Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93

COMMISSION REGULATION (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93
THE COMMISSION OF THE EUROPEAN  COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of  Medicinal Products (1), and in particular Articles 15 (4) and 37 (4) thereof,
Whereas, appropriate provisions should be adopted for the examination of variations to the terms of a marketing authorization of medicinal products which have been authorized in accordance with Regulation (EEC) No 2309/93;
Whereas, it is appropriate to include a notification system or administrative procedures concernng minor variations for which it is necessary to precisely define minor variations;
Whereas, moreover, it is necessary to distinguish from amongst those variations which do not qualify as minor variations, those which must be considered to so fundamentally alter the marketing authorization, particularly form the point of view of the  quality, safety or efficacy of a medicinal product, that a new application for a marketing authorization would be required;
Whereas, the provisions of this Regulation are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use and the Standing Committee on Veterinary Medicinal Products,