PART 1 | Citation and commencement |
| 1. These Regulations are the Health Products (Therapeutic Products) Regulations 2016 and come into operation on 1 November 2016. |
2.—(1) In these Regulations, unless the context otherwise requires —“administer”, in relation to a substance or article, means to give or apply it to a human being, whether —| (a) | orally; | | (b) | by injection or by introduction into the body in any other way; or | | (c) | by external application, whether by direct contact with the body or not; |
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“appropriate non-proprietary name”, in relation to an active ingredient of a therapeutic product, means —| (a) | the name or synonym of the active ingredient described in the relevant monograph appearing in the latest edition of any specified publication; | | (b) | where the active ingredient is not described in a monograph in any specified publication, its international non-proprietary name; 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; |
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“appropriate quantitative particulars”, in relation to a therapeutic product, means —| (a) | the quantity of each active ingredient, identified by its appropriate non-proprietary name, in each dosage unit of the therapeutic product and expressed in terms of weight, volume, capacity or units of activity; or | | (b) | where there is no dosage unit of the therapeutic product, the quantity of each active ingredient, identified by its appropriate non-proprietary name, in the container of the therapeutic product and expressed in terms of weight, volume, capacity or units of activity or percentage by weight or volume of the total quantity; |
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| “Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg; |
“codeine cough preparation” means a therapeutic product that —| (a) | is in liquid or solid form; | | (b) | contains codeine or its salts; and | | (c) | is intended for the treatment of coughs; [S 732/2021 wef 01/10/2021] |
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| “collaborative prescribing practitioner” has the same meaning as in regulation 56C(6) of the Private Hospitals and Medical Clinics Regulations (Cap. 248, Rg 1); [S 119/2018 wef 01/03/2018] |
| “compound”, in relation to a therapeutic product, means to formulate, mix, assemble, package or label the therapeutic product, with the intention of dispensing or administering the therapeutic product to a patient in accordance with the written instructions of a qualified practitioner; |
“container”, in relation to a therapeutic product, means an article or packaging immediately covering the therapeutic product, including any bottle, ampoule, blister pack, sachet, dial dispenser pack, strip pack, syringe, tube, vessel, vial, 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; |
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“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 [S 119/2018 wef 01/03/2018] | | (b) | a qualified pharmacist or a person acting under the supervision of a qualified pharmacist; |
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| “expiry date”, for a therapeutic product, means the date after which, or the month and year after the end of which, the therapeutic product should not be used; |
| “general sale list medicine” means a therapeutic product registered under the classification of “general sale list medicine” in the Register of Health Products; |
“healthcare institution licence” means —| (a) | a licence granted under the Healthcare Services Act 2020 for the provision of any licensable healthcare service; or | | (b) | a licence issued for a healthcare institution under the Private Hospitals and Medical Clinics Act 1980; [S 1081/2021 wef 03/01/2022] |
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| “healthcare institution licensee” means the holder of a healthcare institution licence for a private hospital or medical clinic; |
| “importer’s licence” means an importer’s licence authorising the holder of the licence to import a therapeutic product under section 13 of the Act; |
| “international non-proprietary name”, for an active ingredient, means a name which has been selected by the World Health Organization as a recommended international non-proprietary name for the active ingredient; |
“licensed healthcare institution” means —| (a) | any premises or conveyance specified in a licence granted under the Healthcare Services Act 2020 for the provision of any licensable healthcare service; or | | (b) | a healthcare institution that is licensed under the Private Hospitals and Medical Clinics Act 1980; [S 1081/2021 wef 03/01/2022] |
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| “licensed importer” means the holder of an importer’s licence; |
| “licensed manufacturer” means the holder of a manufacturer’s licence; |
| “licensed retail pharmacy” means premises specified in a pharmacy licence; |
| “licensed wholesaler” means the holder of a wholesaler’s licence; |
| “licensee”, in relation to a therapeutic product, means a licensed manufacturer, licensed importer or licensed wholesaler; |
| “manufacturer’s licence” means a manufacturer’s licence authorising the holder of the licence to manufacture a therapeutic product under section 12 of the Act; |
