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.

PART 2

PROHIBITION AGAINST DEALING WITH ADULTERATED, COUNTERFEIT, ETC., ACTIVE INGREDIENTS

Prohibition against manufacture of adulterated, counterfeit or unwholesome active ingredients

4.—(1)  Subject to paragraph (2), a person must not manufacture, or procure or arrange for the manufacture of, any active ingredient that is —

(a) an adulterated active ingredient;

(b) a counterfeit active ingredient; or

(c) an unwholesome active ingredient.

(2)  Paragraph (1)(c) does not apply in relation to an active ingredient that is unwholesome only by reason of the active ingredient —

(a) not being in conformity as regards quality or purity with the specifications of its manufacturer; or

(b) having a standard of quality or purity which falls below or which differs from, that which is represented on its label.

(3)  In any proceedings for an offence under section 47(4) of the Act for a contravention of paragraph (1), it is a defence for the accused to prove that the accused had taken all such precautions and exercised all such due diligence as could reasonably be expected of the accused in the circumstances to ensure that the active ingredient is not an adulterated, counterfeit or unwholesome active ingredient.

Prohibition against import or supply of adulterated, counterfeit, etc., active ingredients

5.—(1)  A person must not import or supply, or procure or arrange for the import or supply of, any active ingredient that is —

(a) an adulterated active ingredient;

(b) a counterfeit active ingredient;

(c) an active ingredient that has been tampered with; or

(d) an unwholesome active ingredient.

(2)  In any proceedings for an offence under section 47(4) of the Act for a contravention of paragraph (1), it is a defence for the accused to prove that —

(a) the accused —

(i) did not know;

(ii) had no reason to believe; and

(iii) could not, with reasonable diligence, have ascertained,

that the active ingredient was an adulterated active ingredient, a counterfeit active ingredient, an active ingredient that has been tampered with or an unwholesome active ingredient; and

(b) the accused had taken all such precautions and exercised all such due diligence as could reasonably be expected of the accused in the circumstances to ensure that the active ingredient is not an adulterated active ingredient, a counterfeit active ingredient, an active ingredient that has been tampered with or an unwholesome active ingredient.

PART 3

LICENCES

Division 1 — Where licences required

Licence required for manufacture of active ingredients

6.—(1)  Subject to regulation 9, a person must not manufacture any active ingredient unless —

(a) the person holds a valid manufacturer’s licence; and

(b) the manufacture of the active ingredient is carried out in accordance with the conditions of the licence.

(2)  A manufacturer of any active ingredient must not use any premises or facility for the manufacture of the active ingredient unless the premises or facility is authorised for such use under the manufacturer’s licence or the provisions of the Act, or by the Authority.

Licence required for import of active ingredients

7.—(1)  Subject to regulation 10, a person must not import any active ingredient unless —

(a) the person holds a valid importer’s licence; and

(b) the import of the active ingredient is carried out in accordance with the conditions of the licence.

(2)  An importer of any active ingredient must not use any premises or facility for storing the active ingredient upon its entry into Singapore unless the premises or facility is authorised for such use under the importer’s licence held by the importer or the provisions of the Act, or by the Authority.

Licence required for wholesale of active ingredients

8.—(1)  Subject to regulation 11, a person must not supply any active ingredient by wholesale unless —

(a) the person holds a valid wholesaler’s licence; and

(b) the wholesale supply of the active ingredient is carried out in accordance with the conditions of the licence.

(2)  A wholesaler of any active ingredient must not use any premises or facility for storing the active ingredient prior to distribution unless the premises or facility is authorised for such use under the wholesaler’s licence held by the wholesaler or the provisions of the Act, or by the Authority.

Persons who do not require manufacturer’s licences

9.  A person may, without a manufacturer’s licence, manufacture an active ingredient if —

(a) the active ingredient is intended to be used for any purpose other than in the manufacture of a relevant health product;

(b) the active ingredient is manufactured solely for use in the manufacture of a relevant health product that is intended to be used only for a non‑clinical purpose;

(c) the active ingredient is manufactured solely for use in the manufacture of a relevant health product (whether it is manufactured in Singapore or elsewhere) that is intended to be used only in clinical research (whether conducted in Singapore or elsewhere);

(d) the person holds a manufacturer’s licence (other than a manufacturer’s licence only for primary or secondary packaging) for a therapeutic product and the active ingredient is intended for use in the manufacture of a therapeutic product by that person; or

(e) the person holds a manufacturer’s licence (other than a manufacturer’s licence only for secondary packaging) for a CTGT product and the active ingredient is intended for use in the manufacture of a CTGT product by that person.

