Advice on specific application types

Guidance documents - Regulation (EU) 2019/6

Generics 

Guidance for processing of generic and hybrid applications through MRP / SRP / DCP

Guidance for exchange of documentation relating to reference veterinary medicinal products between Member States

Informed consent

Best practice guide for Informed consent for MRP, SRP and DCP

Limited markets

Best Practice Guide for handling marketing authorisations for veterinary medicinal products intended for limited markets (national, mutual recognition and decentralised procedures)

Exceptional circumstances

Best Practice Guide for handling applications for marketing authorisations for veterinary medicinal products in exceptional circumstances (national, mutual recognition and decentralised procedures)

Duplicates

Guidance for duplicate applications in mutual recognition and decentralised procedures

Guidance documents – Directive 2001/82/EC

Generics 

Guidance for the processing of generic applications through MRP/DCP

Guidance for exchange of documentation relating to a reference veterinary medicinal product between MS

Definition of the term "same medicinal product"

Informed consent

Best practice guide Art. 13(c) informed consent applications

Line extension

Line extensions: Requirements for the content of the dossier - Quality part

Duplicates

Duplicate applications in mutual recognition and decentralised procedures