European Commission publishes proposals on new variations procedure

In November 2008 European Commission Regulation No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products was adopted. It makes provision for changes in the ways in which manufacturers make application to vary authorisations and in which regulatory authorities handle them.

The Regulation has been welcomed by industry, which sees it as a means of improving the process by which variations - particularly more trivial ones - can be made to authorisations. Currently the processing and implementation of many minor variations can often take a disproportionate amount of time and administrative effort.

One of the provisions of the Regulation was that the European Commission would publish guidance as to its implementation. Two documents have recently been issued for comment by the Commission that make recommendations for this guidance and on which the views of stakeholders are sought.

The first document describes the operation of the new requirements, including the mechanism for handling variations of the Type IA variety which can be made on a "do and tell" basis. It goes on to describe the system for the submission of other variations of types IB and II which will continue to need to be the subject of prior notifcation to the authorities The second document makes proposals on the classification of the various sorts of variation into the appropriate type.

Consultation on the proposals closes on 18 May and will be the subject of attention by industry, which will no doubt make full responses by the due date.