Bundesportal | Pharmaceuticals; application for a wholesale license

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Publisher

Bavaria

Last update or date of publication

April 17, 2025

Anyone wishing to engage in wholesale distribution of medicinal products within the meaning of Section 2 para. 1 or para. 2 no. 1 of the German Medicinal Products Act (AMG), test sera or test antigens requires a license. The documents to be submitted are listed in Section 52a para. 2 AMG. The application can be submitted informally.

Trading may not commence before the permit has been issued, which is preceded by an inspection. The violation constitutes a criminal offense.

Once all documents have been submitted, the inspection has been carried out and the deficiencies have been rectified, the permit, consisting of a decision and a certificate, will be issued within three months.

Description of the establishment
Site plan of the premises
evidence of suitable and adequate premises, plant and equipment in which the wholesale trade is to take place
Certificate of good conduct of the managing director and the responsible person
Written declaration and undertaking to comply with the provisions applicable to the proper operation of a wholesale trade

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Preconditions

The requirements are set out in Section 52a AMG:

With the application, the applicant must

name the specific establishment as well as the activities and the medicinal products for which the authorization is to be granted,
submit evidence that he has suitable and sufficient premises, facilities and equipment to ensure proper storage and distribution and, where provided, proper decanting, packaging and labeling of medicinal products,
appoint a responsible person who has the necessary expertise to carry out the activity, and
to enclose a declaration in which he undertakes in writing to comply with the regulations applicable to the proper operation of a wholesale business.

Hints

Excluded from the licensing requirement are finished medicinal products released for sale outside pharmacies, which may be dispensed in the travel trade (see Section 52a (1) of the German Medicines Act).

A fee of between €500 and €20,000 is set on the basis of the material and time-consuming administrative work involved and the importance of the matter for the applicant (according to the list of costs - tariff no. 7.IX.8/tariff item 1.1.4). This also includes expenses for necessary on-site inspections by our pharmaceutical officials (according to the list of costs - tariff no. 7.IX.8/tariff item 1.2).

The costs (fees and expenses) are to be borne by the applicant.

Basis for legal action

Verordnung über den Großhandel und die Arzneimittelvermittlung (Arzneimittelhandelsverordnung - AM-HandelsV)

Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)

§ 52a Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)

Legal Remedies

An appeal against the rejection of the application can be lodged with the competent Bavarian Administrative Court.

Procedure

Informal application to the responsible government (Upper Franconia or Upper Bavaria), which will decide on the application. Other authorities are involved ex officio, if at all.

Deadlines

There are no deadlines for the application. It is important to note that wholesale trading may not begin before the permit has been issued (see "Requirements").

Processing time

Legal deadline, if all documents and information are complete, max. 90 days.