This content was withdrawn on 31 January 2020. See Control Testing for current information.Certification of batches of immunological medicinal products or medicinal products derived from human blood or plasma products (including plasma pools) from 1 Jan 2021.
From 1 Jan 2021, the UK will no longer be subject to EU Directive 2001/83/EC (Article 114(1)). 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 1 Jan 2021 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).The regime for UK certification will include the following changes:
Please note: OCABR certificates issued up to and including 1 January 2021 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.
 From the 1 January 2021, 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 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.