Question to the Department of Health and Social Care:

To ask Her Majesty's Government what stages products must go through to have their efficacy verified to receive authorisation to be sold and used in NHS clinical settings.

Suppliers provide a wide range of cleaning and disinfectant products to the NHS through various NHS Supply Chain framework agreements.

The NHS Supply Chain framework agreement specifications state that the standards and regulations for products submitted by suppliers must meet mandatory minimum quality requirements. On submission of products to NHS Supply Chain, suppliers are required to provide evidence of compliance to a wide range of standards as detailed in the specification, for example, market authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) or European Medicines Agency (EMA) in compliance with the Medicines Act 1968 (as amended); or testing by an accredited laboratory.

Where it is required that laboratory test reports are provided, and NHS Supply Chain have asked this of their suppliers, the NHS Supply Chain Technical Team would review the subsequent test data provided to ensure that the source of the data meets the requirements stated – for example, the data is from a United Kingdom Accreditation Service or equivalent accredited laboratory. Any concerns over the test laboratory’s capability and accreditation to perform the required testing to the standards required would be raised prior to a supplier being awarded to the Framework.

These standards and regulations are determined following wide stakeholder engagement (clinical, direct supplier and wider industry) prior to the launch of a new tender and in the development of the specification document. A combination of laboratory reports, certificates, for example, the MHRA, and supplier declarations of conformity provide NHS Supply Chain with assurance that products meet the requirements of the specification.

NHS Supply Chain contractually reserves the right to test the supplier’s goods at the supplier’s expense or request further information from the applicant to ensure the goods comply with the specification at any time during the procurement process, and, if awarded a contract, over the lifetime of the Framework Agreement. In the event that the product(s) do not meet the specification, NHS Supply Chain reserves the right to exclude the affected goods from the Framework Agreement.