Authorisation Procedures

Guidance documents on authorisation procedures - Regulation (EU) 2019/6

Templates 

Applicant's template for request to Member States to act as RMS in MRP, SRP or DCP (Word version)

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)

 

 

Guidance documents on authorisation procedures - Directive 2001/82/EC