5.— (1) The authorisation holder of a medicinal product (or, where subsection (14) applies, a person permitted under that subsection to do so) may make an application in the specified form, accompanied by the fee (if any) prescribed in regulations made under section 29 in respect of this section, to the Board requesting the Board—

(a) to add the medicinal product the subject of the application to the group of interchangeable medicinal products specified in the application, or

(b) to add the group of medicinal products (which must include the first-mentioned medicinal product) the subject of the application to the List of Interchangeable Medicinal Products.

(2) Subject to this section and section 6, where the Board receives an application under subsection (1), it shall, before the expiration of a period of 180 days from the day on which it received the application or such longer period as may be required by the operation of subsection (3), determine the application by—

(a) if paragraph (a) of subsection (1) is applicable—

(i) adding the relevant medicinal product the subject of the application to the group of interchangeable medicinal products specified in the application, or

(ii) refusing to add the medicinal product the subject of the application to the group of interchangeable medicinal products specified in the application,

(b) if paragraph (b) of subsection (1) is applicable—

(i) adding the group of medicinal products the subject of the application to the List of Interchangeable Medicinal Products, or

(ii) refusing to add the group of medicinal products the subject of the application to the List of Interchangeable Medicinal Products.

(3) Where the Board receives an application under subsection (1) but is unable to determine the application under subsection (2) because it requires additional information from the applicant—

(a) the Board shall give notice in writing to the applicant specifying the additional information that it requires from the applicant in order to determine the application, and

(b) the running of the period of 180 days referred to in subsection (2) is, upon the giving of the notice referred to in paragraph (a) to the applicant, suspended in the case of that application unless and until the applicant gives the Board the additional information that the Board requires to determine the application.

(4) Subject to this section and section 6, the Board may, of its own initiative or at the request of the Minister or the Executive—

(a) add a medicinal product to a group of interchangeable medicinal products, or

(b) add a group of medicinal products to the List of Interchangeable Medicinal Products.

(5) The Board shall not under subsection (2)(a) or (4)(a) add a medicinal product to a group of interchangeable medicinal products unless the Board is satisfied that the medicinal product—

(a) has the same qualitative and quantitative composition in each of its active substances as each of the active substances of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products,

(b) is in the same pharmaceutical form as, or in a pharmaceutical form that is appropriate for substitution for, each of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products, and

(c) has the same route of administration as each of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products.

(6) The Board shall not under subsection (2)(b) or (4)(b) add a group of medicinal products to the List of Interchangeable Medicinal Products unless the Board is satisfied that each medicinal product which falls within the group—

(a) has the same qualitative and quantitative composition in each of its active substances as each of the active substances of the other medicinal products which fall within the group,

(b) is in the same pharmaceutical form as, or in a pharmaceutical form that is appropriate for substitution for, each of the other medicinal products which fall within the group, and

(c) has the same route of administration as each of the other medicinal products which fall within the group.

(7) The Board shall not under subsection (2)(a) or (4)(a) add a medicinal product to a group of interchangeable medicinal products if the Board is satisfied that—

(a) there is a difference in bioavailability between the medicinal product and the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products which may lead to a clinically significant difference in efficacy between them,

(b) the medicinal product contains more than 2 active substances,

(c) the device (if any) for the administration of the medicinal product has significantly different instructions for use than the devices (if any) for the administration of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products,

(d) the medicinal product is a biological rather than a chemical entity, or

(e) the medicinal product cannot be safely substituted for each of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products.

(8) The Board shall not under subsection (2)(b) or (4)(b) add a group of medicinal products to the List of Interchangeable Medicinal Products if the Board is satisfied that—

(a) there is a difference in bioavailability between any of the medicinal products which may lead to a clinically significant difference in efficacy between them,

(b) any of the medicinal products contains more than 2 active substances,

(c) the device (if any) for the administration of any one or more of the medicinal products has significantly different instructions for use than one or more of the other such devices,

(d) any of the medicinal products is a biological rather than a chemical entity, or

(e) any of the medicinal products cannot be safely substituted for any one or more of the other medicinal products.

(9) Subject to section 6, the Board shall remove from a group of interchangeable medicinal products an interchangeable medicinal product which it is satisfied—

(a) has ceased to fall within the definition of “medicinal product” in section 2(1), or

(b) has permanently ceased to be marketed in the State.

(10) Subject to section 6, where the Board is satisfied that an interchangeable medicinal product has temporarily ceased to be marketed in the State, it may, after having regard to how long it is expected that the cesser will last and the degree of disruption that the cesser causes or may cause patients who have been using the medicinal product, remove the medicinal product from the group of interchangeable medicinal products concerned.

(11) The Board shall remove a group of interchangeable medicinal products from the List of Interchangeable Medicinal Products if, for whatever reason, only one interchangeable medicinal product falls within the group.

(12) Subject to section 6, where the Board is satisfied that, if an interchangeable medicinal product were not currently an interchangeable medicinal product, it would not, under subsection (2) or (4), cause the medicinal product to become an interchangeable medicinal product, it shall remove the medicinal product from the group of interchangeable medicinal products concerned.

(13) Subject to section 6, where the Board is satisfied that, if a group of interchangeable medicinal products were not currently a group of interchangeable medicinal products, it would not, under subsection (2) or (4), cause the interchangeable medicinal products which fall within the group to become a group of interchangeable medicinal products, it shall remove the group of interchangeable medicinal products from the List of Interchangeable Medicinal Products.

(14) Where a person proposes to make an application to the Board to be granted an authorisation in respect of a medicinal product such that, if the authorisation were granted, the person would be the authorisation holder (within the meaning of this Act) of the medicinal product, the Board may also permit the person to, at the same time, make an application to it under subsection (1) in respect of the medicinal product as if the person were already such authorisation holder, so that the Board, if it does grant such authorisation to the person, may also, at the same time, determine the application under subsection (1) in respect of that medicinal product.