Marketing Authorisation Licensing Procedures for Medicinal Products at BfArM

Role of BfArM in Licensing

BfArM is the competent authority in Germany for granting marketing authorisations for most medicinal products (excluding vaccines, sera, allergens, blood products, and advanced therapy medicinal products, which fall under PEI). It processes applications under national, decentralised, and mutual recognition procedures, and supports the centralised procedure via EMA. The licensing process ensures that only safe, effective, and high-quality medicines reach the market. Licensing procedures - BfArM

Main Licensing Procedures

National Procedure

• For products intended solely for the German market or specific national exemptions.
• Full assessment by BfArM of quality, safety, efficacy, and benefit-risk balance.
• Application dossier submitted directly to BfArM in CTD format.
• Authorisation valid only in Germany.

Decentralised Procedure (DCP)

• For products not yet authorised anywhere in the EU.
• One Reference Member State (RMS, can be Germany/BfArM) performs the main assessment.
• Concerned Member States (CMS) participate and receive simultaneous authorisation.
• Coordinated assessment phase followed by national steps.
• Suitable for broader market entry.

Mutual Recognition Procedure (MRP)

• For products already authorised in at least one EU Member State.
• Existing authorisation from Reference Member State is mutually recognised by other CMS.
• Germany can act as RMS or CMS.
• Includes a 90-day assessment phase and national implementation.

Centralised Procedure (CP)

• Compulsory for biotechnology products, orphan medicines, advanced therapies, and certain new active substances.
• Single application to EMA results in one EU-wide authorisation.
• BfArM contributes as a national authority (e.g., rapporteur, inspections, scientific advice).
• Binding in all EU Member States, including Germany.

Application Requirements

• Common Technical Document (CTD) format mandatory for all procedures.
• Quality (CMC), non-clinical, and clinical data required.
• Benefit-risk assessment and proposed summary of product characteristics (SmPC), labelling, and package leaflet.
• Fees apply according to BfArM tariff; reduced fees for certain categories (e.g., generics, orphans).

Assessment and Decision

• Scientific evaluation focuses on quality, safety, and efficacy.
• Timelines vary: national ~210 days; DCP/MRP coordinated phase ~120–210 days.
• Positive opinion leads to authorisation; negative opinion or withdrawal possible.
• Post-authorisation obligations include pharmacovigilance and variations.

BfArM provides comprehensive guidance, application forms, checklists, and consultation opportunities to support applicants in navigating the appropriate licensing procedure for their medicinal product. Licensing procedures - BfArM