ATT Nru. III ta’ l-2003 ACT No. III of 2003 ATT ma[ru; b’li;i mill-Parlament ta’ AN ACT enacted by the Parliament of Malta.

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,369, 5 ta’ Marzu, 2003

Taqsima A

MALTA

ATT Nru. III ta’ l-2003

ACT No. III of 2003

ATT ma[ru; b’li;i mill-Parlament ta’

AN ACT enacted by the Parliament of

Malta.

Malta.

ATT biex jipprovdi dwar [wejje; li

AN ACT to make provision for matters

g[andhom x’jaqsmu mal-manifattura, il-

connected with the manufacture,

preparazzjoni u l-assembla;;, id-

preparation and assembly, wholesale

distribuzzjoni bl-ingrossa, il-[]in, il-

distribution, storage, destruction,

qirda, it-tne[[ija, ir-reklamar u l-

disposal, advertising and authorisation

awtorizzazzjoni ta’ prodotti medi/inali

of medical products and any activity

u ta’ kull attività li g[andha x’taqsam

connected therewith and the regulation

ma’ dan u r-regolament tal-bejg[ ta’

of the sale of medicinal products,

prodotti medi/inali, spi]eriji u attivitajiet

pharmacies and related pharmaceutical

farma/ewti/i relatati u dwar [wejje;

activities and for any other matters

o[ra an/illari g[al dawn jew li

ancillary thereto or connected therewith.

g[andhom x’jaqsmu mag[hom.

ATT TA’ L-2003 DWAR IL-MEDI¬INI

Arran[ament ta’ l-artikoli

(1)

The short title of this Act is the Medicines Act, Short title and

commencement.

2003. (2) This Act shall come into force on such date as the Minister

responsible for health may by notice in the Gazette appoint, and

different dates may be so appointed for different provisions or

different purposes of this Act.

PART I

PRELIMINARY

Areas of competency.

Anaesthesiology

Analytical Chemistry

Anatomy

Biochemistry

Biotechnology Products

Blood Products

Cardiology

Cosmiceuticals

Dentistry

Dermatology

Diabetes

Endocrinology

ENT Medicine

Epidemiology

Family Medicine

Gastroenterology

Genetics

Geriatrics

Haematology

Herbals

Homeopathics

Immunology

Intensive care

Internal Medicine

Medical Devices

Medical Statistics

Microbiology (such as Virology, Bacteriology)

Molecular Biology

Neurology

Nephrology

Nutraceuticals

Nutrition

Obstetrics & Gynaecology

Oncology

Ophthalmology

Orthopaedics

Paediatrics

Pathology

Pharmaceutical Chemistry

Pharmaceutical Technology

Pharmacognosy

Pharmacology

Physiology

Psychiatry

Radiology

Radiopharmaceuticals

Respiratory Medicine

Rheumatology

Surgery

Toxicology

Transfusion Medicine

Urology

Vaccines

In this Act, unless the context otherwise requires -

Interpretation.

"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;

"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 Cap. 94.

(Constitution) Ordinance authorised by the Licensing Authority to act

on its behalf;

"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 or other

pharmacodynamic effects of one or more medicinal product under

investigation, or to identify any adverse reactions to one or more

medicinal product under investigation or to study absorption,

distribution, metabolism and excretion of one or more investigational

medicinal product with the object of ascertaining its safety or

efficacy; and includes clinical trials carried out in either one site or

multiple sites, whether locally or in one or more states recognised by

the Licensing Authority;

"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 may 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;

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

whether of body or mind;

"dispensing" includes sale or supply of medicinal products;

"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

containing as active ingredients one or more herbal substances or one

or more herbal preparations or one or more 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

and

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, funghi, lichen in an unprocessed, usually in

dried form but sometimes fresh. Certain exudates which have not

been subjected to a specific treatment are also considered to be herbal

substances;

"homeopathic medicinal product" means any medicinal product

prepared from products, substances or compositions referred to as

homeopathic stocks in terms of a homeopathic manufacturing

procedure described by a recognised Pharmacopoeia;

"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 vaccine, toxin, serum or allergen product

where

(a)

vaccine, toxin and serum include -

(i)

agents used to produce active immunity;

(ii) agents used to diagnose immunity;

(iii) agents used to produce passive immunity; and

(b) ''allergen product'' means any medicinal product

which is intended to identify or induce a specific acquired

alteration in the immunological response to an allergising agent;

"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, and includes products already with a

marketing authorisation 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;

