Pharmaceutical law; application for a permit for wholesale trade in pharmaceuticals
The issuance of a wholesale permit is necessary if, for example, companies want to procure, store, dispense or export pharmaceuticals on a professional or commercial basis (exception: dispensing to consumers other than physicians, dentists, veterinarians or hospitals).
Anyone wishing to engage in wholesale trade in medicinal products within the meaning of Section 2 (1) or (2) No. 1 of the German Medicines Act (AMG), test sera or test antigens requires a permit. The documents to be submitted are specified in Section 52a (2) AMG. The application can be made informally.
Trade may not be started before the permit, which is preceded by an inspection, has been granted. The violation constitutes a criminal offense.
If all documents are available, the inspection has been carried out and the deficiencies have been remedied, the permit, consisting of a notice and a certificate, is issued within three months.
The requirements result from § 52a AMG:
With the application, the applicant must
- specify the specific premises, the activities and the medicinal products for which the authorization is to be granted,
- submit evidence that he has suitable and sufficient premises, equipment and facilities to ensure proper storage and distribution and, where provided, proper decanting, packaging and labeling of medicinal products,
- designate a responsible person who possesses the expertise required to perform the activity; and
- attach a declaration in which he undertakes in writing to comply with the regulations applicable to the proper operation of a wholesale business.
Informal application to the responsible government (Upper Franconia or Upper Bavaria); they decide on the application. Other authorities are involved ex officio, if at all.
Exempt from the licensing requirement are finished medicinal products released for circulation outside pharmacies, which may be dispensed in the travel trade (cf. Section 52a (1) of the German Medicines Act).
There are no deadlines for the application. It is important to note that wholesale trading may not commence before the permit has been granted (see under "Prerequisites").
Legal deadline, if all documents and information are complete, max. 90 days.
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
Please select a location in "Localization" so that the address of the responsible authority can be filled in.
A fee of between €500 and €20,000 is set on the basis of the time and material administrative expense incurred and the importance of the matter for the applicant (according to Schedule of Costs - Tariff No. 7.IX.8/Tariff item 1.1.4). This also includes expenses for necessary site inspections by our pharmaceutical officials (according to the schedule of costs - tariff no. 7.IX.8/ tariff item 1.2).
The costs (fees and expenses) are to be borne by the applicant.
Links to more information
Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited