Singapore legislation

Regulation 13

of Health Products (Therapeutic Products) Regulations 2016

Regulation 13

Supply by retail sale of pharmacy-only medicine

Amended byS 811/2023 wef 18/12/2023S 119/2018 wef 01/03/2018

Subregulation 1

Amended byS 811/2023 wef 18/12/2023S 119/2018 wef 01/03/2018

A person must not supply by retail sale any pharmacy-only medicine 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)

the supply is made by a healthcare service licensee to a patient of the healthcare service licensee, and is in accordance with the written instructions of a qualified practitioner or collaborative prescribing practitioner who is a personnel of the healthcare service licensee; or

(c)

the following requirements are satisfied:

(i)

the person is a qualified practitioner or collaborative prescribing practitioner, or a person acting in accordance with the oral or written instructions of a qualified practitioner or collaborative prescribing practitioner;

(ii)

the supply is made to a patient under the care of the qualified practitioner or collaborative prescribing practitioner.

Subregulation 2

A person who supplies by retail sale any pharmacy-only medicine must keep, at the premises where or from which the medicine is supplied, a record of every such supply, and the record must contain all of the following particulars in relation to each supply:

(a)

the date of the supply;

(b)

the name, identity card or other identification document number, and contact details, of the person to whom the pharmacy-only medicine is supplied;

(c)

the name, strength and total amount of pharmacy-only medicine to be supplied;

(d)

the dosage, and the frequency and purpose of the treatment for which the supply is made.

Subregulation 3

The record required under paragraph (2) must be made on the day on which the pharmacy-only medicine is supplied or, if that is not reasonably practicable, within 24 hours after that day, and must be kept for a period of at least 2 years after the date of the supply.

Subregulation 4

A supplier of a pharmacy-only medicine by retail sale must make available for inspection by the Authority at all reasonable times any record made under paragraph (2).

Subregulation 5

This regulation does not apply to the supply of any pharmacy-only medicine by administration to, or application in, any person in the course of any diagnosis, treatment or test.