Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Health Service Products (Provision and Disclosure of Information) Regulations 2018, what criteria his Department uses to decide on which small producers to seek information from.

The Health Service Products (Provision and Disclosure of Information) Regulations 2018 (the Regulations) prescribe when manufacturers, importers and wholesalers of special medicinal products are required to provide information. Since the Regulations entered into force, quarterly information has been received in November 2018 and February 2019 and information is again due at the end of May 2019. The requirement to provide quarterly sales, purchase and volume information about special medicinal products already applies to all manufacturers, importers and wholesalers regardless of their size. Therefore, there is no need for an assessment on the potential merits of requiring all small producers to automatically supply quarterly information.