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EMA publishes a Questions & Answers document on the practical implementation of Article 31 Pharmacovigilance Referral procedure

Alexander Roussanov

29 January 2014
On 20 January 2014, the European Medicines Agency ("EMA") published a Questions & Answers document discussing the practical implementation of the "Article 31 Pharmacovigilance Referral" procedure. The aim of the document is to address questions that marketing authorisation holders may have in relation to this procedure and the manner in which it is handled by the EMA in practice.

Article 31 Pharmacovigilance Referral

The legal basis of the Article 31 Pharmacovigilance Referral is the second paragraph of Article 31(1) of Directive 2001/83/EC ("Community Code on medicinal products"). This Article applies to situations in which pharmacovigilance data relating to one or more medicinal products suggests that there are potential safety issues with the product(s) that may affect patients in more than one EU Member State. Such safety issues may require the variation, suspension or withdrawal of the marketing authorisations for the products affected.

In such circumstances, the matter is referred to EMA's Pharmacovigilance Risk Assessment Committee ("PRAC"). This procedure could be initiated by the competent authorities of the EU Member States, the European Commission, or the marketing authorisation holders. The role of PRAC is to assess the safety issues and to adopt a recommendation concerning the need to vary, suspend, or withdraw the marketing authorisation for the medicinal products in question.

Where at least one of the medicinal products that are subject to the Article 31 Pharmacovigilance Referral procedure is a centrally authorised medicinal product authorised by the European Commission, PRAC's recommendation is addressed to the EMA's Committee for Medicinal Products for Human Use ("CHMP"). On the basis of the recommendation, the CHMP adopts an opinion concerning the variation, suspension or withdrawal of the marketing authorisations for the products. This opinion is addressed to the European Commission. The Commission adopts a final decision concerning the measures that should be taken in relation to the medicinal products that are subject to the Article 31 Pharmacovigilance Referral procedure. These measures could include the variation of the related marketing authorisations and imposition of additional post-marketing obligations. They could also include suspension or withdrawal of the marketing authorisations.

If all of the medicinal products that are subject to the Article 31 Pharmacovigilance Referral are medicinal products authorised by the competent authorities of the EU Member States through the decentralised or mutual recognition marketing authorisation procedure, PRAC's recommendation is addressed to the Co-ordination group for Mutual recognition and Decentralised procedures ("CMD(h)"). The recommendation serves as a basis for a decision by the CMD(h) intended to address the safety concerns identified in relation to this medicinal product. As for centrally authorised medicinal products, the measures can include variation, suspension or withdrawal of the marketing authorisation. The competent authorities of the EU Member States are required to implement this decision according to the timetable agreed by the CMD(h).

The Questions & Answers document

The EMA Questions & Answers document addresses specific practical questions related to the application of the Article 31 Pharmacovigilance Referral procedure. These include, in particular:

  • the medicinal products that could be subject to this procedure and the exclusion of medicinal products that are authorised in only one EU Member State;
  • public disclosure of information concerning the Article 31 Pharmacovigilance Referral procedure;
  • information communicated to the marketing authorisation holders affected by the procedure;
  • requirement for marketing authorisation holders to appoint a contact person for the purposes of the Article 31 Pharmacovigilance Referral procedure;
  • Data and documents collected and assessed in the course of the procedure and the possibility for common submissions of data and documents by two or more marketing authorisation holders;
  • appointment of Rapporteur and Co-Rapporteur in PRAC;
  • participation of marketing authorisation holders in the PRAC assessment and related timetables;
  • implications of the change of the name of the medicinal product or the name or address of the marketing authorisation holder during the course of the Article 31 Pharmacovigilance Referral procedure;
  • implications of the voluntary withdrawal of the marketing authorisation by the marketing authorisation holder or transfer of the authorisation to a new marketing authorisation holder during the course of the Article 31 Pharmacovigilance Referral procedure;
  • content and structure of PRAC recommendation and its publication;
  • requests for examination of PRAC recommendation;
  • content and structure of CHMP opinions and CMD(h) decisions and their publication;
  • absence of fees related to the Article 31 Pharmacovigilance Referral procedure.

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