The UK Department of Health and Social Care (DHSC) has published a consultation proposing twelve technical updates to the Health Service Products (Provision and Disclosure of Information) Regulations 2018 (Information Regulations). These measures aim to align data collection with recent community pharmacy reimbursement reforms and provide health officials with greater visibility over the increasingly complex supply chain. The proposal follows an annual review which determined that – while the core objectives of the regulations remain proportionate – administrative adjustments are necessary to maintain their efficacy.
A primary objective involves expanding routine data collection for products not yet listed in the Drug Tariff. Currently, officials often rely on ad hoc requests to assess whether unlicensed medicines or new generics are suitable for regular reimbursement categories. The new framework would require manufacturers and wholesalers to provide quarterly sales and volume data for these items. This formalisation is intended to support the implementation of Category H, a new reimbursement tier for products with multiple suppliers scheduled for introduction in March 2026.
The proposed amendments also address changes in the pharmacy landscape, specifically the introduction of centralised dispensing models. Under the Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 (Hub and Spoke Regulations), new hub pharmacies have been established to handle assembly and labelling at scale. DHSC intends to amend existing definitions so these hubs are subject to the same record-keeping and reporting obligations as traditional wholesalers. This ensures that data informing reimbursement prices and market oversight reflect all procurement routes.
To ensure the dictionary of medicines and devices (dm+d) remains accurate, the government proposes a new mandatory notification requirement for all health service medicines. Producers would be required to alert the NHS Business Services Authority (NHSBSA) whenever they launch new products or update the price and pack size of existing ones. Officials note that accurate dm+d listings – which represent a standard dictionary of descriptions and codes – are essential for the effective remuneration of primary care providers.
Significant reforms are proposed for the management of medicine shortages. Current regulations require producers to notify officials when they consider a shortage is likely. DHSC argues this subjective wording has led to non-reporting of critical market fluctuations. The new proposal requires companies to report any planned or unplanned reduction in supply – providing a more objective trigger for government intervention. Additionally, the Secretary of State for Health and Social Care (Secretary of State) would gain powers to request stock data for over-the-counter products and for medicines associated with identified public health risks.
To improve compliance, the department suggests a more direct enforcement mechanism. Under current rules, a penalty can only follow the issuance of a compliance notice, which provides a seven-day grace period. The proposal would allow the Secretary of State to bypass this notice and impose immediate fines for failing to report supply issues or product information updates. Officials maintain that the current delay – which requires waiting for a company response – undermines the ability of the Medicines Supply team to mitigate clinical risks.
The consultation remains open until 5 May 2026. Stakeholders – including individual professionals, manufacturers, and wholesalers – may submit responses via the official online survey portal. Following the twelve-week window, DHSC will evaluate the evidence and publish a formal response before implementing the regulatory changes. While the updates increase the administrative requirements for suppliers, the department argues the measures are necessary to ensure the financial sustainability of the health service and the continuity of patient care.
Source: Department of Health and Social Care
Link: Proposed amendments to the Health Service Products (Provision and Disclosure of Information) Regulations 2018: consultation document
Date: 10 February 2026
