Singapore legislation
Regulation 20
Regulation 20
Information to be provided with therapeutic products
Subregulation 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:
the name of the therapeutic product, being the proprietary name and the appropriate non-proprietary name;
the appropriate quantitative particulars of any active ingredient of the therapeutic product;
an appropriate control number, such as a serial number, batch number or lot number;
the expiry date of the therapeutic product;
where the therapeutic product is registered, the registration number assigned to the registered therapeutic product by the Authority.
Subregulation 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.
Subregulation 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.
Subregulation 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.
Subregulation 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) —
must be provided in English; and
must be legible and indelible.