Singapore legislation

Regulation 3

of Health Products (Oral Dental Gums) Regulations 2016

Regulation 3

Supply by retail sale of oral dental gums

Amended byS 432/2023 wef 26/06/2023

Subregulation 1

Amended byS 432/2023 wef 26/06/2023

For the purposes of section 17(1) of the Act, a person must not supply by retail sale an oral dental gum unless —

(a)

the supply is made at or from a licensed retail pharmacy in accordance with regulation 3(1) of the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016);

(b)

[Deleted by S 810/2023 wef 18/12/2023](ba)the supply is made by a healthcare service licensee to a patient of that healthcare service licensee, and in accordance with the written instructions of a qualified practitioner who is a personnel of the healthcare service licensee; or

(c)

the person is a qualified practitioner or a person acting in accordance with the oral or written instructions of a qualified practitioner, and the supply is made to a patient under the care of the qualified practitioner.

Subregulation 2

In addition to the requirements in paragraph (1)(a), a person who supplies by retail sale a prescription‑only oral dental gum under that paragraph must do so in accordance with a valid prescription given by a qualified practitioner.

Subregulation 3

For the purposes of paragraph (2), a prescription is valid only if the prescription —

(a)

is written and signed by a qualified practitioner; and

(b)

contains all of the following particulars:

(i)

the date of the prescription;

(ii)

the name and address of the qualified practitioner giving the prescription;

(iii)

the name, identity card or other identification document number, and contact details, of the individual to whom the prescription relates;

(iv)

the name and total amount of the prescribed oral dental gum to be supplied to the individual.

Subregulation 4

If the person who supplies by retail sale a prescription‑only oral dental gum in paragraph (2) is a qualified pharmacist or a person acting under the supervision of a qualified pharmacist, that person must —

(a)

label every container, or every outer package enclosing a container, of the prescription‑only oral dental gum with all of the following information in English:

(i)

the name of the individual to whom the oral dental gum is to be supplied;

(ii)

the name, address and any identification number or logo of the licensed retail pharmacy where the oral dental gum is supplied;

(iii)

the date that the oral dental gum is supplied;

(iv)

the directions for use of the oral dental gum;

(v)

the name of the oral dental gum;

(b)

mark the prescription in a manner so as to permanently attach to the prescription that person’s name, the address of the licensed retail pharmacy and the date of the supply; and

(c)

retain the prescription for a period of at least 2 years after the date of the supply.