Drug manufacturing: permission Unfortunately this specification of service has not yet been completely translated.

If you want to produce medicines, you need a permit.

If you

  • medicinal products (medicinal products for human or veterinary use, including investigational clinical medicinal products),
  • Testsera or test antigens,
  • active substances of human, animal or microbial origin or produced by genetic engineering, or
  • other substances of human origin intended for the manufacture of medicinal products

, you need a permit for this.

The prerequisite is, among other things, proof of the required expertise of a qualified person to be appointed, the existence of suitable premises and proof that production and testing are carried out according to 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.

Since different documents may be required, it is recommended to contact the competent body in advance.

Hints

The owner of a pharmacy does not need a permit for the production of medicinal products within the framework of normal pharmacy operations.
Information on the subject of drug monitoring can be found on the website of the State Office for Social Services.

  • Drug monitoring
  • §§ 13 et seq. act on the circulation of medicinal products (Arzneimittelgesetz - AMG),
  • Ordinance on the Application of Good Manufacturing Practice in the Manufacture of Medicinal Products and Active Substances and on the Application of Good Professional Practice in the Manufacture of Products of Human Origin (Drug and Active Ingredient Manufacturing Ordinance - AMWHV),
  • Landesverordnung über Verwaltungsgebühren (Allgemeiner Gebührentarif) Subheading 9.8 - VwGebV.

Related Links

  • §§ 13 ff. AMG
  • AMWHV

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