3) Kull meta tqis li jkun hemm għaliex jiġi suspettat li jkun

hemm nuqqas ta’ konformità mal-ħtiġiet legali stipulati f’dan l-Att

u fil-leġislazzjoni sussidjarja magħmula taħtu, inklużi prinċipji u

linji gwida tal-Unjoni Ewropea dwar il-prattiċi tajba ta’ manifattura

u distribuzzjoni, l-Awtorità dwar il-Liċenzjar tista’ twettaq dawk l-

ispezzjonijiet fil-fond

(a) ta’ manufatturi jew distributuri ta’ sustanzi attivi li

jkunu jinsabu f’pajjiżi terzi;

(b) ta’ manufatturi jew importaturi ta’ eċċipjenti.

(4) Jistgħu jsiru wkoll spezzjonijiet imsemmija fis-subartikoli

(2) u (3) fl-Unjoni Ewropea u f ’pajjiżi terzi fuq talba ta’ Stat

Membru tal-Unjoni Ewropea, tal-Kummissjoni tal-Unjoni Ewropea

jew tal-Aġenzija tal-Mediċini Ewropea.

(5) L-ispezzjonijiet jistgħu jsiru wkoll fil-fond ta’ detenturi ta’

awtorizzazzjoni għat-tqegħid fis-suq u ta’ sensara ta’ prodotti

mediċinali.

(6) L-ispezzjonijiet għandhom isiru minn uffiċjali li

jirrappreżentaw lill-Awtorità dwar il-Liċenzjar li jkollhom is-

setgħa li jispezzjonaw kull fond, records, dokumenti u master file

tas-sistema ta’ farmakoviġilanza tad-detentur ta’ awtorizzazzjoni

għat-tqegħid fis-suq jew ta’ ditti mqabbda mid-detentur ta’

awtorizzazzjoni għat-tqegħid fis-suq biex iwettqu attivitajiet ta’

farmakoviġilanza.

(7) L-ispezzjonijiet għandhom isiru kif hemm fil-linji gwida u

fid-dispożizzjonijiet imsemmija fl-artikoli 101 sa 104.

(8) Wara kull spezzjoni, l-Awtorità dwar il-Liċenzjar għandha

tirrapporta dwar jekk entità spezzjonata tkunx tikkonforma mal-

prinċipji tal-Unjoni Ewropea u mal-linji gwida tal-prattiċi tajba ta’

manifattura u distribuzzjoni li jkunu japplikaw, jew dwar jekk id-

detentur ta’ awtorizzazzjoni għat-tqegħid fis-suq ikunx konformi

mal-ħtiġiet ta’ farmakoviġilanza stipulati f ’dan l-Att u fil-

leġislazzjoni sussidjarja magħmula taħtu.

(9) L-Awtorità dwar il-Liċenzjar għandha twassal il-kontenut

ta’ dawk ir-rapporti lill-entità spezzjonata. Qabel ma tadotta r-

rapport, l-Awtorità dwar il-Liċenzjar għandha tagħti lill-entità

spezzjonata involuta l-opportunità li tippreżenta l-kummenti

tagħha.

(10) Mingħajr preġudizzju għal kull arranġament li seta’ sar

bejn l-Unjoni Ewropea u pajjiżi terzi, Stat Membru, il-

Kummissjoni tal-Unjoni Ewropea jew l-Aġenzija tal-Mediċini

Ewropea tista’ titlob lil manufattur stabbilit f ’pajjiż terz

jippreżenta spezzjoni kif imsemmija f’dan l-artikolu.

(11) Fi żmien disgħin jum minn spezzjoni kif imsemmija fis-

subartikolu (1), ċertifikat dwar prattiċi tajba ta’ manifattura jew

distribuzzjoni għandhom, meta dawn ikunu japplikaw, jinħarġu lill-

entità spezzjonata jekk l-eżitu tal-ispezzjoni jkun juri li

jikkonforma mal-prinċipji u l-linji gwida ta’ prattiċi tajba ta’

manifattura jew distribuzzjoni kif previst fil-liġijiet tal-Unjoni

Ewropea.

(12) Jekk isiru spezzjonijiet bħala parti mill-proċedura ta’

ċertifikazzjoni għall-monografi tal-farmakopoeia Ewropea, għandu

jintgħamel ċertifikat.

(13) Iċ-ċertifikati ta’ prattiċi tajba ta’ manifattura u

distribuzzjoni li jinħarġu għandhom jiddaħħlu fid-database tal-

Unjoni Ewropea kif maniġġata mill-Aġenzija tal-Mediċini Ewropea

f ’isem l-Unjoni Ewropea. L-informazzjoni dwar ir-reġistrazzjoni

ta’ importaturi, manufatturi u distributuri ta’ sustanzi attivi

għandha wkoll tiddaħħal f’dik id-database.

