Farmakovijilans mevzuatın uygulanması konusunda sorular ve cevaplar…

Söz konusu sayfa 2010 Farmakovijilans mevzuatının uygulanması konusunda sorular ve cevaplar içermekte. 

Questions and answers on implementation of pharmacovigilance legislation

This page includes questions and answers for pharmaceutical companies on the implementation of the 2010 pharmacovigilance legislation.

These questions and answers were provided by the European Medicines Agency, European Union (EU) Member States and the European Commission in preparation for July 2012, when the legislation began to apply. The Agency encourages company employees to read both documents below.

Practical transitional measures

In May 2012, the European Medicines Agency published questions and answers to clarify some practical considerations that pharmaceutical companies will need to take into account before and after the legislation comes into force:

The document includes the views of the Agency and medicines regulatory authorities in EU Member States in response to questions received on the following topics:

  • good pharmacovigilance practice guidelines;
  • pharmacovigilance system master files and summary of the pharmacovigilance system;
  • risk management plans;
  • post-authorisation safety studies;
  • periodic safety update reports and EU reference date list;
  • literature monitoring;
  • product information and the black symbol;
  • adverse-drug-reaction reporting and signal management;
  • renewals.

The Agency and Member States will update this document on a regular basis, including the answers to additional questions received.

Transitional arrangements

In February 2012, the European Commission published questions and answers on transitional arrangements for the legislation:

The document provides answers to legal and practical questions on:

  • renewal of applications;
  • marketing-authorisation applications pending at the date when the new provisions start to apply;
  • pharmacovigilance system master files;
  • risk management plans ;
  • involvement of the Pharmacovigilance and Risk Assessment Committee (PRAC) for referrals and periodic safety update reports;

post-authorisation safety studies.