GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — Food and Drug Regulations
List A means the document, entitled List of Certain Antimicrobial Active Pharmaceutical Ingredients , that is published by the Government of Canada on its website, as amended from time to time; ( Liste A )
Food and Drug Regulations — Food and Drug Regulations
List B means the document, entitled List of Certain Veterinary Drugs Which May Be Imported But Not Sold , that is published by the Government of Canada on its website, as amended from time to time; ( Liste B )
Food and Drug Regulations — Food and Drug Regulations
List C means the document, entitled List of Veterinary Health Products, that is published by the Government of Canada on its website, as amended from time to time; ( Liste C )
Food and Drug Regulations — Food and Drug Regulations
List D means the document entitled List of Certain Non-prescription Drugs for Distribution as Samples that is published by the Government of Canada on its website, as amended from time to time; ( Liste D )
Food and Drug Regulations — Food and Drug Regulations
non-medicinal ingredient means a substance — other than the pharmacologically active drug — that is added during the manufacturing process and that is present in the finished drug product; ( ingrédient non médicinal )
Food and Drug Regulations — (a)
official drug means any drug (a) for which a standard is provided in these Regulations, or (b) for which no standard is provided in these Regulations but for which a standard is provided in any of the publications mentioned in Schedule B to the Act; ( drogue officielle )
Food and Drug Regulations — Food and Drug Regulations
parenteral use means administration of a drug by means of a hypodermic syringe, needle or other instrument through or into the skin or mucous membrane; ( usage parentéral )
Food and Drug Regulations — Food and Drug Regulations
per cent means per cent by weight unless otherwise stated; ( pour cent )
Food and Drug Regulations — Food and Drug Regulations
pharmaceutical ink means a non-medicinal ingredient or combination of non-medicinal ingredients used to imprint the drug with marks or symbols; ( encre pharmaceutique )
Food and Drug Regulations — (a)
pharmacist means a person who (a) is registered or otherwise entitled under the laws of a province to practise pharmacy, and (b) is practising pharmacy in that province; ( pharmacien )
Food and Drug Regulations — (a)
pharmacy technician means a person who (a) is registered or otherwise entitled under the laws of a province to practise as a pharmacy technician; and (b) is practising as a pharmacy technician in that province; ( technicien en pharmacie )
Food and Drug Regulations — (a)
practitioner means a person who (a) is entitled under the laws of a province to treat patients with a prescription drug, and (b) is practising their profession in that province; ( praticien )
Food and Drug Regulations — Food and Drug Regulations
prescription means an order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order; ( ordonnance )
Food and Drug Regulations — (a)
proper name means, with reference to a drug, the name in English or French (a) assigned to the drug in section C.01.002, (b) that appears in bold-face type for the drug in these Regulations and, where the drug is dispensed in a form other than that described in this Part, the name of the dispensing form, (c) specified in the Canadian licence in the case of drugs included in Schedule C or Schedule D to the Act, or (d) assigned in any of the publications mentioned in Schedule B to the Act in the case of drugs not included in paragraph (a), (b) or (c); ( nom propre )
Food and Drug Regulations — Food and Drug Regulations
salicylate product has the same meaning as in Division 9; ( produit de salicylate )
Food and Drug Regulations — Food and Drug Regulations
serious adverse drug reaction means a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death; ( réaction indésirable grave à une drogue )
Food and Drug Regulations — Food and Drug Regulations
serious unexpected adverse drug reaction means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the drug; ( réaction indésirable grave et imprévue à une drogue )
Food and Drug Regulations — Food and Drug Regulations
teaspoon means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres; ( cuillerée à thé )
Food and Drug Regulations — Food and Drug Regulations
test group means a group that meets the requirements of subsection (3); ( groupe d’essai )
Food and Drug Regulations — (a)
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 )
