GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.08.011.1
C.08.011.1 (1) The Minister may issue a letter of authorization to the manufacturer of a new drug authorizing the holder of an establishment licence to import a specified quantity of the new drug for human or veterinary use, if the following conditions are met: (a) the manufacturer provides the following information to the Minister: (i) the name of the new drug and details concerning the medical emergency for which the new drug will be imported, (ii) the quantity of the new drug to be imported, (iii) the name of the holder of an establishment licence who will import the new drug, (iv) the civic address of the facility where the new drug is to be stored in Canada, and (v) any other information the Minister may request to enable the Minister to determine whether to issue the letter of authorization; (b) the establishment licence authorizes the importation of a new drug in the same category as the one to be imported; and (c) the quantity that is to be imported does not exceed the amount that the Minister determines is likely to be required to address the medical emergency. (2) [Repealed, SOR/2021-271, s. 5] (3) The letter of authorization must contain the following information: (a) the name of the new drug and the medical emergency in respect of which the letter is issued; (b) the quantity of the new drug that may be imported to address the medical emergency; (c) the name of the holder of an establishment licence who is authorized to import the new drug; and (d) the civic address of the facility where the new drug is to be stored in Canada. SOR/2020-212, s. 2 SOR/2021-271, s. 5 SOR/2023-247, s. 4(E)
Food and Drug Regulations — C.08.011.2
C.08.011.2 (1) Despite subsection C.01A.004(1), the holder of an establishment licence may import a new drug in accordance with a letter issued under subsection C.08.011.1(1). (2) Section C.01A.006 and Divisions 2 to 4, except for the following provisions, do not apply to the importation of a new drug referred to in the letter of authorization: (a) sections C.02.003.1 and C.02.004, as they apply to the storage of the new drug by the holder of an establishment licence; (b) section C.02.006, as it applies to the storage of the new drug by the holder of an establishment licence; (c) subsection C.02.012(1); (c.1) section C.02.012.1, as it applies to the storage of the new drug by the holder of an establishment licence; (d) sections C.02.013 and C.02.014; (e) section C.02.015, as it applies to the storage and transportation of the new drug by the holder of an establishment licence; (f) subsection C.02.021(1), as it applies to the storage of the new drug by the holder of an establishment licence; (g) subsection C.02.022(1); (h) section C.02.023; (i) subsection C.02.024(1); and (j) section C.03.013. (k) [Repealed, SOR/2024-238, s. 38] SOR/2020-212, s. 2 SOR/2024-238, s. 38
Food and Drug Regulations — C.08.011.3
C.08.011.3 (1) Despite section C.08.002, the holder of an establishment licence who imports a new drug under section C.08.011.2 may distribute a new drug in accordance with a letter of authorization issued under subsection C.08.010(1). (2) The holder of an establishment licence who distributes to a practitioner, in accordance with subsection (1), a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A must submit to the Minister an annual report identifying the total quantity of the new drug that was distributed, including an estimate of the quantity distributed in respect of each animal species for which the drug is intended. (3) The distribution of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations other than this section. (4) The annual report described in subsection (2) is for a period of one calendar year and must be submitted on or before March 31 of the year following the calendar year covered by the report, beginning with the first full calendar year during which the drug is first distributed. SOR/2020-212, s. 2 SOR/2023-247, s. 5
Food and Drug Regulations — C.08.012
C.08.012 (1) Notwithstanding anything in this Division, a person may sell, pursuant to a written prescription of a veterinary practitioner, a medicated feed if (a) as regards the drug or drugs used as the medicating ingredient of the medicated feed, (i) the Minister has assigned a drug identification number pursuant to section C.01.014.2, or (ii) the sale is permitted by section C.08.005, C.08.011 or C.08.013; (b) the medicated feed is for the treatment of animals under the direct care of the veterinary practitioner who signed the prescription; (c) the medicated feed is for therapeutic purposes only; and (d) the written prescription contains the following information: (i) the name and address of the person named on the prescription as the person for whom the medicated feed is to be mixed, (ii) the species, production type and age or weight of the animals to be treated with the medicated feed, (iii) the type and amount of medicated feed to be mixed, (iv) the proper name, or the common name if there is no proper name, of the drug or each of the drugs, as the case may be, to be used as medicating ingredients in the preparation of the medicated feed, and the dosage levels of those medicating ingredients, (v) any special mixing instructions, and (vi) labelling instructions including (A) feeding instructions, (B) a warning statement respecting the withdrawal period to be observed following the use of the medicated feed, and (C) where applicable, cautions with respect to animal health or to the handling or storage of the medicated feed. (2) For the purposes of this section, medicated feed has the same meaning as in the Feeds Regulations, 2024 . SOR/80-741, s. 1; SOR/92-130, s. 1; SOR/93-202, s. 27; SOR/2018-69, s. 27 SOR/2024-132, s. 88
