In the event of a no-deal Brexit, the National Institute for Biological Standards and Control (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, according to guidance released Tuesday.
The only caveat for such a requirement, according to the guidance, is if a batch has an EU Official Control Authority Batch Release (OCABR) certificate issued on or before 29 March 2019, or was manufactured in and certified by a country with which the UK has a mutual recognition agreement in place, which is “initially expected to cover batches manufactured and released in Switzerland or Israel.”
UK certification will also include the following changes, according to the guidance: “After 29 March 2019 the UK will carry out its own batch release of biological medicines at NIBSC taking a risk-based approach to laboratory testing. NIBSC will decide whether to rely on a paper assessment to issue the UK certificate or to carry out laboratory testing of the batch. NIBSC will review all data, including any release certificate issued by a laboratory in an approved list, where available, as well as potential risks to public health.”..