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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
