Pharmaberater; Beantragung der Anerkennung
Inhalt
Begriffe im Kontext
Fachlich freigegeben am
Fachlich freigegeben durch
- § 75 Abs. 2 und 3 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)
- Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)
Anyone wishing to work as a pharmaceutical consultant who is not a pharmacist, pharmacy assistant or pharmaceutical consultant, for example, must have their examination or training recognized by the competent authority.
Pharmaceutical companies may only appoint persons who have the expertise specified in Section 75 para. 2 of the German Medicinal Products Act (AMG) to visit healthcare professionals on a full-time basis in order to provide them with specialist information on medicinal products within the meaning of Section 2 para. 1 or para. 2 no. 1 AMG (pharmaceutical consultants).
The expertise is possessed by
- Pharmacists or persons with a certificate of having passed an examination after completing a university degree in pharmacy, chemistry, biology, human or veterinary medicine,
- Pharmacy assistants and persons who have completed training as technical assistants in pharmacy, chemistry, biology, human or veterinary medicine,
- pharmaceutical sales representatives.
The competent authority may recognize as sufficient an examination or completed training that is at least equivalent to the training of the persons named in Section 75 (2) AMG.
The following are responsible for recognition
- the government of Upper Bavaria, if the place of (intended) professional practice is in the administrative district of Upper Bavaria, Lower Bavaria or Swabia:
Government of Upper Bavaria
Sachgebiet 55.2 - Rechtsfragen Gesundheit und Verbraucherschutz und Pharmazie
Maximilianstraße 39
80538 München
E-Mail: pharmaberater@reg-ob.bayern.de
- the government of Upper Franconia, if the place of (intended) professional practice is in the administrative district of Upper, Middle and Lower Franconia or in the Upper Palatinate.
Government of Upper Franconia
Fachgebiet 55.2 - Rechtsfragen Gesundheit und Verbraucherschutz
Ludwigstraße 20
95444 Bayreuth
E-Mail: Berufsanerkennungen@reg-ofr.bayern.de
- The application for recognition of training as a pharmaceutical consultant in accordance with Section 75 (3) AMG can be made informally with the following information and documents:
- personal data with address and contact details
- curriculum vitae in tabular form
- confirmation of the (future) employer with indication of the place of work (area specification North or South Bavaria)
- simple copies of the exact course and content of the training, incl. details of subjects/hours
- officially certified copy of the final certificate/diploma (submission by mail)
All documents not written in German are required in the form of a translation. Translations are accepted if they have been prepared by an interpreter or translator appointed or sworn in Germany, the other contracting countries of the EEA or Switzerland. Translations made outside Germany, the EEA or Switzerland will generally not be accepted. Exception: Translations already prepared in a third country must be submitted to an interpreter or translator appointed or sworn in Germany for verification of accuracy and then submitted here.
The fee depends on the administrative costs and is usually EUR 150.
It is to be borne by the applicant.
The processing time depends on the completeness and scope of the documents submitted. It can therefore vary individually.