Regulation 2003/1084 - Examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State - Main contents

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Commission Regulation (EC) No 1084/2003 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 granted by a competent authority of a Member State (Text with EEA relevance)

Official Journal L 159 , 27/06/2003 P. 0001 - 0023

Commission regulation (EC) No 1084/2003

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 granted by a competent authority of a Member State

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(1), and in particular Article 35(1) thereof,

Having regard to Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(2), and in particular Article 39(1) thereof,

Whereas:

• (1) 

  In the light of practical experience in the application of Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State(3), as amended by Regulation (EC) No 1146/98(4), it is appropriate to simplify the procedure for varying the terms of a marketing authorisation.

• (2) 

  Some of the procedures laid down in Regulation (EC) No 541/95 should therefore be adjusted but without departing from the general principles on which those procedures are based.

• (3) 

  In consequence of the adoption of Directives 2001/82/EC and 2001/83/EC, which codified Community legislation in the field of veterinary medicinal products and medicinal products for human use respectively, references to provisions of that legislation should be updated.

• (4) 

  This Regulation should continue to apply also to the examination of applications for variation of the terms of a marketing authorisation granted under Council Directive 87/22/EEC(5) repealed by Directive 93/41/EEC(6).

• (5) 

  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 reference Member State. However, for other types of minor variation evaluation of the submitted documentation by the reference Member State should still be required.

• (6) 

  In cases where the evaluation procedure is maintained the reference Member State should evaluate the file on behalf of all Member States concerned in order to avoid duplication of work.

• (7) 

  The various types of minor variation should be classified according to the conditions to be fulfilled 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.

• (8) 

  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 a marketing authorisation for a medicinal product which has already been authorised, but under a different name and with a different summary of product characteristics.

• (9) 

  It is appropriate to allow national authorities of the reference Member States to reduce the evaluation period in urgent cases or to extend it in the case of a major variation entailing important changes.

• (10) 

  The time-frame for the procedure to be followed where the competent authority imposes urgent safety...

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