Regulation 33

maintain a record of every event or other occurrence that reveals any defect in the therapeutic product or that concerns any adverse effect arising from the use of the therapeutic product; 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 proprietary name or appropriate non‑proprietary name of the therapeutic product 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 therapeutic product;

the nature of the defect or adverse effect;

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

is retained for at least 2 years after the expiry date of the therapeutic product.