Pharmacovigilance scope

In Eebruary 2005, the EC issued a draft consultation regulation for laying down the procedure to adopt the maximum amounts and the conditions and methods for collection of financial penalties imposed by the EC under Regulation No (EC) 726/2004. The scope of this Regulation is wide and includes (but not restricted to) pharmacovigilance and market surveillance, in accordance with chapter 3 of Title II, chapter 3 of Title III of Regulation (EC) No 726/2004 and any other provisions adopted pursuant to them and with Article 9(1) of Regulation (EC) 1085/2003. 

Council Regulation 726/2004/EC (updates and expands the previous regulation 239/1993/EC), which mainly concerns the duties of the European Medicines Agency (EMEA), establishment of the Committee for Medicinal Products for Human Use (CHMP), and the scope and mechanisms of the centralized procedure for marketing authorization applications (MAAs) and pharmacovigilance issues. 

Pharmacovigilance is obligatory for producers, but in some countries it is obligatory for all involved health professionals as well. Radiopharmaceuticals are included in the scope of pharmacovigilance. 

This book has broader scope than the title suggests and covers pharmacovigilance from industry, academic and regulatory perspectives. A new edition is in preparation and it might be best to wait for that. 

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