The course will give an overview of the European regulatory system for human medicines, including the legislative processes and European networks, the different routes for obtaining a licence for the European market, the centralised, the decentralised and the mutual recognition procedures, and the national procedures. In addition, the specific European procedures for orphan drugs, paediatrics, advanced therapies and combination products will be discussed. This will cover the different steps and timelines in the various procedures, the clock-stops, the compiling of questions etc. An introduction to pharmacovigilance, variations and renewals will be given in the context of the lifecycle.
The course will cover the current registration systems available for approval of human medicinal products:
Regulation EC726/2004 on the centralised procedure, including specific marketing authorisations and the European Medicines Agency
Directive 2001/83/EC ‘the Community Code’ on the Mutual Recognition Procedures
Decentralised Procedure and referrals
A case study will enable participants to apply the freshly gained knowledge into their daily practice.