Department Of Health
Detail of outcome
Batch testing is the process of confirming every batch of medicine has the correct composition through laboratory tests by the manufacturer. The government consulted on 4 proposals for a future batch testing policy for Great Britain where medicines are imported from a country with which the UK does not have a mutual recognition agreement on batch testing.
The majority of the responses were in favour of no import testing or UK Qualified Person (QP) certification for medicines imported from countries on the approved list (option A).Responses to the consultation highlighted the benefits of this option for the safety and availability of medicines, as well as avoiding adding additional cost and complexity that could disrupt medicine supply chains.
After careful consideration of all the responses to consultation, alongside other relevant information and evidence, the government has decided to make permanent the approach of maintaining a list of approved countries for import which require no import testing or UKQPcertification. This policy protects patient safety, supports the aims set out by this government in theLife Sciences Visionto stimulate a thriving UK life sciences sector and avoids adding unnecessary regulation to an already highly regulated sector. As this policy is currently in operation and in legislation, there is no need for a 2-year period to allow industry to prepare for implementation.
Original consultation
Consultation description
Batch testing is the process of confirming every batch of medicine has the correct composition through laboratory tests by the manufacturer.
The UKs independence from the EU now means the UK can set its own regulatory policy in Great Britain on how, when and if to accept batch testing results from third countries or choose to require batch testing in the UK of products intended for the UK market.
Were seeking views on the 4 policy options outlined in the attached consultation document, along with the practicalities of implementing them, in relation to medicines imported into Great Britain from a third country with which the UK does not have a mutual recognition agreement (MRA) on batch testing.
