Guidance for Manufacturers of Biological Medicines - Independent Batch Release in the United Kingdom From 1 January 2021

Great Britain will no longer be subject to EU Directive 2001/83/EC. From 1 January 2021, NIBSC will be a stand-alone National Control Laboratory. From 1 January 2021, Great Britain will carry out its own independent certification of batches of biological medicines at NIBSC.

You must inform the MHRA and NIBSC of the intention to place batches of biological medicines on the market in Great Britain at least seven (7) days in advance. You will need to send samples and documentation to NIBSC for all batches to be used in Great Britain.

You must provide MHRA and NIBSC with a UK Marketing Information Form and a copy of the relevant certificate to the email address on the MIF. A NIBSC certificate will be required for products marketed in Northern Ireland where there is no OCABR certificate.

If a batch of product with a United Kingdom Marketing Authorisation (UK) is placed on both the Great Britain and Northern Ireland markets, it will need a NIBSC certificate for Great Britain and an OCABR certificate for Northern Ireland.

Source: MHRA guideline on  Guidance for manufacturers of biological medicines - independent batch release in the United Kingdom from 1 January 2021


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