Health Products (Therapeutic Products) Regulations 2016 · As enacted · Part 6 · Duties and Obligations of Manufacturers, Importers, Etc., of Therapeutic Products
45. Duty to carry out risk management plan
Feedback & supportThe Authority may, for the purposes of minimising risks relating to unsafe and inefficacious use of therapeutic products, direct a registrant of a therapeutic product to implement a risk management plan which includes, but is not limited to, the following:
producing and distributing educational material;
producing and distributing safety information;
performing clinical studies of the therapeutic product;
implementing active surveillance programmes of the therapeutic product;
implementing programmes to restrict the supply of the therapeutic product.
A registrant of a registered therapeutic product who fails to comply with a direction of the Authority under paragraph (1) 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 1
The Authority may, for the purposes of minimising risks relating to unsafe and inefficacious use of therapeutic products, direct a registrant of a therapeutic product to implement a risk management plan which includes, but is not limited to, the following:
producing and distributing educational material;
producing and distributing safety information;
performing clinical studies of the therapeutic product;
implementing active surveillance programmes of the therapeutic product;
implementing programmes to restrict the supply of the therapeutic product.
Subregulation 2
A registrant of a registered therapeutic product who fails to comply with a direction of the Authority under paragraph (1) 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.