Medicinal products; notification of manufacture without authorization

If it is intended to manufacture medicinal products that do not require a license pursuant to Section 13 of the German Medicinal Products Act (AMG), the medicinal products must be notified together with their name and composition.

Description

Prerequisites

The notifying party must be a doctor, dentist or alternative practitioner.

Procedure

The informal notification must be sent to the responsible government with the required information and documents (see information sheet under "Further links").

Deadlines

The notification can only be confirmed after all the necessary documents have been submitted and any unanswered questions have been clarified and a professional assessment has been carried out. The Medicinal Products Act does not set any deadlines.

Processing time

Depending on the questions to be clarified, processing may take some time.

Required documents

  • Description of the production activities

    (if possible, please PDF file)

  • Proof of qualification as a doctor or non-medical practitioner

  • Information on rooms and facilities

Forms

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

  • Prefillable Form, Bavaria-wide: Formlose Anzeige
    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

  • Costs for the notification confirmation: 50 to 5,000 € (according to the list of costs - tariff no. 7.IX.8 / tariff item 1.1.4.3)

    They are to be borne by the notifying party.

Status:20.01.2024

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

Contains machine translated content. Show the original content

  • 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.