Apply to release a vaccine or a blood product to market

AI Summary

This guidance document from the Medicines and Healthcare products Regulatory Agency (MHRA) outlines the mandatory procedures for the independent testing and certification of vaccines and blood-derived products in the United Kingdom. Operating under the Human Medicines Regulation 2012, the guidance requires Marketing Authorisation Holders (MAHs) to obtain certification from the National Institute for Biological Standards and Control (NIBSC) before releasing biological products to the market. A pivotal change occurs on January 1, 2025, with the implementation of the Windsor Framework. From this date, the MHRA will license medicines on a UK-wide basis, and NIBSC certification will be required for all batches sold in the UK, effectively replacing European Commission authorizations in Northern Ireland. To comply, companies must submit a Marketing Information Form (MIF) and a batch release certificate via email. Key requirements for these submissions include ensuring lot numbers match across all documents, verifying that the number of containers does not exceed the certified batch size, and confirming that the product's expiry date is accurate. While the MHRA typically processes these forms within seven working days, an expedited '7-day waiver' is available for urgent situations such as stock shortages or public health emergencies. MAHs are reminded that they hold ultimate responsibility for the formal release of products and must not place batches on the market until the non-objection period has passed or specific authorization is granted.