EudraGMDP is the European database of manufacturing and import authorisations, GMP certificates and statements of non-compliance with GMP. It is maintained by EMA, and a substantial part of it is open to anyone with a browser and no login. Most companies think of it as a place to check a supplier. Rather fewer think about what it says about them.
What the database holds
- Manufacturing and import authorisations (MIAs) issued to sites in the EEA.
- Wholesale distribution authorisations and GDP certificates.
- GMP certificates issued by national competent authorities following a satisfactory inspection.
- Statements of non-compliance with GMP, issued where an inspection concludes that a manufacturer is not compliant.
A non-compliance statement records the nature of the non-compliance and the actions taken or proposed by the issuing authority to protect public health. Both the positive certificates and the non-compliance statements are publicly accessible. Information of a commercially or personally confidential nature is not published, and the decision on what to publish rests with the competent authority of the Member State entering the record.
Why this is a commercial fact, not just a regulatory one
A statement of non-compliance is visible to your customers, your partners, your competitors and anyone conducting due diligence on you — immediately, without a request, and without your involvement. There is no embargo while you remediate.
The practical consequences tend to arrive faster than the regulatory ones:
- customers and licensees run supplier checks against EudraGMDP as routine;
- tender and procurement processes may screen against it;
- partners in third countries use it as a proxy for EU regulatory standing;
- an entry concerning a contract manufacturer becomes your problem, because your product is made there.
Use it before someone uses it on you
Three habits are worth building into the quality system:
Check your own records. Confirm that the authorisations and certificates listed for your sites are current, that the scope of activities and dosage forms is accurate, and that nothing has lapsed or been misrecorded. Errors do occur, and they are easier to correct before a customer finds them.
Check your supply chain, repeatedly. Supplier qualification is not a one-off event at contract signature. A CMO or API manufacturer that was compliant when you qualified it may not be today. Periodic re-checks belong in your supplier management procedure with a defined frequency and a documented owner.
Check before you commit. Due diligence on a prospective manufacturing partner, in-licensing candidate or acquisition target should include the public record for every site involved — including sites in third countries inspected by EU authorities.
If a non-compliance statement concerns one of your sites
Treat it as three parallel workstreams, not one. There is the regulatory response to the issuing authority and the remediation it requires. There is the supply consequence — which products are affected, whether batches already released are implicated, and whether shortage notification obligations are triggered. And there is the communication to customers and partners, who will see the entry whether or not you tell them. Companies that handle the first two well and neglect the third usually find the third does the most lasting damage.
How PQRA helps
We run supplier and contract manufacturer qualification programmes including periodic regulatory-status checks, conduct GMP and GDP audits, prepare sites for inspection by EU authorities and EOF, and support companies through remediation and response where an inspection has gone badly — including the supply-continuity and communication questions that come with it.
If you want your supply chain checked properly, or a site prepared before an inspection rather than after one, speak to our quality assurance team.
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