S.L. 458.50 Art. 1Citation, duration and applicability.

(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.