Pharmaceutical Product Registration and Pharmacovigilance Rules and Guidelines

Product Registration

Getting marketing authorisation for medicinal products in more than one Member State in the EU is done by using one of three procedures:

“Centralised Procedure” – Regulation (EC) No 726/2004

“Mutual Recognition Procedure” and

“Decentralised Procedure” – Directive 2001/83/EC.

As well as these, national authorisations still Pharmacovigilance institute allow products to be marketed in individual countries in the EU. Products could be authorised separately in several Member States by a number of national authorisations, alternatively one of these authorisations could be used to apply for authorization using the Mutual Recognition Procedure. Where products have national authorisation, the regulatory agency of the country concerned has to monitor and assess the safety of any products that have national authorisation.

Centralised Procedure

The EMEA administers the centralized procedure, where a single application, if approved, grants marketing authorisation for all the countries in the European Union (and the European Economic Area, that’s the EU countries plus Iceland, Norway and Liechtenstein). The European Commission becomes the responsible authority for products which come to market through the centralised procedure. This procedure is available to all new or innovative pharmaceuticals and is the only way to authorise biotechnology medicines. Where products contain new substances for treating serious diseases, they would use the centralised procedure.

The regulatory agency of one Member State is then appointed as the Rapporteur and they will then carry out initial assessments of the application for Marketing Authorisation; a second agency is appointed as Co-Rapporteur. These countries will then be responsible for leading the monitoring and assessment of safety of the product when it is subsequently marketed.

Mutual Recognition Procedure

In the Mutual Recognition Procedure the marketing authorisation of one member State is recognised and copied by the other member states. In this procedure, the ‘Reference Member State’, is “mutually recognised” by other ‘Concerned Member States’. Once the application for mutual recognition has gone in, there is a 90 day assessment period. After the assessment period the Member States grant a marketing authorisation with an identical summary of product characteristics to the one in the Reference Member State as long as they accept the original assessment of the product. If a Member State raises objections and does not recognise the original marketing authorisation then the matter may be referred to the EMEA for discussion among the parties: if this fails, binding arbitration is imposed.

Decentralised Procedure

The decentralised procedure can apply where there is no authorisation yet in any of the Member States. The same dossier is submitted to all Member States where a marketing authorisation is needed. The applicant selects a Reference Member State and prepares a preliminary assessment report within 120 days and sends it to the other states, 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.