Persons who do not require importer’s licences

10.  A person may, without an importer’s licence, import an active ingredient if —

(a) the person holds a manufacturer’s licence and the active ingredient is required for use in, or for the purpose of carrying out, the manufacture of any active ingredient, in accordance with the conditions of the manufacturer’s licence;

(b) the person is a specified healthcare service licensee and the active ingredient is imported for the purposes of compounding a therapeutic product in accordance with regulation 46 of the Health Products (Therapeutic Products) Regulations 2016;

(c) the person holds a pharmacy licence and the active ingredient is imported for the purposes of compounding a therapeutic product in accordance with regulation 48 of the Health Products (Therapeutic Products) Regulations 2016;

(d) the person manufactures a laboratory‑developed test under regulation 3B of the Health Products (Medical Devices) Regulations 2010 and the active ingredient is imported only for the purposes of manufacturing the laboratory‑developed test;

(e) the person holds a manufacturer’s licence (other than a manufacturer’s licence only for primary or secondary packaging) for a therapeutic product and the active ingredient is imported for use in the manufacture of a therapeutic product by that person;

(f) the person holds a manufacturer’s licence (other than a manufacturer’s licence only for secondary packaging) for a CTGT product and the active ingredient is imported for use in the manufacture of a CTGT product by that person;

(g) the person holds a manufacturer’s licence for a medical device, other than a manufacturer’s licence that authorises the manufacture of medical devices only by way of secondary assembly, and the active ingredient is imported for use in the manufacture of a medical device by that person; or

(h) the active ingredient is imported solely for use in the manufacture of a relevant health product in Singapore that is intended to be used only in clinical research (whether conducted in Singapore or elsewhere) and the person, before importing the active ingredient, gives the Authority notice of the import in the form and manner, and within the time, specified on the Authority’s website.

Persons who do not require wholesaler’s licences

11.—(1)  A person may, without a wholesaler’s licence, supply by wholesale any active ingredient if —

(a) the person holds a manufacturer’s licence;

(b) the active ingredient is manufactured by the person under the manufacturer’s licence;

(c) the person is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the distribution of the active ingredient as are necessary to prevent the deterioration of the active ingredient while it is in the person’s ownership, possession or control; and

(d) the supply of the active ingredient is in accordance with any terms and conditions that the Authority may specify in the manufacturer’s licence.

(2)  A person may, without a wholesaler’s licence, supply by wholesale any active ingredient if —

(a) the person holds an importer’s licence;

(b) the person imported the active ingredient solely for the purpose of export; and

(c) the supply of the active ingredient is in accordance with any terms and conditions that the Authority may specify in the importer’s licence.

(3)  A person may, without a wholesaler’s licence, supply by wholesale any active ingredient if the active ingredient is intended for use in, or for the purpose of carrying out, the manufacture of a relevant health product that —

(a) is solely for a non‑clinical purpose; and

(b) is not for any supply to the public.

(4)  A person may, without a wholesaler’s licence, supply by wholesale any active ingredient if the active ingredient —

(a) is supplied for any purpose other than in the manufacture of a product for use on or by humans; or

(b) subject to paragraph (5), is supplied solely for use in the manufacture of a relevant health product (whether it is manufactured in Singapore or elsewhere) that is intended to be used only in clinical research (whether conducted in Singapore or elsewhere).

(5)  In addition to paragraph (4)(b), if the active ingredient is supplied solely for use in the manufacture of a relevant health product in Singapore by the same person manufacturing the active ingredient that is intended to be used only in clinical research conducted in Singapore, the person must, before supplying the active ingredient, give the Authority notice of the supply in the form and manner, and within the time, specified on the Authority’s website.

Division 2 — Requirements for issue of licence

Requirements for issue of manufacturer’s licence

12.  For the purposes of section 24(2)(a)(i) of the Act, the requirements that must be satisfied for the issue of a manufacturer’s licence for an active ingredient are that —

(a) the applicant for the licence is able to provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities that are necessary for all of the following:

(i) carrying out the manufacture of the active ingredient to be authorised by the licence;

(ii) the proper handling, storage and distribution of the active ingredient so as to prevent the deterioration of the active ingredient while it is in the applicant’s ownership, possession or control;

(b) the applicant for the licence is able to conduct all manufacturing operations in such a way as to ensure that the active ingredient is of the correct identity and conforms with the applicable standards of quality for that active ingredient; and

(c) the applicant for the licence is able to comply with the Good Manufacturing Practice standard in relation to the manufacture of the active ingredient.

Requirements for issue of importer’s licence

13.  For the purposes of section 24(2)(a)(i) of the Act, the requirements that must be satisfied for the issue of an importer’s licence for an active ingredient are that —

(a) the applicant for the licence is able to provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities for the proper handling and storage of the active ingredient that are necessary to prevent the deterioration of the active ingredient while it is in the applicant’s ownership, possession or control; and

(b) where the active ingredient is to be supplied for the manufacture of a relevant health product intended for any use on or by humans in Singapore — the applicant is able to comply with the requirements in the relevant Good Distribution Practice standard.

Requirements for issue of wholesaler’s licence

14.  For the purposes of section 24(2)(a)(i) of the Act, the requirements that must be satisfied for the issue of a wholesaler’s licence for an active ingredient are that —

(a) the applicant for the licence is able to provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities that are necessary for the proper handling, storage and distribution of the active ingredient to prevent the deterioration of the active ingredient while it is in the applicant’s ownership, possession or control; and

(b) the applicant for the licence is able to comply with the requirements in the relevant Good Distribution Practice standard.

 

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).