11. 3. 95 Official Journal of the European Communities No L 55/15 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 ('), 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 varia- tions ; 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 funda- mentally 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 marke- ting authorization would be required ; Whereas, the provisions of this Regulation are in accor- dance 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 () OJ No L 214, 24. 8. 1993, p. 1. a marketing authorization granted in accordance with Regulation (EEC) No 2309/93. 2. This Regulation does not impede the marketing authorization holder from taking provisional urgent safety restrictions in the event of risk to public or animal health. The holder shall forthwith inform the Agency. If the Agency has not raised any objections within 24 hours, the urgent safety restrictions may be introduced and the corresponding application for this variation shall be submitted without delay to the Agency for the application of the procedures set out in Articles 6 and 7 of this Regu- lation. Article 2 For the purpose of this Regulation, the following defini- tions shall apply; 1. ‘variation to the terms of a marketing authorization’ : an amendment to the contents of the documents referred to in Article 6 (1) and (2) or Article 28 (1) and (2) of Regulation (EEC) No 2309/93 such as they existed at the moment the decision on the marketing authorization has been adopted in accordance with Article 10 or Article 32 of that Regulation or after approval of any previous variations, except where a new application for a marketing authorization must be presented pursuant to Annex II to this Regulation. 2. ‘Urgent safety restriction’: an interim change to product information by the marketing authorization holder restricting the indication(s), and/or dosage, and/or target species of the medicinal product; or adding a contra-indication, and/or warning due to new information having a bearing on the safe use of the product. Article 3 1. (@) A ‘minor variation’ (type 1) means a variation as defined in Article 2 and listed in Annex I to this Regulation, provided the conditions for such varia- tion laid down in the said Annex are met. (b) A ‘major variation’ (type II) means a variation as defined in Article 2 which cannot be deemed to be a type I variation within the meaning of the pre- ceding paragraph.