Food and Drug Regulations — Food and Drug Regulations
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 )
Food and Drug Regulations — C.01.002
inyl) propyl]phenothiazine P.23 Prodilidine 1,2-Dimethyl-3-phenyl-3-pyrrolidinyl propionate P.24 Propranolol 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol P.25 Prothipendyl 9-(3-Dimethylaminopropyl)-10-thia-1,9-diaza-anthracene P.26 Protriptyline 7-(3-Methylaminopropyl)-1,2:5,6-dibenzocycloheptatrien: N-Methyl-5H-dibenzo [ a, d ] cycloheptene-5-propylamine P.27 Pyrazinamide Pyrazinoic acid amide R.1 Rifampin 3-{[(4-methyl-1-piperazinyl)imino]methyl} rifamycin SV : Rifampicin (I.N.N.) (Rifamycin SV is an antibiotic produced by Streptomyces mediterranei ) S.01 Sodium Cromoglycate 4H-1-Benzopyran-2-carboxylic acid, 5,5′-[(2-hydroxy-1,3-propanediyl) bis(oxy)]bis[4-oxo-,disodium salt]: Disodium 5,5′-(2-hydroxytrimethylenedioxy) bis[4-oxo-4H-1-benzopyran-2- carboxylate]: Disodium 4,4′-dioxo-5,5′-(2-hydroxytrimethylenedioxy)di (chromene-2-carboxylate): Cromolyn Sodium (USP): Disodium Cromoglycate S.1 Sulfameter 2-(4-Aminobenzenesulphonamido)-5-methoxypyrimidine: N′-(5-methoxy-2-pyrimidinyl) sulfanilamide: Sulfamethoxydiazine (B.A.N.) S.2 Sulfamethazine N′-(4,6-dimethyl-2- pyrimidyl)sulfanilamide: 2-(p-aminobenzenesulphonamide)-4,6-dimethylpyrimidine: sulphadimedine S.3 Sulfinpyrazone 1,2-diphenyl-4-(2-phenylsulfinilethyl)-3,5-pyrazolidinedione S.4 Sulfisoxazole 3,4-dimethyl-5-sulfanilamidoisoxazole: Sulphafurazole T.1 Tetracaine 2-dimethylaminoethyl-p-n- butylaminobenzoate: Amethocaine T.2 Thiethylperazine 2-Ethylthio-10-[3-(4- methylpiperazin-1-yl) propyl]phenothiazine T.3 Thiopropazate 2-chloro-10-[3-[1-(2-acetoxyethyl)-4-piperazinyl] propyl]phenothiazine T.4 Thioproperazine 2-Dimethylsulphamoyl-10-[3-(4-methylpiperazin-1-yl)- propyl]phenothiazine T.5 Thioridazine 10-{2-[2-(1-methylpiperidyl)] ethyl α}-2-methylthiopheno- thiazine T.6 Tranylcypromine Trans d , 1-2-phenylcyclopropyl- amine T.7 Triamterene 2,4,7-Triamino-6-phenylpteridine T.8 Triflupromazine 10-(3-dimethylaminopropyl)-2-trifluoromethylphenothiazine: Fluopremazine T.9 Trimeprazine 10-(3-dimethylamino-2-methylpropyl) phenothiazine T.10 Trimethadione 3,5,5-trimethyl-2,4-oxazolidine- dione: Troxidone T.11 Trimipramine 5-(3-Dimethylamino-2-methylpropyl)-10,11-dihydro-5H-dibenz[b,f]azepine: 5-(3′-Dimethylamino-2′-methylpropyl)iminodibenzyl T.12 Tybamate 2-Methyl-2-propyltrimethylene butylcarbamate carbamate: 2-(Hydroxymethyl)-2-methyl-pentyl butylcarbamate carbamate V.1 Vinblastine An alkaloid derived from Vinca rosea V.2 Vincristine An alkaloid derived from Vinca rosea SOR/87-565, s. 1; SOR/88-182, s. 1; SOR/88-482, s. 1(F); SOR/90-173, s. 1(F)
Food and Drug Regulations — C.01.003
C.01.003 No person shall sell a drug that is not labelled as required by these Regulations. SOR/80-544, s. 1
Food and Drug Regulations — C.01.004
lling requirements of these Regulations; and (b) the inner label shows (i) the proper name of the drug, the common name of the drug if there is no proper name or, in the case of a drug with more than one medicinal ingredient, the brand name of the drug, (ii) the potency of the drug except where, in the case of a drug with more than one medicinal ingredient, the name used pursuant to subparagraph (i) for that drug is unique for a particular potency of the drug, (iii) the net contents of the drug if it is not in a discrete dosage form, (iv) the route of administration of the drug if other than oral, (v) the lot number of the drug, (vi) the name of the manufacturer of the drug, (vii) the expiration date of the drug, and (viii) the identification of special characteristics of the dosage form if they are not evident from the name of the drug under subparagraphs (i) or (ii). (4) [Repealed, SOR/92-654, s. 2] (5) Subsections (1) to (3) do not apply to a drug that is (a) sold to a drug manufacturer; (b) sold by a pharmacist under a prescription or by a practitioner, if its label shows suitable directions for use and meets the requirements set out in section C.01.005; or (c) listed in Schedule D to the Act. SOR/80-543, s. 2; SOR/81-334, s. 1(E); SOR/85-715, s. 2; SOR/89-229, s. 1; SOR/90-216, s. 1; SOR/90-586, s. 1; SOR/92-654, s. 2; SOR/93-202, s. 2; SOR/97-228, s. 1; SOR/97-515, s. 1; SOR/2000-219, s. 1; SOR/2001-181, s. 4; SOR/2010-105, s. 2; SOR/2011-88, s. 1; SOR/2013-122, ss. 4, 5; SOR/2014-158, s. 3 SOR/2019-170, s. 18 SOR/2023-247, s. 2 SOR/2024-238, s. 3
Food and Drug Regulations — Food and Drug Regulations
“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS.
