Singapore legislation

Regulation 24

of Health Products (Active Ingredients) Regulations 2023

Regulation 24

Duty to maintain records of defects

Subregulation 1

This regulation applies only in relation to the manufacture or import of an active ingredient that is intended for use in the manufacture of a relevant health product intended to be used on or by humans.

Subregulation 2

Every manufacturer or importer of an active ingredient must —

(a)

maintain a record of every event or other occurrence that reveals any defect in the active ingredient; and

(b)

produce such record for inspection by the Authority or an enforcement officer as and when required by the Authority or enforcement officer.

Subregulation 3

A person mentioned in paragraph (2) must ensure that every record mentioned in that paragraph —

(a)

contains all of the following information:

(i)

the appropriate non‑proprietary name and, where applicable, the proprietary name, of the active ingredient which is defective;

(ii)

the date on which the person first became aware of the event or occurrence;

(iii)

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

(iv)

the nature of the defect;

(v)

any other information that the Authority may specify in writing; and

(b)

is retained for at least 2 years after the expiry date of the active ingredient.

Subregulation 4

For the purposes of this regulation, an active ingredient has a defect if —

(a)

it has or has possibly been adulterated or tampered with;

(b)

it is or is possibly a counterfeit or an unwholesome active ingredient; or

(c)

it is or is possibly of inadequate quality or unsafe for its intended purpose.

Read in full context — Health Products (Active Ingredients) Regulations 2023 →