Singapore legislation

Regulation 32

of Health Products (Therapeutic Products) Regulations 2016

Regulation 32

Duty to maintain records of receipt and supply

Amended byS 969/2020 wef 01/12/2020S 436/2023 wef 26/06/2023S 811/2023 wef 18/12/2023

Subregulation 1

Amended byS 969/2020 wef 01/12/2020S 436/2023 wef 26/06/2023S 811/2023 wef 18/12/2023

Paragraphs (2) and (3) apply to a person (P) who is —

(a)

a licensee or registrant of a therapeutic product; or

(b)

the supplier of a therapeutic product in accordance with regulation 47, 49, 51, 58(1)(b), (c) or (d) or 60A(3) or (4).

Subregulation 2

P must —

(a)

if P is not the manufacturer of the therapeutic product, maintain a record of every receipt by P of the therapeutic product;

(b)

maintain a record of every supply by P of the therapeutic product; 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 therapeutic product, all of the following information:

(i)

the proprietary name or appropriate non‑proprietary name of the therapeutic product, if the therapeutic product is supplied by a manufacturer, importer or wholesaler, as the case may be;

(ii)

the date on which the therapeutic product is received;

(iii)

the name and address of the person from whom the therapeutic product is received;

(iv)

the quantity of the therapeutic product received;

(v)

the identification number (including the control number, lot number, batch number or serial number) of the therapeutic product received;

(b)

contains, in relation to each supply by P of the therapeutic product, all of the following information:

(i)

the proprietary name or appropriate non‑proprietary name of the therapeutic product;

(ii)

the date on which the therapeutic product is supplied;

(iii)

the name and address of the person to whom the therapeutic product is supplied;

(iv)

the quantity of the therapeutic product supplied;

(v)

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

(c)

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

Subregulation 4

A person who fails to comply with paragraph (2) or (3) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.

Subregulation 5

A person who, in compliance or purported compliance with paragraph (2) or (3), furnishes the Authority or an enforcement officer with any record which the person knows is false or misleading shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.