Provision of the Services of a Responsible Person for Wholesale Distribution Authorisation at the National Immunisation Office

The HSE intends to establish arrangements with successful Service Provider to provide Services of a

Provision of the Services of a Responsible Person for Wholesale Distribution Authorisation at the National Immunisation Office

Health Service Executive (HSE)

## Summary The Health Service Executive (HSE) is procuring a Responsible Person (RP) to secure a Wholesale Distribution Authorisation (WDA) for the National Immunisation Office (NIO) in Dublin. The successful provider will manage the regulatory application, lead inspections, and provide temporary oversight until internal staff are trained to assume the role.

## Scope & Deliverables - Develop a robust GDP Quality Management System for the NIO. - Train HSE pharmacist staff to operate as Deputy Responsible Persons (DRPs). - Submit a compliant WDA application to the Health Products Regulatory Authority (HPRA). - Lead and prepare the organization for the HPRA inspection process. - Act as the named RP for six months post-authorization, ensuring ongoing compliance with EU GDP guidelines until DRPs can take over.

## Key Requirements - The individual must meet all qualifications and conditions for a Responsible Person as defined by EU legislation and best practice guidelines. - Demonstrated experience in securing Wholesale Distribution Authorizations from the HPRA. - Expertise in Good Distribution Practice (GDP) compliance and quality assurance planning. - Ability to train staff and manage regulatory inspections. - Compliance with grounds for exclusion via the European Single Procurement Document (ESPD).

## Commercials & Timeline - Estimated value: Not stated (listed as 0 Euro in notice). - Submission deadline: 10 June 2026 at 15:00 IST. - Contract duration: 12 months. - Tender validity: 270 days. - Framework/DPS: No framework agreement or Dynamic Purchasing System.

## How to Bid - Submission method: Electronic submission via the eTenders portal. - Language: English. - Key documents: Prepare the ESPD, technical proposal detailing GDP QMS and training methodology, and evidence of relevant RP qualifications and HPRA inspection experience. - Additional info requests: Deadline is 29 May 2026 at 12:00 IST.

## Bid Considerations - Strategic Fit: Ideal for specialized regulatory consulting firms or pharmaceutical logistics experts with strong HPRA relationships. - Opportunity: Provides a clear pathway to influence national immunization supply chain compliance and potential future contract extensions. - Risk: The "0 Euro" valuation suggests a below-threshold procurement; financial terms may be negotiated post-award, creating uncertainty. - Complexity: Success depends heavily on the speed and quality of the HPRA inspection outcome, which carries regulatory risk.

Open procedure. Any interested supplier may submit a tender. There is no shortlisting stage — all compliant bids received by the deadline are evaluated against the published award criteria. It is the most common route for Irish public contracts and is open to SMEs and new entrants.

Health Service Executive (HSE) has 236 tender(s) tracked on TenderScout, of which 20 are currently open. On the EU TED record this buyer has awarded 400 contract(s) worth around €3,627,848,444.

Recent awarded suppliers include 3fivetwo Medical Ltd, Irish Hospital Supplies, Hospital Services Ltd, Astral Healthcare, Varian Medical Systems Ltd.