| “medical clinic” means a medical clinic that is licensed under the Private Hospitals and Medical Clinics Act; |
| “non-clinical purpose” means any purpose not involving any application of a therapeutic product on, or use of a therapeutic product by, humans; |
| “Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products” means the text of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products as set out on the Authority’s website from time to time; |
| “pharmacy licence” means a licence issued under the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016); |
| “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; |
| “private hospital” means a private hospital that is licensed under the Private Hospitals and Medical Clinics Act; |
| “proprietary name” means a word or words used in connection with the sale or supply of a therapeutic product 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 therapeutic product, or offers it for sale or supply; |
| “psychotropic substance” means a substance specified in the First Schedule; |
“qualified pharmacist” means a person who —| (a) | is registered as a pharmacist under the Pharmacists Registration Act 2007; [S 436/2023 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); |
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“qualified practitioner” means —| (a) | a registered medical practitioner under the Medical Registration Act 1997; or [S 436/2023 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 436/2023 wef 31/12/2021] |
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| “relevant fee” means a fee specified in the Eighth Schedule to the Health Products (Fees) Regulations 2022 (G.N. No. S 450/2022); [S 458/2022 wef 01/07/2022] |
“repacking”, in relation to the compounding of a therapeutic product, means removing the therapeutic product from the container in which it is originally supplied by its manufacturer and —| (a) | placing it in a different container; or | | (b) | changing the outer packaging or other packaging in which the container is further enclosed; |
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“specified publication” means any of the following:| (a) | the British Pharmacopoeia; | | (b) | the European Pharmacopoeia; | | (c) | the United States Pharmacopoeia and the National Formulary; |
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| “supply by retail sale” means sale by retail and includes exposure or display as an invitation to treat; |
| “therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to the Act; |
“trade description” means any description, statement or indication which, directly or indirectly and by any means given, relates to any of the following matters in respect of a therapeutic product:| (a) | the quantity, liquid volume or weight of the therapeutic product; | | (b) | the method of manufacture, production, or processing, of the therapeutic product; | | (c) | the characteristics or composition of the therapeutic product; | | (d) | the fitness for purpose (including expiry date), dosage strength, or intended purpose, of the therapeutic product; | | (e) | any physical characteristics or presentation of the therapeutic product not referred to in paragraphs (a) to (d); | | (f) | the testing of the therapeutic product by any person and the results of the test; | | (g) | the approval of the therapeutic product by any person or its conformity with a product description approved by any person; | | (h) | the place or date of manufacture, production, or processing, of the therapeutic product; | | (i) | the name of the person who manufactured, produced or processed the therapeutic product; |
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| “wholesaler’s licence” means a wholesaler’s licence authorising the holder of the licence to supply a therapeutic product by wholesale under section 14 of the Act. |
(2) For the purposes of these Regulations, a prescription is valid only if the prescription —| (a) | is written and signed by a qualified practitioner or collaborative prescribing practitioner; and [S 119/2018 wef 01/03/2018] | | (b) | contains all of the following particulars:| (i) | the date of the prescription; | | (ii) | the name and address of the qualified practitioner or collaborative prescribing practitioner giving the prescription; [S 119/2018 wef 01/03/2018] | | (iii) | the name, identity card or other identification document number, and contact details, of the patient to whom the prescription relates; | | (iv) | the name and total amount of the prescribed therapeutic product to be supplied to, and the dose to be taken by, the patient; | | (v) | where the qualified practitioner or collaborative prescribing practitioner giving the prescription intends for the prescription to be repeated, an indication of the number of times, and the time period between which, the prescribed therapeutic product may be supplied; [S 119/2018 wef 01/03/2018] | | (vi) | where the prescription is given by a dentist, a declaration by the dentist that the prescription is “for dental treatment only”. |
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| 3. These Regulations do not apply to any therapeutic product that is clinical research material as defined in regulation 2(1) of the Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2016 (G.N. No. S 332/2016). |
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