GMP: New answers published about Variations: EMA\'s updated
The European Medicines Agency (EMA) offers a Q&A page which contains a collection of questions and answers on all regulatory activities linked to the issue of drug marketing authorisations. This Q&A page is usually updated on a short notice. Based on the regularity of new developments, a compilation of these questions and answers is published as a guideline entitled \"Post-Authorisation Procedural Advice Human Medicinal Products\".
The source of the news: http://www.gmp-compliance.org/eca_news_2519_6874,6881,6991,6975,6970.html