Information - Services - Formalities by subjects - Business start-up preparations - General - Pharmaceuticals; application for recognition as a central procurement office. - Dienstleistungsportal Bayern

Description

In principle, pharmacy- and prescription-only medicinal products for end use may only be placed on the market in pharmacies (Section 43 (1) of the German Medicinal Products Act - AMG). Exceptions to this provision are conclusively regulated in Section 47 (1) Sentence 1 No. 5 AMG:

According to this, pharmaceutical entrepreneurs and wholesalers may, by way of exception, supply medicinal products, the dispensing of which is reserved for pharmacies, to central procurement agencies for medicinal products 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 competent 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.

Prerequisites

The specific conditions for recognition as a central purchasing body are listed in Section 47 (2) AMG:

1. The body to be designated may only stock for the company's or organization's own requirements.
2. 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 obtain the necessary overview of the medicinal products to be procured, stored and passed on, and to make any instructions that may become necessary at any time. When storing medicinal products, the relevant regulations must be observed.
3. It must have premises suitable for the storage of medicines. In addition, precautions must be taken to prevent access by unauthorized persons. The rooms must always be in 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.

Procedure

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

Interested companies and organizations submit their informal application for recognition as a central procurement body to the competent 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.

Processing time

Depending on the scope of the documents and the required acceptance inspection, up to three months

Required documents

• 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

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 (ohne Unterschrift)

  Please note

  This form requires no signature. You can sent it electronically (e.g. by secure email or De-Mail) or as hardcopy to the responsible authority.

Fees

• Cost range for recognition: 5.00 to 25,000.00 EUR

Legal bases

• § 47 Abs. 2 Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG)
• Verordnung über die Zuständigkeiten der Arzneimittelüberwachungsbehörden und zum Vollzug des Samenspenderregistergesetzes sowie des Gendiagnostikgesetzes (Arzneimittelüberwachungszuständigkeitsverordnung - ZustVAMÜB)

Remedy

Administrative court action