Periodic safety update report: fees

The RD of 21.01.2009 establishes a fee when submitting periodic safety update reports (PSUR’s). This fee shall apply to medicinal products for human and veterinary use authorized by the national procedure, the mutual recognition procedure and the decentralized procedure.

Circular 530 specifies the amount of payments and gives some practical guidelines on this subject.



Last updated on 28/01/2013