Medicinal Products (Labelling and Packaging) Regulations 2003 (tikkettjaruppakkjar)

L.N. 401 of 2003

MEDICINES ACT, 2003

(ACT NO. III OF 2003)

Medicinal Products (Labelling and Packaging) Regulations 2003

IN exercise of the powers conferred by article 106 of the

Medicines Act, 2003, the Minister of Health has made the following

regulations>-

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

commencement.

(Labelling and Packaging) Regulations, 2003.

(2) These regulations shall come into force on the 1 st May,

2004.

The following particulars shall appear on the outer packaging Particulars on outer

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

the immediate packaging>-

(a) where the product contains only one active substance

and if its name is an invented name, the name of the medicinal

product followed by the common name< where a medicinal product

is available in several pharmaceutical forms and, or several

strengths, the pharmaceutical form and, or the strength (baby, child

or adult as appropriate) must be included in the name of the

medicinal product<

(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 guidelines published

by the Commission. However, if the product is injectable, or a

topical or eye preparation, all excipients must be stated<

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

(f) a special warning that the medicinal product must be

stored out of reach 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) special precautions, if appropriate for the disposal of

unused medicinal products or their waste materials<

(k) the name and address of the holder of the market

authorisation<

(l) the number of the market authorisation<

(m) the manufacturer’s batch number<

(n) in the case of self-medication, instruction on the use of

the medicinal products.

(a) The following particulars shall appear on the immediate

packaging when this takes the form of a blister pack and which is then

placed in an outer packaging which complies with the provisions of

these regulations >

(i) the name of the medicinal product

(ii) the name of the holder of the market authorisation<

(iii) the expiry date,

(iv) the batch number.

(b) In the case of small immediate packaging units on which

the particulars laid down under regulations 2 and 8 cannot be

displayed, the following particulars shall appear>

(i) the name of the medicinal product and, if necessary,

the strength and 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.

The particulars referred to in regulations 2, 3 and 8 shall be Clarity of

particulars.

legible, comprehensible and indelible.

A package leaflet shall be included in the packaging of all Inclusion of

package leaflet.

medicinal products unless all the information required by regulations 6

and 8 is directly conveyed on the outer or immediate packaging.

The package leaflet shall be drawn up in accordance with the Package leaflet.

summary of the product characteristics and shall include, in the following

(a)

for the identification of the medicinal product>

(i) if the product contains only one active substance

and if its name is an invented one, the name of the medicinal

product, followed by the common name< where a medicinal

product is available in several pharmaceutical forms and, or

several strengths, the pharmaceutical form, and or the strength,

such as baby, child or adult, shall be included in the name of

the medicinal product<

(b) in the case of each presentation of the medicinal product>

(i) a full statement of the active substances and

excipients expressed qualitatively and a statement of the active

substances expressed quantitatively, using their common

names,

(ii) the full pharmaceutical form and the contents by

weight, by volume or by number of doses of the product,

(iii) the pharmaco-therapeutic group, or type of activity

in terms easily comprehensible for the patient,

(iv) the name and address of the manufacturer and the

holder of the market authorisation<

(c)

the therapeutic indications<

(d) a list of information which is necessary before taking

the medicinal product>

(i) contra-indications,

(ii) appropriate precautions for use,

(iii) forms of interaction with other medicinal products

and other forms of interaction

(iv) special warnings which may affect the action of

the medicinal product>

Provided that the above-mentioned list must take into account the

particular condition of certain categories of users, mention, if

appropriate, potential effects on the ability to drive vehicles or to operate

machinery and detail those excipients, which are included in the

guidelines published by the Commission and knowledge of which is

important for the safe and effective use of the medicinal product<

(e) the necessary and usual instruction for proper use, in

particular>

(i) the dosage,

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

administration,

(iii) the frequency of administration, specifying where

necessary, the appropriate time at which the medicinal product

may or must be administered<

(f)

depending on the nature of the product>

(i) the duration of treatment,

(ii) the action to be taken in the case of an overdose,

(iii) the course of action to take when one or more doses

have not been taken,

(iv) an indication, if necessary, of the risk of

withdrawal effects<

(g) a description of the undesirable effects which can occur

by the normal use of the medicinal product and, any action to be

taken in such a case< the patient should be expressly invited to

communicate any undesirable effect which is not mentioned in

the leaflet to his doctor or to his pharmacist<

(h) a reference to the expiry date indicated on the label,

with>

(i) a warning against using the product after this date,

(ii) where appropriate, special storage precautions,

(iii) if necessary, a warning against certain visible signs

of deterioration<

(i) the date on which the package leaflet was last revised>

Provided that in the case of therapeutic indications the Licensing

Authority may decide that certain therapeutic indications shall not be

mentioned in the package leaflet, where the dissemination of such

information might have serious disadvantages for the patient.

(1)

One or more specimens or mock-ups of the outer Specimens and

mockups.

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 an application for a

marketing authorisation is being submitted.

(2) The Authority shall refuse the marketing authorisation

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

provisions of this regulation or if they are not in accordance with the

particulars listed in the summary of product characteristics.

(3) Changes to the labelling or the package leaflet 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 90 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 information mentioned in regulations 2 and 6 and

any other information compatible with the summary of the product

characteristics which is useful for health education.

(1) The particulars of labelling listed in regulation 2, 6 and

8 shall appear in one of 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 the package leaflet can be printed in

several languages as long as the same information is given in all the

languages used.

(2) The package leaflet must be written in clear and

understandable terms for the users and be clearly legible Maltese or in

English.

(3) The Authority may exempt labels and package leaflets

for specific medicinal products from the obligation that certain

particulars shall appear and that the leaflet must be in Maltese or in

English, when the product is not intended to the delivered to the patient

for self-administration.

The Authority shall suspend the marketing authorisation ,

if, after the service of a notice on the marketing authorisation holder,

the labeling 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 labeling 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 the

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 2 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 of the manufacturer,

(e) the amount of radioactivity as specified in sub-regulation

(2).

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

instruction leaflet in accordance with the provisions of regulation 6 is Authority.

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.