31. Duty to maintain records of manufacture

A manufacturer of a therapeutic product, other than a healthcare service licensee, must maintain records of —

such information relating to the therapeutic product and its manufacture or assembly as the Authority may specify on the Authority’s website or, if the manufacturer is the holder of a manufacturer’s licence, in the manufacturer’s licence; and

the manufacture of each batch of the therapeutic product and of the tests carried out on each of such batch, in the manner specified on the Authority’s website or in the relevant licence issued by the Authority (if applicable).

The manufacturer must maintain for any therapeutic product the records mentioned in paragraph (1) for the longer of the following periods:

one year after the expiry date of the therapeutic product;

5 years after the date of manufacture of the therapeutic product.

A manufacturer of a therapeutic product 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.

A person who, in compliance or purported compliance with paragraph (1), 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.

A manufacturer of a therapeutic product, other than a healthcare service licensee, must maintain records of —

such information relating to the therapeutic product and its manufacture or assembly as the Authority may specify on the Authority’s website or, if the manufacturer is the holder of a manufacturer’s licence, in the manufacturer’s licence; and

the manufacture of each batch of the therapeutic product and of the tests carried out on each of such batch, in the manner specified on the Authority’s website or in the relevant licence issued by the Authority (if applicable).

The manufacturer must maintain for any therapeutic product the records mentioned in paragraph (1) for the longer of the following periods:

one year after the expiry date of the therapeutic product;

5 years after the date of manufacture of the therapeutic product.

A manufacturer of a therapeutic product 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.

A person who, in compliance or purported compliance with paragraph (1), 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.