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The Branded Health Service Medicines (Costs) Regulations 2018

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PART 4GENERAL PROVISIONS

Appeals

27.  Any manufacturer or supplier in respect of whom the Secretary of State has made an enforcement decision(1) under these Regulations has a right of appeal against that decision in accordance with the Health Service Medicines (Price Control Appeal) Regulations 2000.

Revocation, saving and transitional provisions

28.—(1) Subject to paragraph (2), the Health Service Medicines (Information Relating to Sales of Branded Medicines etc.) Regulations 2007(2) and the 2008 Regulations are revoked.

(2) In respect of any liability of a person to pay amounts to the Secretary of State in relation to a breach of the Health Service Medicines (Information Relating to Sales of Branded Medicines etc.) Regulations 2007 or the 2008 Regulations arising under those Regulations prior to the date of the coming into force of these Regulations, those Regulations continue to apply.

Annual review

29.—(1) Before the end of the review period, the Secretary of State must—

(a)carry out a review of these Regulations;

(b)set out the conclusions of the review in a report; and

(c)publish the report.

(2) The report must in particular—

(a)set out the objectives intended to be achieved by the scheme established by these Regulations;

(b)assess the extent to which these objectives are achieved; and

(c)assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.

(3) Under this regulation, “review period” means the period of one year beginning on the date of the coming into force of these Regulations.

(1)

See section 265(7) of the 2006 Act for the definition of enforcement decision, which includes any decision relating to information that is required by virtue of an information notice under section 264A(5) of the 2006 Act.

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