News 2012

07.05.2012
EU: IMPD requirements for the Quality part of biological/biotechnology derived substances defined
- final Guideline released; applicable since April 15, 2012- The European Medicines Agency published the final guideline on the requirements for quality documentation concerning biological ... More
14.06.2012
EU: Review of the Variations Guideline
- Public Consultation Paper released for comment - The European Commission published a consultation paper reviewing the “Guideline on the details of the various categories of variations”. The ... More
10.07.2012
Importation of Active Substances- new Rules for Written Confirmation of GMP-Compliance Published
- New Templates for written Confirmation of GMP-Compliance published; applicable as of July 2, 2013 - On July 10, 2012, the European Commission published the template for written ... More

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