Authorisation Procedures
Guidance documents on authorisation procedures - Regulation (EU) 2019/6
Requests to act as RMS in DCP – Pre-submission instructions for applicants
Decentralised procedure
Best practice guide for veterinary decentralised procedure
Position paper on agreeing the product name during the decentralised procedure
Mutual recognition procedure
Best practice guide for veterinary mutual recognition procedure
Subsequent recognition procedure
Templates
Applicant's template for request to Member States to act as RMS in MRP, SRP or DCP (Word version)
Cover letter template for new MA applications
The Qualified Person's declaration template
Template for CMS LOQ in DCP / MRP / SRP (Word version) (pharmaceuticals, immunologicals)
Template for compiled LOQ in MRP / SRP (Word version) (pharmaceuticals, immunologicals)
Template for LOQ in DCP phase I (Word version) (pharmaceuticals, immunologicals)
Template for LOQ in DCP phase II (Word version) (pharmaceuticals, immunologicals)
Applicant's template for post-authorisation commitments