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

• Coming into Force: 14 March 1995
• End of Effective Date: 30 September 2003
• Celex Number: 31995R0542
• ELI: http://data.europa.eu/eli/reg/1995/542/oj
• Published date: 11 March 1995
• Date: 10 March 1995
• Official Gazette Publication: Official Journal of the European Communities, L 55, 11 March 1995

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31995R0542

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

Official Journal L 055 , 11/03/1995 P. 0015 - 0021

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,

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 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 Regulation.

Article 2

For the purpose of this Regulation, the following definitions 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) A 'minor variation' (type I) means a variation as defined in Article 2 and listed in Annex I to this Regulation, provided the conditions for such variation 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 preceding paragraph.

2. For the purposes of this Regulation, transfer of marketing authorization to a new holder, except for the situations covered by the point 3 of Annex I to this Regulation, and changes to the maximum residue limit (MRL) shall not be considered as a variation in the meaning of Article 2 (1).

Notification procedure for minor variations

Article 4

1. To obtain a type I variation, the holder of the marketing authorization shall submit to the Agency an application, accompanied by documents demonstrating that the conditions laid down in Annex I to this Regulation for the requested variation are met, and all documents amended as a result of the application.

2. An application within the meaning of paragraph 1 shall not concern more than one variation in the marketing authorization. Where several variations are to be made to a single marketing authorization, an application shall be submitted within the meaning of paragraph 1 in respect of each variation sought; each such application shall contain a reference to the other application(s).

3. By derogation from paragraph 2, where a variation in the marketing authorization entails one or more further changes, a single application may cover all such consequential variations. The single application shall describe the relation between the main variation and its consequential variations.

4. To...