§ 11D — Grant of approval for specified services

11D.—(1) After considering any application under section 11C, the Director-General may, subject to subsection (4) —(a)

on payment of an approval fee (if prescribed), grant the approval; or

(b)

refuse to grant the approval.

(2) In determining whether an applicant should be granted an approval for the provision of a specified service, the Director-General is to have regard, and give such weight as the Director-General considers appropriate, to all of the following matters:(a)

whether the applicant is and, where necessary, the following persons are suitable persons to provide or be involved (as the case may be) in providing the specified service to which the application relates:(i)

any key appointment holder of the applicant;

(ii)

any person having a substantial interest in, or control of or direction over, the applicant’s business;

(iii)

any person having control of or direction over the applicant’s operations in relation to the provision of the specified service;

(b)

the likelihood of the applicant providing the specified service to which the application relates in compliance with —(i)

the requirements of this Act and any code of practice relating to that specified service;

(ii)

any other written law applicable to the applicant relating to the provision of the specified service in a safe and proper manner; and

(iii)

the rules of any public scheme established by or under any written law —(A)

relating to the provision of the specified service; and

(B)

under which the applicant is accredited or of which the applicant is a participant;

(c)

the applicant’s ability to provide the specified service to all of the applicant’s patients or customers in a manner that is clinically and ethically appropriate;

(d)

whether there is any other relevant matter that makes it contrary to the public interest to grant the approval.

(3) In granting an approval under this section, the Director-General may impose conditions as the Director-General considers requisite or expedient having regard to the purposes of this Act.

(4) An approval for the provision of a specified service must not be granted to any person who is not a licensee for the licensable healthcare service that the specified service is part of.

(5) The Director-General must, upon granting an approval under this section, amend the licence concerned to state the specified service in respect of which the approval is granted.[Act 11 of 2023 wef 26/06/2023]

—(1) After considering any application under section 11C, the Director-General may, subject to subsection (4) —(a)

on payment of an approval fee (if prescribed), grant the approval; or

(b)

refuse to grant the approval.

(2) In determining whether an applicant should be granted an approval for the provision of a specified service, the Director-General is to have regard, and give such weight as the Director-General considers appropriate, to all of the following matters:(a)

whether the applicant is and, where necessary, the following persons are suitable persons to provide or be involved (as the case may be) in providing the specified service to which the application relates:(i)

any key appointment holder of the applicant;

(ii)

any person having a substantial interest in, or control of or direction over, the applicant’s business;

(iii)

any person having control of or direction over the applicant’s operations in relation to the provision of the specified service;

(b)

the likelihood of the applicant providing the specified service to which the application relates in compliance with —(i)

the requirements of this Act and any code of practice relating to that specified service;

(ii)

any other written law applicable to the applicant relating to the provision of the specified service in a safe and proper manner; and

(iii)

the rules of any public scheme established by or under any written law —(A)

relating to the provision of the specified service; and

(B)

under which the applicant is accredited or of which the applicant is a participant;

(c)

the applicant’s ability to provide the specified service to all of the applicant’s patients or customers in a manner that is clinically and ethically appropriate;

(d)

whether there is any other relevant matter that makes it contrary to the public interest to grant the approval.

(3) In granting an approval under this section, the Director-General may impose conditions as the Director-General considers requisite or expedient having regard to the purposes of this Act.

(4) An approval for the provision of a specified service must not be granted to any person who is not a licensee for the licensable healthcare service that the specified service is part of.

(5) The Director-General must, upon granting an approval under this section, amend the licence concerned to state the specified service in respect of which the approval is granted.[Act 11 of 2023 wef 26/06/2023]