Health (Pricing and Supply of Medical Goods) Act 2013

6.

Action to be taken by Board where it makes decision under section 5.

6.— (1) The Board shall, as soon as is practicable after making a relevant decision (but, in any case, not later than 14 days after making the relevant decision), give notice in writing of the relevant decision, together with its reasons for the relevant decision, to—

( a) in the case of a relevant decision which falls within paragraph (a) of the definition of “relevant decision” in subsection (6), the authorisation holder of the medicinal product added or to be added to the group of interchangeable medicinal products concerned and the authorisation holders of the interchangeable medicinal products which currently fall within that group of interchangeable medicinal products,

( b) in the case of a relevant decision which falls within paragraph (b) of the definition of “relevant decision” in subsection (6), the authorisation holder of the medicinal product that the Board has refused to add to the group of interchangeable medicinal products concerned,

( c) in the case of a relevant decision which falls within paragraph (c) of the definition of “relevant decision” in subsection (6), the authorisation holders of the medicinal products which fall within the group of medicinal products concerned,

( d) in the case of a relevant decision which falls within paragraph (d) of the definition of “relevant decision” in subsection (6), the authorisation holder of a medicinal product who made the application concerned under section 5 (1) ,

( e) in the case of a relevant decision which falls within paragraph (e) of the definition of “relevant decision” in subsection (6), the authorisation holder of the medicinal product added or to be added to the group of interchangeable medicinal products concerned and the authorisation holders of the interchangeable medicinal products which currently fall within that group of interchangeable medicinal products,

( f) in the case of a relevant decision which falls within paragraph (f) of the definition of “relevant decision” in subsection (6), the authorisation holders of the medicinal products which fall within the group of medicinal products added or to be added to the List of Interchangeable Medicinal Products,

( g) in the case of a relevant decision which falls within paragraph (g) of the definition of “relevant decision” in subsection (6), the authorisation holder of the medicinal product removed or to be removed from the group of interchangeable medicinal products concerned, and

( h) in the case of a relevant decision which falls within paragraph (h) of the definition of “relevant decision” in subsection (6), the authorisation holders of the interchangeable medicinal products which fall within the group of interchangeable medicinal products removed or to be removed from the List of Interchangeable Medicinal Products.

(2) The Board may, in a relevant decision which falls within paragraph (a), (c), (e), (f), (g) or (h) of the definition of “relevant decision” in subsection (6), specify a date, or the occurrence of an event, from which the relevant decision shall take effect.

(3) Part 1 of Schedule 1 shall have effect where the Board proposes to make a relevant decision.

(4) The Board shall, for information purposes only, give the Executive a copy of each notice it gives under subsection (1).

(5) Where a relevant decision which falls within paragraph (g) or (h) of the definition of “relevant decision” in subsection (6) is to take effect, the Board shall, as soon as is practicable, cause notice of the relevant decision to be published in such manner as it thinks appropriate to bring the relevant decision to the attention of prescribers and pharmacists, in particular as regards the date, or the occurrence of the event, from which the relevant decision shall take effect.

(6) In this section and Part 1 of Schedule 1 “relevant decision” means a decision of the Board—

( a) under section 5(2)(a)(i) to add the medicinal product referred to in that section to the group of interchangeable medicinal products referred to in that section,

( b) under section 5(2)(a)(ii) to refuse to add the medicinal product referred to in that section to the group of interchangeable medicinal products referred to in that section,

( c) under section 5(2)(b)(i) to add the group of medicinal products referred to in that section to the List of Interchangeable Medicinal Products,

( d) under section 5(2)(b)(ii) to refuse to add the group of medicinal products referred to in that section to the List of Interchangeable Medicinal Products,

( e) under section 5(4)(a) to add a medicinal product to a group of interchangeable medicinal products,

( f) under section 5(4)(b) to add a group of medicinal products to the List of Interchangeable Medicinal Products,

( g) under section 5(9), (10) or (12) to remove an interchangeable medicinal product from a group of interchangeable medicinal products, or

( h) under section 5(13) to remove a group of interchangeable medicinal products from the List of Interchangeable Medicinal Products.