Food and Drug Regulations — Food and Drug Regulations
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. ”.
Food and Drug Regulations — C.01.004.01
C.01.004.01 (1) Every label of a drug for human use in dosage form shall display the following: (a) a telephone number, email address, website address, postal address or any other information that enables communication with a contact person in Canada; and (b) a statement to the effect that any injury to a person’s health that is suspected of being associated with the use of the drug may be reported to the contact person. (2) Subsection (1) does not apply to (a) the labels of a drug that is listed in Schedule C or D to the Act and that is in dosage form; or (b) the inner and outer labels of a drug to which section C.01.004.02 applies. SOR/2014-158, s. 4
Food and Drug Regulations — C.01.004.03
C.01.004.03 In addition to the requirements of section C.01.004, the inner label of a drug to which section C.01.004.02 applies shall display on any panel (a) adequate directions for use of the drug; (b) a quantitative list of the drug’s medicinal ingredients by their proper names or, if they have no proper names, by their common names; and (c) the information referred to in subsection C.01.004.01(1). SOR/2014-158, s. 5
Food and Drug Regulations — C.01.004.1
C.01.004.1 (1) No person shall import a drug in dosage form into Canada for the purpose of sale unless they have in Canada a person who is responsible for the sale of the drug. (2) No person who imports a drug in dosage form into Canada shall sell any lot or batch of the drug unless the name of the person who imports it, and the address of the principal place of business in Canada of the person responsible for its sale, appears on the inner and outer labels of the drug. SOR/82-524, s. 1; SOR/93-475, s. 1; SOR/97-12, s. 2
Food and Drug Regulations — C.01.005
C.01.005 (1) The principal display panel of both the inner label and outer label of a drug in dosage form shall show the drug identification number assigned for that drug, preceded by the expression “Drug Identification Number” or “ Drogue : identification numérique ”, or both, or the abbreviation “DIN”. (2) Subsection (1) does not apply to (a) a drug in dosage form that is compounded by a pharmacist under a prescription or by a practitioner; or (b) a drug in dosage form that is sold under a prescription if the following information appears on the drug’s label: (i) the drug’s proper name, common name or brand name, (ii) the drug’s potency, and (iii) the name of the drug’s manufacturer. (3) In this section and in sections C.01.005.1 and C.01.014, drug in dosage form means a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing. (4) and (5) [Repealed, SOR/81-248, s. 1] SOR/81-248, s. 1; SOR/93-202, s. 3; SOR/98-423, s. 2; SOR/2001-181, s. 4; SOR/2017-259, s. 2; SOR/2018-69, s. 27; SOR/2018-77, s. 1
Food and Drug Regulations — C.01.005.1
C.01.005.1 (1) No pharmacist or practitioner shall sell a Class A opioid — including one that is compounded by a pharmacist under a prescription or by a practitioner — unless (a) the drug’s package has applied to it a warning sticker that meets the specifications set out in the source document; and (b) the drug is accompanied by a patient information handout that meets the specifications set out in the source document. (2) Subsection (1) does not apply in respect of the sale of a Class A opioid by a pharmacist or practitioner if (a) the opioid will be, or is, administered under the supervision of a practitioner; or (b) the sale is to a pharmacist or practitioner. (3) The following definitions apply in this section. Class A opioid means a drug in dosage form set out in Part A of the List of Opioids , published by the Government of Canada on its website, as amended from time to time. ( opioïde de catégorie A ) source document means the document entitled Information for Patients Concerning Opioids , published by the Government of Canada on its website, as amended from time to time. ( document source ) SOR/2018-77, s. 2
Food and Drug Regulations — Food and Drug Regulations
Class A opioid means a drug in dosage form set out in Part A of the List of Opioids , published by the Government of Canada on its website, as amended from time to time. ( opioïde de catégorie A )
Food and Drug Regulations — Food and Drug Regulations
source document means the document entitled Information for Patients Concerning Opioids , published by the Government of Canada on its website, as amended from time to time. ( document source )
Food and Drug Regulations — C.01.006
C.01.006 Where a package of a drug has only one label, that label shall contain all the information required by these Regulations to be shown on both the inner and the outer labels.