MEDIĊINI

Liġijiet ta' Malta — Kapitolu 458 — ATT DWAR IL-MEDIĊINI

Art. 102 — ATT DWAR IL-MEDIĊINI Open official source

(1) Bil-għan li jiġi aċċertat jekk ikunx hemm jew kienx

hemm jew x’aktarx ikun hemm ksur ta’ dan l-Att jew ta’

regolamenti jew regoli magħmulin taħtu, uffiċjal awtorizzat ikollu

d-dritt jispezzjona

(a) kull sustanza jew oġġetti li jidhrulu li jkunu prodott

mediċinali;

(b) kull oġġett li jintuża jew ikun maħsub li jintuża biex

jitqiegħed fih xi prodott mediċinali jew bħala tikketta

jew fuljett li jintuża jew ikun maħsub li jintuża f’dak li

għandu x’jaqsam ma’ xi prodott mediċinali; jew

(ċ) kull impjant jew tagħmir li jidhrulu li jintużaw jew

ikunu maħsuba li jintużaw f’dak li għandu x’jaqsam

mal-manifattura jew l-assemblaġġ ta’ prodotti

mediċinali, u kull proċess ta’ manifattura jew

assemblaġġ ta’ prodotti mediċinali u l-mezzi li

jintużaw għaldaqshekk, f’kull stadju tal-proċess ta’

manifattura jew assemblaġġ, għal ittestjar ta’ kull

materjal wara li jkunu għaddew minn dawk il-proċessi;

(d) kull fond, record, dokument u master file tas-sistema ta’

farmakoviġilanza tad-detentur ta’ awtorizzazzjoni għat-

tqegħid fis-suq jew ta’ ditti mqabbda mid-detentur ta’

awtorizzazzjoni għat-tqegħid fis-suq biex iwettqu

attivitajiet ta’ farmakoviġilanza kif stabbiliti taħt l-

artikolu 31A

Iżda uffiċjal awtorizzat jista’ wkoll jagħmel spezzjonijiet

ta’ manufatturi ta’ materjal tal-bidu wara li ssir talba speċifika għal

dawk il-finijiet minn dak il-manufattur innifsu

Iżda wkoll il-kampjun li jista’ jittieħed jista’ jiġi analizzat

f’laboratorju msemmi identifikat mill-Awtorità.

(2) Uffiċjal awtorizzat jista’, għal kull fini speċifikata fis-

subartikolu preċedenti, jieħu kampjun, inkluż bil-għan li jsiru provi

indipendenti f ’Laboratorju ta’ Kontroll tal-Mediċini Uffiċjali jew

f’laboratorju li jagħmel dak ix-xogħol għal xi Stat Membru tal-Unjoni

Ewropea

(a) ta’ sustanzi jew prodotti mediċinali mibjugħin jew

fornuti jew maħsuba biex jinbiegħu jew jiġu fornuti;

jew

(b) ta’ sustanzi jew oġġetti użati jew maħsuba biex

jintużaw fil-manifattura ta’ xi prodott mediċinali.

(3) Għall-finijiet tas-subartikolu (1) ta’ dan l-artikolu, persuna

awtorizzata jkollha l-jedd

(a) li tispezzjona kull għamla ta’ record, f’liema stat ikun,

li jkollhom x’jaqsmu mal-manifattura, l-assemblaġġ,

il-bejgħ jew il-forniment ta’ xi prodott mediċinali u,

meta tali records ikunu miżmuma f’għamla

elettronika

(i)

jista’ jkollha aċċess għal, u tispezzjona u

tivverifika l-operazzjoni ta’ xi computer, xi

apparat assoċjat jew materjal li jkun jew li kien

qed jintuża f’dak li għandu x’jaqsam mar-

records; u

(ii) tista’ titlob lil kull persuna li tkun responsabbli

minn, jew li xort’oħra jkollha x’taqsam mat-

tħaddim tal-computer, apparat jew materjal, li

tagħtih kull tali assistenza li hija tista’

raġonevolment titlob;

(b) li tagħmel kopji ta’ kull dħul fi ktieb jew dokument

miġjuba konformement mal-paragrafu preċedenti u

meta r-records ikunu miżmuma elettronikament,

permezz ta’ computer jew xort’oħra, teħtieġ li r-

records jinġiebu f’għamla intelliġibbli li tista’ tiġi

trasportata;

(ċ) li tiġbed fotografiji ta’ kull tagħmir, fond, record u

dokument.

(4) Uffiċjal awtorizzat ikollu d-dritt jeleva, jwarrab u jżomm

għandu kull sustanza jew oġġett li jkollu tassew għaliex jaħseb li

jkunu sustanzi jew oġġetti li dwarhom, jew permezz tagħhom, ikun

qed isir jew kien qed isir reat taħt dan l-Att, u kull dokument li

dwaru jkollu tassew għaliex jaħseb li jkun dokument li jista’

jenħtieġ li jinġieb bi prova fi proċedimenti taħt dan l-Att.

(5) Bil-għan li jeżerċita l-jedd mogħti lilu taħt subartikolu (4),

kull persuna awtorizzata tista’, sakemm ikun raġonevolment

meħtieġ biex ikun hemm konformità mad-dispożizzjonijiet ta’ dan

l-Att u ta’ regolamenti jew regoli magħmulin taħtu, teħtieġ lil xi

persuna tiftaħ billi tikser xi kontenitur, pakkett jew makna, jew li

tħalliha tagħmel dan

Iżda meta persuna televa xi sustanza jew oġġett, inkluż xi

dokument, għall-finijiet speċifikati fis-subartikolu (4), hija

għandha tinforma lill-persuna mingħand min dawn ikunu ġew

elevati u tagħtiha riċevuta dwarhom.

