Medicinal products; application for a permit to manufacture medicinal products for human use and active substances requiring a permit

You need a manufacturing authorization if you want to manufacture medicinal products within the meaning of Section 2 (1) or (2) of the German Medicines Act, test sera, test antigens or other specific active substances for the purpose of supplying them to others.

Description

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.

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 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:27.02.2023

Responsible for editing:Bayerisches Staatsministerium für Gesundheit, Pflege und Prävention

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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, 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.