Pharmacovigilance and Drug Safety

A marketing authorisation for a medicinal product in more than one Member State in the EU must be sought via one of three procedures: either the “Centralised Procedure”, determined by Regulation (EC) No 726/2004, the “Mutual Recognition Procedure” or the new “Decentralised Procedure”, regulated by Directive 2001/83/EC.

In addition, national authorisations allow for products to be marketed in individual countries in the EU. A product may be authorised in several Member States by a number of national authorisations, or one of these may be used as the basis for a Mutual Recognition Procedure. The regulatory agency of the country concerned has the responsibility for monitoring and assessing the safety of products with national authorization.

Centralised Procedure

This is administered by the EMEA. It consists of one application which, if approved, grants marketing authorisation for all countries within the European Union (and the European Economic Area, i.e. the EU countries plus Iceland, Norway and Liechtenstein).The European Commission is the responsible authority for the products which come to the market through the centralised procedure. The procedure is available to all new, or innovative pharmaceuticals, and is obligatory for biotechnology medicines. It is used for products containing new substances for which the therapeutic indication is the treatment of serious disease.

The regulatory agency of a Member State is appointed as Rapporteur and carries out the initial assessment of the application for Marketing Authorisation; another agency is appointed as Co-Rapporteur. These countries remain responsible for taking the lead in the monitoring and assessment of safety of the product when it is subsequently marketed.

Mutual Recognition Procedure

Here, the marketing authorisation in one Member State, the ‘Reference Member State’, is “mutually recognised” by other ‘Concerned Member States’. There is a 90 day assessment period after which Member States grant a marketing authorisation with an identical summary of product characteristics to that in the Reference Member State, provided that they accept the assessment of the product. If a Member State raises objections and does not recognise the original marketing authorisation the matter may be referred to the EMEA for discussion among the parties: if this fails, binding arbitration is imposed.

Decentralised Procedure

This process can apply where an authorisation does not yet exist in any of the Member States. Identical dossiers are submitted in all Member States where a marketing authorisation is sought. A Reference Member State, selected by the applicant, prepares a preliminary assessment report within 120 days and sends it to the Concerned Member States. They then approve the assessment or the application will continue into a facilitation or, if this fails, a binding arbitration procedure applies.