C.04.017. A fabricator shall keep necropsy records of all animals that die or are killed after having been used in the production of a drug.
- SOR/97-12, s. 61.
C.04.018. A fabricator shall immediately segregate, and report the fact to the Minister, any animal with actual or suspected vesicular stomatitis, foot and mouth disease, encephalomyelitis, infectious anaemia, glanders, anthrax, tetanus or any other serious infectious disease.
- SOR/97-12, s. 61.
C.04.019. The provisions of section C.01.004 do not apply to a drug as defined in this Division but every package of such drug shall carry
(a) on both the inner and the outer labels
(i) the proper name of the drug, which proper name, where there is a brand name, shall immediately precede or follow the brand name in type not less than one-half the size of that of the brand name,
(ii) the name of the distributor referred to in paragraph C.01A.003(b),
(iii) the potency of the drug, where applicable,
(iv) the recommended dose of the drug,
(v) the lot number,
(vi) the expiration date except upon the inner label of a single-dose container, and
(vii) adequate direction for use; and
(b) on the outer label
(i) the address of the distributor referred to in paragraph C.01A.003(b),
(ii) for whole blood and its components, the establishment licence number of the distributor referred to in paragraph C.01A.003(b), preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof,
(iii) the proper name, or the common name if there is no proper name, and the amount, of any preservative in the drug,
(iv) a statement that the drug shall be stored at a temperature of not less than 2°C and not more than 10°C, unless the Minister has received evidence demonstrating that such a statement is not required,
(v) a statement of the net contents in terms of weight, measure, or number, and
(vi) in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner:
“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS.
SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN.”.
- SOR/78-424, s. 7;
- SOR/93-202, s. 21;
- SOR/97-12, ss. 39, 54, 58;
- SOR/2011-88, s. 6.
C.04.020. Except in the case of the following drugs, every package of a drug listed in Schedule F of these Regulations shall carry the symbol Pr on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label:
(a) a drug sold to a person who holds an establishment licence; and
(b) a drug dispensed pursuant to a prescription.
- SOR/80-543, s. 10;
- SOR/97-12, s. 40;
- SOR/2001-181, s. 4.
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