Food and Drug Regulations — C.01.001
k information set out on the label of the drug; ( réaction indésirable grave et imprévue à une drogue ) teaspoon means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres; ( cuillerée à thé ) test group means a group that meets the requirements of subsection (3); ( groupe d’essai ) veterinary health product means any of the following drugs that is in dosage form and that is not manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms: (a) a substance set out in Column I of Part 1 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of any substances in which all the medicinal ingredients are substances set out in Column I of Part 1 of that list if that combination is, in respect of each of those substances, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those substances; (b) a homeopathic medicine set out in Column I of Part 2 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of homeopathic medicines set out in Column I of Part 2 of that list if that combination is, in respect of each of those homeopathic medicines, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those homeopathic medicines; and (c) a traditional medicine set out in Column I of Part 3 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of traditional medicines set out in Column I of Part 3 of that list if that combination is, in respect of each of those traditional medicines, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those traditional medicines; ( produit de santé animale ) withdrawal period means the length of time between the last administration of a drug to an animal and the time when tissues or products collected from the treated animal for consumption as food contain a level of residue of the drug that would not likely cause risk to human health. ( délai d’attente ) (1.1) For the purposes of the Act, serious adverse drug reaction has the same meaning as in subsection (1). (2) A child resistant package is a package that (a) when tested in accordance with an acceptable method, (i) in the case of a test group comprising children, cannot be opened (A) by at least 85 per cent of those children prior to a demonstration to them of the proper means of opening the package, and (B) by at least 80 per cent of those children after the demonstration, and (ii) in the case of a test group comprising adults (A) can be opened by at least 90 per cent of those adults, and (B) where the package is designed so that, once opened and reclosed, it continues to meet the requirements of subparagraph (i), can be so reclosed by at least 90 per cent of those adults; or (b) complies with the requirements of one of the following standards, namely, (i) Canadian Standards Association Standard CAN/CSA-Z76.1-M90, entitled Recloseable Child-Resistant Packages , published January 1990, as amended from time to time, (ii) European Standard EN 28317:1992, entitled Child-resistant packaging — Requirements and testing procedures for reclosable packages , as adopted by the European Committee for Standardization on October 30, 1992, recognized by the British Standards Institution, and effective February 15, 1993 and by the Association française de normalisation, and effective December 20, 1992, and which reiterates fully the international standard ISO 8317:1989, as amended from time to time, and (ii