Medicines manufactured at the point of care (POC) or by modular manufacture (MM). In the proposal for aDirective on the Union code relating to medicinal products for human use, these processes are referred to asdecentralised manufacture.

The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations

The new regulatory framework will also apply to manufacture in relocatable or "modular" units (MM) rather than in centralised sites, when there are reasons related to deployment for doing so.

The POC and MM changes are being made together since they are both decentralised models of manufacture.Justifications for POC as the only possible method of manufacture or MM for reasons relating to deploymentneed to be provided to and accepted by the MHRA.
The new framework is a modified form of the current regulatory system for medicines approvals, clinical trials,evaluation of regulatory compliance at manufacturing sites and safety monitoring. It is centred on a singleControl Site, which is maintained by the holder of the manufacturing licence, and from which the licence holderoversees all aspects of the POC and MM manufacturing system including the individual manufacturinglocations and their activities. The holder of the manufacturer's licence, who is responsible for the Control Siteand maintaining a Master File which controls the manufacturing sites, is also responsible for ensuring productquality across all manufacturing sites and notifying the MHRA of reportable issues.
The key UK concept for the proportionate supervision for POC and MM is a hub and spoke model – the hubbeing the Control Site and the spokes are the multiple manufacturing sites linked to the Control Site. The huband spoke model is an adaption of the Plasma Master File (PMF) system which was brought into EU law in2003 via Commission Directive 2003/63 within Part III of Annex I of Commission Directive 2001/83 andintroduced an additional Master File concept into EU law.