UK Offers No-Deal Brexit Guidance for Biologics Manufacturers
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.”
If such a certificate is not available, NIBSC will carry out a full laboratory assessment, and the expectation is that NIBSC will independently test and certify batches that are to be marketed exclusively in the UK.
“NIBSC will endeavour to meet current batch release turnaround times and continue to offer parallel testing, which in most cases means submitting samples ahead of documentation to meet your anticipated release date,” the guidance says.
There will also be new fees to enable NIBSC to charge for certification and testing in the UK, which the guidance says will be broadly the same as the current fees charged by NIBSC in its role as an OCABR laboratory.
NIBSC also features a flow chart explaining the procedure to follow if companies want to market a batch in the UK after 29 March.
In addition, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has now published in one place all of the guidance and publications related to a no-deal scenario.
NIBSC guidance