Regulation 17

maintain a record of every event or other occurrence that reveals any defect in the oral dental gum or that concerns any adverse effect arising from the use of the oral dental gum; and

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

contains all of the following information:

the name or description of the oral dental gum which is defective or of which an adverse effect has arisen from its use;

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

the identification number or mark (including the control number, lot number, batch number or serial number) of the oral dental gum; (iv)the nature of the defect or adverse effect; (v)any other information that the Authority may specify in writing; and

is retained for at least 2 years after the expiry date of the oral dental gum.