Source: EURLEX
Language: en
Format: md

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# 91996E2553

**WRITTEN QUESTION No. 2553/96 by Kenneth COLLINS to the Commission. Single trade marks for pharmaceutical products** 
  
*Official Journal C 083 , 14/03/1997 P. 0026*

  

WRITTEN QUESTION E-2553/96 by Kenneth Collins (PSE) to the Commission (8 October 1996)

Subject: Single trade marks for pharmaceutical products

Is it the practice for the Commission to insist that applications for marketing authorizations for pharmaceutical products through the EMEA identify a single trade mark and pack livery for use in all Member States, including in some cases even the colour of the packaging?

If so, will the Commission say on what legal or institutional grounds it bases this practice?

Answer given by Mr Bangemann on behalf of the Commission (5 November 1996)

Any authorization to place a medicinal product on the market that has been issued under the centralized procedure introduced by Council Regulation (EEC) No 2309/93 ((OJ L 214, 24.8.1993. )) of 22 July 1993 laying down Community procedures for the authorization and monitoring of medicines for human and veterinary use and setting up a European Agency for the evaluation of medicinal products is valid throughout the Community and assigns, in each Member State, the same rights and obligations as a marketing authorization issued by that Member State. ((Article 12(1) of the Regulation referred to above. )) It includes the wording of the labelling and insert slip in the form required by Council Directive 92/27/EEC. ((OJ L 113, 30.4.1992. ))

It follows that there is in every sense one version of the Community marketing authorization for the entire Community, and that the same conditions are to apply in every Member State. Where a medicinal product has been authorized under the centralized procedure there is thus a single marketing authorization for the entire Community, a single holder of the marketing authorization, a single authorization number, a single summary of the characteristics of the product, a single product denomination, a single form of labelling and a single insert slip.

For obvious practical reasons, the holder of the marketing authorization is authorized to place on the market packagings containing information in only one, or in several languages, provided that the official language(s) of the Member State(s) concerned are among the languages used. As in the case of a medicinal product authorized by a Member State, the outer packaging of the medicine, a sample of which is attached to the authorization file for that medicine, may not be altered without the agreement of the competent authorities. ((See Article 10 of Directive 92/27/EEC. )) Where there is any such change this will apply throughout the Community.

The use of different colours is permitted where packaging sizes differ, provided that the various sizes relate to the dose rate and that, for a given size, the same packaging is used throughout the Community.

These principles have been applied without difficulty to all of the decisions on marketing authorizations so far issued by the Community on the basis of Regulation (EEC) No 2309/93.

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