Information - Services - Formalities by subjects - Business start-up preparations - General - Pharmaceutical law; application for a permit for wholesale trade in pharmaceuticals - Dienstleistungsportal Bayern

Description

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.

Prerequisites

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.

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

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).

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 "Prerequisites").

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 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.

Legal bases

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

Remedy

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

Links to more information

• Voraussetzungen zur Erteilung einer Erlaubnis für den Großhandel von Arzneimitteln gemäß § 52a Arzneimittelgesetz (AMG)