Certification of batches of immunological medicinal products or medicinal products derived from human blood or plasma products (including plasma pools) if the UK leaves the EU without a deal.
Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario.In the event of a no deal scenario, the UK will no longer be subject to EU Directive 2001/83/EC (Article 114(1)). In this outcome, as outlined in section 1.16 in the further guidance published on 4 January 2019, NIBSC will be a stand-alone National Control Laboratory and the UK will require national certification by NIBSC before batches of biological medicines can be placed onto the UK market, unless the batch has an EU Official Control Authority Batch Release (OCABR) certificate issued on or before exit day or was manufactured in and certified by a country with whom the UK has a mutual recognition agreement (MRA) in place (initially expected to cover batches manufactured and released in Switzerland or Israel).In this situation, the regime for UK certification would include the following changes:
Please note: OCABR certificates issued up to and including exit day would be accepted by the UK, whether they have been issued by the UK or another OCABR laboratory.
The content of this guidance will be updated as new information becomes available.
 If the UK leaves the EU with no deal, for a fixed period NIBSC will review OCABR certificates issued by EU/EEA OCABR laboratories when deciding whether to rely on a paper assessment or to carry out laboratory testing of batches. After this period, the list of countries whose release certificates we will consider will appear on the NIBSC website.