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Stanovisko Európskej komisie: "Definícia pojmu rovnaký liek" 9.5.2005

B.01-4

EUROPEAN COMMISSION

ENTERPRISE DIRECTORATE-GENERAL

Single market, implementation and legislation for consumer goods

Pharmaceuticals : regulatory framework and market authorisations

VMRF/414/04

Brussels, 20.08.2004 - 007857

ENTR/F/2/KK D(2004) 631509

Mrs Maggie Gething

Chairman VMRF Group

EMEA

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4HB

United Kingdom

Definition of the term ”same medicinal product”

Dear Mrs Gething,

Thank you for your letter dated 30 June 2004 concerning the definition of the term “same medicinal product”.

We confirm that the Commission Communication 98/C 229/03 on the Community marketing authorisation procedures for medicinal products (OJ C 229/4 of 22.07.1998) and number 3.1.2 of Chapter 2 of Notice to Applicants Volume 6A identify the same medicinal product as stemming from the same applicant, having the same qualitative and quantitative composition in active substances (i.e. the same strength) as well as having the same pharmaceutical form. Therefore, the mutual recognition procedure has to be followed. A proposed different legal basis can not be considered a reason to accept an application as a mere national one. The legal basis in the Concerned Member States is automatically the same as in the Reference Member State since a mutual recognition procedure is obligatory.

Yours sincerely,

signed

Philippe Brunet
Head of Unit

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