(6) Mingħajr preġudizzju għad-dispożizzjonijiet preċedenti ta’

dan l-artikolu, persuna awtorizzata għandu jkollha l-istess drittijiet

bħal dawk mogħtija b’dawk id-dispożizzjonijiet għar-rigward ta’

oġġetti li jappartjenu lil, jew xi kummerċ ġestit minn, applikant

għal awtorizzazzjoni jew ċertifikat taħt it-Taqsima III ta’ dan l-Att,

u tista’ teżerċita dawk id-drittijiet għall-fini li tivverifika kull

dikjarazzjoni jew informazzjoni li jkun hemm fl-applikazzjoni

għall-awtorizzazzjoni jew iċ-ċertifikat; u, meta bis-saħħa tad-

dispożizzjonijiet ta’ dan is-subartikolu persuna teżerċita xi dritt

bħal dak speċifikat fis-subartikolu (4), dan għandu jkun bla ħsara

għad-dmir impost bis-subartikolu (5).

(7) Minkejja kull ħaġa li tinsab fid-dispożizzjonijiet preċedenti

ta’ dan l-artikolu, meta persuna li tippretendi li tkun qed teżerċita

xi dritt bis-saħħa tal-dispożizzjonijiet ta’ dan l-artikolu tenħtieġ

iġġib xi awtorizzazzjoni jew kredenzjali li jkollha, dak il-jedd jista’

biss jiġi eżerċitat minnha wara li turi dik l-awtorizzazzjoni jew

dawk il-kredenzjali li jkollha.

(8) Wara kull ispezzjoni l-uffiċjal awtorizzat għandu

jirrapporta dwar jekk il-manufattur ikunx qiegħed jikkonforma

ruħu mal-prinċipji u linji direttivi ta’ prattika ta’ manufattura kif

imiss jew, fejn ikun adatt, mal-ħtiġiet li jkollhom x’jaqsmu mal-

farmakoviġilanza. Il-kontenut ta’ dawk ir-rapporti għandhom

jitwasslu lill-manufattur jew lid-detentur tal-awtorizzazzjoni għat-

tqegħid fis-suq li tkun saritlu l-ispezzjoni.

(9) Fi żmien disgħin jum minn ispezzjoni, għandu jinħareġ lil

manufattur ċertifikat ta’ prattika ta’ manufattura kif imiss jekk l-

eżitu tal-ispezzjoni juri li l-manufattur jkun qiegħed jikkonforma

ruħu mal-prinċipji u mal-linji direttivi ta’ prattika ta’ manufattura

kif imiss kif provdut dwar dan bil-leġislazzjoni li tkun qiegħda

sseħħ f’dak il-waqt.

Liġijiet ta' Malta — Kapitolu 458 — ATT DWAR IL-MEDIĊINI

Art. 103 — ATT DWAR IL-MEDIĊINI Open official source

(1) Id-dispożizzjonijiet ta’ dan l-artikolu għandhom

jgħoddu meta uffiċjal awtorizzat jeleva xi sustanza jew oġġett, ħlief

għal dokument, fl-eżerċizzju ta’ dritt bħal dak speċifikat fl-artikolu

102(4) u (6).

(2) Jekk persuna li, skont l-artikolu 102(5) jkollha jedd tiġi

informata bil-qbid ta’ oġġett hekk titlob, kemm fil-waqt tal-qbid

kemm f’xi waqt ieħor li jiġi wara, u li ma jkunx jaħbat aktar tard

minn wieħed u għoxrin ġurnata wara li tkun ġiet informata bil-qbid,

għaldaqstant u bla ħsara għal dawn id-dispożizzjonijiet li ġejjin ta’

dan l-artikolu, l-uffiċjal awtorizzat għandu jew

(a) iwarrab kampjun tas-sustanza jew tal-oġġett elevat;

jew

(b) jittratta dik is-sustanza jew dak l-oġġett bħala

kampjun,

skont liema iqis l-aktar adatt meta titqies ix-xorta ta’ dik is-

sustanza jew ta’ dak l-oġġett.

(3) Uffiċjal awtorizzat ma jkunx meħtieġ bis-saħħa tas-

subartikolu (2) iwarrab kampjun, jew jittratta sustanza jew oġġett

bħala kampjun, jekk ix-xorta tas-sustanza jew tal-oġġett tkun tali li

ma jkunx raġonevolment prattikkabbli li taġixxi b’dak il-mod.

(4) Meta skont is-subartikolu (2) uffiċjal awtorizzat iwarrab

kampjun, jew jittratta sustanza jew oġġett bħala kampjun, huwa

għandu jaqsmu fi tliet partijiet, hekk li kull parti tiġi mmarkata u

siġillata jew marbuta b’dak il-mod li x-xorta tagħha tkun

tippermetti, u għandu jagħti parti waħda minnhom lill-persuna li

tkun għamlet it-talba taħt is-subartikolu (2).

