The European Medicines Agency has published a set of questions and answers concerning the initial phases of the operation of the pharmacovigilance legislation.
The document clarifies some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year. It includes the agreed position of the European Union (EU) regulatory network, following discussions between the Agency, national regulatory authorities and the European Commission services.
The document includes answers to frequently asked questions on the following topics:
The Agency will update the question-and-answer document on a regular basis with questions received at firstname.lastname@example.org. The Agency cannot reply directly to questions submitted to this address.
The Agency encourages company employees to read this document in conjunction with the questions and answers on transitional arrangements published by the European Commission in February 2012.
Source: EMA press release