MEDICINAL PRODUCTS (LABELLING AND PACKAGING) REGULATIONS

SUBSIDIARY LEGISLATION 458.33

MEDICINAL PRODUCTS (LABELLING AND

PACKAGING) REGULATIONS

30th October, 2005

LEGAL NOTICE 393 of 2005, as amended by Legal Notices 372 of 2012,

351 of 2013 and 309 of 2024.

(1) The title of these regulations is the Medicinal Products

(Labelling and Packaging) Regulations.

(2) The scope of these regulations is transpose Directive 2001/

83/EC, and to transpose amendments to Directive 2001/83/EC on the

Community code relating to medicinal products for human use,

brought about by Directive 2010/84/EU, as regards

pharmacovigilance, Directive 2011/62/EU, as regards the prevention

of the entry into the legal supply chain of falsified medicinal products,

and Directive 2012/26/EU, as as regards pharmacovigilance.

For the purposes of these regulations

"the Commission" means the Commission in accordance with

Council Decision 1999/468/EC of 28 June, 1999;

"common name" means the international non-proprietary name

recommended by the World Health Organisation, or, if such name

does not exist, the usual common name;

"electronic package leaflet" means the package leaflet displayed in

an electronic format in an official language or official languages of

Malta and which is accessible through a machine-readable format

displayed on the outer packaging of the medicinal product, and where

the outer and immediate packaging is not in the official language or

languages of Malta, it shall include the particulars to be found on the

outer and immediate packaging of medicinal products in accordance

with the provisions of these regulations;

"immediate packaging" means the container or other form of

packaging immediately in contact with the medicinal product;

"labelling" means information on the immediate or outer

packaging;

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

either an invented name not liable to confusion with the common

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

mark or the name of the marketing authorisation holder;

"outer packaging" means the packaging into which the

immediate packaging is placed;

"package leaflet" means a leaflet containing information for the

user which accompanies the medicinal product;

"representative of the marketing authorisation holder" means the

person, commonly known as local representative, designated by the

marketing authorisation holder to represent him in the Member

State concerned;

MEDICINAL PRODUCTS

(LABELLING AND PACKAGING)

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

active substances expressed quantitatively per dosage unit, per unit

of volume or weight according to the dosage form.

The following particulars shall appear on the outer

packaging of medicinal products or, where there is no such outer

packaging, on the immediate packaging

(a) the name of the medicinal product followed by its

strength and pharmaceutical form, and, if appropriate,

whether it is intended for babies, children or adults;

where the product contains up to three active

substances, the international non-proprietary name

(INN) shall be included, or, if one does not exist, the

common name;

(b) a statement of the active substances expressed

qualitatively and quantitatively per dosage unit or

according to the form of administration for a given

volume or weight, using their common names;

(c) the pharmaceutical form and the contents by weight,

by volume or by number of doses of the product;

(d) a list of those excipients known to have a recognised

action or effect and which are included in the detailed

guidance published by the Commission pursuant to

Article 65 of Directive 2001/83/EC as amended by

Directive 2004/27/EC. However, if the product is an

injectable, or a topical or eye preparation, all

excipients must be stated;

(e) the method of administration and, if necessary, the

route of administration. Space shall be provided for

the prescribed dose to be indicated;

(f)

a special warning that the medicinal product must be

stored out of the reach and sight of children;

(g) any special warning that may be necessary for the

particular medicinal product;

(h) the expiry date in clear terms (month/year);

(i)

special storage precautions, if any;

(j)

specific precautions, relating to the disposal of unused

medicinal products or waste derived from medicinal

products, where appropriate, as well as reference to

any appropriate collection system in place;

(k) the name and address of the marketing authorisation

holder and, where applicable, the name of the

representative appointed by the holder to represent

him;

(l)

the number of the marketing authorisation;

(m) the manufacturer’s batch number;

(n) in the case of non-prescription medicinal products,

instructions for use;

(o) for

medicinal

products

other

than

radiopharmaceuticals referred to in paragraph (p),

safety features enabling wholesale distributors and

persons authorised or entitled to supply medicinal

products to the public to

(i) verify the authenticity of the medicinal product,

and

(ii) identify individual packs,

as well as a device allowing verification of whether

the outer packaging has been tampered with;

(p)

medicinal products subject to prescription shall bear

the safety features referred to in paragraph (o), unless

they have been listed in accordance with the procedure

pursuant to Article 54a of Directive 2001/83/EC as

amended.

