Singapore legislation

Regulation 2

of Health Products (Licensing of Retail Pharmacies) Regulations 2016

Regulation 2

Definitions

Amended byS 455/2022 wef 01/07/2022S 433/2023 wef 26/06/2023S 433/2023 wef 26/06/2023S 106/2021 wef 01/03/2021S 120/2018 wef 01/03/2018S 433/2023 wef 26/06/2023S 433/2023 wef 26/06/2023S 808/2023 wef 18/12/2023S 808/2023 wef 18/12/2023S 433/2023 wef 31/12/2021S 433/2023 wef 31/12/2021S 433/2023 wef 31/12/2021S 120/2018 wef 01/03/2018S 106/2021 wef 01/03/2021S 433/2023 wef 26/06/2023

In these Regulations, unless the context otherwise requires —“application fee” means the applicable application fee specified in the Fifth Schedule to the Health Products (Fees) Regulations 2022 (G.N. No. S 450/2022);“approved conveyance”, “approved permanent premises” and “permanent premises” have the meanings given by section 2(1) of the Healthcare Services Act 2020;“Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg;“collaborative prescribing practitioner” has the meaning given by regulation 2 of the Healthcare Services (Collaborative Prescribing Service) Regulations 2023 (G.N. No. S 398/2023);“CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Act;“dispense”, in relation to a therapeutic product, means to prepare and supply the therapeutic product to a patient, where the preparation and supply is made by —

(a)

a qualified practitioner or collaborative prescribing practitioner, or a person acting under the supervision of a qualified practitioner or collaborative prescribing practitioner; or

(b)

a qualified pharmacist or a person acting under the supervision of a qualified pharmacist; “general sale list medicine” means a therapeutic product registered under the classification of “general sale list medicine” in the Register of Health Products;“healthcare service licensee” means a person who holds a licence under the Healthcare Services Act 2020 to provide a licensable healthcare service;“in-store pharmaceutical officer” means —

(a)

a qualified pharmacist engaged or employed to provide pharmacy services at or from a retail pharmacy specified in a pharmacy licence; or

(b)

a person acting under the supervision of the qualified pharmacist mentioned in paragraph (a), when providing pharmacy services at or from the retail pharmacy mentioned in that paragraph;[Deleted by S 433/2023 wef 26/06/2023]“licensable healthcare service” has the meaning given by section 3(1) of the Healthcare Services Act 2020;[Deleted by S 808/2023 wef 18/12/2023][Deleted by S 808/2023 wef 18/12/2023]“oral dental gum” means a health product categorised as an oral dental gum in the First Schedule to the Act;“personnel”, in relation to a healthcare service licensee providing a licensable healthcare service, means any individual employed or engaged by the healthcare service licensee to assist the licensee in providing the licensable healthcare service;“pharmacy department”, in relation to a healthcare service licensee, means the part of any approved permanent premises, approved conveyance or temporary premises of the healthcare service licensee set aside for the supply, dispensing or compounding of therapeutic products on order or prescription to patients at the approved permanent premises, approved conveyance or temporary premises;“pharmacy licence” means a licence, issued by the Authority under these Regulations, to carry on a retail pharmacy business at or from the retail pharmacy specified in the licence;“qualified pharmacist” means a person who —

(a)

is registered as a pharmacist under the Pharmacists Registration Act 2007;

(b)

holds a valid practising certificate granted under section 23 of that Act; and

(c)

is in active practice as defined in regulation 2 of the Pharmacists Registration (Practising Certificates) Regulations 2008 (G.N. No. S 438/2008);“qualified practitioner” means —

(a)

a registered medical practitioner under the Medical Registration Act 1997; or

(b)

a registered dentist under the Dental Registration Act 1999 whose name appears in the first division of the Register of Dentists maintained and kept under section 13(1)(a) of that Act;“retail pharmacy” means any premises at or from which a retail pharmacy business is or is to be conducted, and excludes a pharmacy department;“retail pharmacy business” means a business (not being a professional practice carried out by a qualified practitioner or collaborative prescribing practitioner) that consists of or includes the provision of retail pharmacy services to the general public;“retail pharmacy services” means the sale or dispensing of one or more specified health products, whether or not accompanied by advice or counselling on the effective and safe use of those products;“specified health product” means a health product specified in the First Schedule;“telepharmacy services” means the provision of retail pharmacy services by a qualified pharmacist at a retail pharmacy, through a computer, or video or audio link;“temporary premises” means any premises other than permanent premises;“therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act.

