Mon 27 Mar 2023 09:27:47 BST

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Wholesale Distributor Authorisation

Wholesale distributors of medicinal products must possess an authorisation to engage in activity as a wholesaler in medicinal products.

Member States shall enter the information relating to the authorisations referred to article 77(4) in the Union Database(EudraGMDP) as referred to in article 111(6) of the Directive 2001/83/EC as amended.

The Community format for the Wholesale Distribution Authorisations document is published in the Compilation of Community Procedures, which can be found at the following location :

Compilation of Community Procedures on Inspections and Exchange of Information

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA.Pleaseclick hereto get list of NCA's.

Due to the restrictions caused by COVID-19, the period of validity GMP and GDP certificates issued by EEA authorities is automatically extended until the end of 2023, except where clarifying remarks in the document state otherwise. Manufacturers, and importers and distributors must continue to comply with GMP/GDP and all other legal obligations. On-site inspections are conducted where and when possible. Competent authorities reserve the right to perform risk based supervision of sites by either on-site inspections or distant assessments and, based on the outcome, may continue to issue, withdraw or restrict GMP certificates, as appropriate.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.

As of 28 January 2022, the source of organisational data will change. Additional information and instructions are available on EMA's website