New Applications for a Wholesale Distribution Authorisation (WDA)
You must apply for a Wholesale Distribution Authorisation (WDA) if you wish to wholesale medicines in Ireland. You must complete and submit an Application for a Wholesale Distribution Authorisation. A copy of this form can be downloaded below.
We assess the applications for a WDA. Part of this assessment includes an inspection to determine if a WDA can be issued.
Guidance on applying
You should refer to our Guide to New Applications and Variations to Wholesale Distribution Authorisations, along with the helpful checklists on this page, to ensure that your application meets the specific requirements for a new application for a WDA. A copy of this Guide can be found below.
Helpful Checklists
Site Readiness Checklist
Applicants must complete the following actions before submission:
| To Do | Check? | Further Detail |
| There is a permanent physical site that is continuously accessible. | See guide, page 4. | |
| There is a legally registered address that matches in all databases. Please note, companies should have the records for the organisation matching in the EMA database 'SPOR' and the Irish database 'CORE' | See guide, page 4. | |
| There is a record-keeping system that can be updated in real-time at the site. | See guide, page 4. | |
| There is sufficient equipment at the site. | See guide, page 4. | |
| There are sufficient trained staff at the site. | See guide, page 4. | |
| The Responsible Person (RP) and Deputy (DRP) are prepared for an inspection. | See 'Further Information' section for essential guidance. |
Submission Checklist
Applicants must include the below information and documentation in a submission. Please note, mandatory items are marked with a '*'. Items without this symbol may be required on a case-by-case basis.
| To Submit | Check? | Further Detail |
Completed application form* with a signed declaration. | See guide, page 4. | |
| Certificate of incorporation* | See guide, page 4. | |
| Business document (if using a trading style) | See guide, page 4. | |
Details of the proposed wholesale distribution model. This should include details on operations*, customer types*, supplier types*, and transport model. Please note, temperature mapping studies and risk assessments must be confirmed for Holding or Transport. | See guide, pages 6-7, and 13. | |
Statement on premises and equipment. This should include details on storage*, inventory control*, picking*, cold chain storage*, and security arrangements*. | See guide, page 14. | |
Statement on quality system specific to the wholesaling site. This should include a list of documented procedures* and quality manual*. | See guide, page 15. | |
Details of personnel. This should include the RP, DRP*, warehouse manager, and quality personnel. | See guide, page 15. | |
Written confirmation relating to the use of a proposed outsourced provider. This should include the contract RP or DRP, the contract Wholesale Distribution Site, and the contract Transport Provider. Please note, temperature mapping studies, risk assessments, audits and technical agreements must be confirmed for use of an outsourced provider. | See guide, pages 10-12. | |
| Name and address of a proposed broker | See guide, page 15. | |
Classification of facility size* | See guide, page 16. | |
| Proof of payment for relevant fee* | See 'Fees' section. |
How to know that a submitted application has been approved
Before granting a WDA, the HPRA must complete these steps:
- Acknowledge the submitted application via email, providing the company with a HPRA Reference Number.
- Assess the submitted application, following up with the company if there are any questions.
- Inspect the wholesaling site for compliance with Good Distribution Practice (GDP) and EU and national legislation.
- Review the applicant’s responses to inspection findings and any other aspects to be resolved.
- HPRA Issue an electronic WDA with e-Signatures to EudraGMDP.
- Issue a GDP cert or certificate of non-conformance to EudraGMDP depending on the outcome of the GDP inspection.
Will a hard copy of the authorisation be issued?
The HPRA do not routinely issue hard copies of Manufacturing Authorisations (MIAs), Wholesale Distribution Authorisation (WDAs) and Active Substances Registrations (ASRs). These can be found on the EudraGMDP website. The authenticity or integrity of electronic authorisations may be verified on the EudraGMDP database.
You can find a list of authorised wholesalers of medicines on the EudraGMDP website.
Fees
Please refer to our Guide to fees for human products and review the fee for New Applications. A copy of this Guide can be found below.
Further Information
Essential guidance and special topics relating to wholesaling in Ireland have been provided below. All enquiries should be sent to the Licensing Section of the HPRA. Please see the Contact Us page.