Module 18 2021

07/02/2021

Centralised Procedure

• No previous licenses exist in the EU for the product • Application is submitted to, and the procedure coordinated by, the European Medicines Agency (EMA) • Defined timelines for review of the application • Outcome is a single license that is valid in all EU Member states • Fee for application for a single strength, one pharmaceutical form, one presentation is €296,500 (currently)

The Organisation for Professionals in Regulatory Affairs

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Decentralised Procedure

• No previous licenses exist in the EU for the product • Select a Reference Member State who will conduct the main review of the application • Select 1 or more Concerned Member States who will base their decision on granting a licence on the review conducted by the RMS (CMS should only disagree with a positive opinion of the RMS on the basis of a serious safety issue, however, in reality, other reasons are often observed) • Outcome is a NATIONAL licence in each of the Member states who agree/approve the product

• Defined timelines for review of the application • Fees are paid nationally and can vary considerably.

The Organisation for Professionals in Regulatory Affairs

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