National Marketing Authorisation Procedure

In the national marketing authorisation procedure, the Paul-Ehrlich-Institut (PEI) assesses the quality, safety, environmental compatibility and efficacy of the veterinary medicinal product in the responsibility of the Paul-Ehrlich-Institut for which a marketing authorisation has been applied, independently of other European regulatory authorities. This is done in conjunction with the provisions of Regulation (EU) 2019/6.

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

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