The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024
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 Substitution of regulation 52B
For regulation 52B (application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.), substitute— Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc. 52B. (1) This Regulation applies where an application is made for a UKMA(UK) by reference to another medicinal product as reference medicinal product which is, or has been, authorised for not less than eight years under regulation 49(1)(a) and one or more of the following circumstances applies in respect of the application— (a) the medicinal product to which the application relates does not fall within the definition of generic medicinal product; (b) bioequivalence with the reference medicinal product cannot be demonstrated through bioavailability studies; or (c) the medicinal product to which the application relates differs from the reference medicinal product in terms of changes in the active substance, therapeutic indications, strength, pharmaceutical form or route of administration. (2) The applicant may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials relating to the reference medicinal product, but must provide the results of the appropriate pre-clinical tests or clinical trials relating to the applicable circumstances in paragraph (1). (3) Paragraphs (2), (6) and (7) of regulation 51B apply to the application as they apply to an application made in accordance with paragraph (1) of that regulation. .
39 Substitution of regulation 52B
For regulation 52B (application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.), substitute— Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc. 52B. (1) This Regulation applies where an application is made for a UKMA(UK) by reference to another medicinal product as reference medicinal product which is, or has been, authorised for not less than eight years under regulation 49(1)(a) and one or more of the following circumstances applies in respect of the application— (a) the medicinal product to which the application relates does not fall within the definition of generic medicinal product; (b) bioequivalence with the reference medicinal product cannot be demonstrated through bioavailability studies; or (c) the medicinal product to which the application relates differs from the reference medicinal product in terms of changes in the active substance, therapeutic indications, strength, pharmaceutical form or route of administration. (2) The applicant may, by way of derogation from paragraph 10 of Schedule 8, omit from the application the results of pre-clinical tests and of clinical trials relating to the reference medicinal product, but must provide the results of the appropriate pre-clinical tests or clinical trials relating to the applicable circumstances in paragraph (1). (3) Paragraphs (2), (6) and (7) of regulation 51B apply to the application as they apply to an application made in accordance with paragraph (1) of that regulation. .
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.