Singapore legislation
Regulation 3
of Health Products (Licensing of Retail Pharmacies) Regulations 2016
Regulation 3
Requirements for supply by retail sale of specified health products
Subregulation 1
For the purposes of section 17 of the Act, a person (P) must not supply by retail sale any specified health product, unless —
P is the holder of a pharmacy licence;
the supply of the specified health product is carried out at or from the retail pharmacy specified in the pharmacy licence —
by an in-store pharmaceutical officer; or
in the absence of that officer, by a special mode with the prior approval of the Authority;
the supply of the specified health product is carried out under, and in accordance with the conditions of, the pharmacy licence;
a proper record of every supply of the specified health product is made by the in-store pharmaceutical officer mentioned in sub-paragraph (b)(i), or using that special mode of supply mentioned in sub-paragraph (b)(ii);
P keeps the record made under sub-paragraph (d) for at least 2 years after the date of the supply of the specified health product to which the record relates;
P ensures that only an in-store pharmaceutical officer may have access to specified health products (other than a controlled drug) stored at the retail pharmacy; and
P ensures that only a qualified pharmacist may have access to any controlled drug stored at the retail pharmacy.
Subregulation 2
In addition to the requirements in paragraph (1), P must not supply by retail sale any prescription-only medicine, unless —
the prescription-only medicine is supplied —
to a patient in accordance with a valid prescription given by a qualified practitioner or collaborative prescribing practitioner; or
in accordance with the oral or written instructions of a qualified practitioner or collaborative prescribing practitioner who undertakes, when giving the instructions, to give a valid prescription within 24 hours after giving the instructions; or
in the case of therapeutic products only, the prescription-only medicine supplied —
is specified in the list of prescription-only medicines exempted for limited sale and supply;
is labelled to show a maximum daily dose not exceeding that specified in the list of prescription‑only medicines exempted for limited sale and supply;
does not exceed the maximum supply specified in the list of prescription-only medicines exempted for limited sale and supply;
is to a person who is of or above any minimum age specified in the list of prescription-only medicines exempted for limited sale and supply, and a record of the supply is made in accordance with regulation 16 of the Health Products (Therapeutic Products) Regulations 2016 (G.N. No. S 329/2016).
Subregulation 3
To avoid doubt, paragraphs (1) and (2) do not apply to —
[Deleted by S 808/2023 wef 18/12/2023](aa)any of the following persons who supplies a specified health product by retail sale to a patient of a healthcare service licensee in accordance with the written instructions of a qualified practitioner or collaborative prescribing practitioner, who is a personnel of the healthcare service licensee:
the healthcare service licensee;
a person who is authorised by the healthcare service licensee to make that supply; or
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, supplying a specified health product to a patient under the care of the qualified practitioner or collaborative prescribing practitioner.
Subregulation 3A
Paragraph (2) does not apply to a holder of a pharmacy licence in respect of —
the supply by retail sale of influenza vaccines in accordance with the conditions of such supply specified in item 2A of the Third Schedule to the Health Products (Therapeutic Products) Regulations 2016; or
the supply by retail sale of adrenaline administered using an autoinjector in accordance with the conditions of such supply specified in item 2B of the Third Schedule to the Health Products (Therapeutic Products) Regulations 2016.
Subregulation 4
An application for the Authority’s approval under paragraph (1)(b)(ii) must —
be made in the form and manner specified on the Authority’s website; and
be accompanied by the application fee.
Subregulation 5
In this regulation —
Definition
“controlled drug” has the same meaning as in section 2 of the Misuse of Drugs Act 1973;
Definition
“list of prescription-only medicines exempted for limited sale and supply” means the list, as published on the Authority’s website, of therapeutic products classified as prescription‑only medicines that may be supplied at or from a retail pharmacy without the need for a valid prescription;
Definition
“prescription-only medicine” means a therapeutic product or a CTGT product registered under the classification of “prescription-only medicine” in the Register of Health Products;
Definition
“valid prescription” means a prescription that is valid within the meaning in regulation 2(2) of the Health Products (Therapeutic Products) Regulations 2016 or regulation 2(2) of the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 (G.N. No. S 104/2021), as the case may be.
Subregulation 6
In relation to a collaborative prescribing practitioner mentioned in paragraphs (2)(a) and (3), references to prescription-only medicine in paragraph (2)(a) and specified health product in paragraph (3) are references to a therapeutic product only.