Health Products (Oral Dental Gums) Regulations 2016

No. S 539

Health Products Act

(CHAPTER 122D)

Health Products (Oral Dental Gums)
Regulations 2016

In exercise of the powers conferred by sections 71 and 72 of the Health Products Act, the Health Sciences Authority, with the approval of the Minister for Health, makes the following Regulations:

PART 1

Preliminary

Citation and commencement

1.  These Regulations are the Health Products (Oral Dental Gums) Regulations 2016 and come into operation on 1 November 2016.

Definitions

2.  In these Regulations, unless the context otherwise requires —

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

“container”, in relation to any oral dental gum, means an article or packaging immediately covering the oral dental gum, including any bottle, bubble pack, blister pack, strip pack, wrapper or other similar article, but does not include —

(a) an article for ingestion; or

(b) an outer package or other packaging in which the container is further enclosed;

“expiry date”, for any oral dental gum, means the date after which, or the month and year after the end of which, the oral dental gum should not be used;

“Fees Regulations” means the Health Products (Fees) Regulations 2022 (G.N. No. S 450/2022);

[S 457/2022 wef 01/07/2022]

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

[S 432/2023 wef 26/06/2023]

[Deleted by S 432/2023 wef 26/06/2023]

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

[S 432/2023 wef 26/06/2023]

“licensed retail pharmacy” means premises specified in a pharmacy licence issued under the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016);

“licensee”, in relation to any oral dental gum, means the holder of a manufacturer’s licence, an importer’s licence or a wholesaler’s licence for the oral dental gum;

[Deleted by S 810/2023 wef 18/12/2023]

[Deleted by S 810/2023 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;

[S 810/2023 wef 18/12/2023]

“prescription‑only oral dental gum” means an oral dental gum that is registered under the classification of “prescription‑only oral dental gum” in the Register of Health Products;

“qualified pharmacist” means a person who —

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

[S 432/2023 wef 31/12/2021]

(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

[S 432/2023 wef 31/12/2021]

(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;

[S 432/2023 wef 31/12/2021]

“sales promotion” means any advertisement of an oral dental gum in the form of —

(a) a sales campaign (including door‑to‑door sales and price discounts);

(b) an exhibition;

(c) a competition; or

(d) any other activity meant to introduce, publicise or raise the profile, public awareness or visibility of, the oral dental gum,

for the purpose of promoting the sale or use of the oral dental gum;

“supply by retail sale” means sale by retail and includes exposure or display as an invitation to treat.

PART 2

Supply of oral dental gums

Supply by retail sale of oral dental gums

3.—(1)  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

[S 432/2023 wef 26/06/2023]

(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.

(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.

(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.

(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.

Records of supply by retail sale of oral dental gums

4.—(1)  For the purposes of section 17(2)(f) of the Act, a person who supplies by retail sale an oral dental gum must keep at the premises where or from which the oral dental gum is supplied a record, complying with paragraphs (2) and (3), of every such supply.

(2)  The record in paragraph (1) must contain all of the following particulars:

(a) the date of supply;

(b) the name, identity card or other identification document number, and contact details, of the individual to whom the oral dental gum is supplied;

(c) the name and the total amount of the oral dental gum supplied;

(d) if the oral dental gum is a prescription‑only oral dental gum, the name and address of the qualified practitioner who signed the prescription.

(3)  The record in paragraph (1) must be made on the day on which the oral dental gum is supplied and must be kept for a period of at least 2 years after the date of the supply.

(4)  A supplier must make available for inspection by the Authority at all reasonable times any record made under paragraph (1).

