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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

Best practice guide for 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

 

 

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

Decentralised procedure

Best practice guide for veterinary decentralised procedure

Mutual recognition procedure

Best practice guide for veterinary mutual recognition procedure

Repeat use procedure

Best practice guide for the repeat use procedure

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