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Pharmaceutical production - authorization

Service Description

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

Who should I contact?

Contact the authority responsible for drug monitoring.

You can find these on the website of the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) under Medicinal Products/ Directory of Authorities and Institutions.

Which documents are required?

  • Informal application with exact name of the applicant and details of the legal form
  • Extract from the commercial register, if applicable
  • Designation of the business premises (name, street, town)
  • Site plans of the company buildings and premises for production, testing and storage
  • If available, details of external warehouses (also addresses and site plans)
  • Proof of availability of the rooms
  • Appointment of a competent person in accordance with Section 15 of the German Medicines Act (AMG), stating telephone and fax number
  • Proof of the required expertise of the persons in the original or a certified copy
  • Details of manufacturing activities (products, processes, volume per year)
  • Medicinal products for human use/veterinary medicinal products
  • Designation of the medicinal products and pharmaceutical forms, scope of manufacture and, where applicable, procedures
  • If applicable, details of the companies responsible for testing in accordance with the Medicinal Products Act
  • Current "Site Master File" or description of the facility, quality assurance manual
  • List of manufacturing activities

What are the fees?

Fees are charged for the issue of the manufacturing authorization and the acceptance inspection.

In accordance with the Thuringian Administrative Cost Regulations for the Ministry of Social Affairs, Family and Health of March 14, 2006 (BVBl. V. 30.03.2006 p. 73 ff.), fees of 150.00 to 3,500.00 euros are charged.

What deadlines do I have to pay attention to?

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

Legal basis

Appeal

The above list of application documents no. 1 to 13 only provides an overview of the documents that generally need to be submitted. The competent regulatory authority for medicinal products will be happy to provide you with a detailed information sheet tailored to your project.

What else should I know?

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

The owner of a pharmacy does not require a license for the manufacture of medicinal products as part of normal pharmacy operations.

Author

The text was automatically translated based on the German content.

Source: Zuständigkeitsfinder Thüringen (Linie6Plus)

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