PART 1 | Citation and commencement |
| 1. These Regulations are the Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2016 and come into operation on 1 November 2016. |
2.—(1) In these Regulations, unless the context otherwise requires —“administer”, in relation to any clinical research material, means to give or apply 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 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 a monograph in any such 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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| “Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg; |
| “auxiliary CRM” means any clinical research material that is used for the needs of any clinical research as described in the protocol, but not as the material to be tested or used as a reference in the research; |
| “clinical research” means any research involving human beings (whether or not a regulated clinical trial); |
| “clinical research material” means any therapeutic product or placebo that is manufactured, imported or supplied for the purpose of being used in any clinical research by way of administration to a subject in accordance with the protocol for the research; |
“codeine cough preparation” means a therapeutic product that —| (a) | is in liquid form; | | (b) | contains codeine; and | | (c) | is intended by the person who manufactured the product for the treatment of cough; |
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“institutional review board” means an independent body which —| (a) | is constituted of medical, scientific, and non‑scientific members, whose responsibility is to ensure the protection of the rights, safety and wellbeing of subjects by, among other things, reviewing, approving and providing continuing review of the protocol, amendments, and the methods and materials to be used in obtaining and documenting informed consent of the subjects; and | | (b) | when Part 4 of the Human Biomedical Research Act 2015 (Act 29 of 2015) comes into operation, is appointed under that Act; |
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| “investigational CRM” means any clinical research material that is to be tested or used as a reference in any clinical research; |
“in-store pharmaceutical officer” means —| (a) | a qualified pharmacist engaged or employed to provide pharmacy services at or from a licensed retail pharmacy; or | | (b) | a person acting under the supervision of the qualified pharmacist mentioned in paragraph (a) when providing pharmacy services at or from the licensed retail pharmacy; |
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| “licensed retail pharmacy” means the premises specified in a pharmacy licence; |
| “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; |
| “proprietary name” means a word or words used in connection with the 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 supply; |
| “protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of any clinical research; |
| “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 (Cap. 230); | | (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 (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; |
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“regulated clinical trial” means any clinical trial that is —| (a) | authorised by the Authority, or notified to the Authority and the notification accepted by the Authority, under regulation 8 or 9 of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016); or | | (b) | issued with a certificate under regulation 8 of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016); |
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| “sponsor” means a person who takes responsibility for the initiation, management or financing of any clinical research; |
“subject” means a human being, whether or not a patient, who participates in any clinical research —| (a) | as a recipient of the clinical research material to which the research relates, or of some other treatment or procedure in that research; or | | (b) | as a control, without receiving any such clinical research material, or any such treatment or procedure; |
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| “therapeutic product” means a health product categorised as a therapeutic product in the First Schedule to 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; 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 subject to whom the prescription relates; | | (iv) | the name and total amount of the prescribed clinical research material to be supplied to, and the dose to be taken by, the subject; | | (v) | where the qualified 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 clinical research material may be supplied; | | (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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