Outcome of the public Consultation on the Review of the Variations Guidelines
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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
Related GMP News
21.10.2026Switzerland: GMP Compliance by Foreign Manufacturers
14.10.2026EU Pharma Package: Council Adopts New Rules
14.10.2026ICH Publishes New Training Material for Quality Guidelines
14.10.2026WHO issues Draft Guidance on Quality Risk Management
26.08.2026GMP and "Planned Deviations" - a Contradiction?
19.08.2026Why Root Cause Analysis is the Key to efficient CAPA