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Renewal of Marketing Authorisations and Registrations

Renewal of Marketing Authorisations and Registrations of Medicinal Products in Accordance with Sections 31, 39 of the German Medicines Act (Arzneimittelgesetz, AMG) and Art. 24 of Directive 2001/83/EC

Licenses and registrations are valid for 5 years after granting, unless an application for renewal is submitted at least 9 months prior to the expiry date.

Licenses and registrations that are renewed are not subject to a time limit, unless the competent superior federal authority orders a further renewal of 5 years in order to further guarantee the safe marketing of the medicinal product.

The renewal of medicinal products licensed via the centralised procedure is granted on the basis of Article 14 of the EC Regulation No. 726/2004. The renewal of medicinal products licensed via national procedures and registrations as well as via mutual recognition (MRP) and decentralised (DCP) procedures is granted on the basis of Article 24 of Directive 2001/83/EC. The legal regulations laid down in Article 24 of Directive 2001/83/EC have been translated into national law for licensed medicinal products in Section 31 sub-section 1 number 3 AMG, for registrations of homeopathic medicinal products in Section 39 sub-section 2b AMG and for registrations of traditional herbal medicinal products in Section 39c sub-section 3 AMG.

The different renewal procedures can be structured as follows:

National procedures
Procedures within the European Union
  • Registrations in accordance with § 39 of the German Drug Law
  • MRP (Mutual recognition procedures)
  • Marketing authorisations in accordance with § 31 of the German Drug Law
  • Centralised procedures
  • Chemical entities (without model text)
  • DCP (Decentralised procedures)
  • Renewal procedures on the basis of a model SPC and package leaflet
  • Herbal medicines and homeopathic medicinal products
  • Parallel import