Medicinal Products (Labelling and Packaging)

L.N. 351 of 2013

MEDICINES ACT

(CAP. 458)

Medicinal Products (Labelling and Packaging)

(Amendment) Regulations, 2013

IN exercise of the powers conferred by article 106 of the

Medicines Act, the Minister for Health, after consultation with the

Licensing Authority, has made the following regulations:-

(1) The title of these regulations is the Medicinal Citation, scope

Products (Labelling and Packaging) (Amendment) Regulations, 2013, and

commencement.

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

Medicinal Products (Labelling and Packaging) Regulations, S.L.458.33

hereinafter referred to as "the principal regulations".

(2) The scope of these regulations is to transpose amendments

to Directive 2001/83/EC on the Community code relating to

medicinal products for human use, brought about by Directive 2012/

26/EU, as regards pharmacovigilance.

(3) These regulations shall be deemed to have come into force

on the 28th October, 2013.

Regulation 10 of the principal regulations shall be Amends

regulation 10 of

amended as follows

the principal

regulations.

(a)

in sub-regulation (1) thereof, for the words from

"The particulars" to "languages of Malta:" there shall be

substituted the following

"The particulars for labelling listed in regulations

3, 7 and 9 shall appear in an official language or official

languages of Malta:";

(b) in sub-regulation (2) thereof, for the words from

"The package leaflet" to the words "languages of Malta" there

shall be substituted the following

"The package leaflet must 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 must be

clearly legible in an official language or official languages

of Malta:"; and

(c)

for sub-regulation (3) thereof there shall be

substituted the following

"(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.".

€0.18