EMEA and EU Commission – Topical News
European Commission: Draft Guidelines according to Articles 4 (1) (a) and 4 (1) (b) of the New Variations Regulation (EC) No. 1234/2008
Dr. Brigitte Friese
Rechtsanwältin, Wyk-Wrixum auf Föhr (Germany)
On 24 November 2008 the new Commission Regulation (EC) No. 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products has been issued and published in the Official Journal on 12 December 2008 (OJ No. L 334, p. 7 ff). It shall apply from 1 January 2010. On March 20, 2009, the Commission issued 2 draft guidelines for public consultation until 18 May 2009. One of these guidelines (Operational Guideline) offers guidance on the operation of the different variation procedures including the new procedures for grouping of variation, recommendation on unforeseen variations and worksharing procedure. The second guideline (Categorisation Guidline) deals with the categorisation of the different types of variations containing lists of variations, examples for type IA variations requiring immediate notification, marked type IAIN variations and examples for type IB notifications and type II variations. Furthermore, conditions to be fulfilled for the categorisation of variations are pointed out.
pharmind 2009, Nr. 4, Seite 604