Medicinal products not subject to prescription shall

not bear the safety features referred to in paragraph

(o), unless, by way of exception, they have been listed

in accordance with the procedure pursuant to Article

54a of Directive 2001/83/EC as amended, after having

been assessed to be at risk of falsification;

(q) the Licensing Authority may, for the purposes of

reimbursement or pharmacovigilance, extend the

scope of application of the unique identifier referred to

in paragraph (o) to any medicinal product subject to

prescription or subject to reimbursement;

(r) the Licensing Authority may, for the purposes of

reimbursement,

pharmacovigilance

and

pharmacoepidemiology, use the information contained

in the repositories system as may be established by the

Commission referred to in Article 54a of Directive

2001/83/EC as amended;

(s) the Licensing Authority may, for the purposes of

patient safety, extend the scope of application of the

anti-tampering device referred to in paragraph (o) to

any medicinal product

Provided that where the outer packaging, or immediate

packaging in the absence of an outer packaging, of the

medicinal product includes the name of the product,

the active substance or substances, pharmaceutical

form and strength, in the Roman alphabet, all of the

particulars in paragraphs (a) to (n) of this regulation

may alternatively be included and accessed by means

of the electronic package leaflet

Provided further that this electronic package leaflet may

only be used for medicinal products procured for the

national health service.

(a) The particulars laid down under regulation 3 shall

appear on immediate packagings other than those

referred to in paragraphs (b) and (c) hereof.

(b) At least the following particulars shall appear on the

immediate packaging when this takes the form of a

blister pack which is then placed in an outer packaging

which complies with the provisions laid down in

regulations 3 and 9

(i)

the name of the medicinal product as laid down

under regulation 3(a);

(ii) the name of the holder of the marketing

authorisation;

(iii) the expiry date;

(iv) the batch number.

(c) In the case of small immediate packaging units on

which the particulars laid down under regulations 3

and 9 cannot be displayed, the following particulars at

least shall appear

(i)

the name of the medicinal product as laid down

in regulation 3(a), and, if necessary, the route of

administration,

(ii) the method of administration;

(iii) the expiry date;

(iv) the batch number;

(v) the contents by weight, by volume or by unit

Provided that where the immediate packaging of

the medicinal product includes the name of the

product, the active substance or substances,

pharmaceutical form and strength, in the Roman

alphabet, all or any of the particulars in

paragraphs (b) and (c) of this regulation, unless

already included in the outer packaging may

alternatively be included and accessed by means

of the electronic package leaflet

Provided further that this electronic package leaflet

may only be used for medicinal products procured

for the national health service.

(1) The particulars referred to in regulations 3, 4 and 9

shall be easily legible, clearly comprehensible and indelible.

(2) The name of the medicinal product, as referred to in

regulation 3(a), must also be expressed in Braille format on the

packaging. The marketing authorisation holder shall ensure that the

package information leaflet is made available on request from

patients’ organisations in formats appropriate for the blind and

partially-sighted.

Notwithstanding the proviso to regulation 8(2), the

Licensing Authority may require the use of certain forms of

labelling of the medicinal product making it possible to ascertain

(a) the price of the medicinal product;

(b) the reimbursement conditions of social security

organizations;

(c) the legal status for supply tothe patient, in accordance

with Title VI of Directive 2001/83/EC, as amended;

and

(d) authenticity and identification in accordance with

regulation 3(q), (r) and (s).

A package leaflet shall be included in the packaging of all

medicinal products unless all the information required by

regulations 7 and 9 is directly conveyed on the outer or immediate

packaging

Provided that the information in the package leaflet may

alternatively be displayed and accessed by means of the electronic

package leaflet when the medicinal product is procured for the

national health service.

(1) The package leaflet shall be drawn up in accordance

with the summary of the product characteristics and shall include,

in the following order

(a) for the identification of the medicinal product

(i)

the name of the medicinal product followed by

its strength and pharmaceutical form, and, if

appropriate, whether it is intended for babies,

children or adults. The common name shall be

included where the product contains only one

active substance and if its name is an invented

name;

(ii) the pharmaco-therapeutic group or type of

activity in terms easily comprehensible for the

patient;

(b) the therapeutic indications;

(c) a list of information which is necessary before the

medicinal product is taken

(i) contra-indications;

(ii) appropriate precautions for use;

(iii) forms of interaction with other medicinal

products and other forms of interaction (e.g.

alcohol, tobacco, foodstuffs) which may affect

the action of the medicinal product;

(iv) special warnings;

(d) the necessary and usual instructions for proper use,

and in particular

(i) the dosage;

(ii) the method and, if necessary, route of

administration;

(iii) the frequency of administration specifying, if

necessary, the appropriate time at which the

medicinal product may or must be administered,

and, as appropriate, depending on the nature of

the product;

