Pharmaceuticals; application for recognition as a central procurement office

Pharmaceutical companies and wholesalers may, by way of exception, supply medicinal products that are reserved for pharmacies to central procurement offices for medicinal products recognized by the competent authority.

Formloser Antrag (ohne Unterschrift)

This form can be submitted electronically without signature (e.g. via a secure contact form or by e-mail) or in paper form to the responsible authority.

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Secure contact form

Street address

Maximilianstraße 39
80538 München

Hinweis: Wir empfehlen eine vorherige Terminvereinbarung bei persönlichen Vorsprachen

Postal address

80534 München

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In principle, pharmacy-only and prescription-only medicinal products for final consumption may only be placed on the market in pharmacies (Section 43 (1) of the German Medicinal Products Act (AMG)). An exception to this provision can be found in Section 47 para. 1 sentence 1 no. 5 AMG.

According to this provision, pharmaceutical companies and wholesalers may, by way of exception, supply medicinal products that are reserved for pharmacies to central procurement agencies for medicinal products that have been established on a statutory basis or recognized by the competent authority.

Recognition as a central procurement office can be applied for informally by e-mail to the responsible government:

Government of Upper Franconia: responsible for the administrative districts of Upper Palatinate, Upper Franconia, Middle Franconia and Lower Franconia
Government of Upper Bavaria: responsible for the administrative districts of Lower Bavaria, Upper Bavaria and Swabia

Recognition is granted in consultation with the Federal Ministry of Health.

Recognition as a central procurement agency enables the recognized companies or organizations to conclude contracts with the pharmaceutical companies in question under their own responsibility and authority.

The specific conditions for recognition as a central procurement office are listed in Section 47 para. 2 AMG:

The entity to be designated may only stockpile for the company's or organization's own requirements.
It must be under the professional management of a pharmacist; if necessary, a corresponding contract must be concluded with an external pharmacist.
The professional management of a central procurement office requires a certain amount of time and manpower for this activity in order to maintain the necessary overview of the medicinal products to be procured, stored and passed on and to issue any instructions that may become necessary at any time. The relevant regulations must be observed when storing medicines.
It must have suitable premises for the storage, inspection and testing of medicinal products. In addition, precautions must be taken to prevent access by unauthorized persons. The rooms must always be in a proper condition, in particular dry, clean and well ventilated and, depending on the size of the central procurement office, sufficiently large and properly equipped to ensure proper storage and quality of the medicinal products.

written assurance that the medicinal products are obtained exclusively for their own use in the performance of their duties
Certified copy of trade register excerpt / business registration (as proof of legal form and power of representation)
Location plan of the buildings on the site or location plan of the premises within the building.
Floor plan

Description of the rooms intended for the testing, inspection and storage of the medicinal products (scale 1:100), details of the location, size and number of rooms and a drawing of the personnel and material flow
Proof of availability of the rooms (e.g. copy of the rental contract or extract from the land register)
Contractual agreement with a pharmacist (presentation of a certified copy of the licence to practise pharmacy) to take on the position of "pharmacist in charge of the central procurement office".
Written confirmation from the pharmacist in charge of the central procurement office on the suitability of rooms and facilities
Evidence that the staff involved in the maintenance of the central purchasing body are trained for their task.
Detailed description of the system for regular monitoring of stocks for deterioration or other degradation.
Detailed description of the measures taken to protect medicinal products from unauthorised access
Description of the pest control measures
Detailed description of measures to control and ensure compliance with storage conditions (temperature, humidity, warning and action limits), alarming if necessary

The recognition of central purchasing bodies is granted by the competent authority of the federal state in which the purchasing body is to be based. In Bavaria, these are the locally responsible district governments.

Interested companies and organizations submit their informal application for recognition as a central purchasing body to the responsible district government. On the basis of the documents submitted and, if necessary, an acceptance inspection, recognition is granted in consultation with the Federal Ministry of Health.