L 159/24 Official Journal of the European Union 27.6.2003 COMMISSION REGULATION (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, (4) Having regard to the Treaty establishing the European Com- munity, Having regard to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (1), as amended by Commission Regulation (EC) No 649/98(2) and in particular Articles 15(4) and 37(4) thereof, Whereas: (1) In the light of practical experience in the application of Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation falling within the (6) scope of Council Regulation (EEC) No 2309/93 (%), as amended by Regulation (EC) No 1069/98 (4), it is appropriate to simplify the procedure for varying the terms of a marketing authorisation. (2)  Due to the technical adaptation of Annex I to Directive 2001/83[EC of the European Parliament and of the Council of 6 November 2001 on the Community code related to medicinal products for human use (%), it is 7) appropriate to introduce in this Regulation provisions on variations related to plasma master files and vaccine antigen master files. (3)  Some of the procedures laid down in Regulation (EC) No 542/95 should therefore be adjusted but without ®) departing from the general principles on which those procedures are based. OJ L 214,24. 8.1993,p. 1. OJ L 88,24.3.1998,p. 7. OJ L 55,11.3.1995,p. 15. 9) OJ L 153,27.5.1998, p. 11. OJ L 311,28.11.2001, p. 67. It is appropriate to provide for a simplified and rapid notification procedure to enable the introduction of certain minor changes, which do not affect the approved quality, safety or efficacy of the product, without prior evaluation by the European Agency for the evaluation of medicinal products (hereinafter referred to as ‘the Agency’). However, for other types of minor variations evaluation of the submitted documentation by the Agency should still be required. The various types of minor variation should be classified in order to determine the procedure to follow; it is particularly necessary to give a precise definition of the type of minor variation for which no prior evaluation is needed. It is necessary to clarify the definition of an ‘extension’ to a marketing authorisation, although it should still be possible to submit a separate, full application for marketing authorisation for a medicinal product which has already been authorised but under a different name and with summary of product characteristics. It is appropriate to allow the Agency to reduce the evaluation period in urgent cases or to extend it in the case of a major variation entailing important changes. It is necessary to simplify the administrative procedures for minor variations regarding the updating of marketing authorisations by allowing the Commission to group these updates every six months in one single decision. The time-frame for the procedure to be followed where the Commission imposes urgent safety restrictions should be clarified.