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Duty to maintain records of defects and adverse effects

Health Products (Therapeutic Products) Regulations 2016

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—(1) Every manufacturer, importer or registrant of a therapeutic product must —(a)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(b)produce such record for inspection by the Authority or an enforcement officer as and when required by the Authority or enforcement officer.(2) A person mentioned in paragraph (1) must ensure that every record mentioned in that paragraph —(a)contains all of the following information:(i)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;(ii)the date on which the person first became aware of the event or occurrence;(iii)the identification number or mark (including the control number, lot number, batch number or serial number) of the therapeutic product;(iv)the nature of the defect or adverse effect;(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 therapeutic product.(3) A person who fails to comply with paragraph (1) or (2) 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.(4) A person who, in compliance or purported compliance with paragraph (1) or (2), 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.

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