Food and Drug Regulations

C.08.003.1 In examining a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, the Minister may, for the purpose of assessing the safety and effectiveness of the new drug for which the submission or supplement was filed, examine

• (a) information or material provided by any person under the Act;

• (b) information or material obtained from sites at which the new drug or any active ingredient, as defined in subsection C.01A.001(1), of the new drug is or is proposed to be fabricated or packaged/labelled within the meaning of those terms in that subsection, or tested; and

• (c) information or material obtained directly or indirectly from a foreign regulatory authority, as defined in subsection C.10.001(1).