Medicinal products; application for a licence to manufacture medicinal products for human and veterinary use and active substances subject to authorisation

You require a manufacturing authorisation if you wish to manufacture medicinal products within the meaning of Section 2(1) or (2)(1) of the German Medicinal Products Act, test sera, test antigens or active substances of human or animal or microbial origin or produced by genetic engineering, as well as other substances of human origin intended for the manufacture of medicinal products, on a commercial or professional basis for the purpose of supplying them to others.

Description

A manufacturing authorisation in accordance with Section 13 of the German Medicines Act (AMG) is required by anyone who

  • Medicinal products within the meaning of Section 2(1) or (2)(1) of the AMG,
  • test sera,
  • test antigens,
  • active substances which are of human, animal or microbial origin or are produced by genetic engineering, as well as other substances of human origin intended for the production of medicinal products

manufactured commercially or professionally for the purpose of supply to others.

Manufacture is the extraction, production, preparation, treatment, processing, decanting, including filling, packaging, labelling and release of medicinal products.

The manufacturing authorization must be applied for informally prior to commencement of the activity.

The Governments of Upper Bavaria and Upper Franconia are responsible for the supervision of manufacturers of human and veterinary medicinal products, active substances as well as substances of human origin for the manufacture of medicinal products who require a licence according to § 13 AMG. Locally, the Government of Upper Bavaria is responsible for the administrative districts of Lower Bavaria, Upper Bavaria and Swabia and the Government of Upper Franconia for the administrative districts of Middle Franconia, Upper Franconia, Lower Franconia and Upper Palatinate.

Prerequisites

The requirements can be found in the information sheet.

Forms

Please select a location in "Localization" so that the address of the responsible authority can be filled in.

  • Prefillable Form, Bavaria-wide: Formloser Antrag (mit Unterschrift)
    Please note

    This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

    Dieser Assistent unterstützt Sie bei der Erstellung eines formlosen Schreibens, wenn die zuständige Stelle kein Antragsformular zur Verfügung stellt.

Fees

  • A fee of between € 500 and € 50,000 is set on the basis of the administrative effort and time involved and the importance of the matter for the applicant (according to the Schedule of Costs - Tariff No. 7.IX.8/Tariff item 1.1.1.1). This also includes expenses for necessary site inspections by our pharmaceutical officials (according to the schedule of costs - tariff no. 7.IX.8/ tariff item 1.2).

Remedy

Administrative court proceedings; information

administrative claim

Status: 11.10.2021

Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege

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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
Bild zur Leistungsbeschreibung

Responsible for you

If you select a location under "Localization" the contact details of the responsible authority and, if applicable, locally valid information will be displayed.