PART 3

Presentation of oral dental gums

Display of information on oral dental gums

5.  For the purposes of section 18(1) of the Act, every container of an oral dental gum, or every outer package enclosing a container of an oral dental gum, must be labelled with all of the following information:

(a) the name of the oral dental gum or an appropriate description of the oral dental gum;

(b) the list of ingredients in accordance with regulation 6;

(c) if the oral dental gum is manufactured in Singapore, the name and address of the manufacturer of the oral dental gum;

(d) if the oral dental gum is imported, the name and address of the importer;

(e) the batch reference given by the manufacturer of the oral dental gum to the batch of which the oral dental gum forms a part;

(f) the expiry date of the oral dental gum;

(g) all precautions to be observed in the use of the oral dental gum.

List of ingredients

6.—(1)  For the purposes of regulation 5(b), every ingredient of an oral dental gum must, subject to paragraphs (2) to (5), be listed by volume or by mass in descending order using nomenclature from the latest edition of any of the following publications:

(a) the British Pharmacopoeia;

(b) the Chemical Abstracts Service;

(c) the Codex Alimentarius;

(d) the Food Chemicals Codex;

(e) the United States Pharmacopoeia.

(2)  Where an oral dental gum contains tartrazine, it must be specified in the list of ingredients as —

(a) tartrazine;

(b) colour (102); or

(c) colour (FD and C Yellow No. 5).

(3)  Any flavour used as an ingredient of an oral dental gum must be specified in the list of ingredients by the word “flavour” or the ingredients of the flavour.

(4)  A substance need not be specified in the list of ingredients if it is only present as a trace which could not reasonably have been removed during or after the manufacture of the oral dental gum.

(5)  The Authority may, on the application of a person who intends to supply an oral dental gum, allow any ingredient of the oral dental gum to be specified as “other ingredient” in the list of ingredients if the Authority is satisfied that —

(a) revealing the ingredient in the list of ingredients would prejudice a trade secret; and

(b) including the ingredient in the oral dental gum is unlikely to be harmful to any consumer.

(6)  In this regulation, “flavour” means a substance used as an ingredient of any oral dental gum solely to impart a taste to the oral dental gum.

Manner in which particulars are to be stated

7.—(1)  For the purposes of section 18(1) of the Act, all of the information required by this Part to be labelled on every container of an oral dental gum or every outer package enclosing a container of an oral dental gum must —

(a) be provided in English;

(b) be legible and indelible; and

(c) appear conspicuously in a prominent position on such container or package so as to be clearly visible to a person who intends to purchase or use the oral dental gum.

(2)  Where the container for the oral dental gum is in the form of a bubble pack, blister pack or other sealed unit and is part of a continuous series comprising a sheet or strip of like containers, regulation 5 is taken to have been complied with if the information required to be stated is printed, displayed or otherwise marked at prominent positions at frequent intervals on the sheet or strip of such containers.

PART 4

Advertisement of oral dental gums

Prohibition against advertisement of prescription‑only oral dental gum

8.—(1)  For the purposes of section 21(1) of the Act, no advertisement of an oral dental gum by a non‑public sector person may relate to a prescription‑only oral dental gum.

(2)  In this regulation, “non‑public sector person” means a person other than —

(a) a public authority established by a public Act for a public purpose; or

(b) a person authorised by the Minister.

No advertisement of oral dental gums except with prior approval of Authority

9.—(1)  Subject to the prohibition in regulation 8, for the purposes of section 21(1) of the Act, a person must not advertise or cause to be advertised any oral dental gum in an advertisement, unless the advertisement is approved by the Authority.

(2)  An application for, or to renew, the Authority’s approval of any advertisement must —

(a) be made in the form and manner specified on the Authority’s website;

(b) be accompanied by such particulars, information or material as the Authority may require; and

(c) be accompanied by the relevant application and approval fees specified in the Fees Regulations.

[S 457/2022 wef 01/07/2022]

(3)  Any approval by the Authority under this regulation —

(a) may be subject to such conditions as the Authority may impose; and

(b) is valid for a period of one year after the date on which the approval is granted or renewed, unless the approval is cancelled earlier under section 27 of the Act.

Application for variation of approved advertisement

10.—(1)  For the purposes of section 21(1) of the Act, a person must not make any variation to the contents of an advertisement approved by the Authority under regulation 9, unless the variation is approved by the Authority.

