Types of Marketing Authorisation Procedures for Medicinal Products in Germany (BfArM)

Overview of Authorisation Pathways

In Germany, medicinal products require marketing authorisation before being placed on the market. BfArM is the competent authority for nationally authorised products and participates in EU procedures. There are four main procedures, aligned with EU pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No 726/2004). The choice depends on the product's characteristics, therapeutic indication, and intended geographic scope. Types of marketing authorisation - BfArM

National Procedure

• Applies to products intended only for the German market or specific national needs.
• BfArM conducts a full assessment of quality, safety, and efficacy.
• Suitable for generics, well-established use products, or certain homeopathics/traditional herbal medicines.
• Authorisation is valid only in Germany.

Decentralised Procedure (DCP)

• Used for products not yet authorised in any EU Member State.
• One Reference Member State (RMS, which can be Germany/BfArM) leads the assessment; Concerned Member States (CMS) participate.
• Simultaneous authorisation in multiple EU countries.
• Ideal for products targeting several markets at once.

Mutual Recognition Procedure (MRP)

• Used when a product is already authorised in at least one EU Member State (Reference Member State).
• The RMS assessment is mutually recognised by other CMS.
• Germany can act as RMS or CMS.
• Allows extension of existing national authorisations to additional EU countries.

Centralised Procedure (CP)

• Mandatory for certain products (e.g., biotechnological, orphan, advanced therapy, or those with new active substances for specific indications).
• Managed by the European Medicines Agency (EMA); results in a single EU-wide authorisation.
• BfArM contributes as a national competent authority during EMA assessment (e.g., rapporteur/co-rapporteur roles, inspections).
• Binding across all EU Member States.

Additional Notes

• Hybrid applications combine elements of different procedures.
• BfArM provides guidance on procedure selection, application requirements, fees, and timelines.
• All procedures require submission of a Common Technical Document (CTD) dossier.

These pathways ensure that medicinal products in Germany meet high standards of quality, safety, and efficacy while facilitating timely access for patients, whether through national flexibility or EU-wide harmonisation. Types of marketing authorisation - BfArM