This content applies to human and veterinary medicines.
The EudraGMDP database is the Community database on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-practice (GMP) and good-distribution-practice (GDP) certificates. A public version of the database has been available since 2011, which allows public access to the information in the database that is not of a commercially or personally confidential nature.
The database aims to:
- improve the sharing of information between regulators and the public, including the pharmaceutical industry;
- aid the coordination of inspections of manufacturers in third countries among national competent authorities;
- eliminate the need for industry to submit paper documents to support marketing-authorisation and variation applications;
- help protect the medicine distribution chain and active-substance supply chain by facilitating the verification of legitimate actors;
- facilitate the sharing of information on the outcomes of inspections conducted by European Economic Area (EEA) authorities with regulatory authorities elsewhere in the world.
EEA Member States include data in the EudraGMDP database as it becomes available. Regulatory authorities in the EEA have full read and write access to EudraGMDP.
Several international regulatory partners have unrestricted read access to the database. Those with mutual recognition agreements have also been offered write access, to replace the exchange of paper certificates needed for these agreements to operate: the first of these to start entering information into the database were the Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) in October 2013.
For more information, see:
Guidance on authorisation, registration and certificate formats, together with relevant procedures, is available below.
From 28 January 2022, manufacturers, importers and distributors need to ensure their organisation-related details such as name and address are correctly recorded in EMA’s Organisation Management Service (OMS) before applying to national competent authorities for any of the following (whether new or updated):
- Manufacturing and importation authorisation
- GMP compliance certificate
- Wholesale distribution authorisation
- Registration of an active substance manufacturer, importer or distributor
This applies to all EU and non-EU manufacturers, importers and distributors of human and veterinary medicines or active substances, which are mentioned in documentation uploaded in the EudraGMDP database.
Applicants whose details are not correctly recorded in OMS should submit a change request in OMS. National competent authorities (NCA) will no longer manually enter organisation-related details into EudraGDMP, but will rely on the master data held in OMS from January 2022.
Until further notice, these requirements do not apply to GDP compliance certificates for companies distributing human and veterinary medicines. Organisation-related details for these applications can continue to be registered in EudraGMDP.
Guidance is available under 'Documents' in OMS and an EMA webinar for EurdaGMDP users:
- Organisation Management Service: SPOR portal
- Integration of EudraGMDP and OMS - Webinar for industry (12/10/2021)
- Organisation Management Service (OMS)
For queries on this topic, contact email@example.com.
This change supports the entry into force of the Veterinary Medicinal Products Regulation (Regulations (EU) 2019/6 and 2021/16, Article 9(h)), which aims to:
- ensure more reliable data in EudraGMDP via the consistent use of organisation master data;
- reduce the need for data entry and cleansing;
- enhance the interoperability of IT systems.
The European Medicines Agency first launched the system in April 2007, with a second release in July 2009 including GMP non-compliance of manufacturers.
It added a third module in December 2012 to include a planning module for national competent authorities (medicines regulators in European Union Member States) to share inspection plans for manufacturers in third countries (countries outside the EU). This planning module is not visible in the public version of the database.
In April 2013, the Agency launched a further module, extending coverage to GDP-related information and registration of manufacturers, importers and distributors of active substances.