EU Licensed · GDP Certified

Verifiable compliance, by the licence number.

EU GDP compliant · IGJ supervised · EU regulatory aligned · Formally audited and annually reviewed. Licence numbers shown as plain text — verification documents shared privately with qualified partners.

Authorisations

Two licences, both verifiable.

The Wholesale Distribution Authorisation and GDP Certificate below are the operational backbone of every transaction we run.

Wholesale Distribution Authorisation

WDA Licence

No. 16615 G

Issued on: 01/06/2021
Renewal: Yearly renewable

Issued by the Dutch Ministry of Health (Farmatec | CIBG). Authorises procurement, supply, and export operations — including medicinal products without a Marketing Authorisation in the EEA intended for export, plus cold-chain handling.

Medicinal products with a Marketing Authorisation in EEA country(s)
Medicinal products without a Marketing Authorisation in the EEA and intended for exportation
Authorised operations: Procurement, Supply, Export
Cold-chain products (requiring low-temperature handling)

Licence verification, qualification documents, and the full compliance package are available privately to qualified partners on request.

Good Distribution Practice

GDP Certificate

NL/G24/2053458

Issued on: 04/11/2024
Issued by: IGJ

Good Distribution Practice certification issued by the Dutch Health and Youth Care Inspectorate (IGJ) confirms that our distribution operation meets the EU GDP Guidelines (2013/C 343/01) — the quality framework for handling medicinal products for human use.

Documented Quality Management System
Continuous temperature-monitored storage
Qualified personnel and validated equipment
Traceable batch documentation end-to-end

Regulatory framework

The rulebook we operate under.

Compliant by default — supervised by the IGJ (Dutch Health & Youth Care Inspectorate) and aligned with EU regulatory requirements.

EU GDP compliant
IGJ supervised
EU regulatory aligned
Formally audited and annually reviewed

Qualification

Standard operating procedures, shared privately.

All trading partners — suppliers and customers — undergo a formal qualification process before any first transaction.

Supplier Qualification SOP
Standard operating procedure for the qualification of drug suppliers — provided privately to qualified partners after first contact.
Customer Qualification SOP
Standard operating procedure for the qualification of customers — provided privately to qualified partners after first contact.

Request Compliance Package

Our quality standards

What partners can expect, on every shipment.

Continuous compliance, not an annual event.

Fully documented QMS

Version-controlled SOPs covering all distribution activities, reviewed on a defined cadence.

End-to-end traceability

Across all products and shipments — every batch with a complete chain of custody.

Designated Responsible Persons

Named on the WDA licence and registered with the Dutch authorities.

Documentation on request

Full compliance package available privately to qualified partners after first contact.

Corporate registration

Legal, fiscal, and customs identifiers.

Every identifier that a partner, bank, or customs authority may request is listed in one place.

Operational entity: ESNA Care B.V. · KVK 78518563
Holding entity: ESNA Healthcare B.V. · KVK 74103830
VAT number: NL861433701B01
EORI number: NL861433701
REX number: NLREX7738
Head Office: Newtonlaan 115, 3584 BH Utrecht, The Netherlands
Warehouse: Markkaweg 1, 2153 NB Nieuw-Vennep, The Netherlands