01
Start with the exact legal entity and site
Do not search only for a trading name. Record the legal company name, registered details and the physical site involved in procurement, holding, supply or export. Authorisation scope can differ between sites belonging to the same organisation.
Compare the information supplied by the counterparty with independent official records. Resolve spelling, address or company-number differences before progressing.
02
Five checks to make in official records
- 01
Locate the WDA
Search EudraGMDP and, where relevant, the national competent-authority register for the legal entity and site.
- 02
Read the authorised scope
Check which wholesale operations and medicinal-product categories the authorisation covers.
- 03
Review GDP information
Look for the applicable inspection outcome, GDP certificate or non-compliance statement and its date.
- 04
Confirm the proposed route
Make sure the planned procurement, supply, holding, import or export activity is consistent with the parties’ authorisations.
- 05
Record the evidence
Retain the source, date checked and relevant identifiers in the transaction due-diligence record.
03
What a WDA record can and cannot show
| A WDA record can help confirm | A WDA record does not by itself confirm |
|---|---|
| The named authorisation holder and site | That the counterparty currently controls a specific batch |
| The authorised wholesale operations | That a quoted product, quantity or price is genuine |
| Product categories or restrictions in scope | That the proposed destination and route are lawful |
| The responsible national competent authority | That every supporting document is authentic or current |
| Related GDP or non-compliance information | That a particular transaction has been accepted |
04
Transaction-specific evidence still matters
- Exact product, presentation, batch, serialisation and expiry information
- Evidence of lawful procurement and an appropriate supply chain
- Storage and transport controls for the product profile
- Buyer authority, destination and import or export requirements
- Sanctions, adverse information and suspicious-offer review
- Commercial documents that identify the actual contracting parties
Important: EMA guidance warns wholesalers to assess suspicious offers and verify supplier identity. Unexpected economic, language or geographic circumstances can require additional investigation.
05
How PharmaBatch uses verification boundaries
PharmaBatch limits verified seller applications to eligible EU-27 legal entities and records organisation and authorisation evidence before selling tools open. The platform also separates buyer-only and verified-seller permissions.
These controls support safer matching; they are not a blanket guarantee. River Pharma GmbH performs its own review of a proposed transaction before deciding whether to accept the wholesale execution role.
06
Frequently asked questions
What is EudraGMDP?
EudraGMDP is the public EU database operated by EMA that contains information entered by national competent authorities, including WDAs, GDP certificates and non-compliance statements.
Who issues an EU Wholesale Distribution Authorisation?
The national competent authority of the Member State where the wholesale activities take place issues the WDA and inspects the distributor.
Does a valid WDA guarantee authentic stock?
No. It is a critical organisation and scope check, but the specific product, batch, supply route and transaction evidence must also be reviewed.
How often should a wholesaler be checked?
Checks should be risk-based and refreshed when records expire or change, when a new site or activity is involved, and before a transaction where the existing evidence is not sufficiently current.
07
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.