On December 15th 2022 the MHRA has published the outcome to their key consultation “The future strategy for batch testing of medicinal products in Great Britain: government response“.
The outcome of the consultation is to maintain the status quo where no import testing or UK Qualified Person (QP) certification for medicines imported from countries on the approved list is required. The approved list of countries is available on the MHRA website. This option requires that a Responsible Person (import) (RPi) in the UK verifies that the batch has been tested and certified by a QP in the EU.
The Department of Health and Social Care (DHSC) ran a public consultation seeking views on 4 policy options 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 (MRA) on batch testing. A range of stakeholders across the UK and internationally expressed comments and views. The majority of the responses were in favour of option A: no import testing or UK Qualified Person (QP) certification for medicines imported from countries on the list of approved countries for import. 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, making the UK a less attractive market.
After careful consideration of all the responses to the 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 UK QP certification. This policy protects patient safety, supports the aims set out by this government in the Life Sciences Vision to 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.