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

Name of Contracting Authority:
Health Service Executive (HSE)
Publish on behalf of:
Health Service Executive
Title:
Provision of the Services of a Responsible Person for Wholesale Distribution Authorisation at the National Immunisation Office
CfT CA Unique ID:
HSE 28630
Evaluation Mechanism:
Most Economically Advantageous Tender (MEAT)
Allow different Evaluation Mechanism in the MC/SC:
Description:
The HSE intends to establish arrangements with successful Service Provider to provide Services of a Responsible Person (RP) for a Wholesale Distribution Authorisation (WDA) at the National Immunisation Office. A service provider is sought to prepare the NIO for a successful application for a wholesaler distribution authorisation (WDA) to the HPRA as soon as possible, including necessary audits. The successful tenderer will be expected to train Specified NIO staff in GDP to the level that at least two staff can operate as deputy Responsible Person (DRP), lead the inspection by HPRA and when successful in being granted a WDA, act as RP for the NIO for a period of 6 months and until such time that they have provided sufficient training and supervision that a DRP can take over the duties of RP. The RP should meet the qualifications and all conditions provided for by EU legislation and best practice guidelines. The RP must ensure that the conditions of the WDA have been and are being complied with and that the GDP guidelines are being followed for the duration of time the individual is named on the authorisation as RP. Scope of the Services • A robust GDP Quality Management System • Train HSE NIO pharmacist staff to act as Deputy RPs • Submit a complete and compliant WDA application to the HPRA • Prepare and lead the organisation through the HPRA inspection for a WDA • Provide ongoing RP oversight and compliance monitoring • Achieve full compliance with EU GDP and HPRA GDP guidelines
Procurement Type:
Services
CPC Category:
Health and social services
Directive:
2014/24/EU (Classic)
Procedure:
Open
CfT Involves:
A Public Contract
CPV Codes:
85100000-Health services
85140000-Miscellaneous health services
72224200-System quality assurance planning services
72225000-System quality assurance assessment and review services
98110000-Services furnished by business, professional and specialist organisations
98113000-Services furnished by specialist organisations
Award per Item:
No
Inclusion of e-Auctions :
No
NUTS codes:
IE
Estimated value (EUR):
0
Above or Below threshold:
Below
Time-limit for receipt of tenders or requests to participate:
10/06/2026 15:00
Deadline for dispatching invitations:
End of clarification period:
29/05/2026 12:00
Tenders Opening Date:
10/06/2026 15:30
Allow suppliers to make an online Expression Of Interest:
Yes
Contract awarded in Lots:
No
Contract duration in months or years, including any options and renewals:
12 months
Validity of Tender in days or months:
270 days
EU funding:
No
Multiple tenders will be accepted:
No
Date of Publication/Invitation:
20/05/2026 10:14
TED links for published notices:
Date of Awarding:
Language of publication:
EN
Number of openers:
Two