A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral, the European Medicines Agency (EMA) conducts a scientific assessment of a particular medicine or class of medicines on behalf of the European Union (EU).

Referral procedures can be initiated by the European Commission, any Member State or the MAH of the medicine concerned.

Pharmacovigilance  referrals are assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) and the PRAC’s assessment conclusion is forwarded to the EMA Committee for Medicinal Products for Human Use (CHMP) or to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), as applicable.

The start of pharmacovigilance referrals, as well as the PRAC recommendations issued at the end of the assessment, are announced by the EMA in the PRAC meeting highlights (and subsequently translated into Romanian on the NAMMDR website, in the section Agency – Press Releases).

For most referrals, the European Commission issues a decision to all Member States, reflecting the measures to be taken to implement the EMA`s recommendation.

For all referrals, the conclusions of the assessment are published in CHMP meeting highlights or CMDh press releases.

General information on referrals, including safety-related referrals, is available on the EMA website in the Referrals section.

Information on completed or ongoing referrals, including safety-related referrals, is also available on the EMA website,  in an excel table format, that can be accessed here.

MAHs are advised to monitor these procedures and to implement recommendations issued at the end of the assessment, as applicable.

Reference legislation (available on NAMMDR website):

• Law no. 95/2006 on healthcare reform, as republished, Title XVIII – The Medicinal Product;

• DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use;
• DIRECTIVE 2010/84/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use;

• Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance;

• Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council;

• REGULATION (EU) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

• REGULATION (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products.