MEDICINAL PRODUCTS
(LABELLING AND PACKAGING) _g S.L.458.33 1
SUBSIDIARY LEGISLATION 458.33
MEDICINAL PRODUCTS (LABELLING AND 
PACKAGING) REGULATIONS
1st May, 2004
LEGAL NOTICE 401 of 2003.
Citation.
(Labelling and Packaging) Regulations.
Particulars on outer 
packaging.
2. 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 ) 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;
2 _g S.L.458.33
MEDICINAL PRODUCTS
(LABELLING AND PACKAGING)
( n ) in the case of self-medication, instruction on the use of
the medicinal products.
Blister packs. 3. ( 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.
Clarity of 
particulars.
4. The particulars referred to in regulations 2, 3 and 8 shall be
legible, comprehensible and indelible.
Inclusion of 
package leaflet.
5. A package leaflet shall be included in the packaging of all
medicinal products unless all the information required by
regulations 6 and 8 is directly conveyed on the outer or immediate
packaging.
Package leaflet. 6. 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) 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;
(ii) 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
MEDICINAL PRODUCTS
(LABELLING AND PACKAGING) _g S.L.458.33 3
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;
4 _g S.L.458.33
MEDICINAL PRODUCTS
(LABELLING AND PACKAGING)
( 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.
Specimens and 
mockups.
7. (1) One or more specimens or 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 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 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.
Promotion not to 
be included.
8. 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.
Labelling 
particulars.
9. (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.
MEDICINAL PRODUCTS
(LABELLING AND PACKAGING) _g S.L.458.33 5
(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.
Suspension of 
marketing 
authorisation.
10. 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.
Radionuclides.
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
subregulations (2) and (3).
(2) The label on the shielding shall include the particulars
mentioned in regulation 2 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 of the manufacturer;
( e ) the amount of radioactivity as specified in
subregulation (2).
Duty of the 
Authority.
12. It shall be the duty of the Authority to ensure that a
detailed instruction leaflet in accordance with the provisions of
regulation 6 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.
