CRED ERP 25

European Regulatory Procedures: Pre-Read Centralised Procedure

The objective of this pre-read summary of the Centralised Procedure (CP) is to enable you to become familiar with the key features of the approval process related to the CP before attending the TOPRA CRED course on EU Regulatory Procedures. During the course itself, expert speakers will give a brief outline of the different EU regulatory procedures and how they work and will then focus on covering real-life examples of what running these procedures in practice entails, how best to organise your company team internally as well as covering common pitfalls and how to avoid them. In order for you to get the most out of the course and the presentations, a certain amount of background reading and study on your part constitutes helpful preparation. The presenters will assume that you have reviewed the pre-read materials and that you are at least familiar with the following topics:

1. Legal basis for the Centralised Procedure 2. Preparing for a CP (including eCTD compilation) 3. Roles and Responsibilities (EMA; CHMP; PRAC; EC) 4. Managing the procedure 5. Interacting with the EMA/(Co-)Rapporteurs 6. Post submission 7. The Commission decision making process 8. Re-examination of an Opinion 9. Questions for the TOPRA presenters

By ensuring that you have familiarised yourself with this material in advance it will enable the presenters to further elaborate on the reality of how these procedures work in practice versus what is described by regulatory requirements and the Medicinal Products Directive (MPD) 2001/83/EC.

1. Legal basis

The legal basis for the establishment of the Centralised Procedure, created by Council Regulation (EEC) No 2309/93 and implemented on 1 st January 1995, is laid down in Regulation (EC) No 726/2004 and Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (“the Regulation”) which makes provision for a centralised Community procedure allowing for: • a single application • a single evaluation • a single authorisation • direct access to the single market of the EEA-EFTA Overview of the procedure The procedure is coordinated by the EMA and is assessed by appointed CHMP Rapporteur and Co Rapporteur, PRAC Rapporteur. The PRAC rapporteur should always be a PRAC member from another MS than the CHMP rapporteur The CHMP scientific opinion to grant an opinion – positive or negative - is voted upon by CHMP (1 vote per each of 27 Member States plus 5 co-opted members) with a consensus or simple majority vote (17 votes out of 32)being required. The final decision to grant approval is made by European Commission based upon the CHMP opinion resulting in a single EU-wide Marketing Authorisation issued by the European Commission. Data exclusivity and market protection includes: 8+2 years (8 years data In addition, it makes provision for the establishment of a European Medicines Agency (EMA).