Rare Cancers Act 2026
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Change 1
1 Review of law on marketing authorisations
(1) The Secretary of State must— (a) carry out a review of the law relating to marketing authorisations for orphan medicinal products that are for the diagnosis, prevention or treatment of cancer, and (b) prepare and publish a report setting out the conclusions of the review. (2) In carrying out the review the Secretary of State must, in particular, consider regulatory approaches in other countries. (3) The report must be published before the end of the period of three years beginning with the day on which this Act is passed. (4) The Secretary of State must lay a copy of the report before Parliament. (5) In this section— “Human Medicines Regulations” means the Human Medicines Regulations 2012 (S.I. 2012/1916); “marketing authorisation” has the meaning given by section 9 of the Medicines and Medical Devices Act 2021; “medicinal product” has the meaning given by regulation 2 of the Human Medicines Regulations; “orphan medicinal product” means a medicinal product in relation to which the orphan criteria set out in regulation 50G(2) of the Human Medicines Regulations are met.
1 Review of law on marketing authorisations
(1) The Secretary of State must— (a) carry out a review of the law relating to marketing authorisations for orphan medicinal products that are for the diagnosis, prevention or treatment of cancer, and (b) prepare and publish a report setting out the conclusions of the review. (2) In carrying out the review the Secretary of State must, in particular, consider regulatory approaches in other countries. (3) The report must be published before the end of the period of three years beginning with the day on which this Act is passed. (4) The Secretary of State must lay a copy of the report before Parliament. (5) In this section— “Human Medicines Regulations” means the Human Medicines Regulations 2012 (S.I. 2012/1916); “marketing authorisation” has the meaning given by section 9 of the Medicines and Medical Devices Act 2021; “medicinal product” has the meaning given by regulation 2 of the Human Medicines Regulations; “orphan medicinal product” means a medicinal product in relation to which the orphan criteria set out in regulation 50G(2) of the Human Medicines Regulations are met.
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