Singapore Statutes Online Current version as at 26 Aug 2021 PDF created date on: 26 Aug 2021Trade descriptions
19.—(1)  For the purposes of section 18(1) of the Act, the presentation of a 
therapeutic product must comply with all of the following requirements:
(a) a trade description which is false or misleading must not be applied to the 
therapeutic product;
(b) a trade description which explicitly or implicitly suggests that the supply or 
use of the therapeutic product is promoted or endorsed by the Authority, 
the Ministry of Health or the Health Promotion Board must not be applied 
to the therapeutic product.
(2)  For the purposes of paragraph (1)(a), a trade description is false or misleading 
if —
(a) it contains any false statement or information concerning the therapeutic 
product; or
(b) it is likely to create an erroneous impression regarding the formulation, 
composition, quality, safety, efficacy or uses of the therapeutic product.
(3)  For the purposes of paragraph (1), a person applies a trade description to a 
therapeutic product if the person —
(a) affixes or annexes the trade description to, or in any manner marks it on or 
incorporates it in —
(i) the therapeutic product; or
(ii) any thing in or on the therapeutic product or with which the 
therapeutic product is supplied;
(b) places the therapeutic product in, on or with any thing which the trade 
description has been affixed or annexed to, marked on or incorporated in; 
or
(c) makes any oral or written statement of the trade description, or uses the 
trade description in any other manner, which is likely to be understood as 
referring to the therapeutic product.
(4)  A person supplying a therapeutic product is taken to have applied a trade 
description to the therapeutic product if —
(a) the therapeutic product is supplied pursuant to a request in which the trade 
description is used; and
(b) it is reasonable in the circumstances to infer that any therapeutic product so Singapore Statutes Online Current version as at 26 Aug 2021 PDF created date on: 26 Aug 2021supplied will correspond to that trade description.
Information to be provided with therapeutic products
20.—(1)  In addition to regulation 19, a therapeutic product must, for the purposes of 
section 18(1) of the Act, be accompanied by all of the following information, where 
applicable, when it is supplied:
(a) the name of the therapeutic product, being the proprietary name and the 
appropriate non-proprietary name;
(b) the appropriate quantitative particulars of any active ingredient of the 
therapeutic product;
(c) an appropriate control number, such as a serial number, batch number or 
lot number;
(d) the expiry date of the therapeutic product;
(e) where the therapeutic product is registered, the registration number 
assigned to the registered therapeutic product by the Authority.
(2)  Where a therapeutic product contains any substance specified in the first column 
of the Fourth Schedule, the therapeutic product must be labelled with a statement 
declaring the presence of that substance, and that substance may be described by a 
corresponding term specified in the second column of that Schedule.
(3)  Where a therapeutic product contains any substance specified in the first column 
of the Fifth Schedule, the therapeutic product must be labelled with the caution set out in 
the second column of that Schedule.
(4)  Where a therapeutic product is contained in a container, which is in the form of a 
bubble, blister or other sealed unit and is part of a continuous series comprising a sheet 
or strip of like containers, paragraph (2) or (3), as the case may be, is taken to have been 
complied with if the statement mentioned in paragraph (2) or the caution mentioned in 
paragraph (3) is printed or displayed or otherwise marked in a prominent position at 
frequent intervals on the sheet or strip of the container.
(5)  All information accompanying the therapeutic product mentioned in 
paragraph (1), including the statement mentioned in paragraph (2) and the caution 
mentioned in paragraph (3) —
(a) must be provided in English; and
(b) must be legible and indelible.Singapore Statutes Online Current version as at 26 Aug 2021 PDF created date on: 26 Aug 2021FOURTH SCHEDULE
Regulation 20(2)
First column Second column
Substance Term to be used
1. Tartrazine tartrazine (Code E102)
tartrazine (Code 102)
tartrazine (Code FD and C Yellow No. 5) 
2. Benzoic acid benzoic acid
benzoic acid (Code E210)
3. Sodium benzoate sodium benzoate
sodium benzoate (Code E211)
FIFTH SCHEDULE
Regulation 20(3)
CAUTIONARY INFORMATION TO BE LABELLED ON THERAPEUTIC PRODUCTS
First column  Second column
Therapeutic product  Cautionary information
1. Therapeutic product containing aspirin or 
acetylsalicylic acid for oral administration Caution: Not to be given to persons below 
16 years of age except under the direction 
of a doctor.
2. Therapeutic product containing any of the 
following substances for oral administration:  Caution: This may cause drowsiness. If 
affected, do not drive or operate 
machinery.
(a) Diphenoxylate   
(b) Loperamide   
(c) The following anti-histamine 
substances:  
   Antazoline   
   Azatadine   
   Bamipine   
   Bromodiphenhydramine   Singapore Statutes Online Current version as at 26 Aug 2021 PDF created date on: 26 Aug 2021   Bromopheniramine   
   Buclizine   
   Carbinoxamine   
   Chlorcyclizine   
   Chlorpheniramine   
   Cinnarizine   
   Clemastine   
   Clemizole   
   Cyclizine   
   Cyproheptadine   
   Dexchlorpheniramine   
   Dimethpyrindene   
   Diphenhydramine   
   Diphenylpyraline   
   Doxylamine   
   Embramine   
   Flunarizine   
   Homochlorcyclizine   
   Isothipendyl   
   Levocabastine   
   Mebhydrolin   
   Meclastine   
   Meclozine   
   Mepyramine   
   Mequitazine   
   Methdilazine   Singapore Statutes Online Current version as at 26 Aug 2021 PDF created date on: 26 Aug 2021   Oxatomide   
   Oxomemazine   
   Phenindamine   
   Pheniramine   
   Phenyltoloxamine   
   Promethazine   
   Pyrathiazine   
   Pyrrobutamine   
   Thenalidine   
   Thenyldiamine   
   Thiazinamium   
   Tolpropamine   
   Tripelennamine   
   Triprolidine