325 tal-2006 - Regolamenti tal-2006 dwar Arranġamenti Transitorji dwar il-Fuljett ta’ Tagħrif u Ippakkettjar fi Prodotti Mediċinali

L.N. 325 of 2006

MEDICINES ACT

(CAP. 458)

Medicinal Products (Package Leaflets and Labelling)

(Transitional Arrangements) Regulations, 2006

BY virtue of the powers conferred by article 106 of the Medicines

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

the following regulations>–

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

duration and

(Package Leaflets and Labelling) (Transitional Arrangements) applicability.

Regulations, 2006.

(2) The transitional arrangements made in these regulations

shall, subject to any amendments that may be made thereto, apply until

the 31 st December, 2009 unless earlier revoked or their period of

application is further extended.

(3) The transitional arrangements made in these regulations

shall apply for all medicinal products for human use, for which a

marketing authorisation, an authorisation in line with article 4(2) of the

Medicines (Marketing Authorisation) Regulations, 2004 or a parallel L.N. 387 of 2004.

import licence is granted.

(4) Provided that the transitional arrangements made in these Interpretation.

regulations shall in no way prejudice the language requirements in

relation to applications for the granting of a marketing authorisation in

accordance with the community procedures laid down in Council

Regulation (EC) No. 726#2004 of the European Parliament and of the L.N. 393 of 2005.

Council of 31 March 2004 laying down Community procedures for the

authorisation and supervision of medicinal products for human and

veterinary use and establishing a European Medicines Agency.

Any authorised medicinal product may be placed on the market Language

requirements for

in Malta if the packaging and package leaflet, as approved, are either in medicinal products

to be placed on the

the English or Maltese language or both.

market in Malta.

The Licensing Authority may, in the case of specific products,

order that the package leaflet shall be in both the English and Maltese

languages.

In the case of medicinal products for which an authorisation

is required for placing on the market, all the documentation required by

the Medicines Authority may be submitted in the English and, or Maltese

language.

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