Therapeutic Goods Regulations 1990

For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.

Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:

a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and

a written undertaking:

to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and

allow an authorised officer to do the things mentioned in regulation 12AC.