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

Tender 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