Singapore legislation
Regulation 23
Regulation 23
Duty to maintain records of receipt and supply
Subregulation 1
Paragraphs (2) and (3) apply to a person (P) who is a manufacturer, an importer or a wholesaler of an active ingredient.
Subregulation 2
P must —
if P is not the manufacturer of the active ingredient, maintain a record of every receipt by P of the active ingredient;
maintain a record of every supply by P of the active ingredient; and
produce for inspection by the Authority or an enforcement officer the record of every receipt or supply as and when required by the Authority or enforcement officer.
Subregulation 3
P must ensure that every record mentioned in paragraph (2) —
contains, in relation to each receipt by P of the active ingredient, all of the following information:
the appropriate non‑proprietary name and, where applicable, the proprietary name, of the active ingredient, if the active ingredient is supplied by a manufacturer, an importer or a wholesaler, as the case may be;
the date on which the active ingredient is received;
the name and address of the person from whom the active ingredient is received;
the quantity of the active ingredient received;
the identification number (including the control number, lot number, batch number or serial number) of the active ingredient received;
contains, in relation to each supply by P of the active ingredient, all of the following information:
the proprietary name or appropriate non‑proprietary name of the active ingredient;
the date on which the active ingredient is supplied;
the name and address of the person to whom the active ingredient is supplied;
the quantity of the active ingredient supplied;
the identification number (including the control number, lot number, batch number or serial number) of the active ingredient supplied; and
is retained for at least 2 years after the date on which the active ingredient is so supplied to another person.