Decentralised Manufacture: Marketing Authorisation application

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the requirements for Marketing Authorisation Applications (MAA) involving Decentralised Manufacture (DM). To utilize this model, applicants must first obtain a DM designation, which serves as the legal justification for the process. This designation must be included in the application, and any significant changes to the supporting information require a new designation request. While the guidance is general and does not name a specific company or inspection date, it establishes a strict regulatory framework requiring that the Control Site hold an appropriately scoped Manufacturing Licence. A critical action for applicants is ensuring a valid Certificate of Good Manufacturing Practice (GMP) Compliance is submitted; failure to do so by the time a Request for Information is processed may result in the refusal of the application. The framework also emphasizes that standard principles of product development, process validation, and characterization apply, with more substantial data required for complex products. If Real Time Release Testing is proposed, applicants must provide evidence of enhanced process knowledge as per Eudralex Vol 4 Annex 17. Overall, successful applications require maintaining accurate documentation and demonstrating comparability between manufacturing locations through representative process validation batches.