advertisement on health products
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HEALTH PRODUCTS ACT
(CHAPTER 122D)
HEALTH PRODUCTS (ADVERTISEMENT OF
THERAPEUTIC PRODUCTS) REGULATIONS 2016
In exercise of the powers conferred by section 72 of the Health Products Act, the Health Sciences Authority, with the approval of the Minister for Health, makes the following Regulations:
Citation and commencement
1. These Regulations are the Health Products (Advertisement of Therapeutic Products) Regulations 2016 and come into operation on 1 November 2016.
Definitions
2. In these Regulations, unless the context otherwise requires —
“enrolled nurse” means an individual who is enrolled as a nurse under the Nurses and Midwives Act (Cap. 209);
“licensee”, in relation to a therapeutic product, means a holder of a manufacturer’s licence, an importer’s licence or a wholesaler’s licence for the therapeutic product;
“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;
“pharmacy-only medicine” means a therapeutic product registered under the classification of “pharmacy‑only medicine” in the Register of Health Products;
“prescription-only medicine” means a therapeutic product registered under the classification of “prescription‑only medicine” in the Register of Health Products;
“publish”, in relation to the advertisement of a therapeutic product, includes to distribute, show, display, exhibit, issue, disseminate or broadcast by any form of communication or in any manner;
“qualified practitioner” means —
(a) a registered medical practitioner under the Medical Registration Act (Cap. 174); or
(b) a registered dentist under the Dental Registration Act (Cap. 76) whose name appears in the first division of the Register of Dentists maintained and kept under section 13(1)(a) of that Act;
“registered midwife” means an individual who is registered as a midwife under the Nurses and Midwives Act;
“registered nurse” means an individual who is registered as a nurse under the Nurses and Midwives Act;
“registered pharmacist” means an individual who is registered as a pharmacist under the Pharmacists Registration Act (Cap. 230);
“relevant health professionals” means individuals within any class of persons specified in the First Schedule;
“sales promotion” means any advertisement of a therapeutic product in the form of a sales campaign (including door‑to‑door sales), exhibition, competition or any other activity meant to introduce, publicise or raise the profile or public awareness or visibility of the therapeutic product for the purpose of promoting the sale or use of the therapeutic product;
“therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act.
Requirements for advertisement of therapeutic products
3. For the purposes of section 21(1) of the Act, an advertisement of a therapeutic product must, subject to the modifications in regulation 11, 12, 13 or 14 —
(a) comply with regulations 4, 5 and 6; and
(b) be undertaken in accordance with regulations 7, 8, 9 and 10.
Matters to be excluded in advertising therapeutic products
4. An advertisement of a therapeutic product must not —
(a) be likely to lead to a consumer of the therapeutic product self‑diagnosing or inappropriately treating any serious disease by himself or herself;
(b) give the impression that advice from a registered pharmacist or qualified practitioner on the use of the therapeutic product is not necessary;
(c) give the impression that a medical consultation or surgical operation is not necessary if the therapeutic product is used;
(d) encourage, or be likely to encourage, inappropriate or excessive use of the therapeutic product;
(e) mislead, or be likely to mislead, directly or by implication or through emphasis, contrast or omission, any person with regard to the quality or efficacy of the therapeutic product;
(f) compare or contrast the therapeutic product with any other named therapeutic product or a
(CHAPTER 122D)
HEALTH PRODUCTS (ADVERTISEMENT OF
THERAPEUTIC PRODUCTS) REGULATIONS 2016
In exercise of the powers conferred by section 72 of the Health Products Act, the Health Sciences Authority, with the approval of the Minister for Health, makes the following Regulations:
Citation and commencement
1. These Regulations are the Health Products (Advertisement of Therapeutic Products) Regulations 2016 and come into operation on 1 November 2016.
Definitions
2. In these Regulations, unless the context otherwise requires —
“enrolled nurse” means an individual who is enrolled as a nurse under the Nurses and Midwives Act (Cap. 209);
“licensee”, in relation to a therapeutic product, means a holder of a manufacturer’s licence, an importer’s licence or a wholesaler’s licence for the therapeutic product;
“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;
“pharmacy-only medicine” means a therapeutic product registered under the classification of “pharmacy‑only medicine” in the Register of Health Products;
“prescription-only medicine” means a therapeutic product registered under the classification of “prescription‑only medicine” in the Register of Health Products;
“publish”, in relation to the advertisement of a therapeutic product, includes to distribute, show, display, exhibit, issue, disseminate or broadcast by any form of communication or in any manner;
“qualified practitioner” means —
(a) a registered medical practitioner under the Medical Registration Act (Cap. 174); or
(b) a registered dentist under the Dental Registration Act (Cap. 76) whose name appears in the first division of the Register of Dentists maintained and kept under section 13(1)(a) of that Act;
“registered midwife” means an individual who is registered as a midwife under the Nurses and Midwives Act;
“registered nurse” means an individual who is registered as a nurse under the Nurses and Midwives Act;
“registered pharmacist” means an individual who is registered as a pharmacist under the Pharmacists Registration Act (Cap. 230);
“relevant health professionals” means individuals within any class of persons specified in the First Schedule;
“sales promotion” means any advertisement of a therapeutic product in the form of a sales campaign (including door‑to‑door sales), exhibition, competition or any other activity meant to introduce, publicise or raise the profile or public awareness or visibility of the therapeutic product for the purpose of promoting the sale or use of the therapeutic product;
“therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act.
Requirements for advertisement of therapeutic products
3. For the purposes of section 21(1) of the Act, an advertisement of a therapeutic product must, subject to the modifications in regulation 11, 12, 13 or 14 —
(a) comply with regulations 4, 5 and 6; and
(b) be undertaken in accordance with regulations 7, 8, 9 and 10.
Matters to be excluded in advertising therapeutic products
4. An advertisement of a therapeutic product must not —
(a) be likely to lead to a consumer of the therapeutic product self‑diagnosing or inappropriately treating any serious disease by himself or herself;
(b) give the impression that advice from a registered pharmacist or qualified practitioner on the use of the therapeutic product is not necessary;
(c) give the impression that a medical consultation or surgical operation is not necessary if the therapeutic product is used;
(d) encourage, or be likely to encourage, inappropriate or excessive use of the therapeutic product;
(e) mislead, or be likely to mislead, directly or by implication or through emphasis, contrast or omission, any person with regard to the quality or efficacy of the therapeutic product;
(f) compare or contrast the therapeutic product with any other named therapeutic product or a
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Answer :
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