Erlaubnis zu Arzneimittelherstellung beantragen

Anyone wishing to manufacture medicinal products requires a permit to do so.

If you

• 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 produced by genetic engineering or
• other substances of human origin intended for the manufacture of medicinal products

for the manufacture of medicinal products, you require a license.

Prerequisites include proof of the required expertise of a competent person to be appointed, the existence of suitable premises and proof that production and testing are carried out in accordance with the state of the art in science and technology and that the requirements of the EU Guide to Good Manufacturing Practice (GMP) are met. As part of the procedure, an acceptance inspection is carried out by the competent authority.

As different documents may be required, it is recommended that you contact the responsible office in advance.

Fees are charged for the issue of the manufacturing permit and the acceptance inspection in accordance with the state ordinance on administrative fees (general fee schedule). Detailed information on this can be obtained from the responsible office.

The owner of a pharmacy does not require a license to manufacture medicines as part of normal pharmacy operations.
Information on the subject of drug monitoring can be found on the website of the State Office for Social Services.

To the State Office for Social Services (LAsD).