Section 264A of the National Health Service Act 2006 (“the 2006 Act”) provides for the Secretary of State to make regulations to require UK producers to record and keep information which the Secretary of State may require for the purpose set out in subsection (3) of that section and to provide that information to Secretary of State (section 264A(2) of the 2006 Act).
Link: The Health Service Products (Provision and Disclosure of Information) Regulations 2018
Source: Legislation .gov.uk