Singapore legislation

Regulation 58

of Health Products (Therapeutic Products) Regulations 2016

Regulation 58

Prescribed exceptions

Amended byS 436/2023 wef 26/06/2023S 436/2023 wef 26/06/2023S 811/2023 wef 18/12/2023S 436/2023 wef 26/06/2023S 436/2023 wef 26/06/2023S 811/2023 wef 18/12/2023S 436/2023 wef 26/06/2023S 811/2023 wef 18/12/2023S 436/2023 wef 31/12/2021

Subregulation 1

For the purposes of section 15(1) of the Act and without prejudice to any other provision in these Regulations, the prescribed exceptions to the prohibition in that section against the supply of a health product that is not registered, are the following:

(a)

[Deleted by S 811/2023 wef 18/12/2023](b)the supply of a therapeutic product compounded under regulation 46 by a specified healthcare service licensee (other than an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis service licensee) at any approved permanent premises, temporary premises or approved conveyance of the specified healthcare service licensee to any of the following:

(i)

[Deleted by S 811/2023 wef 18/12/2023](ii)another approved permanent premises, temporary premises or approved conveyance of that specified healthcare service licensee;

(iii)

any approved permanent premises, temporary premises or approved conveyance of another specified healthcare service licensee (other than an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis service licensee);

(c)

the supply of a therapeutic product compounded under regulation 46 by a specified healthcare service licensee (other than an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis service licensee) to a patient of a qualified practitioner, who is a personnel of any specified healthcare service licensee;

(ca)the supply of a therapeutic product compounded under regulation 46 by a specified healthcare service licensee who is an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis service licensee at any approved permanent premises, temporary premises or approved conveyance, for the use of a patient of a qualified practitioner and, if the supply for this purpose involves the supply by the specified healthcare service licensee to —

(i)

[Deleted by S 811/2023 wef 18/12/2023](ii)another approved permanent premises of the specified healthcare service licensee; or

(iii)

any approved permanent premises of another specified healthcare service licensee,the Authority’s approval for the supply has been obtained under regulation 46(5);

(d)

the supply of a therapeutic product that has been compounded at a licensed retail pharmacy in accordance with, and supplied for the purposes mentioned in, regulation 48;

(e)

the supply of a therapeutic product by a qualified practitioner to the qualified practitioner’s patient;

(f)

the supply of a therapeutic product by a licensed importer to a specified healthcare service licensee in accordance with the requirements in regulation 5(1)(b)(i);

(g)

the supply by a specified healthcare service licensee of a therapeutic product that is imported under regulation 51(1) to a patient of a qualified practitioner, who is a personnel of the specified healthcare service licensee;

(h)

the supply of a therapeutic product by a holder of a pharmacy licence pursuant to a valid prescription given by a qualified practitioner for the use of the qualified practitioner’s patient under regulation 51(2);

(i)

the supply of a therapeutic product by a person, who has imported the therapeutic product under regulation 52, to a member of the person’s family;

(j)

the supply of a therapeutic product for use on a ship or an aircraft in accordance with the requirements in regulation 5(1)(b)(iv) or (v), respectively;

(k)

the supply of a therapeutic product for —

(i)

the purpose of scientific education or research and development; or

(ii)

a non-clinical purpose,provided there is no supply of the therapeutic product to the public;

(l)

the supply by wholesale of a therapeutic product that does not contain a psychotropic substance or is not a controlled drug and is —

(i)

manufactured solely for export; or

(ii)

imported solely for re-export;

(m)

the export of any therapeutic product, subject to the approval of the Authority under regulation 8 or 9, where applicable.

Subregulation 2

Amended byS 436/2023 wef 31/12/2021

In paragraph (1)(l), “controlled drug” has the same meaning as in the Misuse of Drugs Act 1973.

Read in full context — Health Products (Therapeutic Products) Regulations 2016 →