Wholesale distribution authorization acc. to § 52a AMG and import/export permission acc. to §§ 72-74 AMG & GDP certificate – Your pharmaceutical distribution in the EU
As a pharmaceutical wholesaler in Germany and Europe, you are responsible for ensuring that the quality and integrity of medicinal products are maintained throughout all activities, such as procurement, storage, dispensing, and export, and that no counterfeit medicines enter the legal supply chain.
To guarantee this, a wholesaler in Germany needs a wholesale distribution authorization according to § 52a AMG if no manufacturing authorization according to § 13 AMG has been established to date. As far as EU import from countries outside the European Economic Area according to §§ 72-74 AMG are to be included, an appropriate permit must be obtained. The application for the wholesale distribution authorization must be submitted to the appropriate state authority. The authority checks whether you comply with the "Verordnung über den Großhandel und die Arzneimittelvermittlung (Arzneimittelhandelsverordnung – AM-HandelsV)" and the EU Guidelines on Good Distribution Practice (GDP) for medicinal products (2013/C 343/01).
No GDP certificate without a QMS
These regulations specify the implementation of a quality management system, which sets out the responsibilities, procedures, and principles of risk management in relation to your sales activities. Furthermore, you must name at least one responsible person in charge of the proper operation and compliance with the regulations. Your premises, facilities, and equipment must ensure the proper storage and distribution of the medicinal products.
As a wholesaler, you must ensure that the drugs you distribute are produced by manufacturers with a manufacturing authorization according to § 13 AMG or from holders with a wholesale distribution authorization. You are obliged to check that wholesalers you work with comply with the guidelines of Good Distribution Practice and that they hold a wholesale distribution authorization.
After successfully completing the GDP audit by the supervising state authority (in Germany), you will receive your wholesale distribution authorization, the so called GDP certificate. To ensure long-term compliance with the requirements, surveillance audits are carried out every 12 to 24 months, a re-certification is due after 3 years.
To ensure that you receive your GDP certificate promptly, our team of experts offers the following services:
- Application (according to § 52a AMG)
- Preparation of the QP declaration, necessary for the import of medicinal products into the EU
- Implementation of a QMS and preparation of the QM manual
- Creation of Standard Operating Procedures (SOPs) and related forms
- Performance of temperature mappings
- Support in the selection of personnel in key positions (e.g., responsible person)
- Identification and selection of external service providers (e.g., transport, storage)
- Audits and contractual agreements for external services
- GMP training of your employees
- Mock inspection in preparation for inspection
- Support during inspection
