Regulation 1995/541 - Examination of variations to the terms of a marketing authorization granted by a competent authority of a Member State - Main contents

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Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization granted by a competent authority of a Member State

Official Journal L 055 , 11/03/1995 P. 0007 - 0014

COMMISSION REGULATION (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization granted by a competent authority of a Member State

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 75/319/EEC of 20 May 1975, on the approximation of provisions laid down by law, regulations or administrative action relating to medicinal products (1), as last amended by Council Directive 93/39/EEC (2) of 14 June 1993, and in particular Article 15 thereof,

Having regard to Council Directive 81/851/EEC of 28 September 1981, on the approximation of legislation of the Member States relating to veterinary medicinal products (3), as last amended by Council Directive 93/40/EEC (4), and in particular Article 23 thereof,

Whereas, appropriate provisions should be adopted for the examination of variations to the terms of a marketing authorization of medicinal products which have benefited from the procedures of mutual recognition foreseen in Articles 7 and 7a of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (5), as last amended by Directive 93/39/EEC, in Article 9 (4) of Council Directive 75/319/EEC or in Articles 8, 8a and 17 (4) of Council Directive 81/851/EEC, and medicinal products for which there has been a referral to the procedures foreseen by Articles 13 and 14 of Directive 75/319/EEC or Articles 21 and 22 of Directive 81/851/EEC;

Whereas, these provisions should also apply to the examination of applications to vary the terms of a marketing authorization which had been considered within the scope of application of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high technology medicinal products, particularly those derived from biotechnology (6);

Whereas, it is appropriate to include a notification system or administrative procedures concerning 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 from 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,

HAS ADOPTED THIS REGULATION:

Scope and definitions

Article 1

• 1. 

  This Regulation lays down the procedure for the examination of applications for variations to the terms of a marketing authorization of medicinal products which have been considered within the scope of application of Directive 87/22/EEC, of medicinal products having benefited from the procedures of mutual recognition foreseen in Articles 7 and 7a of Directive 65/65/EEC, Article 9 (4) of Directive 75/319/EEC or Articles 8, 8a and 17 (4) of Directive 81/851/EEC, and medicinal products for which there has been a referral to the procedures foreseen by Articles 13 and 14 of Directive 75/319/EEC or Articles 21 and 22 of Directive 81/851/EEC.

• 2. 

  This Regulation does not impede the marketing authorization holder(s) from taking provisional urgent safety restrictions in the event of risk to public or animal health. The holder(s)...

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