(iv) the duration of treatment, where it should be

MEDICINAL PRODUCTS

(LABELLING AND PACKAGING)

limited;

(v)

the action to be taken in case of an overdose

(such as symptoms, emergency procedures);

(vi)

what to do when one or more doses have not

been taken;

(vii)

indication, if necessary, of the risk of withdrawal

effects;

(viii) a specific recommendation to consult the doctor

or the pharmacist, as appropriate, for any

clarification on the use of the product;

(e) a description of the adverse reactions which may occur

under normal use of the medicinal product and, if

necessary, the action to be taken in such a case;

(f)

a reference to the expiry date indicated on the label,

with

(i)

a warning against using the product after that

date;

(ii) where appropriate, special storage precautions;

(iii) if necessary, a warning concerning certain

visible signs of deterioration;

(iv) the full qualitative composition (in active

substances and excipients) and the quantitative

composition in active substances, using common

names, for each presentation of the medicinal

product;

(v) for each presentation of the product, the

pharmaceutical form and content in weight,

volume or units of dosage;

(vi) the name and address of the marketing

authorisation holder and, where applicable, the

name of his appointed representatives in Malta;

(vii)

the name and address of the manufacturer;

(g) where the medicinal product is authorised in

accordance with the mutual recognition and

decentralised procedure under different names in the

Member States concerned, a list of the names

authorised in each Member State;

(h) the date on which the package leaflet was last revised;

(i)

for medicinal products included in the list referred to

in Article 23 of Regulation (EC) No 726/2004, the

following additional statement shall be included "This

medicinal product is subject to additional monitoring".

This statement shall be preceded by the black symbol

referred to in Article 23 of Regulation (EC) No 726/

2004 and followed by an appropriate standardized

explanatory sentence.

For all medicinal products, a standardized text shall be

included, expressly asking patients to communicate any suspected

a d v e r s e r e a c t i o n t o h i s / h e r d o c t o r, p h a r m a c i s t , h e a l t h c a r e

professional or directly to the national spontaneous reporting

system referred to in regulations 24 and 25 of the

Pharmacovigilance Regulations, and specifying the different ways

of reporting available (electronic reporting, postal address and/or

others) in compliance with regulation 25 of the Pharmacovigilance

Regulations.

(2)

The list set out in subregulation (1)(c) hereof shall

(a) take into account the particular condition of certain

categories of users (children, pregnant or

breastfeeding women, the elderly, persons with

specific pathological conditions);

(b) mention, if appropriate, possible effects on the ability

to drive vehicles or to operate machinery;

(c) list those excipients knowledge of which is important

for the safe and effective use of the medicinal product

and which are included in the detailed guidance

published by the Commission pursuant to Article 65 of

Directive 2001/83/EC as amended by Directive 2004/

27/EC.

(3) The package leaflet shall reflect the results of consultations

with target patient groups to ensure that it is legible, clear and easy

to use.

(1) One or more mock-ups of the outer packaging and the

immediate packaging of a medicinal product, together with the

draft package leaflet, shall be submitted to the Licensing Authority,

hereinafter called the Authority, when the marketing authorisation

is requested. The results of assessments carried out in co-operation

with target patient groups shall also be provided to the Authority.

(2) The Authority shall refuse the marketing authorisation if

the labelling or the package leaflet do not comply with any of the

provisions of these regulations or if they are not in accordance with

the particulars listed in the summary of product characteristics

Provided that the Authority shall not prohibit or impede the

placing on the market of medicinal products on grounds connected

with labelling or the package leaflet where these comply with the

requirements of these regulations.

(3) All proposed changes to an aspect of the labelling or the

package leaflet covered by these regulations which are not

connected with the summary of product characteristics shall be

submitted to the Authority

Provided that if the Authority does not oppose a proposed

change within ninety days of receipt of the request, the applicant

may put the change into effect

Provided further that the legal liability of the manufacturer

and the marketing authorisation holder shall remain unaltered if the

Authority, contrary to the provisions of this regulation, approves a

marketing authorisation or a change to the labelling or the package

leaflet.

The outer packaging and the package leaflet shall not

include elements of a promotional nature but may include symbols

or pictograms designed to clarify certain information mentioned in

regulations 3 and 7(1) and other information compatible with the

summary of the product characteristics which is useful for the

patient.

(1) The particulars for labelling listed in regulations 3, 7 and

9 whether provided in printed form or by means of the electronic

package leaflet shall appear in an official language or official

languages of Malta

Provided that it will be possible for these particulars to be

indicated in several languages, as long as the same particulars

appear in all the languages used

Provided further that in the case of certain orphan

medicinal products, the particulars listed under regulation 3 may on

reasoned request, appear in one of the official languages of the

Community.