(5)

(a) Meta jkun ġie elevat xi prodott mediċinali taħt id-

dispożizzjonijiet ta’ dan l-Att u sid il-prodott jagħti l-

kunsens tiegħu bil-miktub għall-qirda ta’ dak il-prodott

mediċinali, l-Awtorità dwar il-Liċenzjar tista’, wara li

tieħu dawk il-kampjuni li tista’ tkun teħtieġ biex

t i n ġ i e b p r o v a t a r- r e a t , t o r d n a l i d a k i l - p r o d o t t

mediċinali jiġi meqrud mingħajr preġudizzju għal kull

proċediment li jista’ jsir kontra l-persuna responsabbli

għar-reat, u l-imsemmija Awtorità dwar il-Liċenzjar

għandha tirrimborsa l-ispejjeż kollha li jkunu saru fil-

qirda tal-prodott mediċinali.

(b) F’dawk il-każijiet fejn is-sid jonqos milli jagħti l-

kunsens tiegħu għall-qirda tal-prodott mediċinali, l-

Awtorità dwar il-Liċenzjar tista’ wara li tippreżenta

rikors fejn titlob lill-Qorti tordna l-qirda bi spejjeż tas-

sid, tgħaddi biex twettaq dik il-qirda.

Liġijiet ta' Malta — Kapitolu 458 — ATT DWAR IL-MEDIĊINI

Art. 104 Dispożizzjonijiet supplimentari dwar id-dritt ta’ dħul. — ATT DWAR IL-MEDIĊINI Open official source

(1) Persuna li tidħol f’xi proprjetà jew f’xi fond,

bastiment, inġenju tal-ajru, posta jew post ieħor skont id-

dispożizzjonijiet tal-artikolu 101, tista’ tkun akkompanjata minn

kull persuna oħra jew tieħu magħha dak it-tagħmir li jista’ jidhrilha

li jkun meħtieġ; u meta titlaq minn hemmhekk għandha, jekk il-

proprjetà ma tkunx okkupata jew jekk l-okkupant jew kull persuna

oħra li tkun qegħda tieħu ħsieb il-bastiment, l-inġenju tal-ajru, il-

posta jew post ieħor tkun temporanjament assenti, tħalli hemmhekk

magħluq fiż-żgur kif kien.

(2) L-uffiċjal awtorizzat għandu wkoll ikollu kull tali poter

ieħor li jistgħu jiġu preskritti b’regolamenti magħmulin mill-

Ministru għall-eżekuzzjoni tal-funzjonijiet tiegħu kif imiss.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 104A — MEDICINES ACT Open official source

(3) The Minister shall prescribe the penalties that may be

demanded by the Licensing Authority in relation to any specified

offence

Provided that such penalty shall not exceed an amount of

twenty-three thousand and two hundred and ninety-three euro and

seventy-three cents (23,293.73).

(4) Where a notice under this article has been given, the person

named in the notice may, within twenty-one days of the service of

the notice, accept responsibility for the offence specified in the

notice and within the same period pay the penalty indicated in the

notice, and comply with the relative provision of this Act, or of the

regulations or rules made thereunder and no further proceedings

may be taken under this Act in respect of such offence.

(5) Where the person to whom notice is given under subarticle

(1) has not paid the penalty within the twenty-one day period

referred to in subarticle (3) and has not, within the time specified,

complied with the requirements of this Act, criminal proceedings

may be taken against him in accordance with the provisions of the

Criminal Code, of this Act and of any other law applicable of the

offence.

PART VII

ENFORCEMENT

101. (1) Subject to the provisions of this article, and without

prejudice to the other provisions of this Act, any person duly

a u th o r i s e d i n w r i t i n g b y th e L i c e ns in g A ut h o r i ty s h a ll , o n

production of his authorisation or credentials, have a right at any

reasonable time to enter and carry out repeated and unannounced

inspections at any premises

(a) for the purpose of ascertaining whether there is or has

been, or there is likely to be any contravention of any

provisions of this Act or of any regulations or rules

made thereunder;

(b) generally for the purposes of the exercise by the

Licensing Authority of its function under this Act or

under any regulations or rules made thereunder.

For the purposes of this Part, premises shall include any

building, structure, any other place whatsoever or any means of

transport.

(2) Any authorised officer shall, on the production of his

authorisation, have a right at any reasonable time to board any ship

or aircraft for the purpose of ascertaining whether there is in the

ship or aircraft any substance or article imported in contravention

of any provisions of this Act or of any regulations or rules made

thereunder or whether the said craft is carrying out any activity in

contravention to any of the said provisions.

101A. (1) The Licensing Authority shall, in cooperation with

the European Medicines Agency, ensure that the legal requirements

governing medicinal products are complied with, by means of

inspections, if necessary unannounced, and, where appropriate, by

asking an Official Medicines Control Laboratory or a laboratory

designated for that purpose to carry out tests on samples. This

cooperation shall consist in sharing information with the European

Medicines Agency on both inspections that are planned and that

have been conducted as well as in the coordination of inspections in

third countries.

