Questions and answers on implementation of pharmacovigilance legislation

This page includes information for pharmaceutical companies on the implementation of the 2010 pharmacovigilance legislation.

These documents 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 all of the 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. These were updated in November 2012:

• Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation

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.

Stakeholders can submit specific questions on this document to qanda-pv-legislation@ema.europa.eu. Unfortunately the Agency is not able respond to questions directly. However, it will add responses to the most frequently asked questions to the document. The document is updated on a regular basis.

Transitional arrangements

In February 2012, the European Commission published questions and answers on transitional arrangements for the legislation. These were updated in July 2012:

• Questions and answers on transitional arrangements

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 (updated in July 2012);
• risk management plans;
• involvement of the Pharmacovigilance and Risk Assessment Committee (PRAC) for referrals and periodic safety update reports;
• post-authorisation safety studies;
• periodic safety update reports (new in July 2012).

Questions on this document should be sent to sanco-pharmaceuticals-d5@ec.europa.eu.

The Agency has also published a document highlighting the transitional arrangements for reporting requirements for individual case safety reports (ICSRs) applicable to marketing-authorisation holders during the interim period:

• Reporting requirements of ICSRs applicable to marketing-authorisation holders during the interim period (updated 26/03/2013)

The document includes information on reporting in EU Member States for:

• serious EU ICSRs;
• serious non-EU ICSRs;
• non-serious EU ICSRs.