Arzneimittel; Anzeige der erlaubnisfreien Herstellung
Bayern
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99005111169000
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Typ 3
Inhalt
Begriffe im Kontext
Fachlich freigegeben am
Fachlich freigegeben durch
- § 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)
A license pursuant to Section 13 (1) of the German Medicinal Products Act (AMG) is not required for physicians or alternative practitioners 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 must be notified in accordance with Section 67 Para. 2 AMG.
The persons concerned must notify the competent authority of their planned activity. The authority will check whether the activity may require a license.
- 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
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.
The informal notification must be sent to the responsible government with the required information and documents (see information sheet under "Further links").
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.