Applications for a variation to a Wholesale Distribution Authorisation
Companies must apply for a variation to a Wholesale Distribution Authorisation (WDA) if they are proposing any changes to the wholesaling site which holds an authorisation. There are two types of variations:
- An administrative variation is considered a minor change to the wholesale distribution model at the site.
- A technical variation is considered a major change to the wholesale distribution model at the site. Please note, a GDP inspection may be required as part of the assessment for this variation.
How do I apply?
Where can I find instructions for an application for variation?
You can find information on completing the two different types of variation application in our Guide to New Applications and Variations to Wholesale Distribution Authorisations. A copy of this can be found below on this page.
Please refer to this guidance document, along with the helpful checklists on this page, to ensure that your application meets the specific requirements for an application for variation.
What are the timelines for a variation?
For technical and administrative variations of standard applications, the timeline can vary from 30 to 90 days. This depends on whether additional information is requested by the HPRA and if an inspection is required.
How do I know that a variation application has been approved?
Before approving a submitted application, the HPRA must complete these steps:
- Acknowledge receipt of the 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 or concerns.
- A GDP inspection may be required as part of the assessment for a technical variation.
- Once approved, you will be issued with an updated electronic WDA with e-Signatures.
Will a hard copy of the authorisation be issued?
What are the fees?
Applications for a variation to a WDA are charged as either a technical or administrative variation. You can find information on the relevant fee in our Guide to fees for human products. A copy of this can found below on this page.
Where can I find more information?
We have provided links to essential guidance and special topics about wholesaling in Ireland further down on this page. You can send any queries to the Licensing Section of the HPRA. Please see the Contact Us page.
Helpful Checklists
Site Readiness Checklist
Applicants must complete the following actions before submission:
To Do | Check? | Further Detail |
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. | |
| 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. This must include a signed declaration, details on the background to variation, details of the proposed changes, and the impact on compliance with GDP. | See guide, page 4. | |
| Certificate of incorporation* | See guide, page 4. | |
Business document (if using a trading style) | See guide, page 4. | |
| Supporting documentation for a proposed change to Applicant Details | See guide, page 5. | |
| Supporting documentation for a proposed change to Annex 1 | See guide, pages 6-7. | |
| Supporting documentation for a proposed change to Annex 2 | See guide, pages 10-11. | |
| Supporting documentation for a proposed change to Annex 3 | See guide, page 12. | |
Written confirmation relating to the use of a proposed outsourced provider. This must include the contract RP or DRP, contract Wholesale Distribution Site, and 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. | |
Proof of payment for relevant fee*. | See 'Fees' Section. |
Essential guidance for wholesaling in Ireland
You can find links to some essential guidance for wholesaling in Ireland below.
- The European Commission's Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01).