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
43 Amendment of regulation 39
After regulation 39(4) (consideration of application for manufacturing authorisation) insert— (4A) If the application for a manufacturing authorisation relates (wholly or partially) to an MM investigational medicinal product, the licensing authority shall take into consideration the arrangements for— (a) supervising and controlling operations at a modular unit specified in the application; and (b) ensuring that manufacture or assembly is under appropriate control so that the MM investigational medicinal product consistently meets the requirements in the MM (IMP) master file when manufactured at that modular unit. (4B) If the application for a manufacturing authorisation relates (wholly or partially) to a POC investigational medicinal product, the licensing authority shall take into consideration the arrangements for— (a) supervising and controlling operations at any POC (IMP) site specified in the application; and (b) ensuring that manufacture or assembly is under appropriate control so that the POC investigational medicinal product consistently meets the requirements in the POC (IMP) master file when manufactured at that site. .
43 Amendment of regulation 39
After regulation 39(4) (consideration of application for manufacturing authorisation) insert— (4A) If the application for a manufacturing authorisation relates (wholly or partially) to an MM investigational medicinal product, the licensing authority shall take into consideration the arrangements for— (a) supervising and controlling operations at a modular unit specified in the application; and (b) ensuring that manufacture or assembly is under appropriate control so that the MM investigational medicinal product consistently meets the requirements in the MM (IMP) master file when manufactured at that modular unit. (4B) If the application for a manufacturing authorisation relates (wholly or partially) to a POC investigational medicinal product, the licensing authority shall take into consideration the arrangements for— (a) supervising and controlling operations at any POC (IMP) site specified in the application; and (b) ensuring that manufacture or assembly is under appropriate control so that the POC investigational medicinal product consistently meets the requirements in the POC (IMP) master file when manufactured at that site. .
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.