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Procedure descriptions

Manufacture of medicinal products - apply for a licence

If you want to manufacture medicinal products and are based in Baden-Württemberg, you need a licence from the Baden-Württemberg Medicines Monitoring Centre.

The control centre monitors both human and veterinary medicinal products throughout the state

  • the classic pharmaceutical drug manufacturers,
  • Manufacturers of blood products,
  • pharmaceutical companies,
  • Exporters,
  • Importers and
  • external testing laboratories for medicinal products.

Responsible authority

Regierungspräsidium Tübingen - Control Centre for Drug Monitoring Baden-Württemberg

Regierungspräsidium Tübingen

Details

Prerequisite

  • In your company there are
    • a competent person with the necessary reliability and
    • suitable rooms and facilities for the intended manufacture, testing and storage of the medicinal products
  • You can guarantee that you
    • Manufacture and test medicinal products in accordance with the state of the art in science and technology and
    • also comply with the provisions of the second section of the Transfusion Act when collecting blood and blood components.

Procedure

You can apply informally to the competent authority for authorisation. Your application must contain the following information:

  • exact name of the applicant and details of the legal form
  • Designation of the business premises (name, street, town)
  • Details of external warehouses (including address)
  • Name, telephone and fax number
    • a qualified person in accordance with § 15 of the German Medicines Act,
    • a production manager and
    • a head of quality control
  • whether you are applying for authorisation for human or veterinary medicinal products
  • Designation of the medicinal product and pharmaceutical forms, process and planned manufacturing volume (quantity per year)
  • Details of the companies authorised to carry out tests in accordance with the Medicinal Products Act, if applicable

Tip: Contact the competent body before submitting the application to clarify the detailsclarify the details.

Once the complete documentation has been submitted, the competent body will carry out an acceptance inspection.

Deadlines

Your complete application should be submitted at least three months before the planned start of production.

Required documents

  • Site plans and floor plans of the company buildings and operating rooms for production, testing and storage
  • for external warehouses: site and floor plans
  • Proof of availability of the rooms, e.g:
    • Copy of the rental agreement or
    • Extract from the land register
  • Proof of the required expertise of the competent person(s) (for deeds: certified copy in paper form)
  • Proof of the required reliability of the competent person(s) and the applicant ("certificate of good conduct for submission to an authority")
  • current "Site Master File", description of the facility or quality assurance manual
  • List of manufacturing activities

Costs

Fees are charged in accordance with the state fee schedule.

Miscellaneous

Website of the Baden-Württemberg Drug Monitoring Centre

Detailed information

  • Details on the required documents can be found in the information sheet about applying for a manufacturing authorisation ("Merkblatt Herstellungserlaubnis").

Release note

20.11.2023 Ministerium für Soziales, Gesundheit und Integration

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