(2)  An application for variation of an approved advertisement must —

(a) be made in the form and manner specified on the Authority’s website;

(b) be accompanied by such particulars, information or material as the Authority may require; and

(c) be accompanied by the relevant application fee specified in the Fees Regulations.

[S 95/2019 wef 02/04/2019]

[S 457/2022 wef 01/07/2022]

(3)  If the Authority approves any variation of an approved advertisement, the variation —

(a) may be subject to such conditions as the Authority may impose; and

(b) takes effect from such date as the Authority may specify in its approval of the variation.

(4)  To avoid doubt, the variation under paragraph (3) does not extend the period of approval of an advertisement under regulation 9.

Application for transfer of approval of an advertisement

10A.—(1)  For the purposes of section 21(1) of the Act, a person must not transfer an approval of an advertisement granted under regulation 9 (called in this regulation an advertisement approval) to another person, unless the transfer of the advertisement approval is approved by the Authority (called in this regulation a transfer approval).

(2)  An application for a transfer approval must —

(a) be made in the form and manner specified on the Authority’s website;

(b) be accompanied by such particulars, information or material as the Authority may require; and

(c) be accompanied by the relevant application fee specified in the Fees Regulations.

[S 457/2022 wef 01/07/2022]

(3)  Any transfer approval granted by the Authority under this regulation —

(a) may be subject to such conditions as the Authority may impose; and

(b) takes effect from such date as the Authority may specify in its transfer approval.

(4)  To avoid doubt, a transfer approval granted by the Authority under this regulation in respect of an advertisement does not extend the period of the advertisement approval granted for that advertisement under regulation 9.

[S 95/2019 wef 02/04/2019]

Exception for trade, business or profession

11.  Regulations 8, 9, 10 and 10A do not apply to an advertisement of an oral dental gum if the advertisement —

(a) is directed exclusively at a person who may lawfully supply any oral dental gum in the course of the person’s trade, business or profession; and

(b) is not accessible to the general public.

[S 95/2019 wef 02/04/2019]

Exception for trade advertisement

12.  Regulations 8, 9, 10 and 10A do not apply to an advertisement of an oral dental gum if the advertisement —

(a) is in a catalogue, price list or other document for the purpose of supplying the oral dental gum by wholesale; and

(b) does not contain any recommendation relating to the use of the oral dental gum other than as part of the name of the oral dental gum.

[S 95/2019 wef 02/04/2019]

Sales promotions

13.  To avoid doubt, a sales promotion is an advertisement to which this Part applies.

PART 5

Matters relating to licences and registration

Requirements for issue of importer’s licence

14.  For the purposes of section 24(2)(a)(i) of the Act, the requirements that must be satisfied for the issue, to an applicant, of an importer’s licence for an oral dental gum are —

(a) that the applicant is a fit and proper person to be issued with the licence; and

(b) that the applicant is —

(i) a registrant of the oral dental gum to be imported; or

(ii) otherwise authorised by the registrant of the oral dental gum to import that oral dental gum.

Requirement for registration of oral dental gums

15.  For the purposes of section 30(2)(a)(iii) of the Act, the Authority may register any oral dental gum if the Authority is satisfied, based on the formulation and specifications of the oral dental gum, that the oral dental gum is safe for its intended use.

Prescribed time for cancellation of registration of oral dental gum for non‑payment of retention fee

15A.  For the purposes of section 37(2) of the Act, the prescribed time is 60 days after the anniversary of the date of the registration of the oral dental gum.

[S 457/2022 wef 01/07/2022]

 

Made on 27 October 2016.

KANDIAH SATKUNANANTHAM

Chairman,
Health Sciences Authority,
Singapore.

[HSA/LPPD/711:12/35-001; AG/LEGIS/SL/122D/2015/9 Vol. 1]

(To be presented to Parliament under section 72(5) of the Health Products Act).