"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 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 device" means any instrument, apparatus, appliance,

material or other article, whether used alone or in combination,

including any software necessary for its proper application intended

by the manufacturer to be used for human beings for the purpose of -

(a)

diagnosis, prevention, monitoring, treatment or

alleviation of disease;

(b) diagnosis, monitoring, treatment, alleviation of or

compensation for an injury or handicap;

(c) investigation, replacement or modification of the

anatomy or of a physiological process; and

(d) control of conception and which does not achieve its

principal intended action in or on the human body by

pharmacological, immunological or metabolic means, but which

may be assisted in its function by such means;

"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 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 presented for treating or preventing disease in human

beings, as well as any substance or combination of substances which

may be administered to human beings with a view to making a

medical diagnosis or to restoring, correcting or modifying

physiological functions in human beings;

"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;

"official formula" means any medicinal product that is prepared

in a pharmacy in accordance with instructions found in a prescription

of a recognised pharmacopoeia and which is intended to be supplied

directly to a patient being served by the said 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;

"pre-packaging" means the act by which a pharmacist divides a

medicinal product into quantities more appropriate for individual

patient use, thus changing the outer packaging of this product for the

act of dispensing;

"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 removed by elution or by any other

method and used in a radiopharmaceutical;

"radionuclide kit" means any preparation to be reconstituted or

combined with radionuclides in the final radiopharmaceutical, usually

prior to its administration;

"radionuclide precursor" means any radionuclide not being a

radiopharmaceutical, radionuclide generator or radionuclide kit

which is produced for the radio-labelling of another substance prior to

administration;

"radiopharmaceutical" means a medicinal product which, when

ready for use, contains one or more radionuclides 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);

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

provisions of this Act;

"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, extracts), vegetable (including micro-organisms, plants,

parts of plants, vegetable secretions, extracts), or chemical (including

elements, naturally occurring chemical materials or 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;

"veterinary surgeon" means a person who is authorised to

exercise such profession under the Veterinary Services Act, 2002, or

any other law replacing the same;

"wholesale distribution" in relation to a medicinal product,

includes all activities consisting of procuring, holding, supplying,

distributing, exporting or importing medicinal products, other than

retail sale or for personal use.

PART II

ADMINISTRATION

Title I - The Licensing Authority

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.

(1) The Superintendent of Public Health shall be the Functions of the

Licensing

Licensing Authority for the purposes of this Act.

Authority.

(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)(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

Conditions and criteria where any person can have or not have a

direct or indirect interest in a pharmacy

(1) No person shall qualify for a licence if he is a medical

practitioner, dental surgeon, dentist or veterinary surgeon or if he is

the husband or wife of any such medical practitioner, dental surgeon,

dentist or veterinary surgeon.

(2) No licence shall be granted or renewed if a medical

practitioner, dental surgeon, dentist or veterinary surgeon has any

direct or indirect interest in a pharmacy.

(3) It shall not be lawful for any medical practitioner, dental

surgeon, dentist or veterinary surgeon or any other person authorised

to issue prescriptions under the Medicines Act or any other Act, to

enter into any agreement with any pharmacist or any other person for

any share in the profits of a pharmacy, or to have any direct or

indirect interest of whatever nature in any pharmacy.

(4) It shall not be lawful for any pharmacist

(a)

to carry on the business of a pharmacy on account

of, or in partnership with any medical practitioner, dental

surgeon, dentist or veterinary surgeon or any other person

authorised to issue prescriptions under the Medicines Act or any

other Act;

(b) to enter into any agreement with any medical

practitioner, dental surgeon, dentist or veterinary surgeon or any

other person authorised to issue prescriptions as aforesaid, for

any share in the profits of a pharmacy;

(c)

to lend his name in order that the business may be

carried out by some other person.

Passed by the House of Representatives at Sitting No. 875 of the

25th February, 2003.

A NTON T ABONE

Speaker

R ICHARD J. C AUCHI

Clerk to the House of Representatives

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

There shall be established a Medicines Authority, which

shall be headed by a Chief Executive Officer.

(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

behalf in any judicial proceedings or in any act, contract, instrument

or other document whatsoever.

(1)

The Medicines Authority shall have the following Functions of the

Medicines

functions

Authority.

(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; and

(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.

(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 in the fields listed in the First Schedule, 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 .

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.

(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 Minister prior to the expiry of his term

of office where, in the opinion of the Minister, he has been guilty of

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.

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

any other enactment applicable thereto, and without prejudice to the the

Authority.

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 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 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.

