The Official Control Authority Batch Release (OCABR) Network for human vaccines and medicinal products derived from human blood and plasma and the National Institute of Biological Standards and Control (NIBSC, United Kingdom) have signed a memorandum of understanding (MOU) to renew, post-Brexit, the exchange and collaboration on common activities related to batch release of human vaccines and medicinal products derived from human blood and plasma. The MOU enters into force on 21 January 2021. It makes NIBSC an observer to the OCABR Network for human biologicals and reinstates the sharing of information related to batch release activity in this field.
Mutual recognition of certificates is not within the scope of this MOU, however. Mutual recognition of OCABR, as defined in European Union legislation, would require a formal agreement between the EU and the UK that included also OCABR. The network looks forward to continuing a fruitful exchange with the United Kingdom OMCL in this new framework.
- Batch Release for Human Biologicals: vaccines, blood and plasma derivatives
- Brexit: End of mutual recognition with the UK
- Human OCABR Guidelines