Information - Services - Formalities by subjects - Preparations for business start-up - Erlaubnispflichtige und überwachungspflichtige Unternehmen - Medicinal products; notification of unauthorised manufacture - Dienstleistungsportal Bayern

Description

A licence pursuant to Section 13(1) of the German Medicines Act (AMG) is not required by a doctor or non-medical practitioner if the medicinal products are manufactured under their direct professional responsibility for the purpose of personal use on a specific patient. However, the manufacture of medicinal products is subject to notification according to Section 67 (2) AMG.

The persons concerned must notify the competent authority of their planned activity. The authority checks whether the activity is subject to authorisation, if applicable.

Prerequisites

The person making the announcement must be a doctor, dentist or alternative practitioner.

Procedure

The informal notification is to 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, open questions have been clarified and a technical assessment has been carried out. The Medicines Act does not set any deadlines.

Processing time

Depending on the questions to be clarified, the 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.

  Dieser Assistent unterstützt Sie bei der Erstellung der formlosen Anzeige. Die Angaben die erforderlich sind, können Sie dem Merkblatt unter "Weiterführende Links" entnehmen.

Fees

• Costs for the confirmation of the advertisement: 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 advertiser.

Legal bases

• § 67 Abs. 2 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)
• § 13 Abs. 1 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)
• § 2 Abs. 1 Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)

Links to more information

• Merkblatt: Anzeige über die erlaubnisfreie Herstellung von Arzneimitteln gemäß § 13 Abs. 2b Arzneimittelgesetz (AMG) für durch Ärzte, Zahnärzte oder und Heilpraktiker