(2) The inspections shall include but not be limited to the ones

mentioned in paragraphs (a) and (b) as follows

(a) manufacturers, located in the European Union or in

third countries, and wholesale distributors of

medicinal products shall be subject to repeated

inspections;

(b) the Licensing Authority shall have a system of

supervision including by inspections at an appropriate

frequency based on risk, at the premises of the

manufacturers, importers, or distributors of active

substances, located in Maltese territory, and effective

follow-up thereof.

(3) Whenever it considers that there are grounds for suspecting

non-compliance with the legal requirements laid down in this Act

and subsidiary legislation made thereunder, including the European

Union principles and guidelines of good manufacturing practice

and good distribution practices, the Licensing Authority may carry

out inspections at the premises of

(a) manufacturers or distributors of active substances

located in third countries;

(b) manufacturers or importers of excipients.

(4) Inspections referred to in sub-articles (2) and (3) may also

be carried out in the European Union and in third countries at the

request of a European Union Member State, the European Union

Commission or the European Medicines Agency.

(5) Inspections may also take place at the premises of

marketing authorisation holders and of brokers of medicinal

products.

(6) Inspections shall be carried out by officials representing the

Licensing Authority who shall be empowered to inspect the

premises, records, documents and pharmacovigilance system

master file of the marketing authorisation holder or any firms

employed by the marketing authorisation holder to perform any

pharmacovigilance activities.

(7) Inspections shall be carried out in accordance with the

guidelines and provisions referred to in articles 101 to 104.

(8) After every inspection, the Licensing Authority shall report

on whether the inspected entity complies with the European Union

principles and guidelines of good manufacturing practice and good

distribution as applicable, or on whether the marketing

authorisation holder complies with the pharmacovigilance

requirements laid down in this Act and subsidiary legislation made

thereunder.

(9) The Licensing Authority shall communicate the content of

those reports to the inspected entity. Before adopting the report, the

Licensing Authority shall give the inspected entity concerned the

opportunity to submit comments.

(10) Without prejudice to any arrangements which may have

been concluded between the European Union and third countries, a

Member State, the European Union Commission or the European

Medicines Agency may require a manufacturer established in a

third country to submit to an inspection as referred to in this article.

(11) Within ninety days of an inspection as referred to in sub-

article (1), a certificate of good manufacturing practice or good

distribution practices shall, when applicable, be issued to the

inspected entity if the outcome of the inspection shows that it

complies with the principles and guidelines of good manufacturing

practice or good distribution practices as provided for by European

Union legislation.

(12) If inspections are performed as part of the certification

procedure for the monographs of the European Pharmacopoeia, a

certificate shall be drawn up.

(13) Certificates of good manufacturing practice and good

distribution practices issued shall be entered in the European Union

database managed by the European Medicines Agency on behalf of

the European Union. Information shall also be entered in that

database regarding the registration of importers, manufacturers and

distributors of active substances.

102. (1) For the purpose of ascertaining whether there is or has

been or there is likely to be a contravention of this Act or of any

regulations or rules made thereunder, an authorised officer shall

have a right to inspect

(a) any substance or article appearing to him to be a

medicinal product;

(b) any article used or intended to be used to contain any

medicinal product or to be a label or leaflet used or

intended to be used in connection with a medicinal

product;

(c) any plant or equipment appearing to him to be used or

intended to be used in connection with the

manufacture or assembly of medicinal products, and

any process of manufacture or assembly of any

medicinal products and the means employed, at any

stage in the process of manufacture or assembly, for

testing the materials after they have been subjected to

those processes; or

(d) any premises, records, documents and pharmacovigilance

system master file of the marketing authorisation holder

or any firms employed by the marketing authorisation

holder to perform pharmacovigilance activities as

established under article 31A

Provided that an authorized officer may also carry out

inspections of starting material manufacturers after a specific

request for the purpose is made by such manufacturer himself

Provided further that the samples that may be collected may

be analysed at a designated laboratory identified by the Authority.

(2) An authorised officer may, for the purpose specified in the

preceding subarticle, take a sample, including with a view to

independent tests being carried out by an Official Medicines Control

Laboratory or a laboratory designated for that purpose by an European

Union Member State, of any

(a) substance or medicinal product sold or supplied or

intended to be sold or supplied; or

(b) substance or article used or intended to be used in the

manufacture of a medicinal product.

(3) For the purposes of subarticle (1), an authorised person

shall have the right

(a) to inspect any records, in whatever form they are held,

related to the manufacture, assembly, sale or supply of

a medicinal product and, where such records are kept

in electronic form

(i)

may have access to, and inspect and check the

operation of any computer, any associated

apparatus or material which is or has been in use

in connection with the records; and

(ii) may require any person having charge of, or

otherwise connected with the operation of, the

computer, apparatus or material to afford him

such assistance as he may reasonably require;

(b) to take copies of any entry in any book or document

produced in pursuance of the preceding paragraph and

where the records are kept electronically, by means of

a computer or otherwise, require the records to be

produced in an intelligible form which may be taken

away;

(c) to take photographs of any equipment, premises,

records and documents.

