Health Products (Therapeutic Products) Regulations 2016 · As enacted · Part 3 · Supply of Therapeutic Products
13. Supply by retail sale of pharmacy-only medicine
Feedback & supportLast amended by an amending law of 2023. 2 amendments in all.
A person must not supply by retail sale any pharmacy-only medicine unless —
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);
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
the following requirements are satisfied:
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;
the supply is made to a patient under the care of the qualified practitioner or collaborative prescribing practitioner.
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:
the date of the supply;
the name, identity card or other identification document number, and contact details, of the person to whom the pharmacy-only medicine is supplied;
the name, strength and total amount of pharmacy-only medicine to be supplied;
the dosage, and the frequency and purpose of the treatment for which the supply is made.
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.
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).
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.
Subregulation 1
A person must not supply by retail sale any pharmacy-only medicine unless —
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);
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
the following requirements are satisfied:
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;
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:
the date of the supply;
the name, identity card or other identification document number, and contact details, of the person to whom the pharmacy-only medicine is supplied;
the name, strength and total amount of pharmacy-only medicine to be supplied;
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.