Authorisation Procedures

 

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

 

Decentralised procedure

 

Mutual recognition procedure

 

Subsequent recognition procedure

 

Templates 

To be developed

 

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

 

Decentralised procedure

 

Mutual recognition procedure

 

Repeat use procedure

 

Templates