The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
Write the words of this act the way you think they should read. Solon shows your change as a redline against the published text and pins it to that exact text, so it can never be applied to wording you did not see.
Change 1
39 Amendment of regulation 2
In regulation 2(1) (interpretation), at the appropriate places insert— “manufacturer’s licence (MM)” has the meaning given in regulation 8(1) of the 2012 Regulations; ; “manufacturer’s licence (POC)” has the meaning given in regulation 8(1) of the 2012 Regulations; ; “manufacturing authorisation (MM)” means a manufacturing authorisation that authorises the manufacture or assembly of MM investigational medicinal products; ; “manufacturing authorisation (POC)” means a manufacturing authorisation that authorises the manufacture or assembly of POC investigational medicinal products; ; “MM” means modular manufacture; ; “MM (IMP) control site” means the premises at which the holder of a manufacturing authorisation (MM) supervises and controls the manufacture or assembly of MM investigational medicinal products; ; “MM (IMP) master file” means a detailed description of the arrangements for manufacture or assembly of an MM investigational medicinal product; ; “MM investigational medicinal product” means an investigational medicinal product that, for reasons relating to deployment, the licensing authority determines it necessary or expedient to be manufactured or assembled in a modular unit; ; “modular unit” means a relocatable manufacturing unit; ; “POC” means point of care; ; “POC (IMP) control site” means the premises at which the holder of a manufacturing authorisation (POC) supervises and controls the manufacture or assembly of POC investigational medicinal products; ; “POC (IMP) master file” means a detailed description of the arrangements for the manufacture or assembly of a POC investigational medicinal product; ; “POC (IMP) site” means a site at which the manufacture or assembly of a POC investigational medicinal product takes place; ; “POC investigational medicinal product” means an investigational medicinal product that, for reasons relating to method of manufacture, shelf life, constituents or method or route of administration, can only be manufactured at or near the place where the product is to be used or administered; .
39 Amendment of regulation 2
In regulation 2(1) (interpretation), at the appropriate places insert— “manufacturer’s licence (MM)” has the meaning given in regulation 8(1) of the 2012 Regulations; ; “manufacturer’s licence (POC)” has the meaning given in regulation 8(1) of the 2012 Regulations; ; “manufacturing authorisation (MM)” means a manufacturing authorisation that authorises the manufacture or assembly of MM investigational medicinal products; ; “manufacturing authorisation (POC)” means a manufacturing authorisation that authorises the manufacture or assembly of POC investigational medicinal products; ; “MM” means modular manufacture; ; “MM (IMP) control site” means the premises at which the holder of a manufacturing authorisation (MM) supervises and controls the manufacture or assembly of MM investigational medicinal products; ; “MM (IMP) master file” means a detailed description of the arrangements for manufacture or assembly of an MM investigational medicinal product; ; “MM investigational medicinal product” means an investigational medicinal product that, for reasons relating to deployment, the licensing authority determines it necessary or expedient to be manufactured or assembled in a modular unit; ; “modular unit” means a relocatable manufacturing unit; ; “POC” means point of care; ; “POC (IMP) control site” means the premises at which the holder of a manufacturing authorisation (POC) supervises and controls the manufacture or assembly of POC investigational medicinal products; ; “POC (IMP) master file” means a detailed description of the arrangements for the manufacture or assembly of a POC investigational medicinal product; ; “POC (IMP) site” means a site at which the manufacture or assembly of a POC investigational medicinal product takes place; ; “POC investigational medicinal product” means an investigational medicinal product that, for reasons relating to method of manufacture, shelf life, constituents or method or route of administration, can only be manufactured at or near the place where the product is to be used or administered; .
One line that says what changes, such as "Halve the dog tax".
Who it helps, what it costs, what it fixes. It is what persuades people to support it.
How this law is officially changed
Solon does not know this law's official route yet. The proposal is recorded all the same, and the route appears here once its source is added.
A proposal here is not law. Support on Solon is evidence that people want the change; the official route says what it takes to make it law.
Sign in to file your proposal. What you have written stays on this page.
Sign in to file itThink it through
Ask what your change would do, who would gain and who would bear a cost, and where something like it is already law. The assistant reads your draft as it stands, cites the law and the studies it finds, and takes no side. What you file stays yours.