(4) Any authorised officer shall have a right to seize, remove

and detain any substance or article which he has reasonable cause

to believe to be a substance or article in relation to which, or by

means of which, an offence under this Act is being or has been

committed, and any document which he has reasonable cause to

believe to be a document which may be required as evidence in

proceedings under this Act.

(5) For the purpose of subarticle (4), any authorised person

m a y, s o f a r a s i s r e a s o n a b l y n e c e s s a r y i n o r d e r t o s e c u r e

compliance with the provisions of this Act and any regulations or

rules made thereunder, require any person to break open any

container, package or machine, or to permit him to do so

Provided that where a person seizes any substance or

article, including any document, for the purposes specified in

subarticle (4), he shall inform the person from whom it is seized

and give him a receipt thereof.

(6) Without prejudice to the preceding provisions of this

article, any authorised person shall have the same rights conferred

by those provisions in relation to things belonging to, or any

business carried on by, an applicant for an authorisation or

certificate under Part III of this Act, and may exercise such rights

for the purpo se of veri fying any statements o r information

contained in the application for the authorisation or certificate; and,

where by virtue of the provisions of this subarticle a person

exercises any such right as is specified in subarticle (4), he shall be

subject to the duty imposed by subarticle (5).

(7) Notwithstanding anything in the preceding provisions of

this article, where a person claiming to exercise a right by virtue of

the provisions of this article is required to produce his authorisation

or credentials, the right shall only be exercisable by him on the

production of the authorisation or credentials.

(8) After every inspection the authorized officer shall report on

whether the manufacturer complies with the principles and

guidelines of good manufacturing practice or, where appropriate,

with the requirements relating to pharmacovigilance. The content

of such reports shall be communicated to the manufacturer or

marketing authorisation holder who has undergone the inspection.

(9) Within ninety days of an inspection a certificate of good

manufacturing practice shall be issued to a manufacturer if the

outcome of the inspection shows that the manufacturer complies

with the principles and guidelines of good manufacturing practice

as provided for by legislation in force at the time.

103. (1) The provisions of this article shall apply where an

authorised officer seizes a substance or article, other than a

document, in the exercise of such a right as is specified in article

102(4) and (6).

(2) If any person who in accordance with article 102(5) is

entitled to be informed of the seizure so requests, either at the time

of the seizure or at any subsequent time, not being later than

twenty-one days after he is informed of the seizure, then subject to

the following provisions of this article, the authorised officer shall

either

(a) set aside a sample of the substance or article seized; or

(b) treat that substance or article as a sample,

whichever he considers more appropriate having regard to the

nature of that substance or article.

(3)

An authorised officer shall not be required by virtue of

subarticle (2) to set aside a sample, or to treat a substance or article

as a sample, if the nature of the substance or article is such that it is

not reasonably practicable to do either of those things.

(4) Where in accordance with subarticle (2) an authorised

officer sets aside a sample, or treat a substance or article as a

sample, he shall divide it into three parts, each part to be marked

and sealed or fastened up in such manner as its nature will permit,

and shall supply one excerpt of it to the person who made the

request under subarticle (2).

(5)

(a) Where any medicinal product has been seized under

the provisions of this Act, and the owner thereof

consents in writing to the destruction of such

medicinal product, the Licensing Authority may, after

taking such samples as may be required to prove the

offence, direct that the said medicinal product be

destroyed without prejudice to the taking of any

proceedings against the person responsible for the

offence, and the said Licensing Authority shall recoup

all the expenses involved in the destruction of the

medicinal product.

(b) In those cases where the owner fails to consent to the

destruction of the medicinal product, the Licensing

Authority may, after filing an application requesting

the Court to order the destruction at the expense of the

owner, proceed with such destruction.

104. (1) Any person entering any property or any other

premises, ship, aircraft, stall or place in accordance with the

provisions of article 101, may be accompanied by such other

person o r ta ke such e qui pm en t as may a pp ear t o h im to b e

necessary; and on leaving any such property shall, if the property is

unoccupied or the occupier or any other person who is in charge of

a ship, aircraft, vehicle, stall or place, is temporarily absent, leave

it as effectively secured.

(2) The authorised officer shall also have such other powers as

may be prescribed by regulations made by the Minister for the

proper execution of his functions.

104A. Any person who, by any means whatsoever, hinders or

obstructs the Licensing Authority or an authorised officer from

exercising any of his powers and functions under this Act shall be

guilty of an offence against this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 104B Proof of controls carried out. — MEDICINES ACT Open official source

(1) The holder of the marketing authorization for a

medicinal product and, where appropriate, the holder of the

manufacturing authorization, shall furnish proof of the controls

carried out on the medicinal product and, or the ingredients and of

the controls carried out at an intermediate stage of the

manufacturing process, in accordance with the methods laid down

in Article 8(3)(h) of Directive 2001/83/EC and any amendments

thereto.

(2)

Manufacturers of immunological products shall submit to

the Authority copies of all the control reports signed by the

qualified person.

