MEDICINAL PRODUCTS (PACKAGE LEAFLETS AND LABELLING)(TRANSITIONAL ARRANGEMENTS) REGULATIONS

M ED ICI NA L PR OD UC TS (PAC KA GE LEAF LETS A ND

LA BELL ING )( TRA NS IT IO NAL ARRA NG EM EN TS )

SUBSIDIARY LEGISLATION 458.50

MEDICINAL PRODUCTS (PACKAGE LEAFLETS

AND LABELLING)(TRANSITIONAL

ARRANGEMENTS) REGULATIONS

19th December, 2006

LEGAL NOTICE 325 of 2006, as amended by Legal Notice 253 of 2010.

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

(Package Leaflets and Labelling) (Transitional Arrangements)

Regulations.

(2) The transitional arrangements made in these regulations

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

until the 31st December, 2014 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, or a parallel

import licence is granted.

(4) Provided that the transitional arrangements made in these

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 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 in Malta if the packaging and package leaflet, as approved,

are either in the English or Maltese language or both.

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

au tho risatio n is r eq uir ed f o r p lacin g o n th e mar ket, all the

documentation required by the Medicines Authority may be

submitted in the English and, or Maltese language.