No-deal Brexit guidance for manufacturers of biological medicines

If the United Kingdom (UK) leaves the European Union (EU) with no-deal, the National Institute for Biological Standards and Control (NIBSC) will become a stand-alone National Control Laboratory.

The UK will require national certification by NIBSC before batches of biological medicines can be placed onto the UK market. However, this does not apply if a batch has an EU Official Control Authority Batch Release (OCABR) certificate issued on or before 29th March 2019, or if the batch was manufactured in and certified by a country with which the UK has a mutual recognition agreement in place. The mutual recognition agreement is initially expected to cover batches manufactured and released in Switzerland or Israel.

According to the guidance, UK certification will also include the following changes: “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 this is not possible, then NIBSC will carry out a full laboratory assessment, and it is expected that NIBSC will independently test and certify batches that are to be marketed exclusively in the UK.

The guidance from NIBSC also contains a flow chart which outlines the procedure companies should follow if they would like to market a batch in the UK after 29th March 2019. Also, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have published in one place all the guidance related to a no-deal scenario.

To read the no-deal Brexit guidance for manufacturers of biological medicines from the NIBSC, please click here.