Food and Drug Regulations — C.01.007
C.01.007 No reference, direct or indirect, to the Act or to these Regulations shall be made upon any label of or in any advertisement for a drug unless such reference is a specific requirement of the Act or these Regulations.
Food and Drug Regulations — C.01.009
C.01.009 If any Act of Parliament or any of its regulations prescribes a standard or grade for a drug and that standard or grade is given a name or designation in the Act or regulation, no person shall, on a label of or in any advertisement for that drug, use that name or designation unless the drug conforms with the standard or grade. SOR/2017-18, s. 13
Food and Drug Regulations — C.01.010
C.01.010 If it is necessary to provide adequate directions for the safe use of a parenteral drug or prescription drug that is used in the treatment or prevention of any disease, disorder or abnormal physical state mentioned in Schedule A.1 to the Act, the disease, disorder or abnormal physical state may be mentioned on the drug’s labels, including any package insert and any document that is provided on request and that sets out supplementary information on the use of the drug, and, in that respect, the drug is exempt from subsections 3(1) and (2) of the Act. SOR/2013-122, s. 6; SOR/2014-158, s. 6; SOR/2017-18, s. 21(F); SOR/2018-69, s. 14(F) SOR/2021-46, s. 10
Food and Drug Regulations — C.01.011
C.01.011 (1) A drug referred to in subsection 10(2) of the Act shall be exempt from the standard for any drug contained in any publication mentioned in Schedule B to the Act to the extent that such drug differs from that standard with respect to colour, flavour, shape and size, if such difference does not interfere with any method of assay prescribed in any such publication. (2) [Repealed, SOR/93-243, s. 2] (3) Where a manufacturer’s standard is used for a drug, the manufacturer shall make available to the Minister, on request, details of that standard and of a method of analysis for the drug acceptable to the Minister. (4) No person shall use a manufacturer’s standard for a drug that provides (a) a lesser degree of purity than the highest degree of purity, or (b) a greater variation in potency than the least variation in potency, provided for that drug in any publication mentioned in Schedule B to the Act. (5) Subsection (4) does not apply in respect of new drugs, other than those listed in Schedule C to the Act. SOR/93-243, s. 2; SOR/2018-69, ss. 31(E), 32(F) SOR/2024-238, s. 4
Food and Drug Regulations — C.01.012
C.01.012 A manufacturer who makes representations on a label of a drug in oral dosage form, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of the drug, or the availability to the body of a medicinal ingredient of the drug, shall (a) before making the representations, conduct such investigations, using an acceptable method, as may be necessary to demonstrate that the site, rate or extent of release to the body of the medicinal ingredient of the drug and the availability to the body of the medicinal ingredient of the drug, correspond to the representations; and (b) on request submit the record of such investigations to the Minister. SOR/89-455, s. 2; SOR/94-36, s. 1; SOR/2018-69, s. 27
Food and Drug Regulations — C.01.013
C.01.013 (1) Where the manufacturer of a drug is requested in writing by the Minister to submit on or before a specified day evidence with respect to a drug, the manufacturer shall make no further sales of that drug after that day unless he has submitted the evidence requested. (2) If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing. (3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to a drug is not sufficient, he shall make no further sales of that drug unless he submits further evidence and is notified in writing by the Minister that that further evidence is sufficient. (4) A reference in this section to evidence with respect to a drug means evidence to establish the safety of the drug under the conditions of use recommended and the effectiveness of the drug for the purposes recommended. SOR/2018-69, ss. 15, 27
Food and Drug Regulations — C.01.013.1
C.01.013.1 Section C.01.013 does not apply in respect of a veterinary health product. SOR/2017-76, s. 2
Food and Drug Regulations — C.01.014
C.01.014 (1) No manufacturer shall sell a drug in dosage form unless a drug identification number has been assigned for that drug and the assignment of the number has not been cancelled under section C.01.014.6. (2) Subsection (1) does not apply in respect of a veterinary health product, a study drug as defined in section C.03.301 or a medicated feed as defined in subsection 1(1) of the Feeds Regulations, 2024 . SOR/81-248, s. 2; SOR/97-12, s. 3; SOR/2013-179, s. 1; SOR/2017-259, s. 3; SOR/2018-77, s. 3 SOR/2024-132, s. 85