Health (Assisted Human Reproduction) Act 2024
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Material amendment to licence | ||
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159. (1) The holder of a licence who wishes to amend the licence in any material way shall make a licence application for such amendment and, in the case of such application, section 153 and the other provisions of this Part (including section 157 and Chapter 6) applicable to a licence application and its determination under section 155 shall, with all necessary modifications, apply accordingly. | ||
(2) Subject to subsections (3) and (4), the Minister may by regulations specify classes of amendments to a licence that are, for the purposes of this section, non-material. | ||
(3) Where the Minister makes regulations under subsection (2), he or she shall, in addition to having regard to the other provisions of this Act, also have regard to the principle that the amendments that fall within the class should be trivial, insignificant, minor or inconsequential. | ||
(4) On and after the establishment day, the Minister shall not make regulations under subsection (2) except after consultation with the AHRRA. | ||
(5) (a) The holder of a licence who wishes to make an amendment to the licence which it considers to be non-material amendment may make an application in the specified form, accompanied by the specified fee, to the AHRRA for the AHRRA to make such amendment to the licence. | ||
(b) Where the AHRRA is satisfied that the amendment sought is a non-material amendment (including in any case where it is so satisfied by virtue of submissions referred to in paragraph (c) made to it), it shall make the amendment to the licence and issue the licence as so amended to the holder and the licence as so amended shall, on and after the date of such issue and for all purposes, replace the licence as in force immediately before it was so amended. | ||
(c) Where the AHRRA is not satisfied that the amendment sought is a non-material amendment, it shall, in the interest of procedural fairness, give a notice in writing to the holder stating— | ||
(i) the AHRRA’s reasons why it is not satisfied, and | ||
(ii) that the holder may, if the holder wishes to do so, within the period specified in the notice (being a period of not less than four weeks from the date that the holder receives the notice), make, in view of those reasons only, submissions in writing on those reasons for the AHRRA’s further consideration before the AHRRA decides whether or not it is satisfied that the amendment is a non-material amendment. | ||
(d) Where submissions referred to in paragraph (c) made before the expiration of the period concerned referred to in that paragraph do not satisfy the AHRRA that the amendment sought is a non-material amendment, or no such submissions are made before the expiration of that period, the AHRRA shall, as soon as is practicable after that expiration, give the holder notice in writing that the AHRRA is not satisfied that the amendment sought is a non-material amendment and setting out the reasons why the AHRRA is not so satisfied. | ||
(e) Where paragraph (b) applies, the AHRRA shall, as soon as is practicable after issuing the amended licence as referred to in that paragraph to the holder, publish on its website, at a minimum, sufficient particulars of the amendment made to the licence to enable members of the public to understand the nature of the amendment and sufficient particulars of the licence to readily identify it. | ||
(f) Where paragraph (d) applies, the AHRRA shall, as soon as is practicable after it gives the notice referred to in that paragraph to the holder, publish on its website, at a minimum, a copy of the notice. | ||
(6) In this section— | ||
“material amendment”, in relation to a licence, means any amendment to the licence other than a non-material amendment; | ||
“non-material amendment”, in relation to a licence, means an amendment which falls within a class of amendments specified in regulations made under subsection (2). |