(3) Where the Authority considers it necessary in the interests

of public health, it may require the holder of an authorization for

marketing -

(a)

live vaccines,

(b) immunological medicinal products used in the primary

immunization of infants or of other groups at risk,

(c) immunological medicinal products used in public

health immunization programmes,

(d) new

immunological

medicinal

products

or

immunological medicinal products manufactured

using new or altered kinds of technology or new for a

particular manufacturer, during a transitional period

normally specified in the marketing authorization,

to submit samples from each batch of the bulk and, or the medicinal

product for examination by a laboratory designated for that purpose

before release on to the market unless, in the case of a batch

manufactured in another Member State, the competent authority of

that Member State has previously examined the batch in question

and declared it to be in conformity with the approved

specifications. The Authority shall ensure that any such

examination is completed within sixty days of the receipt of the

samples.

(4) In the interests of public health, the Authority may require

the marketing authorization holder for medicinal products derived

from human blood or human plasma to submit samples from each

batch of the bulk and, or the medicinal product for testing by a

laboratory designated for that purpose before being released into

free circulation, unless the competent authorities of another

Member State have previously examined the batch in question and

declared it to be in conformity with the approved specifications.

The Authority shall ensure that any such examination is completed

within sixty days of the receipt of the samples.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 104C Recalls and rapid alerts. — MEDICINES ACT Open official source

(1) The Licensing Authority shall ensure that there is a

system in place which aims at preventing medicinal products that

are suspected to present a danger to health from reaching the

patient.

(2) The system referred to in sub-article (1) shall cover the

receipt and handling of notifications of suspected falsified

medicinal products as well as of suspected quality defects of

m ed ici na l prod uct s. Th e sy stem shal l also c ove r re call s o f

medicinal products by marketing authorisation holders or

withdrawals of medicinal products from the market ordered by

national competent authorities from all relevant actors in the supply

chain both during and outside normal working hours. The system

shall also make it possible to recall, where necessary with the

assistance of health professionals, medicinal products from patients

who received such products.

(3) If the medicinal product in question is suspected of

presenting a serious risk to public health, the Licensing Authority

shall, without any delay, transmit a rapid alert notification to all

European Union Member States and all actors in the supply chain

in Malta. In the event of such medicinal products being deemed to

have reached patients, urgent public announcements shall be issued

within twenty-four hours in order to recall those medicinal products

from the patients. Those announcements shall contain sufficient

information on the suspected quality defect or falsification and the

risks involved.

PART VIII

MISCELLANEOUS PROVISIONS

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 105 Recognition of equivalent standards. — MEDICINES ACT Open official source

For the purposes of this Act, the Minister may, on the

advice of the Licensing Authority, by regulations prescribe that a

provision or provisions in relation to the marketing authorisation of

a medicinal product shall be deemed to be satisfied, if the standards

of manufacture, medicinal product quality, safety or efficacy, or the

provisions in relation to the granting of a marketing authorisation

of a country designated in such regulations, are satisfied.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 106 Power of Minister to make regulations. — MEDICINES ACT Open official source

The Minister may, after consultation with the Licensing

Authority, amend the schedules to this Act, prescribe by regulations

anything that may be prescribed under this Act and make provision

o n a n y m a t t e r r e l at i n g t o m e d i c i n a l p r o d u c t s , p o i s o n s a n d

pharmacies in order to give fuller effect to the provisions of this

Act, and, in particular, but without prejudice to the generality of the

aforesaid, shall by such regulations regulate or otherwise provide

for

(a) the grant of marketing authorisations;

(b) the manufacture of medicinal products and raw

materials used in such manufacture;

(c) the wholesale distribution of medicinal products;

(d) the sale and supply of medicinal products;

(e) the licensing of pharmacies;

(f)

the reporting of adverse drug reactions;

(g) advertising in respect of medicinal products, and the

presentation and information contained in the advert

Provided that the advertising of certain medicinal

products or classes of medicinal products may, by such

regulations, be prohibited;

(h) the conduct of clinical trials;

(i)

the classification of medicinal products;

(j)

the testing of medicinal products;

(k) the regulation of homeopathic medicinal products;

radiopharmaceuticals and medicinal products derived

from human blood and human plasma; immunological

products, and herbal products;

(l)

the

roles and

responsibilities

of

a

licence

or

MEDICINES

authorisation holder;

(m) the roles and responsibilities of the managing

pharmacist, responsible person and qualified person;

(n) standards of good practice in the manufacture,

wholesale, distribution and dispensing of medicinal

products

Provided that in the case of dispensing the Minister

may take the opinion of the Pharmacy Board;

(o) the recognition of equivalent standards for medicinal

product quality and efficacy in relation to such

countries as may be prescribed;

(p) the recognition of equivalent standards for good

practice in manufacture in relation to such countries as

may be prescribed;

(q) the fees that may be levied and the funds wherein such

fees may be deposited by the Licensing Authority, the

Medicines Authority and any other Committee

established by or under this Act or regulations made

thereunder;

