Where to find GDP Certificates and Wholesale Distributor Authorisations

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Where to find reliable information on whether a particular company is in possession of a Wholesale Distribution Authorisation (WDA) or GDP certificate? Depending on the location of the company in question, certain databases are available for searching.

EudraGMDP

The wholesale distribution of medicinal products requires a WDA. Within the European Union, these authorisations are issued by the national competent authority of the member state in which the wholesale distributor operates. A GDP certificate is issued by the national competent authority that carried out an inspection if the outcome of the inspection confirms that the wholesale distributor complies with GDP.

EudraGMDP is an EU GMP and GDP-related database in which manufacturing and wholesale authorizations, certificates and non-compliance reports are published. The database is maintained and operated by the European Medicines Agency (EMA) and the member states shall enter the information via an interface.

• Search for Wholesale Distributor Authorisations
• Search for GDP Certificates

MHRA-GMDP

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, as of 01 January 2021, they are no longer included or updated, with the exception of documents relating to sites in Northern Ireland.

Following Brexit, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has set up its own GMDP database, which contains information from the MHRA on manufacturing and wholesale licenses and certificates as well as non-compliance statements.

• Search for Wholesale Distributor Authorisations
• Search for GDP Certificates

SwissGMDP Database

Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices, is planning to launch a SwissGMDP database, similar to the EudraGMDP database. It will list the GMP and GDP certificates of all companies in Switzerland with a valid establishment licence issued by Swissmedic.

According to a press release from September 2023, the SwissGMDP is expected to be launched on the Swissmedic website in the last first quarter of 2024.

USA

There is currently no national database for the US in which all certificates are compiled. However, individual states have their own databases and search options. The website of the U.S. Food and Drug Administration (FDA) provides an overview with links to the respective websites of the authorities of the U.S. states responsible for the approval of wholesalers.

• Check Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers