35. Duty to notify Authority concerning recall

For the purposes of section 44(1) of the Act, every manufacturer, importer, supplier or registrant of a therapeutic product who intends to recall a therapeutic product must immediately, but in any case no later than 24 hours before the start of the intended recall, notify the Authority of, and the reasons for, the intended recall.

The notice in paragraph (1) must be made in such form and manner as the Authority may require.

Where the Authority has been notified of the intended recall of a therapeutic product under paragraph (1), the Authority may by written notice require the manufacturer, importer, supplier or registrant of the therapeutic product to do either or both of the following:

investigate the matter occasioning the recall of the therapeutic product and provide a report of the findings of the investigation;

take such other measures as the Authority thinks necessary.

A person to whom a notice in paragraph (3) is given must comply with the notice at the person’s own cost and within the time specified in the notice or, if no time is specified in the notice, within a reasonable time after the date of the notice.

A person who fails to comply with paragraph (4) 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.

For the purposes of section 44(1) of the Act, every manufacturer, importer, supplier or registrant of a therapeutic product who intends to recall a therapeutic product must immediately, but in any case no later than 24 hours before the start of the intended recall, notify the Authority of, and the reasons for, the intended recall.

The notice in paragraph (1) must be made in such form and manner as the Authority may require.

Where the Authority has been notified of the intended recall of a therapeutic product under paragraph (1), the Authority may by written notice require the manufacturer, importer, supplier or registrant of the therapeutic product to do either or both of the following:

investigate the matter occasioning the recall of the therapeutic product and provide a report of the findings of the investigation;

take such other measures as the Authority thinks necessary.

A person to whom a notice in paragraph (3) is given must comply with the notice at the person’s own cost and within the time specified in the notice or, if no time is specified in the notice, within a reasonable time after the date of the notice.

A person who fails to comply with paragraph (4) 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.