Guidance on reporting medicines shortages updated
Updated guidance to clarify the obligations on UK suppliers to report shortages and discontinuations of medicines that have a direct impact on patients in one or more nations of the UK have been published by the Department of Health and Social Care.
The new guidance clarifies the obligations on suppliers in Regulation 28 and 29 of the Health Service Products (Provisions and Disclosure of Information) Regulations 2018.
In January 2019, voluntary arrangements to manage medicines supply issues were replaced by mandatory requirements to provide information about the availability of medicines and about discontinuation or anticipated supply shortages.
The requirements aim to ensure that the DHSC has information as early as possible to help manage supply shortages and mitigate any potential impacts on patients.
Marketing authorisation holders (MAHs) are expected to be fully accountable for their supply chain to the UK market and required to understand the potential impact on patients should supplies of their products become unavailable.
The guidance document provides an overview of DHSC reporting requirements of MAHs for medicine supply issues set out in the regulations.