Singapore legislation
Regulation 60A
Regulation 60A
Manufacture, import and supply of emergency therapeutic product
Subregulation 1
For the purposes of section 12(1) of the Act and without prejudice to regulations 30, 31, 33, 34 and 35, the manufacture of an emergency therapeutic product for or on behalf of the Government is a prescribed exception to the prohibition in that provision against the manufacture of a therapeutic product without a licence.
Subregulation 2
For the purposes of section 13(1) of the Act and without prejudice to regulations 30, 33, 34 and 35, the import of an emergency therapeutic product for or on behalf of the Government is a prescribed exception to the prohibition in that provision against the import of a therapeutic product without a licence.
Subregulation 3
For the purposes of section 14(1) of the Act and without prejudice to regulations 30, 32, 34 and 35, the supply by wholesale of an emergency therapeutic product for or on behalf of the Government is a prescribed exception to the prohibition in that provision against the supply by wholesale of a therapeutic product without a licence.
Subregulation 4
For the purposes of section 15(1) of the Act and without prejudice to regulations 30, 32, 34 and 35, the supply of an emergency therapeutic product for or on behalf of the Government is a prescribed exception to the prohibition in that provision against the supply of a therapeutic product that is not registered.
Subregulation 5
In this regulation —
Definition
“civil defence emergency” means a civil defence emergency declared under section 102(1) of the Civil Defence Act 1986;
Definition
“emergency therapeutic product” means a therapeutic product that is for such time designated by the Minister as an emergency therapeutic product for the purposes of this regulation, where —
the therapeutic product is needed —
to treat any medical condition resulting from a civil defence emergency; (ii)to prevent the spread or possible outbreak of an infectious disease; or (iii)to treat an infectious disease or any medical condition associated with an infectious disease,where the medical condition or infectious disease is potentially serious or life-threatening; and
in the opinion of the Authority, there is —
preliminary scientific evidence that the therapeutic product has the potential —
to treat the medical condition resulting from the civil defence emergency;
to prevent the spread or possible outbreak of the infectious disease; or (C)to treat the infectious disease or any medical condition associated with the infectious disease,as the case may be; and
ongoing scientific evidence that the potential benefits of the therapeutic product outweigh the known risks of the therapeutic product, to a person on whom the therapeutic product is used;
Definition
“infectious disease” has the meaning given by section 2 of the Infectious Diseases Act 1976.