UK Recognition of EU/EEA Batch Testing does not end on 1 January 2023

Recommendation

27/28 October 2021

GMP for Medical Devices - EU versus USA - Live Online

The EU-UK Trade and Cooperation Agreement (TCA) mentions medicinal products only briefly, but has a dedicated Annex on medicinal products and related GMP requirements; albeit not in great detail.

These provisions stipulate, for example, that the EU and the United Kingdom (UK) recognise each other's inspections of manufacturing sites and also accept corresponding GMP documents. Nevertheless, the Parties may suspend such recognition and continue to carry out their own inspections. Further details can be found in our news of 13 January 2021.

There are no major facilitations for the pharmaceutical industry, as they could have been established e.g. by a so-called Mutual Recognition Agreement (MRA). Medicinal products from the UK must be certified by a Qualified Person (QP) within the EU after appropriate testing when exported to the EU.

The UK, however, has unilaterally established transitional provisions. Thus, EU batch testing continues to be recognised. The end of this transitional provision was previously scheduled for 31 December 2022. Now the British government has published a "Letter to medicines and medical products suppliers" in which this deadline is now extended. The letter literally states: "the continued recognition of EU/EEA batch testing will not be ending on 1 January 2023".