| answer text |
<p>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.</p><p>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.</p><p>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.</p>
|
|
