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)

Publication Date27 Jun 2003
SubjectTechnical barriers,Internal market - Principles,public health
Official gazette publicationOfficial Journal of the European Union, L 159, 27 June 2003
EUR-Lex - 32003R1084 - EN 32003R1084

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 restrictions should be clarified.

(11) Further clarification should be introduced as regards revision of the summary of product characteristics, labelling and package leaflet/insert; nevertheless the procedures laid down in this Regulation should not apply to changes to the labelling or to the package leaflet/insert which are not consequential to changes to the summary of product characteristics.

(12) For the sake of clarity, it is appropriate to replace Regulation (EC) No 541/95.

(13) The measures provided for in 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:

Article 1

Subject matter

This Regulation lays down the procedure for the examination of notifications of and applications for variations to the terms of a marketing authorisation 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 set out in Articles 17, 18 and 28(4) of Directive 2001/83/EC or Articles 21, 22 and 32(4) of Directive 2001/82/EC, and medicinal products for which there has been a referral to the procedures set out in Articles 32, 33 and 34 of Directive 2001/83/EC or Articles 36, 37 and 38 of Directive 2001/82/EC.

Article 2

Scope

This Regulation shall not apply to:

(a) extensions of marketing authorisations which fulfil the conditions set out in Annex II to this Regulation;

(b) transfers of a marketing authorisation to a new holder;

(c) changes to the maximum residue limit as defined in Article 1(1)(b) of Council Regulation (EEC) No 2377/90(7).

The extensions referred to in point (a) of the first paragraph shall be examined in accordance with the procedure referred to in Article 17 of Directive 2001/83/EC and in Article 21 of Directive 2001/82/EC.

Article 3

Definitions

For the purposes of this Regulation, the following definitions shall apply:

1. "Variation to the terms of a marketing authorisation" means:

(a) for medicinal products for human use: an amendment to the contents of the documents referred to in Articles 8 to 12 of Directive 2001/83/EC;

(b) for veterinary medicinal products: an amendment to the contents of the documents referred to in Articles 12 to 15 of Directive 2001/82/EC.

2. A "minor variation" of Type IA or Type IB means a variation listed in Annex I which fulfils the conditions set out therein.

3. A "major variation" of Type II means a variation which cannot be deemed to be a minor variation or an extension of the marketing authorisation.

4. "Reference Member State" means the Member State which, for a given medicinal product, has produced the assessment report which served as the basis for the procedures referred to in Article 1 or alternatively the Member State chosen in this respect by the marketing authorisation holder with a view to application of this Regulation.

5. "Urgent safety restriction" means an interim change to the product information concerning particularly one or more of the following items in the summary of product characteristics, the indications, posology, contraindications, warnings, target species and withdrawal periods, due to new information having a bearing on the safe use of the medicinal product.

Article 4

Notification procedure for minor variations type IA

1. With regard to minor variations of type IA, the marketing authorisation holder (hereinafter referred to as the holder) shall submit simultaneously to the competent authorities of...

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