Health Products (Therapeutic Products) Regulations 2016 · As enacted · Part 6 · Duties and Obligations of Manufacturers, Importers, Etc., of Therapeutic Products
44. Submission of benefit-risk evaluation reports
Feedback & supportThe Authority may require any registrant of a therapeutic product to submit, within the timelines specified by the Authority, a benefit-risk evaluation report relating to the therapeutic product.
Where the Authority has not specified any timelines within which a benefit-risk evaluation report is required to be submitted, a registrant of a therapeutic product who is required by the Authority to submit such a report must submit the report —
for an initial period of 2 years, at intervals of 6 months commencing from either the date of registration of the therapeutic product, or its international birth date; and
annually, for the next 3 years.
A person who fails to provide a benefit-risk evaluation report —
as required by the Authority under paragraph (1); or
within the timelines stipulated under paragraph (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.
In paragraph (2)(a), “international birth date”, for a therapeutic product, means the date of the first marketing approval granted to any person for the sale of the therapeutic product in any country in the world.
Subregulation 1
The Authority may require any registrant of a therapeutic product to submit, within the timelines specified by the Authority, a benefit-risk evaluation report relating to the therapeutic product.
Subregulation 2
Where the Authority has not specified any timelines within which a benefit-risk evaluation report is required to be submitted, a registrant of a therapeutic product who is required by the Authority to submit such a report must submit the report —
for an initial period of 2 years, at intervals of 6 months commencing from either the date of registration of the therapeutic product, or its international birth date; and
annually, for the next 3 years.
Subregulation 3
A person who fails to provide a benefit-risk evaluation report —
as required by the Authority under paragraph (1); or
within the timelines stipulated under paragraph (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.
Subregulation 4
In paragraph (2)(a), “international birth date”, for a therapeutic product, means the date of the first marketing approval granted to any person for the sale of the therapeutic product in any country in the world.