NEYPPC Pharmacy: Unlicensed Imported Medicines (wave 2)

The North East and Yorkshire NHS Pharmaceutical Purchasing Consortium intends to establish a framework agreement for the supply of Unlicensed Imported Medicines on behalf of NHS organisations and other eligible public sector bodies. The framework will provide access to a defined range of unlicensed imported medicines, including products requiring over-labelling and translation. These medicines do not hold a UK Marketing Authorisation but are licensed in their country of origin and may be imported and supplied in accordance with Regulation 167 of the Human Medicines Regulations 2012 where a patient's clinical needs cannot be met by a suitable licensed alternative. Suppliers will be required to hold all relevant MHRA licences, authorisations and approvals necessary to import, distribute and supply unlicensed medicines within the UK, and to demonstrate compliance with applicable Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. The framework will provide participating organisations with access to safe, compliant and quality-assured products through a robust and competitive procurement arrangement. Products and suppliers will be subject to comprehensive quality, risk and commercial assessment to support regulatory compliance, supply chain resilience, continuity of patient care and value for money across the NHS.