Food and Drug Regulations (C.R.C., c. 870)
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Regulations are current to 2021-01-10 and last amended on 2020-09-28. Previous Versions
PART BFoods (continued)
DIVISION 28Novel Foods (continued)
Pre-Market Notification (continued)
B.28.003 (1) Within 45 days after receiving a notification referred to in paragraph B.28.002(1)(a), the Minister shall review the information included in the notification and
(a) if the information establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient; or
(b) if additional information of a scientific nature is necessary in order to assess the safety of the novel food, request in writing that the manufacturer or importer submit that information.
(2) Within 90 days after receiving the additional information requested under paragraph (1)(b) the Minister shall assess it and, if it establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient.
- SOR/99-392, s. 1
- SOR/2018-69, s. 27
PART CDrugs
DIVISION 1
General
- acetaminophen product
acetaminophen product has the same meaning as in Division 9; (produit d’acétaminophène)
- adult standard dosage unit
adult standard dosage unit has, with reference to a drug, the same meaning as in Division 9; (dose normale pour adultes)
- adverse drug reaction
adverse drug reaction means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function; (réaction indésirable à une drogue)
- antibiotic
antibiotic means any drug or combination of drugs such as those named in C.01.410 to C.01.592 which is prepared from certain micro-organisms, or which formerly was prepared from micro-organisms but is now made synthetically and which possesses inhibitory action on the growth of other micro-organisms; (antibiotique)
- authorization holder
authorization holder[Repealed, SOR/2017-259, s. 1]
- brand name
brand name means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,
- case report
case report means a detailed record of all relevant data associated with the use of a drug in a subject; (fiche d’observation)
- children’s standard dosage unit
children’s standard dosage unit has, with reference to a drug, the same meaning as in Division 9; (dose normale pour enfants)
- child resistant package
child resistant package means a package that meets the requirements of subsection (2); (emballage protège-enfants)
- common name
common name means, with reference to a drug, the name in English or French by which the drug is
- discontinue
discontinue means, in respect of the sale of a drug by the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug, to permanently cease the sale of the drug; (cesser)
- expiration date
expiration date means
- flavour
flavour means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug solely to produce or mask a particular taste. It does not include an ingredient or combination of ingredients that impart only a sweet taste to the drug; (saveur)
- fragrance
fragrance means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug to produce or mask a particular odour; (parfum)
- immediate container
immediate container means the receptacle that is in direct contact with a drug; (récipient immédiat)
- internal use
internal use means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane; (usage interne)
- List A
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)
- List B
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)
- List C
List C means the document, entitled Veterinary Health Products, that is published by the Government of Canada on its website, as amended from time to time; (Liste C)
- List D
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)
- non-medicinal ingredient
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)
- official drug
official drug means any drug
- parenteral use
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)
- per cent
per cent means per cent by weight unless otherwise stated; (pour cent)
- pharmaceutical ink
pharmaceutical ink means a non-medicinal ingredient or combination of non-medicinal ingredients used to imprint the drug with marks or symbols; (encre pharmaceutique)
- pharmacist
pharmacist means a person who
- pharmacy technician
pharmacy technician means a person who
- practitioner
practitioner means a person who
- prescription
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)
- proper name
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)
- salicylate product
salicylate product has the same meaning as in Division 9; (produit de salicylate)
- serious adverse drug reaction
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)
- serious unexpected adverse drug reaction
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)
- teaspoon
teaspoon means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres; (cuillerée à thé)
- test group
test group means a group that meets the requirements of subsection (3); (groupe d’essai)
- veterinary health product
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
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 injury 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,
(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
(iii) Code of Federal Regulations (United States), Title 16, Section 1700.15, entitled Poison prevention packaging standards, as amended from time to time.
(3) For the purposes of this section, test group means
(4) For the purpose of this section, an amendment from time to time to a standard referred to in paragraph (2)(b) becomes effective 18 months after the date designated by the competent authority as the effective date for the amendment.
- SOR/80-543, s. 1
- SOR/85-966, s. 1
- SOR/86-93, s. 1
- SOR/87-484, s. 1
- SOR/92-654, s. 1
- SOR/93-202, s. 1
- SOR/95-411, s. 1
- SOR/95-521, s. 1
- SOR/96-399, s. 1
- SOR/96-240, s. 1
- SOR/97-543, s. 5
- SOR/2010-105, s. 1
- SOR/2013-74, s. 1
- SOR/2013-122, s. 3
- SOR/2016-139, s. 1
- SOR/2017-76, s. 1
- SOR/2017-133, s. 1
- SOR/2017-259, s. 1
- SOR/2020-74, s. 1
- Date modified: