Singapore legislation

Regulation 23

of Health Products (Active Ingredients) Regulations 2023

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 —

(a)

if P is not the manufacturer of the active ingredient, maintain a record of every receipt by P of the active ingredient;

(b)

maintain a record of every supply by P of the active ingredient; and

(c)

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) —

(a)

contains, in relation to each receipt by P of the active ingredient, all of the following information:

(i)

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;

(ii)

the date on which the active ingredient is received;

(iii)

the name and address of the person from whom the active ingredient is received;

(iv)

the quantity of the active ingredient received;

(v)

the identification number (including the control number, lot number, batch number or serial number) of the active ingredient received;

(b)

contains, in relation to each supply by P of the active ingredient, all of the following information:

(i)

the proprietary name or appropriate non‑proprietary name of the active ingredient;

(ii)

the date on which the active ingredient is supplied;

(iii)

the name and address of the person to whom the active ingredient is supplied;

(iv)

the quantity of the active ingredient supplied;

(v)

the identification number (including the control number, lot number, batch number or serial number) of the active ingredient supplied; and

(c)

is retained for at least 2 years after the date on which the active ingredient is so supplied to another person.