(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 six weeks after the end

of each financial year, present to the Minister and the permanent

secretary the audited accounts together with a report on the workings

of the agency which report shall state the manner in which the agency

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 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.

Except with the approval of the 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 one hundred thousand liri or such

other amount as the 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.

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.

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

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

shall be composed of three members and three substitute members of

Review Board.

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.

(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.

(1)

It shall be the function of the Medicines Review

Board

(a) to hear any appeal made by any person aggrieved by

any recommendation of the Medicines Authority in relation to

the safety, quality and efficacy of a medicinal product following

an application for a marketing authorisation submitted by the

appellant;

(b) to provide advice and make its recommendations to

the Licensing Authority regarding any appeal or request made

to it.

(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.

(1) Where an applicant for a marketing authorisation Procedure of

feels aggrieved by the findings and recommendations made by the appeal.

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.

(1) The Medicines Review Board shall appoint the Public hearing.

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

Title I - Marketing Authorisation Relating to Medicinal Products

(1) The provisions of articles 20 to 36 shall apply to

industrially produced medicinal products for human use intended to

be placed on the market in Malta.

(2) Articles 20 to 36 shall not apply to -

(a) any medicinal product prepared in accordance with

a magistral formula;

(b) any medicinal product prepared in accordance with

an official formula;

(c) medicinal products intended for research and

development trials;

(d) intermediate products intended

for

further

processing by an authorised manufacturer;

(e)

radionuclides in the form of sealed sources.

(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.

Where the Licensing Authority or the applicant disagree Review or

with the findings or recommendations of the Medicines Authority, appeal.

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

the manner established under this Act.

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

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

authorisation.

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.

(1) In granting or refusing a marketing authorisation, Notification of

the Licensing Authority shall also inform the Medicines Authority of marketing

authorisation.

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.

(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.

(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 determinining any such application.

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.

(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.

(1) The Licensing Authority shall suspend or revoke a Suspension or

marketing authorisation for a medicinal product where that product revocation

marketing

proves to be harmful in the normal conditions of use, or where its authorisation.

therapeutic efficacy is lacking, or where its qualitative and

quantitative composition is not as declared. For the purpose of this

article therapeutic efficacy shall be deemed to be lacking when it is

established that therapeutic results cannot normally be obtained with

the medicinal product.

(2) An authorisation shall also be suspended or revoked 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.

(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 Licensing

Authority shall not be bound by the recommendations made by the

Medical Review Board.

(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 paragraph (b) of

subarticle (1) is classified under paragraph (a) of subarticle (1).

(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.

(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).

A medicinal product may only be advertised in accordance Advertising of

medicinal

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

products.

The provisions of this Part shall apply to homeopathic Homeopathic

medicinal products for human use except for homeopathic medicinal medicinal

products.

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.

The provisions of this Part shall apply to medicinal Products

products based on blood constituents which are prepared industrially derived

human blood or

by a private or a public establishment but shall not apply to blood, human plasma.

plasma or blood cells of human origin.

The marketing authorisation referred to in article 20 shall Radiopharmace

be required for generators, kits, precursor radiopharmaceuticals and utical

product.

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.

(1) The provisions of this Part shall apply to Immunological

medicinal

immunological medicinal products.

products.

(2) The Licensing Authority may prescribe rules regulating the

issue or otherwise of a marketing authorisation for immunological

medicinal products.

(1) The provisions of this Part shall apply to herbal

medicinal products other than herbal medicinal products prepared in

accordance with a magistral or an official formula

(2) 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

Without prejudice to any exemption that may be granted

under this Act, no person shall 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.

(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.

(1) The Licensing Authority shall, before determining Granting of

an application, inspect the premises indicated in the application and manufacturer's

licence.

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.

Where the Licensing Authority considers that Notice for

circumstances may exist which would render necessary the further

information.

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.

(1) The Licensing Authority may suspend a Suspension or

manufacturer's licence under this Act for such period as it may revocation

manufacturer's

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

(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, .

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

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

expire at the end of its validity.

(2) Any licence so granted shall, unless previously revoked, be

renewable upon an application by the licensee made at least three

months before the expiry of the validity period.

(3) The Licensing Authority may by rules establish the period

of validity of any licence issued under this Part.

(4) On an application to the Licensing Authority for the

renewal of a licence under this Part, 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.

(5) The provisions of articles 25, 39 and 40 shall apply to such

applications.

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

of

licence -

manufacturer's

licence holder.

(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.

(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 at all times be present at the

premises when the activity is being carried out

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.

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.

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.

