Key Rules in Pharmaceutical Product Registration and Pharmacovigilance

Pharmacovigilance rules and regulations are understandably complex, aimed at ensuring there is always ongoing good quality reporting and monitoring of pharmaceutical products. There’s no substitute for the professional advice of a pharmacovigilance services company, but this article provides a brief guide to some of the key regulations and guidelines for products marketed in the EU. This guide can be a useful adjunct to professional advice to allow better pharmacovigilance work liaison with related teams in understanding of how the Centralised Procedure, Mutual Recognition Procedure and Decentralised Procedure operate in the EU.

The Three Routes for Pharmaceutical Product Registration

Pharmaceutical products which are to be marketed in one or more member states of the EU must be subjected to one of three procedures to gain the correct Marketing Authorisations status:

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

“Mutual Recognition Procedure”

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

There are also certain extra-national authorisations which allow products to be marketed in some single EU member states. This means products may be regulated under separate authorisation in two or more individual EU countries. The Mutual Recognition Procedure allows for application for a national authorisation. The regulatory body in the country in which the original national authorisation was obtained is deemed responsible for product monitoring and safety assessment.

About The Centralised Procedure

This is the Pharmacovigilance training institute in hyderabad administrative responsibility of the EMEA. A single application for marketing authorisation for all the countries in the European Union (and the European Economic Area, meaning all EU countries, Iceland, Norway and Liechtenstein) is made. If applications are approved, at the point they enter the market then all products become the responsibility of The European Commission instead.

This option applies for all new or novel pharmaceutical products and stands as the only route at this time for any biotechnology medicines. It’s also the route for any product which contains novel substances which have the intended purpose of modifying serious disease.

The regulatory agency of one EU country is charged with becoming the Rapporteur, who completes the initial assessments required for a Marketing Authorisation. Their Rapporteur will undertake initial assessments which are necessary for the application for a Marketing Authorisation. In addition, as a double-checking system, there will be the appointment of a Co-Rapporteur, a second agency to oversee things, from a second EU country. Between the two agencies, the safety assessment and monitoring are directed in a controlled manner to allow the product to be introduced onto the market. They will also hold responsibility for the continuing pharmacovigilance work during the time the product will be on sale after its introduction.

Application for a Marketing Authorisation is a key stage to involve a pharmacovigilance services company to ensure the process is properly administrated and staff understand fully what is required at all stages to avoid mistakes.