Food and Drug Regulations — C.08.013
C.08.013 (1) Notwithstanding anything in this Division, a person may sell a new drug proposed for use in animals to an experimental studies investigator in a quantity specified by the Minister for the purpose of conducting an experimental study in animals if (a) the experimental studies investigator has been issued an experimental studies certificate pursuant to subsection C.08.015(1) and the certificate has not been suspended or cancelled pursuant to section C.08.018; and (b) the drug is labelled in accordance with subsection C.08.016(1). (2) For the purposes of this section and sections C.08.014 to C.08.018, experimental studies certificate means a certificate issued pursuant to subsection C.08.015(1); ( certificat d’études expérimentales ) experimental studies investigator means a person named as the investigator in an experimental studies certificate; ( expert en études expérimentales ) experimental study means a limited test of a new drug in animals carried out by an experimental studies investigator. ( étude expérimentale ) SOR/81-333, s. 1; SOR/2018-69, s. 27
Food and Drug Regulations — Food and Drug Regulations
experimental studies certificate means a certificate issued pursuant to subsection C.08.015(1); ( certificat d’études expérimentales )
Food and Drug Regulations — Food and Drug Regulations
experimental studies investigator means a person named as the investigator in an experimental studies certificate; ( expert en études expérimentales )
Food and Drug Regulations — Food and Drug Regulations
experimental study means a limited test of a new drug in animals carried out by an experimental studies investigator. ( étude expérimentale )
Food and Drug Regulations — C.08.014
C.08.014 (1) For the purpose of obtaining an experimental studies certificate, an applicant shall submit to the Minister, in writing, the following information and material: (a) the brand name of the new drug or the identifying name or code proposed for the new drug; (b) the objectives and an outline of the proposed experimental study of the new drug; (c) the species, number and production type of animals in respect of which the new drug is to be administered; (d) the name and address of the manufacturer of the new drug; (e) the address of the premises in which the experimental study is to be conducted; (f) a description of the facilities to be used to conduct the experimental study; (g) the name, address and qualifications of the proposed experimental studies investigator; (h) the chemical structure, if known, and the relevant compositional characteristics of the new drug; (i) the proposed quantity of the new drug to be used for the experimental study; (j) the results of any toxicological or pharmacological studies that may have been conducted with the new drug; (k) the written agreement referred to in subsection (2); and (l) such other information and material as the Minister may require. (2) Where a food-producing animal is involved in an experimental study, the applicant referred to in subsection (1) shall, for the purposes of obtaining an experimental studies certificate, obtain from the owner of the animals, or from a person authorized by the owner, a written agreement not to sell the animal or any products from it without prior authorization from the experimental studies investigator. (3) The Minister may request the manufacturer of a new drug to submit to him samples of the new drug or of any ingredient of the drug and, in satisfactory form and manner, any other information that the Minister requests and where such samples or information are not submitted, the Minister may refuse to issue an experimental studies certificate. SOR/81-333, s. 1; SOR/93-202, s. 28; SOR/2018-69, s. 27
Food and Drug Regulations — C.08.015
C.08.015 (1) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Minister has determined that (a) the applicant is qualified as an experimental studies investigator for the purposes of the proposed experimental study, (b) the facilities for the conduct of the experimental study are adequate for the purposes of the proposed experimental study, and (c) the proposed experimental study can be conducted without undue foreseeable risk to humans or animals, the Minister shall issue an experimental studies certificate for the purposes of the proposed experimental study and shall specify therein the quantity of the new drug that may be sold to the experimental studies investigator. (2) If, on receipt of the information and material submitted under section C.08.014, the Minister determines that the requirements of paragraphs (1)(a), (b) and (c) have not been met, the Minister shall refuse to issue an experimental studies certificate. SOR/81-333, s. 1; SOR/2018-69, ss. 25, 27 SOR/2022-197, s. 9 SOR/2023-247, s. 6
Food and Drug Regulations — C.08.016
C.08.016 (1) The label of a new drug that is sold pursuant to section C.08.013 shall show (a) the brand name of the new drug or the identifying name or code proposed for the new drug; (b) a warning statement to the effect that the drug is for use only in an experimental study in animals; (c) the lot number of the drug; (d) the name and address of the manufacturer of the drug; and (e) the name of the person to whom the drug has been supplied. (2) Sections C.01.004, C.01.005 and C.01.014 do not apply to a drug that is sold pursuant to section C.08.013 and labelled in accordance with subsection (1). SOR/81-333, s. 1; SOR/88-378, s. 2; SOR/93-202, s. 29
