Pharmaceuticals; application for a wholesale license

A wholesale license is required if, for example, companies wish to procure, store, dispense or export medicinal products on a professional or commercial basis (exception: supply to consumers other than doctors, dentists, veterinarians or hospitals).

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.

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.

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.

• 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