Na­tion­al Pro­ce­dure

In the national procedure pursuant to the Animal Health Act (Tiergesundheitsgesetz, TierGesG) in conjunction with the Animal Vaccine Regulation, the Paul-Ehrlich-Institut (PEI) assesses the quality, safety, environmental compatibility and efficacy of the immunological veterinary product for which a marketing authorisation has been applied, independently of other European regulatory authorities.

This type of procedure may be used for veterinary medicinal products which are not yet authorised in a Member State of the European Union (EU) or the European Economic Area (EEA). If the pharmaceutical operator already has an authorisation for the veterinary medicinal product in another EU / EEA Member State, authorisation must be granted in the mutual recognition procedure.

Updated: 21.11.2019