Outcome of the public Consultation on the Review of the Variations Guidelines

The European Commission, Health and Consumers Directorate-General has published the outcome of the public consultation on the review of Regulation (EC) 1234/2008 article 4 (variations guidelines).

The document summarises 40 contributions made by stakeholders. Fourteen were made by industry associations and the same number by individual companies. Five were made by national authorities like for example the German BfArM and the Danish Health and Medicines Authority.

The summary mainly reflects comments related to new variations or new wording in the classification of variations, given by a significant number of stakeholders. Quite a few descriptions of variations seemed to be unclear and more clarification has been requested, others have been considered as not appropriate.

Source: http://ec.europa.eu/health/better-regulation-var_2013_en.htm