Regulations, 2024

L.N. 309 of 2024

MEDICINES ACT

(CAP. 458)

Medicinal Products (Labelling and Packaging) (Amendment)

Regulations, 2024

IN EXERCISE of the powers conferred by article 106 of the

Medicines Act, the Minister responsible for public health, after

consultation with the Licensing Authority, has made the following

regulations:-

(1) The title of these regulations is the Medicinal

Products (Labelling and Packaging) (Amendment) Regulations, 2024

and these regulations shall be read and construed as one with the

Medicinal Products (Labelling and Packaging) Regulations,

hereinafter referred to as the "principal regulations".

(2) These regulations shall come into force within two (2)

months from the date of their publication in the Gazette.

In regulation 2 of the principal regulations, immediately

after the definition "common name" there shall be added the

following new definition

""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;".

In paragraph (s) of regulation 3 of the principal regulations,

the words "to any medicinal product." shall be substituted by the

words "to any medicinal product:" and immediately after, there shall

be added the following new proviso

"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.".

In sub-paragraph (v) of paragraph (c) of regulation 4 of the Amends

principal regulations, the words "by unit." shall be substituted by the regulation

the principal

words "by unit:" and immediately after, there shall be added the regulations.

following new proviso

"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.".

In regulation 6 of the principal regulations, the words Amends

"outer or immediate packaging." shall be substituted by the words regulation

the principal

"outer or immediate packaging:" and immediately after, there shall regulations.

be the added the following new proviso

"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.".

Regulation 10 of the principal regulations shall be amended Amends

regulation 10 of

as follows

the principal

regulations.

(a) in sub-regulation (1) thereof, immediately after the

words "regulations 3, 7 and 9" there shall be added the words

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

package leaflet";

(b) sub-regulation (2) thereof shall be substituted by the

following new sub-regulation

"(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.".

In sub-regulation (1) of regulation 12 of the principal

regulations immediately after the words "Moreover, the labelling"

there shall be added the words ", whether in printed form or by means

of the electronic package leaflet".

Immediately after regulation 14 of the principal

regulations, there shall be added the following new regulation

Any person who obtains any product from a

"Access to printed

pharmacy or from any other place licensed to dispense

information leaflet.

medicinal products, which includes an electronic

package leaflet, shall be entitled to request the product

leaflet in a printed form without any additional cost.".

€0.27