The Human Medicines (Amendment) (No. 2) Regulations 2014
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
20 Insertion of regulation 191A
After regulation 191 (obligation on holder to submit periodic safety update reports: general requirements) insert— Obligation on holder of a parallel import licence to submit periodic safety update reports 191A. (1) The holder of a parallel import licence must submit reports known as periodic safety update reports (“PSURs”) to the licensing authority if notified to do so by the licensing authority. (2) Each PSUR must contain— (a) summaries of data relevant to the benefits and risks of the product, including results of all studies, with a consideration of their potential impact on the licence for the product; (b) a scientific evaluation of the risk-benefit balance of the product; and (c) all data relating to the volume of sales of the product and any data the holder of the licence has relating to the volume of prescriptions, including an estimate of the population exposed to the product. (3) For the purposes of paragraph (2)(b), the scientific evaluation must be based on all available data, including data from clinical trials conducted outside the terms of the authorisation for the product. (4) Each PSUR must be submitted electronically. (5) The PSUR must be submitted to the licensing authority within the period specified by that authority.
20 Insertion of regulation 191A
After regulation 191 (obligation on holder to submit periodic safety update reports: general requirements) insert— Obligation on holder of a parallel import licence to submit periodic safety update reports 191A. (1) The holder of a parallel import licence must submit reports known as periodic safety update reports (“PSURs”) to the licensing authority if notified to do so by the licensing authority. (2) Each PSUR must contain— (a) summaries of data relevant to the benefits and risks of the product, including results of all studies, with a consideration of their potential impact on the licence for the product; (b) a scientific evaluation of the risk-benefit balance of the product; and (c) all data relating to the volume of sales of the product and any data the holder of the licence has relating to the volume of prescriptions, including an estimate of the population exposed to the product. (3) For the purposes of paragraph (2)(b), the scientific evaluation must be based on all available data, including data from clinical trials conducted outside the terms of the authorisation for the product. (4) Each PSUR must be submitted electronically. (5) The PSUR must be submitted to the licensing authority within the period specified by that authority.
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.