The UK is leaving the EU. This page tells you how to prepare for Brexit and will be updated if anything changes.This information was originally published on 19 February 2019.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
In the event of a no-deal Brexit, 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. The list of EEA states at exit day is:
Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden
The list of states with a Mutual Recognition Agreement (MRA) in relation to independent batch release testing of biological medicines is:
Both MRAs include provisions allowing for the re-examination of batches by NIBSC where there are public health concerns.