Food and Drug Regulations — C.08.017
C.08.017 An experimental studies investigator shall (a) use the new drug only in accordance with the outline of the experimental study; (b) report immediately to the Minister all serious adverse drug reactions associated with the use of the new drug; (c) report promptly to the Minister, on request, the results of the experimental study; (d) return to the manufacturer, on request, all quantities of the new drug not used in the experimental study; (e) maintain all records of the experimental study for a period of at least two years after the conclusion of the study and, on request, make such records available to the Minister; (f) report promptly to the Minister any known disposition of animals involved in the study or of any products from the animals that is contrary to the terms of the agreement referred to in subsection C.08.014(2); and (g) account to the Minister, on request, for all quantities of the new drug received by him. SOR/81-333, s. 1; SOR/2001-203, s. 10; SOR/2018-69, s. 27
Food and Drug Regulations — C.08.018
C.08.018 (1) If the Minister determines that it is necessary in order to safeguard animal health or public health or to promote public safety, he or she may suspend for a definite or indefinite period or cancel an experimental studies certificate. (2) Without limiting the generality of subsection (1), the Minister may suspend or cancel an experimental studies certificate if (a) the information and material submitted pursuant to section C.08.014 contains an untrue statement or contains any omission concerning the properties of the drug that were known or ought reasonably to have been known to the manufacturer or the experimental studies investigator; (b) the labelling of the new drug is, at any time, false, misleading, deceptive or incomplete; (c) the qualifications of the experimental studies investigator prove to be inadequate; (d) there is evidence that the experimental studies investigator has not complied with the conditions referred to in section C.08.017; or (e) an action of the manufacturer in respect of the new drug has resulted in his conviction for a violation of section C.08.002. SOR/81-333, s. 1; SOR/2018-69, ss. 26, 27
Food and Drug Regulations — C.09.001
C.09.001 This Division does not apply to (a) a drug that is required by these Regulations or the Narcotic Control Regulations to be sold only on prescription; or (b) a drug for use exclusively in animals. SOR/84-145, s. 4
Food and Drug Regulations — C.09.010
C.09.010 No manufacturer or importer shall, after June 30, 1986, sell a drug for analgesia that contains a combination of (a) a salt or derivative of salicylic acid with another salt or derivative of salicylic acid or with salicylamide; or (b) acetaminophen with a salt or derivative of salicylic acid or with salicylamide. SOR/84-145, s. 4
Food and Drug Regulations — C.09.011
C.09.011 Each label of a drug that is intended for internal use and contains acetaminophen, salicylic acid or a salt or derivative thereof shall, after June 30, 1986, carry a caution (a) to consult a physician if the underlying condition requires continued use for more than five days; and (b) that it is hazardous to exceed the maximum recommended dose unless advised by a physician. SOR/84-145, s. 4; SOR/86-589, s. 1
Food and Drug Regulations — C.09.012
C.09.012 Each label of a drug that is intended for internal use and contains salicylic acid or a salt or derivative thereof shall after June 30, 1986, carry a warning statement to consult a physician before taking the drug during the last three months of pregnancy or when nursing. SOR/84-145, s. 4
Food and Drug Regulations — C.09.020
C.09.020 (1) The adult standard dosage unit of acetaminophen shall be 325 mg. (2) The children’s standard dosage units of acetaminophen shall be 80 mg or 160 mg. SOR/84-145, s. 4; SOR/90-587, s. 4
Food and Drug Regulations — C.09.021
C.09.021 (1) In this Division, acetaminophen product means a drug that contains (a) acetaminophen as a single medicinal ingredient; or (b) acetaminophen in combination with caffeine. (2) No manufacturer or importer shall sell an acetaminophen product unless it meets the requirements of this Division. (3) [Repealed, SOR/90-587, s. 5] SOR/84-145, s. 4; SOR/90-587, s. 5
Food and Drug Regulations — C.09.022
C.09.022 (1) Subject to subsections (2) to (4), an acetaminophen product sold in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of acetaminophen per individual dosage form. (2) An acetaminophen product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain 500 mg of acetaminophen per individual dosage form if it has a label that states that it is not a standard dosage unit product. (3) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration may contain 325 mg of acetaminophen for immediate release and another 325 mg for subsequent release, if it has a label that states that it is not a standard dosage unit product. (4) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per individual dosage form. (5) An acetaminophen product in the form of a liquid that is intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per millilitre of the product. (6) A package of an acetaminophen product described in subsection (5) shall be accompanied by a measuring device capable of accurately delivering 0.5 mL of the product. (7) An acetaminophen product in the form of a liquid that is not intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit per teaspoon of the product. (8) An acetaminophen product in the form of a liquid shall contain one adult standard dosage unit of acetaminophen per teaspoon of the product. SOR/84-145, s. 4; SOR/85-966, s. 4; SOR/86-954, s. 1; SOR/99-441, s. 1
