Health (Assisted Human Reproduction) Act 2024

PART 11

Enforcement

Chapter 1

Definitions

Definitions - Part 11

170. In this Part—

“code of practice” means a code of practice published or approved of under section 173 as it is in effect from time to time;

“complainant”, in relation to a complaint, means the person who made the complaint;

“complaint” means a complaint under section 180 ;

“enforcement notice” means a notice under section 176 (2);

“holder” means the holder or former holder, as appropriate, of a licence;

“investigation” means an investigation under section 182 ;

“investigation report”, in relation to an investigation, means a report in writing prepared, following the completion of the investigation, by the authorised officer appointed under section 182 (1)(b) to carry out the investigation—

(a) stating that the authorised officer—

(i) is satisfied that a relevant contravention by the holder of a licence the subject of the investigation has occurred or is occurring, or

(ii) is not so satisfied,

as appropriate,

(b) if paragraph (a)(i) is applicable, stating the grounds on which the authorised officer is so satisfied, and

(c) if paragraph (a)(ii) is applicable, stating—

(i) the basis on which the authorised officer is not so satisfied, and

(ii) the authorised officer’s opinion, in view of such basis, on whether or not a further investigation of the holder of the licence is warranted and, if warranted, the authorised officer’s opinion on the principal matters to which the further investigation should relate;

“major sanction”, in relation to the holder of a licence, means—

(a) the revocation of the licence and a prohibition (which may be a permanent prohibition, a prohibition for a specified period or a prohibition subject to specified conditions) against the former holder of the licence making a licence application for a new licence or a particular class of licence,

(b) the suspension for a specified period of the licence and a prohibition for a specified period against the holder of the suspended licence making a licence application for a new licence or a particular class of new licence,

(c) a direction to the holder that the holder pay a sum, as specified in the direction but not exceeding €50,000, to the AHRRA, being the whole or part of the cost to the AHRRA of an investigation of the holder, or

(d) any combination of the sanctions specified in paragraph (a) or (b) with the sanction specified in paragraph (c);

“minor sanction”, in relation to the holder of a licence, means—

(a) the issue, to the holder, of—

(i) advice,

(ii) a caution,

(iii) a warning, or

(iv) a reprimand,

or

(b) any combination of any of the sanctions specified in paragraph (a);

“relevant contravention”, in relation to the holder or former holder of a licence, means that the holder—

(a) has contravened a relevant provision,

(b) is contravening a relevant provision,

(c) has contravened a relevant provision in circumstances that make it likely that the contravention will continue or be repeated,

(d) has given information to the AHRRA under Part 10 , in relation to an application made under that Part, that was false or misleading in a material particular, or

(e) has failed to comply with an enforcement notice;

“relevant provision” means a provision of—

(a) a licence, or

(b) this Act.