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.

Description

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.

Prerequisites

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.

Procedure

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.

Special notes

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).

Deadlines

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").

Processing time

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

Required documents

  • 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

Forms

Please select a location in "Localization" so that the address of the responsible authority can be filled in.

  • Prefillable Form, Bavaria-wide: Formloser Antrag (mit Unterschrift)
    Please note

    This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

    Dieser Assistent unterstützt Sie bei der Erstellung eines formlosen Schreibens, wenn die zuständige Stelle kein Antragsformular zur Verfügung stellt.

Fees

  • 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.

Remedy

Administrative court proceedings; information

An action may be brought before the competent Bavarian Administrative Court against the rejection of the application.

Status: 11.10.2021

Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege

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  • 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
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