01
The three records answer different questions
An official record should never be reduced to a generic “licensed” badge. Reviewers need to identify the actual activity, legal entity and site, then select the record that addresses that question.
In the EU, the relevant national competent authorities issue authorisations and conduct inspections. EMA operates EudraGMDP and coordinates EU-level inspection activity, while the database content is supplied by the competent authorities.
02
WDA, GDP certificate and MIA compared
| Record | What it addresses | What to inspect |
|---|---|---|
| Wholesale Distribution Authorisation (WDA) | Permission to carry out the wholesale operations stated for the holder and site. | Holder, site, authorised operations, medicinal-product scope and restrictions. |
| GDP certificate | The recorded outcome of an inspection against Good Distribution Practice. | Inspected site, issuing authority, inspection date, scope and any non-compliance record. |
| Manufacturing and Importation Authorisation (MIA) | Permission for the manufacturing or importation activities stated in its scope. | Authorised site, operations, dosage forms or products and any restrictions. |
Important: A certificate or database result must be read in full. A name match alone does not show that the proposed activity is within scope.
03
When a wholesaler needs a WDA
EMA states that anyone engaged in wholesale distribution of medicinal products in the EEA must hold a WDA issued by the national competent authority of the Member State where those activities take place. The same authority is responsible for inspecting the distributor.
Manufacturing authorisation holders do not require a separate WDA to distribute products already covered by their manufacturing authorisation. This is scope-specific and does not turn one MIA into a general permission for unrelated wholesale activity.
04
A GDP certificate is not the authorisation itself
Wholesale distributors must comply with EU GDP to obtain and maintain the relevant wholesale authority. Following an inspection, the competent authority records a GDP certificate or a non-compliance statement in EudraGMDP.
The WDA and GDP information should be reviewed together. The authorisation explains permitted activities; inspection records help reviewers understand the compliance status of a site at the recorded time.
05
A practical record-review sequence
- Match the exact legal entity and operating site to official records
- Identify the activities involved: procurement, holding, supply, export, manufacturing or importation
- Read the full authorisation scope and any restrictions instead of relying on the document title
- Check the associated GDP certificate and non-compliance information
- Confirm that the proposed medicine category and route fit the authorised scope
- Record the source, identifiers and date of the review in the transaction file
06
What official records still do not prove
A WDA, GDP certificate or MIA does not prove that a particular batch exists, belongs to the counterparty, is authentic or is suitable for a proposed destination. Product, batch, traceability, route, buyer-authority and commercial evidence still require transaction-specific review.
PharmaBatch uses organisation and authorisation records as part of seller review, while River Pharma GmbH independently considers the proposed wholesale transaction under the published operating model.
07
Frequently asked questions
Is a GDP certificate the same as a WDA?
No. The WDA is the wholesale authorisation and defines the permitted scope. A GDP certificate records an inspection outcome against Good Distribution Practice.
Is an MIA the same as a WDA?
No. An MIA covers the manufacturing or importation activities in its scope. A manufacturing-authorisation holder may distribute products covered by that authorisation, but the record is not a general WDA for unrelated products or operations.
Does EMA issue these authorisations?
National competent authorities issue WDAs and MIAs and perform the relevant inspections. EMA operates EudraGMDP and coordinates EU-level GMP/GDP inspection activity.
Where can these records be checked?
EudraGMDP provides public searches for WDAs, GDP certificates, MIAs, GMP certificates and related non-compliance information. National competent-authority registers may also be relevant.
08
Primary sources
Regulatory statements on this page are grounded in the following official sources. Always check the current record and guidance for a real transaction.