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.

Without prejudice to article 32, the provisions of articles Manufacture of

37 to 48 shall apply to the manufacture and assembly of homeopathic homeopathic

medicinal

medicinal products other than the products listed in article 32(a) (b) products.

and (c).

Without prejudice to article 33, the provisions of articles Manufacture of

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

products derived

manufacture and assembly of medicinal products derived from human from human

blood and

blood and human plasma other than the products listed in article 32(a) human plasma,

etc.

(b) and (c).

Without prejudice to article 34, the provisions of articles Manufacture of

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

ceuticals.

manufacture and assembly of radiopharmaceutical medicinal

products other than the products listed in article 32(a) (b) and (c).

Without prejudice to article 35, the provisions of articles Immunological

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

product.

manufacture and assembly of immunological medicinal products

other than the products listed in article 32(a) (b) and (c).

Without prejudice to article 36, the provisions of articles Herbal

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

products.

manufacture and assembly of herbal medicinal products other than

the products listed in article 32(a) (b) and (c).

Title III - Wholesale Distribution of Medicinal Products

for Human Use

(1) Without prejudice to any exemptions that may be Wholesale

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

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.

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

licence shall be made to the Licensing Authority and shall contain a dealer's

such information, documents, 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 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.

(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.

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.

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

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

wholesale

dealer's licence.

expire at the end of its validity.

(2) Any licence so granted shall, unless previously revoked, be

renewable upon an application by the licensee made at least three

months before the expiry of the validity period.

(3) The Licensing Authority may by rules establish the period

of validity of any licence issued under this Part.

(4) On an application to the Licensing Authority for the

renewal of a licence under this Part, 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.

(5) The provisions of articles 25, 39 and 40 shall apply to such

applications.

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

holder of

licence -

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.

(1) The responsible person shall ensure that standards of Responsibilities

good practice in wholesale distribution as may be prescribed are of

responsible

complied with at all times.

person.

(2) The qualified or responsible person shall at all times be

present at the premises when the licenced activity is being carried out

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.

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.

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.

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.

(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.

Without prejudice to the provisions of this Part, the Special

Licensing Authority may by rules establish additional requirements provisions.

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

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

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

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.

(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) 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 dispensing of medicinal products;

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

professionally responsible for all activities;

(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.

(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 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.

Where the Licensing Authority considers that Notice for

circumstances may exist which would render necessary the further

information.

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.

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

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

pharmacy

expire at the end of its validity.

licence.

(2) Any licence so granted shall, unless previously revoked, be

renewable upon an application by the licensee made at least three

months before the expiry of the validity period.

(3) The Licensing Authority may by rules establish the period

of validity of any licence issued under this Part.

(4) On an application to the Licensing Authority for the

renewal of a licence under this Part, the Licensing Authority

(a)

shall 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.

(5) The provisions of articles 25 and 39 shall apply to such

applications.

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.

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.

(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.

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

Obligations of

the holder of a

pharmacy

(a)

to inform the Licensing Authority of any change of

licence.

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;

(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) other responsibilities as may be established from

time to time by or under this Act.

(1) Every pharmacy shall be managed by a pharmacist Managing

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 sells or

supervises the sale of medicinal products present in the

pharmacy and keep records of the pharmacist who was present

at all times 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.

(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.

The conditions and criteria where any person can have or

not have a direct or indirect interest in a pharmacy are to be defined in

the Third Schedule to this Act.

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.

(1) A pharmacy shall only dispense in medicinal Medicinal

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

sold from a

may from time to time be established by rules made by the Licensing pharmacy.

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.

(1) A pharmacist shall prepare or dispense any Dispensing of a

medicinal product required by any person presenting a prescription medicinal

product.

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, formulation 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.

(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.

The Licensing Authority may by rules prescribe the

format, content and presentation of a prescription required by or

under this Act.

The pharmacist shall label each medicinal product or

magistral formula or official formula dispensed in accordance with

such regulations or rules made under this Act.

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, 2002, 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.

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

to keep anywhere within the pharmacy any medicinal product in any medicinal

products in

container or under such conditions which are not suitable to the pharmacy.

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.

Premises, facilities, records and equipment used for the Premises, etc.,

storage, preparation and dispensing of medicinal products are to be in

with

kept in accordance with the requirements and standards established requirements

and standards.

by or under this Act.

The preparation of magistral and official formulas, and the Pharmacist to be

pre-packing, reconstitution, dispensing and administration of guided

standards.

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.

