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Procedure descriptions
Manufacture of medicinal products – applying for a licence
If you wish to manufacture medicinal products and are based in Baden-Württemberg, you will need a licence from the Baden-Württemberg Medicines Monitoring Centre.
The Centre supervises both human and veterinary medicines throughout the state
- traditional pharmaceutical manufacturers,
- manufacturers of blood products,
- pharmaceutical operators,
- exporters,
- importers and
- external testing laboratories for medicinal products.
Responsible authority
Tübingen Regional Council – Baden-Württemberg Medicines Monitoring Centre
Regierungspräsidium Tübingen
Contact
Details
Prerequisite
- Within your organisation, there is
- a qualified person who is sufficiently trustworthy and
- suitable premises and facilities for the intended manufacture, testing and storage of medicinal products
- You can guarantee that you
- manufacture and test medicinal products in accordance with the current state of science and technology, and
- in addition, when collecting blood and blood components, comply with the provisions of Part Two of the Transfusion Act.
Procedure
You can apply for the permit informally at the relevant authority. Your application must include the following details:
- the full name of the applicant and details of their legal form
- Name of the business premises (name, street, town)
- Details of off-site storage facilities (including addresses)
- Name, telephone and fax numbers
- of a competent person in accordance with Section 15 of the Medicines Act,
- a head of manufacturing and
- a head of quality control
- whether you are applying for authorisation for medicinal products for human or veterinary use
- the names of the medicinal products and their dosage forms, the manufacturing processes and the planned scale of production (annual quantity)
- Details of the establishments commissioned to carry out tests in accordance with the Medicines Act, where applicable
Tip: Contact the relevant authority before submitting your application to clarify the specificrequirements.
Once the complete documentation has been submitted, the competent authority will carry out an acceptance inspection.
Deadlines
Your complete application should be submitted no later than three months before the planned start of production.
Required documents
- Site plans and floor plans of the company’s buildings and premises used for manufacturing, testing and storage
- for off-site storage facilities: site plans and floor plans
- Evidence of the availability of the premises, for example:
- A copy of the tenancy agreement or
- extract from the land register
- Proof of the required expertise of the competent person(s) (for certificates: a certified paper copy)
- Proof of the required integrity of the competent person(s) and the applicant (“Certificate of Good Conduct for submission to a public 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 Fees Regulations.
Detailed information
- Details on the required documents can be found in the information sheet about applying for a manufacturing authorisation ("Merkblatt Herstellungserlaubnis").
Legal basis
Zweiter Abschnitt des Transfusionsgesetzes (TFG) (Gewinnung von Blut und Blutbestandteilen)
Gesetz über den Verkehr mit Arzneimitteln (AMG)
Verordnung (EU) Nummer 536/2014 des Europäischen Parlaments und des Rates vom 16. April 2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG
Verordnung (EU) 2019/6 des Europäischen Parlaments und des Rates vom 11. Dezember 2018 über Tierarzneimittel und zur Aufhebung der Richtlinie 2001/82/EG
Release note
machine generated, based on the German release by: Sozialministerium Baden-Württemberg, 18.06.2026