Health Products (Active Ingredients) Regulations 2023

No. S 831

Health Products Act 2007

Health Products
(Active Ingredients) Regulations 2023

In exercise of the powers conferred by sections 47 and 72 of the Health Products Act 2007, 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 (Active Ingredients) Regulations 2023 and come into operation on 18 December 2023.

Definitions

2.—(1) In these Regulations —

“appropriate non‑proprietary name”, in relation to an active ingredient, means —

(a)

the name or a synonym of the active ingredient described in the relevant monograph appearing in the latest edition of any of the following publications:

(i)	the British Pharmacopoeia;
(ii)	the European Pharmacopoeia;
(iii)	the United States Pharmacopoeia and the National Formulary;

(b)

where the active ingredient is not described in any publication mentioned in paragraph (a) — the name selected by the World Health Organisation as a recommended international non‑proprietary name for the active ingredient; or

(c)

where paragraph (a) or (b) is not applicable — the accepted scientific name or other name descriptive of the true nature of the active ingredient;

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

“clinical research” has the meaning given by regulation 2(1) of the Health Products (Clinical Research Materials) Regulations 2016 (G.N. No. S 332/2016);

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

“Good Distribution Practice standard” means the Authority’s Guidance Notes on Good Distribution Practice and any other good distribution practice standard approved by the Authority;

“Good Manufacturing Practice standard” means the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co‑operation Scheme Guide to Good Manufacturing Practice for Medicinal Products;

“importer’s licence” means a licence authorising the holder of the licence to import any active ingredient;

“laboratory‑developed test” has the meaning given by regulation 2 of the Health Products (Medical Devices) Regulations 2010 (G.N. No. S 436/2010);

“manufacture”, in relation to an active ingredient, means to make, fabricate, produce or process the active ingredient, and includes —

(a)	any process carried out in the course of so making, fabricating, producing or processing the active ingredient; and
(b)	the packaging and labelling of the active ingredient before it is supplied;

“manufacturer’s licence” means a licence authorising the holder of the licence to manufacture any active ingredient;

“medical device” means a medical device described in the First Schedule to the Act;

“minimal manipulation”, in relation to a cell or tissue, has the meaning given by regulation 2(1) of the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 (G.N. No. S 104/2021);

“non‑clinical purpose”, in relation to any health product, means any purpose not involving the application of the health product on, or use of the health product by, humans;

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

“proprietary name” means a word or words used in connection with the sale or supply of an active ingredient for the purpose of indicating that it is the product of a particular person who manufactures, selects the name of, certifies or deals with the active ingredient, or offers it for sale or supply;

“psychotropic substance” means a substance specified in the First Schedule to the Health Products (Therapeutic Products) Regulations 2016 (G.N. No. S 329/2016);

“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);

“relevant health product” means a health product specified in regulation 3(a), (b) or (c);

“specified healthcare service licensee” has the meaning given by regulation 2(1) of the Health Products (Therapeutic Products) Regulations 2016;

“supply”, in relation to an active ingredient, means to transfer possession of the active ingredient by any means whether or not for reward, and includes the following:

(a)

to sell the active ingredient, whether by retail, wholesale or auction;

(b)

to expose or display the active ingredient as an invitation to treat;

(c)

to transfer possession of the active ingredient by exchange or gift;

(d)

to supply the active ingredient in connection with —

(i)	a contract for the provision of any goods or the performance of any service; or
(ii)	any advertising, sponsorship or promotional activity;

(e)

to offer, agree or attempt to supply the active ingredient in any of the ways described in paragraphs (a) to (d) or to cause or permit the active ingredient to be so supplied;

(f)

to keep or possess the active ingredient for the purpose of supplying the active ingredient in any of the ways described in paragraphs (a) to (e);

“therapeutic product” means a therapeutic product described in the First Schedule to the Act;

“wholesale”, in relation to an active ingredient, means any one or more of the following:

(a)	supplying the active ingredient to a person who obtains the active ingredient for the purposes of supplying the active ingredient again to some other person;
(b)	supplying the active ingredient to a person as a commercial sample in the normal course of a lawful trade;
(c)	supplying the active ingredient to a Government department or statutory body which requires the active ingredient for the purposes of the public service or use in connection with the exercise of any statutory power;
(d)	supplying the active ingredient to a person or an institution concerned with scientific education or research which requires the active ingredient for the purpose of education or research;
(e)	supplying the active ingredient to a person who requires to use the active ingredient for the purpose of the person’s business or trade;
(f)	supplying the active ingredient by export to a party outside Singapore;

“wholesaler’s licence” means a licence authorising the holder of the licence to supply any active ingredient by wholesale.

(2) For the purposes of these Regulations —

(a)

an active ingredient is adulterated if it contains or has been mixed with any substance or ingredient that is not stated on its label as being one of its constituent substances or ingredients;

(b)

an active ingredient is counterfeit if —

(i)	it is presented in such a manner as to resemble or pass off as an active ingredient with a proprietary name when in fact it is not; or
(ii)	it is presented with any false information as to its manufacturer or origin;

(c)

an active ingredient has been tampered with if it has been modified or interfered with in any way, including through the introduction or incorporation in the active ingredient of any substance or component that is not referred to in the specifications of its manufacturer; and

(d)

an active ingredient is unwholesome if —

(i)	it is not in conformity as regards quality or purity with the specifications of its manufacturer;
(ii)	it has a standard of quality or purity which falls below or which differs from, that which is represented on its label;
(iii)	any of its constituent substances or ingredients, as stated on its label, has been extracted or omitted from it;
(iv)	it consists in whole or in part of any filthy, putrid or decomposed substance;
(v)	it has been manufactured or stored under unsanitary conditions;
(vi)	it has been kept in a package which is composed in whole or in part of any substance which may render the contents injurious to health;
(vii)	it has been packed with any substance so as to reduce the purity, quality or beneficial properties that it would have had if it had not been so packed; or
(viii)	it has passed its expected useful life or its expiry date as assigned by its manufacturer.

Application

3. For the purposes of section 46 of the Act, Part 9 of the Act and these Regulations apply to and in relation to the active ingredients specified in the Schedule that are usable in the manufacture of any of the following health products (called in these Regulations a relevant health product):

(a)	any therapeutic product;
(b)	any CTGT product that is not a result of only minimal manipulation of cell or tissue;
(c)	any medical device.

Made on 24 November 2023.

BENJAMIN ONG

Chairperson,
Health Sciences Authority,
Singapore.

[401:04/01-000; AG/LEGIS/SL/122D/2020/11 Vol. 1]

(To be presented to Parliament under section 72(5) of the Health Products Act 2007).

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