(r) the regulation of the use of medical devices for

medical and, or research purposes, but without

prejudice to the generality of this paragraph, the

Minister may make regulations for all or any of the

following purposes

(i)

for prescribing the conditions under which the

authorisations may be granted, renewed,

suspended, transferred or cancelled;

(ii) for providing the manner in which applications

for the grant, renewal, suspension, transfer or

cancellation of the authorisations or of any one

or more categories or classes thereof are to be

made;

(iii) for providing the manner in which applications

for such authorisations and approvals as may be

prescribed are to be publicised and for providing

the manner in which any person who may be

prejudiced by such the authorisations and

approvals may make an objection or

representation thereon;

(iv) for establishing the duration of the validity of

the authorisations or of any one or more

categories or classes thereof;

(v) for establishing the qualifications that certain

key personnel involved in or with the premises

may be required to possess;

(vi) for regulating inspections to be carried out at the

premises;

(vii) for prescribing the inventory controls, registers,

records and databases that have to be kept by the

licence holder at the premises and any financial

guarantees which the licence holder shall have to

give;

(viii) for the establishment of quality controls and

quality assurances, other than those already

established under this Act, and any matter in

relation to any activity carried on any premises

or by any person licensed under this legislation;

(ix) for establishing the fees leviable in respect of

the authorisations, approvals and for any other

service provided by the Medicines Authority

such as scientific advice or other work as may be

deemed necessary for the Medicines Authority

to carry out its function

Provided that regulations made under this sub-

paragraph may establish the minimum and the

maximum of any fees leviable in respect of the

authorisations, approvals and for any other

service provided by the Medicines Authority

such as scientific advice or other work as may be

deemed necessary for the Medicines Authority

to carry out its function; and

(x) for establishing the penalties or administrative

sanctions to which any offender against the

provisions of this Act or any regulations made

thereunder shall be liable;

(s)

the establishing of offences and the relative penalty in

relation to the contravention of any provisions of this Act

or regulations issued under this Act which penalty shall

not be less than a fine (multa) of twelve thousand euro

(€12,000) and not exceeding one hundred and twenty

thousand euro (€120,000) or to imprisonment for a term

not exceeding two years, or to both such fine and

imprisonment;

(t)

exceptions to any provision in the interest of public

health.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 107 Transitory provision. — MEDICINES ACT Open official source

Any medicinal products on the market on the date of the

coming into force of article 20 shall only be subject to the

provisions of that article at such time and subject to such

conditions as may by rules be established by the Licensing

Authority.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 108 Amendment of Medical and Kindred Professions Ordinance. — MEDICINES ACT Open official source

Omitted under the Statute Law Revision Act, 1980.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 109 Saving. — MEDICINES ACT Open official source

(1) Any regulations made under the provisions of the

articles, of the Medical and Kindred Professions Ordinance, which

have been repealed by article 108, shall, until provision is made

under or by virtue of this Act, continue in force and have effect as

if made under this Act.

(2) Any licence, permission or other authorisation granted

under any provision of the repealed articles as aforesaid, shall

continue in force thereafter as if it were a licence, permission or

authorisation granted under a corresponding provision or authority

granted under this Act and shall be treated and dealt with

accordingly.

(3) Any action taken or proceedings commenced against or in

relation to any person under the repealed articles as aforesaid shall

continue to have effect as if it were action or proceedings taken or

commenced under a corresponding provision of this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 109A Designation of competent authority. — MEDICINES ACT Open official source

* (1) The Prime Minister may, following consultation with

the Minister responsible for health, by Order in the Gazette

designate any authority to carry out the functions carried out by the

Medicines Authority under this Act.

(2) Any such Order may delete any of the provisions of articles

5 and 7 to 13.

(3) Any such Order may also amend or delete subarticle (3) of

article 3 and articles 4 and 6.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 110 Saving provisions. — MEDICINES ACT Open official source

(1) Nothing in this Act shall in any way derogate from

any Acts or regulations for the radiation protection of persons

u n d e rg o in g m e d i c a l e x a m i n a t i o n o r t r e a tm en t , or f r o m t he

Community rules laying down the basic safety standards for the

health protection of the general public and workers against the

dangers of ionizing radiation.

(2) This Act shall be without prejudice to Council Decision 86/

346/EEC of 25 June 1986 accepting on behalf of the Community

the European Agreement on the Exchange of Therapeutic

Substances of Human Origin.

(3) The provisions of this Act shall not affect the powers of the

Authority either as regards the setting of prices for medicinal

products or their inclusion in the scope of national health insurance

schemes, on the basis of health, economic and social conditions.

(4) This Act shall not affect the application of any law

prohibiting or restricting the sale, supply or use of medicinal

products as contraceptives or abortifacients.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 111 Medical devices and in vitro diagnostic medical devices. — MEDICINES ACT Open official source

Any regulations issued under the Product Safety Act

dealing with medical devices and in vitro diagnostic medical devices

shall be deemed to have been issued under this Act.

Laws of Malta — Chapter 458 — MEDICINES ACT

Art. 112 Language. — MEDICINES ACT Open official source

Regulations made under any provision of this Act may be

made in the English language only.

*this article was originally added as article 110 by Act XXIX. 2007.21.