Definition

“application fee” means the applicable application fee specified in the Fifth Schedule to the Health Products (Fees) Regulations 2022 (G.N. No. S 450/2022);

Amended byS 455/2022 wef 01/07/2022

Definition

“approved conveyance”, “approved permanent premises” and “permanent premises” have the meanings given by section 2(1) of the Healthcare Services Act 2020;

Amended byS 433/2023 wef 26/06/2023

Definition

“Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg;

Definition

“collaborative prescribing practitioner” has the meaning given by regulation 2 of the Healthcare Services (Collaborative Prescribing Service) Regulations 2023 (G.N. No. S 398/2023);

Amended byS 433/2023 wef 26/06/2023

Definition

“CTGT product” means a health product categorised as a cell, tissue or gene therapy product in the First Schedule to the Act;

Amended byS 106/2021 wef 01/03/2021

Definition

“dispense”, in relation to a therapeutic product, means to prepare and supply the therapeutic product to a patient, where the preparation and supply is made by —

(a)

a qualified practitioner or collaborative prescribing practitioner, or a person acting under the supervision of a qualified practitioner or collaborative prescribing practitioner; or

(b)

a qualified pharmacist or a person acting under the supervision of a qualified pharmacist;

Amended byS 120/2018 wef 01/03/2018

Definition

“general sale list medicine” means a therapeutic product registered under the classification of “general sale list medicine” in the Register of Health Products;

Definition

“healthcare service licensee” means a person who holds a licence under the Healthcare Services Act 2020 to provide a licensable healthcare service;

Amended byS 433/2023 wef 26/06/2023

Definition

“in-store pharmaceutical officer” means —

(a)

a qualified pharmacist engaged or employed to provide pharmacy services at or from a retail pharmacy specified in a pharmacy licence; or

(b)

a person acting under the supervision of the qualified pharmacist mentioned in paragraph (a), when providing pharmacy services at or from the retail pharmacy mentioned in that paragraph;

Definition

“licensable healthcare service” has the meaning given by section 3(1) of the Healthcare Services Act 2020;

Amended byS 433/2023 wef 26/06/2023

Definition

“oral dental gum” means a health product categorised as an oral dental gum in the First Schedule to the Act;

Definition

“personnel”, in relation to a healthcare service licensee providing a licensable healthcare service, means any individual employed or engaged by the healthcare service licensee to assist the licensee in providing the licensable healthcare service;

Amended byS 808/2023 wef 18/12/2023

Definition

“pharmacy department”, in relation to a healthcare service licensee, means the part of any approved permanent premises, approved conveyance or temporary premises of the healthcare service licensee set aside for the supply, dispensing or compounding of therapeutic products on order or prescription to patients at the approved permanent premises, approved conveyance or temporary premises;

Amended byS 808/2023 wef 18/12/2023

Definition

“pharmacy licence” means a licence, issued by the Authority under these Regulations, to carry on a retail pharmacy business at or from the retail pharmacy specified in the licence;

Definition

“qualified pharmacist” means a person who —

(a)

is registered as a pharmacist under the Pharmacists Registration Act 2007;

(b)

holds a valid practising certificate granted under section 23 of that Act; and

(c)

is in active practice as defined in regulation 2 of the Pharmacists Registration (Practising Certificates) Regulations 2008 (G.N. No. S 438/2008);

Amended byS 433/2023 wef 31/12/2021

Definition

“qualified practitioner” means —

(a)

a registered medical practitioner under the Medical Registration Act 1997; or

(b)

a registered dentist under the Dental Registration Act 1999 whose name appears in the first division of the Register of Dentists maintained and kept under section 13(1)(a) of that Act;

Amended byS 433/2023 wef 31/12/2021S 433/2023 wef 31/12/2021

Definition

“retail pharmacy” means any premises at or from which a retail pharmacy business is or is to be conducted, and excludes a pharmacy department;

Definition

“retail pharmacy business” means a business (not being a professional practice carried out by a qualified practitioner or collaborative prescribing practitioner) that consists of or includes the provision of retail pharmacy services to the general public;

Amended byS 120/2018 wef 01/03/2018

Definition

“retail pharmacy services” means the sale or dispensing of one or more specified health products, whether or not accompanied by advice or counselling on the effective and safe use of those products;

Definition

“specified health product” means a health product specified in the First Schedule;

Definition

“telepharmacy services” means the provision of retail pharmacy services by a qualified pharmacist at a retail pharmacy, through a computer, or video or audio link;

Amended byS 106/2021 wef 01/03/2021

Definition

“temporary premises” means any premises other than permanent premises;

Amended byS 433/2023 wef 26/06/2023

Definition

“therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act.