Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of the case for reviewing the expiry dates of antibiotics, including in respect of savings for public expenditure.

The Medicines and Healthcare products Regulatory Agency (MHRA), the Government agency responsible for ensuring that medicines and medical devices work and are acceptably safe, has not made an assessment on the case for reviewing the expiry dates of antibiotics.

Medicine expiry dates, including for antibiotics, are necessary to ensure that the safety and effectiveness of a medicine is maintained over its long-term shelf life. The active ingredient in many medicines can degrade over time resulting in a loss of potency or the formation of impurities in the product. Physical changes to a medicine such as discolouration, may also occur upon prolonged storage. Medicine expiry dates are supported by stability studies completed by the pharmaceutical company, which demonstrate that a medicine remains safe and effective throughout its shelf life. Any change to the expiry date of a medicine requires an independent review of the stability data by the MHRA.

Companies can and often do extend the shelf life of their medicines once the product is on the market, and as additional stability data become available. It is not possible, however, to extend the expiry date of all medicines unilaterally in the absence of supporting stability data.