Medicinal Products (Labelling and Packaging) Regulations, 2005

L.N. 393 of 2005

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Medicinal Products (Labelling and Packaging) Regulations, 2005

IN exercise of the powers conferred by article 106 of the Medicines

Act, 2003, the Minister of Health, the Elderly and Community Care has

made the following regulations>-

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

commencement and

(Labelling and Packaging) Regulations, 2005.

scope.

(2) These regulations shall come into force on the 30th

October, 2005.

(3) The scope of these regulations is transpose Directive

2001#83#EC.

For the purposes of these regulations>

Interpretation.

“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<

“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<

“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.

(a) The particulars laid down under regulation 3 shall appear Blister packs.

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.

(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.

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.

(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

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< the patient should be expressly

asked to communicate any adverse reaction which is not mentioned

in the package leaflet to his doctor or pharmacist<

(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.

(2) The list set out in paragraph (c) of sub-regulation(1)

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 Mockups.

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 cooperation 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 Promotion not to be

included.

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 Labelling

particulars.

and 9 shall appear in the 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 must be written and designed to be

clear and understandable, enabling the users to act appropriately, when

necessary with the help of health professionals. The package leaflet

must be clearly legible in the official languages of Malta>

Provided that this shall not prevent the package leaflet from being

printed in several languages, provided that the same information is given

in all the languages used.

(3) When the product is not intended to be delivered directly

to the patient, the Authority may grant an exemption to the obligation

that certain particulars should appear on the labelling and in the package

leaflet and that the leaflet must be in the 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

shall comply with the provisions set out in sub-regulations (2) and (3)

hereof.

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

mentioned in regulation 3 and shall>

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

(ii) 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 Duty of the

Authority.

instruction leaflet in accordance with the provisions of regulation 7 is

enclosed with the packaging of radiopharmaceuticals, radionuclide

generators, radionuclide kits and radionuclide precursors. The 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 sub-regulation (2) of this Homeopathic

regulation, homeopathic medicinal products shall be labeled in medicinal products.

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,

2005, 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 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.

14. The Medicinal Products (Labelling and Packaging)

Repeals L.N. 401 of

2003. Regulations, 2003 are hereby repealed.

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