PL EN

EMA: Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products

25.09.2014
This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and chapter 3 of Regulation (EC) No726/2004 [REG], which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union (EU).

kapitał ludzki

fundusz społeczny

Narodowe Centrum Badań i Rozwoju

innowacyjna gospodarka

rozwój regionalny