(1) The Licensing Authority shall have the right to Inspections of

inspect pharmacies and any premises licensed for use as stores under pharmacies.

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.

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

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.

It shall not be lawful for any person to keep for sale, Keeping, etc., of

manufacture, sell or otherwise distribute or deal in any poison without poisons.

a licence from the Licensing Authority .

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

granted to manufacturers of, and dealers in chemical products, of poisons.

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.

Every person granted a licence under article 91 shall keep Keeping of

all poisonous substances in a separate and safe place the key whereof poisonous

substances in a

safe place.

shall be always kept by the licence holder.

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

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

substances.

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.

The Licensing Authority or any authorised officer, may in Power of

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

premises of manufacturers of and dealers in chemical products and of

the other persons referred to in article 91.

Without prejudice to the provisions of the Pesticides Poisoned grain,

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

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

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.

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) sell or supply, or offer or expose for sale or supply,

or have in his possession for the purpose of sale or supply, any

medicinal product whose composition has been injuriously

affected by the addition or abstraction of any substance.

PART VI

OFFENCES AND PENALTIES

(1) Without prejudice to any other liability under any

other law, any person who fails to comply with any of the 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, 24, 28, 37, 39, 41 and

43, to a fine (multa ) of not less than ten thousand liri and not

exceeding fifty thousand liri or to imprisonment for a term not

exceeding two years, or both such fine and imprisonment;

(b) the provisions of articles 54, 56, 58 and 61, to a fine

(multa) of not less than five thousand liri and not exceeding

thirty thousand liri or to imprisonment for a term not exceeding

six months, or both such fine and imprisonment;

(c)

the provisions of articles 44, 45, 66(1), 71, 75(3),

75(4), 76(1), 81(1), 91 and 98, to a fine (multa) of not less than

two thousand liri and not exceeding twenty thousand liri or to

imprisonment for a term not exceeding three months, or to both

such fine and imprisonment;

(d) the provisions of articles 59, 60, 65, 74(b), 75(1),

75(2), 84, 93, 94(1) and 96, to a fine (multa) of not less than five

hundred liri and not exceeding ten thousand liri;

(e)

the provisions of articles 31, 66(2), 78, 85(1), 85(2)

and 94(2), to a fine (multa) of not less than two hundred liri and

not exceeding five thousand liri;

(f)

the provisions of articles 29, 73(1) and 94(3), to a

fine (multa) of not less than one hundred liri and not exceeding

one thousand liri.

(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, and the

conviction is the third or subsequent conviction, the Court shall, at the

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

aforesaid licence or authorisation.

(1) Notwithstanding any other law providing for the Special

trial of offences, where the Licensing Authority believes that a person procedure.

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 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

ten thousand liri.

(3) 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.

(4) 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

(1) Subject to the provisions of this article, and without

prejudice to the other provisions of this Act, any person duly

authorised in writing by the Licensing Authority shall, on production

of his authorisation or credentials, have a right at any reasonable time

to enter 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.

(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; or

(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.

(2) An authorised officer may, for the purpose specified in the

preceding subarticle, take a sample 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.

(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

may, so far as is reasonably necessary in order to secure 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 purpose of

verifying any statements or 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.

(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).

(1) Any person entering any property or any other Supplementary

premises, ship, aircraft, stall or place in accordance with the provisions

right of entry.

provisions of article 101, may be accompanied by such other person

or take such equipment as may appear to him to be 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.

PART VIII

MISCELLANEOUS PROVISIONS

(1) For the purposes of this Act, the Minister may, on Recognition of

the advice of the Licensing Authority, by regulations prescribe that a equivalent

standards.

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.

The Minister may, after consultation with the Licensing Power of

Authority, amend the schedules to this Act, prescribe by regulations Minister

make

anything that may be prescribed under this Act and make provision on regulations.

any matter relating to medicinal products, poisons and 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

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 by the Licensing

Authority and the Medicines Authority;

(r)

exceptions to any provision in the interest of public

health.

Any medicinal products on the market on the date of the Transitory

coming into force of article 20 shall only be subject to the provisions provision.

of that article at such time and subject to such conditions as may by

rules be established by the Licensing Authority.

Articles 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, Amendment of

35, 36, 37, 38, 39, 41, 42, 48, 88, 89, 92, 93 and 95 of the Medical and Medical

Kindred

Kindred Professions Ordinance shall be deleted.

Professions

Ordinance, Cap.

31.

(1) Any regulations made under the provisions of the Saving.

articles, of the Medical and Kindred Professions Ordinance, which

are being 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.