Singapore legislation

Regulation 33

of Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021

Regulation 33

Duty to maintain records of receipt and supply

Amended byS 437/2023 wef 26/06/2023S 801/2023 wef 18/12/2023

Subregulation 1

Amended byS 437/2023 wef 26/06/2023S 801/2023 wef 18/12/2023

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

(a)

a manufacturer, an importer, a wholesaler or a registrant of a CTGT product; or

(b)

the supplier of a CTGT product in accordance with regulation 12 or 15(1)(a), (b), (c), (ea) or (ec).

Subregulation 2

P must —

(a)

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

(b)

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

(i)

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

(ii)

the date on which the CTGT product is received;

(iii)

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

(iv)

the quantity of the CTGT product received;

(v)

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

(b)

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

(i)

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

(ii)

the date on which the CTGT product is supplied;

(iii)

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

(iv)

the quantity of the CTGT product supplied;

(v)

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

(c)

is retained for at least 30 years after the expiry date of the CTGT product or any other shorter period that the Authority allows in a particular case.

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), provides the Authority or an enforcement officer with any record which the person knows is false or misleading in a material particular 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.