Food and Drug Regulations

C.05.009. If the information and documents submitted in respect of an application under section C.05.005 or an application for amendment under section C.05.008 are insufficient to enable the Minister to determine whether any of the reasons referred to in paragraph C.05.006(1)(b) or C.05.008(1)(b) exist, the Minister may require the sponsor to submit, within two days after receipt of the request, samples of the drug or additional information relevant to the drug or the clinical trial that are necessary to make the determination.