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New UK Medicine Batch Testing Regime - Have Your Say

on Wednesday, 08 June 2022.

The Department for Health and Social Care is consulting on a new regime for batch testing of medicines which have been imported.

This follows a standstill position after the end of the Brexit transition period since January 2021, under which the UK has unilaterally recognised the testing role taking place in the EU, without any corresponding recognition from the EU. The DHSC has set out four options and people have until 26 July 2022 to respond to the consultation.


Under the Human Medicines Regulations 2012 :

  • Manufacturers and importers hold an MIA licence to carry out their operations.
  • Particular medicinal products are authorised through a Marketing Authorisation (MA), outlining how they are formulated, manufactured, packaged and tested.
  • Every batch of licensed medicinal product must have full qualitative and quantitative testing, and must be certified by a Qualified Person (QP). Batch testing is the process where every batch of medicine is confirmed as having the correct composition through laboratory tests carried out by the manufacturer. This is designed to ensure patients get the right medicines with the right quality.
  • Where batches of medicine are imported, full qualitative and quantitative testing must be carried out after import, before the QP can certify the batch.
  • However, where there is a Mutual Recognition Agreement (MRA) in place with a third country, the import testing can be waived but the batches must still be certified by the QP. The UK has MRAs with Australia, Canada, Israel, Japan, New Zealand, Switzerland and USA to recognise batch testing of medicines in each others' countries. The UK does not have an MRA with the EU and this is likely to continue as the EU did not want one as part of the Trade and Cooperation Agreement.

Before the UK left the EU, a QP based anywhere in the EU or UK could certify any medicine released for the EU or UK market. Now, since the end of the Brexit transition period on 1 January 2021, the UK continues to recognise QPs based in the EU, but the EU does not recognise QPs based in Great Britain. Medicines from the European Economic Area (EEA) can be imported by a UK wholesaler under the Responsible Person (import) (RPi) provisions, which ensures the batch has been batch tested and certified by a QP in the EEA.

The UK's DHSC is now consulting on what the position should be going forwards for medicines imported into the UK. The DHSC has set out four options.

What Are the Four Options?



Have Your Say

You have until 26 July to submit your input into the consultation.

Option A is the situation most similar to the status quo, but what do you think?  We would be interested in hearing your views.

If you would like to tell us your thoughts on this issue, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 07795 570 072, or complete the form below.

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