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Source: BUS Sachsen-Anhalt (Linie6PLus)

Applying for authorisation to manufacture medicinal products


If you want to manufacture medicinal products (medicinal products for human or veterinary use, including clinical investigational medicinal products), test sera or test antigens, active substances of human, animal or microbial origin or which are produced by genetic engineering or other substances of human origin intended for the manufacture of medicinal products on a commercial or professional basis, you need a licence to do so.

  • informal application with exact name of the applicant and information on the legal form, if applicable excerpt from the commercial register
  • Name of the permanent establishment (name, street, place),
  • site plans of the company buildings and premises for production, testing and storage,
  • if available, information on external warehouses (also addresses and site plans),
  • proof of room availability,
  • Designation of a qualified person in accordance with § 15 of the German Medicines Act, stating telephone and fax numbers,
  • proof of the required expertise of the persons according to 6. in the original or certified copy,
  • information on manufacturing activities (products, processes, volume per year),
  • medicinal products for human use/veterinary medicinal products,
  • the name of the pharmaceutical and pharmaceutical forms, the scope of manufacture and, where appropriate, the method,
  • if applicable, information on the establishments commissioned with inspections in accordance with the Medicinal Products Act,
  • current "Site Master File" or description of the facility, quality assurance manual,
  • List of manufacturing activities.

Fees shall be charged for the granting of the manufacturing authorisation and the inspection inspection.

Applications should be submitted in full at least three months before the planned start of the production plant.

Contact the State Administration Office.

The above list of application documents No. 1 to 13 contains only an overview of the documents to be submitted in principle. The pharmaceutical supervisory authority responsible for you will be happy to provide you with a detailed leaflet tailored to your project.

As part of the procedure, an acceptance inspection is carried out by the competent authority.

The owner of a pharmacy does not need a licence for the manufacture of medicinal products within the framework of normal pharmacy operations.

The text was automatically translated based on the German content.

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