(2) The package leaflet, or electronic package leaflet, shall be

written and designed in such a way as to be clear and

understandable, enabling users to act appropriately, when necessary

even with the help of health professionals. The package leaflet, or

electronic package leaflet, shall be clearly legible in an official

language or official languages of Malta. When making use of the

electronic package leaflet and including the details of the outer

packaging through electronic means, the information shall be

presented in the following order: the full details of the outer

package, any information of the immediate packaging which is not

found on the outer packaging, followed by the information in the

package leaflet. No additional information shall be included

Provided that this shall not prevent the package leaflet or

electronic package leaflet from being accessible or printed in several

languages, provided that the same information is given in all the

languages used.

(3) Where the medicinal product is not intended to be delivered

directly to the patient, or where there are severe problems in respect of

the availability of the medicinal product, the Licensing Authority may,

subject to measures they consider necessary to safeguard human

health, grant an exemption to the obligation that certain particulars

should appear on the labelling and in the package leaflet. The

Licensing Authority may also grant a full or partial exemption to the

obligation that the labelling and the package leaflet must be in an

official language or official languages of Malta.

The Authority shall suspend the marketing authorisation if,

after the serving of a notice on the marketing authorisation holder,

the labelling and the package leaflet of the medicinal product in

question do not comply with any of the provisions of these

regulations. Such suspension shall cease to be effective as soon as

the labelling and package leaflet of the product in question have

been made to comply with the requirements of these regulations.

(1) In the case of radionuclides, the outer carton and

container of the medicinal product shall be labelled in accordance

with the regulations for the safe transport of radioactive materials

laid down by the International Atomic Energy Agency. Moreover,

the labelling, whether in printed form or by means of the electronic

package leaflet shall comply with the provisions set out in sub-

regulations (2) and (3).

(2) The label on the shielding shall include the particulars

mentioned in regulation 3 and shall

(a) explain in full, the codings used on the vial, and

(b) indicate, where necessary, for a given time and date,

the amount of radioactivity per dose or per vial and the

number of capsules, or, for liquids, the number of

millilitres in the container.

(3)

The vial shall be labelled with the following information

(a) the name or code of the medicinal product, including

the name or chemical symbol of the radionuclide,

(b) the batch identification and expiry date,

(c) the international symbol for radioactivity,

(d) the name and address of the manufacturer,

(e) the amount of

radioactivity

as

specified

in

subregulation (2).

It shall be the duty of the Authority to ensure that a

detailed instruction leaflet in accordance with the provisions of

regulation 7 is enclosed with the packaging of radio-

pharmaceuticals, radionuclide generators, radionuclide kits and

radionuclide precursors. T he leaflet shall also include any

precautions to be taken by the user and the patient during the

preparation and administration of the medicinal product and special

precautions for the disposal of the packaging and its unused

contents.

(1) Without prejudice to subregulation (2), homeopathic

medicinal products shall be labeled in accordance with the

provisions of these regulations and shall be identified by a

reference on their labels, in clear and legible form, to their

homeopathic nature.

(2) In addition to the clear mention of the words "homeopathic

medicinal product", the labelling and, where appropriate, the

package insert for the homeopathic medicinal products which have

qualified for a special simplified registration procedure referred to

in regulation 10 of the Medicines (Marketing Authorisation)

Regulations, shall bear the following, and no other, information

(a) the scientific name of the stock or stocks followed by

the degree of dilution, making use of the symbols of

the pharmacopoeia referred to in the definition of a

homeopathic medicinal product; if the homeopathic

MEDICINAL PRODUCTS

(LABELLING AND PACKAGING)

medicinal product is composed of two or more stocks,

the scientific names of the stocks on the labelling may

be supplemented by an invented name;

(b) name and address of the registration holder and, where

appropriate, of the manufacturer;

(c) method of administration and, if necessary, route;

(d) expiry date, in clear terms (month, year);

(e) pharmaceutical form;

(f)

contents of the sales presentation;

(g) special storage precautions, if any;

(h) a special warning if necessary for the medicinal

product;

(i)

manufacturer’s batch number;

(j)

registration number;

(k) homeopathic medicinal product without approved

therapeutic indications;

(l)

a warning advising the user to consult a doctor if the

symptoms persist.

Any person who obtains any product from a pharmacy or

from any other place licensed to dispense medicinal products,

which includes an electronic package leaflet, shall be entitled to

request the product leaflet in a printed form without any additional