Arzneimittelherstellung - Erlaubnis

For the commercial or professional manufacture of medicinal products, you need a permit from the competent authority.

If you want to manufacture medicinal products (human or veterinary medicinal products, including investigational medicinal products), test sera or test antigens, active substances that are of human, animal or microbial origin or that 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 permit to do so.

• Informal application with exact designation of the applicant and information on the legal form
• Excerpt from the commercial register, if applicable
• Designation of the business premises (name, street, place)
• Site plans of the company buildings and premises for production, testing and storage
• if available, details of external storage facilities (addresses and site plans here too)
• Proof of availability of the rooms
• Nomination of a competent person according to § 15 German Medicines Act (AMG) including telephone and fax numbers
• Proof of the required expertise of the persons in the original or certified copy
• Details of manufacturing activities (products, processes, volume per year)
• Medicinal products for human use/ veterinary medicinal products
• Designation of the medicinal product and dosage forms, scope of manufacture and, if applicable, procedure
• If applicable, details of the companies commissioned to carry out tests in accordance with the German Medicines Act
• Current "Site Master File" or description of the facility, quality assurance manual
• List of manufacturing activities

Fees are charged for the issuance of the manufacturing permit and the acceptance inspection.

In accordance with the Thuringian administrative cost regulations for the area of responsibility of the Ministry of Social Affairs, Family and Health of 14 March 2006 (BVBl. V. 30.03.2006 p. 73 ff.), fees of between 150.00 and 3,500.00 euros are incurred.

Applications should be complete at least three months prior to the planned start of manufacturing operations.

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

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

• Permission is required for the commercial or professional manufacture of medicinal products
• written application must be submitted with required documents
• Fees are charged for the issuance of the manufacturing permit and the acceptance inspection.
• Responsible: The authority responsible for drug monitoring. This can be found 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.

Contact the authority responsible for drug monitoring.

This can be found 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.

The above list of application documents Nos. 1 to 13 contains only an overview of the documents to be submitted in principle. The drug regulatory authority responsible for you will be happy to provide you with a detailed information sheet tailored to your project.