Food and Drug Regulations — C.09.030
C.09.030 (1) The adult standard dosage unit of a salicylate shall be (a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 325 mg; and (b) in the case of choline salicylate, 435 mg. (2) The children’s standard dosage unit of a salicylate shall be (a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 80 mg; and (b) in the case of choline salicylate, 110 mg. SOR/84-145, s. 4
Food and Drug Regulations — C.09.031
C.09.031 (1) In this Division, salicylate product means a drug that contains (a) a salt or derivative of salicylic acid as a single medicinal ingredient; (b) a salt or derivative of salicylic acid in combination with caffeine; (c) a salt or derivative of salicylic acid in combination with one or more buffering agents or antacids; or (d) a salt or derivative of salicylic acid in combination with caffeine and one or more buffering agents or antacids. (2) No manufacturer or importer shall sell a salicylate product after June 30, 1986 unless it meets the requirements of this Division. (3) No manufacturer or importer shall, until June 30, 1986, sell a salicylate product in a dosage unit other than one mentioned in this Division, unless the salicylate product was legally available for sale in Canada on February 1, 1984. SOR/84-145, s. 4; SOR/85-966, s. 5(E)
Food and Drug Regulations — C.09.032
C.09.032 (1) Subject to subsections (2) and (3) and section C.09.035, a salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of a salicylate per individual dosage form. (2) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain (a) 500 mg of acetylsalicylic acid, sodium salicylate or magnesium salicylate, or (b) 670 mg of choline salicylate per individual dosage form if it has a label that states that it is not a standard dosage unit product. (3) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain (a) two adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains two adult standard dosage units; and (b) three adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains three adult standard dosage units. SOR/84-145, s. 4; SOR/85-966, s. 6
Food and Drug Regulations — C.09.033
C.09.033 (1) Subject to subsection (2), a salicylate product in the form of a liquid shall contain one adult standard dosage unit of a salicylate per teaspoon. (2) A salicylate product in the form of a liquid may contain (a) two adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains two adult standard dosage units; and (b) three adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains three adult standard dosage units. SOR/84-145, s. 4
Food and Drug Regulations — C.09.034
C.09.034 A salicylate product that is claimed to be buffered shall provide at least 1.9 milliequivalents of acid neutralizing capacity per adult standard dosage unit of a salicylate. SOR/84-145, s. 4
Food and Drug Regulations — C.09.035
C.09.035 A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of a salicylate per individual dosage form. SOR/84-145, s. 4
Food and Drug Regulations — Food and Drug Regulations
foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction. ( autorité réglementaire étrangère )
Food and Drug Regulations — (a)
public health official means (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act ; (b) the Chief Medical Officer of Health, or equivalent, of a province; (c) the Surgeon General of the Canadian Armed Forces; or (d) the Chief Medical Officer of Public Health for the Department of Indigenous Services. ( responsable de la santé publique )
Food and Drug Regulations — C.10.002
C.10.002 (1) A sale of a drug that is imported under subsection C.10.001(2) is exempt from the provisions of these Regulations only if the drug is sold to a person within the jurisdiction of a public health official who has notified the Minister as described in paragraph C.10.001(2)(a), for use in respect of the same urgent public health need for which it was imported. (2) Any person who wholesales such a drug must hold an establishment licence to wholesale a drug in the same category and despite subsection (1), the following provisions apply in respect of the wholesale: (a) sections C.02.003.1 and C.02.004 as they apply to the storage of the drug by the licensee; (b) section C.02.006 as it applies to the storage of the drug by the licensee; (c) subsection C.02.012(1); (c.1) section C.02.012.1 as it applies to the storage of the drug by the licensee; (d) section C.02.013; (d.1) section C.02.014; (e) section C.02.015 as it applies to the storage and transportation of the drug by the licensee; (e.1) subsection C.02.021(1) as it applies to storage; (f) subsection C.02.022(1); (f.1) [Repealed, SOR/2023-247, s. 7] (g) section C.02.023; and (h) subsection C.02.024(1). SOR/2017-133, s. 2 SOR/2022-197, s. 10 SOR/2023-247, s. 7 SOR/2024-238, s. 40
Food and Drug Regulations — C.10.003
C.10.003 Every licensee who imports a drug under subsection C.10.001(2) must notify the Minister within 15 days after the day on which it is imported by providing the following information: (a) the name, title and contact information of the person who imported the drug; (b) the brand name of the drug; (c) the medicinal ingredients, strength, dosage form and route of administration of the drug and any identifying code or number assigned to it in the country in which it was authorized for sale; (d) the name of the country from which the drug was imported; and (e) the total quantity of the drug imported. SOR/2017-133, s. 2 SOR/2023-18, s. 3