In the national procedure pursuant to Sections 21et seq. of the German Medicinal Products Act (AMG), the Paul-Ehrlich-Institut (PEI) assesses the quality, efficacy and safety of medicinal products for which a marketing authorisation application has been submitted, independently of other European regulatory authorities. This type of procedure is normally only an option for medicinal products that are not yet authorised in a Member State of the European Union (EU) or the European Economic Area (EEA).
If the pharmaceutical manufacturer already has an authorisation for the medicinal product in another EU/EEA Member State, a marketing authorisation shall be carried out by means of the Mutual Recognition Procedure (MRP).
If the medicinal product is not authorised in the EU/EWR and is to be marketed not only in Germany but also in other EU / EEA Member States, the decentralised procedure (DCP) must be applied.
A special form of national marketing authorisation exists for medicinal products imported in parallel (simplified procedure).
The application documents must be submitted electronically using the electronic common technical document (eCTD) format. Applications are to be submitted via the Common European Submission Platform (CESP).
The electronic application form (eAF) must be completed when applying for authorization of a medicinal product via the national procedure.
Updated: 02.05.2024
