Module 18 2021

07/02/2021

Mutual Recognition Procedure

Similar to Decentralised procedure with one key difference: • The product is already approved in the Reference Member State • CMSs should only disagree with approving the product on the basis of a serious safety risk (although in practice, other grounds for non-approval 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

29

National Procedure

• Application made to a single EU member state • No defined timelines for review • Cannot make a parallel national application in another EU member state

The Organisation for Professionals in Regulatory Affairs

30

15