Pharmaceutical law; application for a licence for the wholesale trade in medicinal products
The granting of a wholesale permit is required if, for example, companies wish to procure, store, supply or export medicinal products on a professional or commercial basis. The supply of medicinal products to consumers other than doctors, dentists, veterinarians or hospitals is excluded.
Any person wishing to engage in wholesale trade in medicinal products within the meaning of Section 2(1) or (2)(1) of the German Medicines Act (AMG), test sera or test antigens requires a licence. The documents to be submitted are listed in § 52a Para. 2 AMG. The application can be made informally.
Trade may not be commenced before the permit, which is preceded by an inspection, has been granted. The violation constitutes a criminal offence.
If all documents are available, the inspection has been carried out and the deficiencies have been remedied, the licence, consisting of a notice and a certificate, is granted within three months.
The requirements result from Section 52a AMG:
With the application, the applicant must
- specify the specific premises as well as the activities and the medicinal products for which the authorisation 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 for, proper decanting, packaging and labelling of medicinal products,
- designate a responsible person who possesses the necessary expertise to carry out the activity, and
- enclose a declaration in which he undertakes in writing to comply with the rules applicable to the proper operation of a wholesale establishment.
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.
Exempted from the obligation to obtain a licence are finished medicinal products released for sale outside pharmacies, which may be supplied in the course of itinerant trade (cf. Section 52a(1) of the German Medicines Law).
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 "Requirements").
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 administrative effort and time involved and the importance of the matter for the applicant (according to the 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