GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — C.01A.005
, specifying for each building the activities and the categories of drugs and, for each category, the dosage form classes, if any, and whether any drug will be in a sterile form; and (o) in the case of an importer referred to in paragraph (n), (i) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or (ii) other evidence establishing that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4. (2) An application for an establishment licence that relates to one or more activities set out in Table I to section C.01A.008 that are to be carried out in respect of a category of drugs that is set out in Table II to that section and that includes a drug that is fabricated, sold or represented for use in relation to a condition described in the List of Conditions that Threaten Public Health , as defined in section C.08.001.1, may include a statement to that effect. SOR/97-12, s. 5; SOR/2000-120, s. 2; SOR/2002-368, s. 4; SOR/2011-81, s. 2; SOR/2013-74, s. 5; SOR/2018-144, s. 369 SOR/2019-171, s. 24 SOR/2021-45, s. 3 SOR/2024-238, s. 9
Food and Drug Regulations — C.01A.006
C.01A.006 (1) A person who wishes to amend an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the information and documents referred to in section C.01A.005 that relate to the amendment. (1.1) An application to amend an establishment licence that relates to one or more activities set out in Table I to section C.01A.008 that are to be carried out in respect of a category of drugs that is set out in Table II to that section and that includes a drug that is fabricated, sold or represented for use in relation to a condition described in the List of Conditions that Threaten Public Health , as defined in section C.08.001.1, may include a statement to that effect. (2) An establishment licence must be amended where the licensee proposes (a) to add an activity or category of drugs, as set out in the tables to section C.01A.008; (b) in respect of a category of drugs and activity indicated in the licence, to authorize sterile dosage forms of the category; (c) to add any building in Canada at which drugs are authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, or to add, for an existing building, an authorization to fabricate, package/label, test or store a category of drugs, or sterile dosage forms of the category; and (d) in addition to the matters set out in paragraphs (a) to (c), in the case of an importer, (i) to add a fabricator, packager/labeller or tester of a drug, (ii) to amend the name or address of a fabricator, packager/labeller or tester indicated in the licence, and (iii) if the address of the buildings at which drugs are authorized to be fabricated, packaged/labelled or tested is indicated in the licence, to add additional buildings or, for an existing building, to add an authorization to fabricate, package/label or test a category of drugs, or sterile dosage forms of the category. SOR/97-12, s. 5; SOR/2011-81, s. 3 SOR/2021-45, s. 4 SOR/2024-238, s. 10
Food and Drug Regulations — C.01A.007
C.01A.007 (1) The Minister may, on receipt of an application for an establishment licence, an amendment to an establishment licence or the review of an establishment licence, require the applicant to submit further details pertaining to the information contained in the application that are necessary to enable the Minister to make a decision. (2) When considering an application, the Minister may require that (a) an inspection be made during normal business hours of any building referred to in paragraph C.01A.005(1)(g) or (h); and (b) the applicant, if a fabricator, a packager/labeller, a person who performs tests required under Division 2, a distributor referred to in paragraph C.01A.003(b) or an importer, supply samples of any material to be used in the fabrication, packaging/labelling or testing of a drug. SOR/97-12, s. 5; SOR/2011-81, s. 4 SOR/2021-45, s. 5(F)
Food and Drug Regulations — C.01A.008
79, s. 2] 4 Drugs that are listed in Schedule D to the Act, other than vaccines 5 Drugs listed in Schedule C to the Act 6 Drugs that are prescription drugs, controlled drugs as defined in section G.01.001, narcotics as defined in the Narcotic Control Regulations and drugs containing cannabis as defined in subsection 2(1) of the Cannabis Act 7 Active pharmaceutical ingredients set out in List A that are for veterinary use SOR/97-12, s. 5; SOR/2000-120, s. 3; SOR/2002-368, s. 5; SOR/2013-74, s. 6; SOR/2013-122, s. 15; SOR/2013-179, s. 2; SOR/2017-76, s. 9; SOR/2017-259, s. 14; SOR/2018-144, s. 370 SOR/2019-171, s. 24 SOR/2021-45, s. 6 SOR/2021-46, s. 11(E) SOR/2022-100, s. 4 SOR/2024-238, s. 11
Food and Drug Regulations — (a)
(a) an active pharmaceutical ingredient; or
Food and Drug Regulations — (b)
(b) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act
Food and Drug Regulations — Food and Drug Regulations
Drugs that are prescription drugs, controlled drugs as defined in section G.01.001, narcotics as defined in the Narcotic Control Regulations and drugs containing cannabis as defined in subsection 2(1) of the Cannabis Act
Food and Drug Regulations — C.01A.009
C.01A.009 (1) The holder of an establishment licence that is not suspended shall submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referrred to in section C.01A.005. (2) The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted by the holder and any other relevant information in the Minister’s possession. SOR/97-12, s. 5; SOR/97-298, s. 1; SOR/2011-81, s. 5
Food and Drug Regulations — C.01A.010
C.01A.010 (1) The Minister may refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if (a) the applicant has made a false or misleading statement in relation to the application for the licence; or (b) the applicant has had an establishment licence suspended in respect of the matter. (2) The Minister shall refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that issuing or amending an establishment licence in respect of the matter would constitute a risk to the health of the consumer. (3) Where the Minister refuses to issue or amend an establishment licence, the Minister shall (a) notify the applicant in writing of the reasons for the refusal; and (b) give the applicant an opportunity to be heard. SOR/97-12, s. 5
Food and Drug Regulations — C.01A.011
C.01A.011 (1) Every person who holds an establishment licence shall comply with (a) the requirements of the establishment licence; and (b) the applicable requirements of Divisions 2 to 4. (2) [Repealed, SOR/2000-120, s. 4] SOR/97-12, s. 5; SOR/2000-120, s. 4 SOR/2021-45, s. 7
Food and Drug Regulations — C.01A.012
C.01A.012 (1) The Minister may amend the terms and conditions of an establishment licence that are imposed under subsection C.01A.008(4) if the Minister believes on reasonable grounds that an amendment is necessary to prevent risk to the health of the consumer. (2) The Minister shall give at least 15 days notice in writing to the holder of the establishment licence of the proposed amendment, the reasons for it and its effective date. SOR/97-12, s. 5 SOR/2021-45, s. 8 SOR/2021-46, s. 11(E)
Food and Drug Regulations — C.01A.012.1
C.01A.012.1 (1) Despite subsection C.01A.008(4), the Minister may, at any time, including when issuing an establishment licence, impose terms and conditions on an establishment licence that is issued or amended under section C.01A.008 on the basis of an application referred to in subsection C.01A.005(2) or C.01A.006(1.1) that contains the statement referred to in the applicable subsection. (2) For greater certainty, terms and conditions that may be imposed under subsection (1) are not limited to those that may be imposed under subsection C.01A.008(4). (3) For greater certainty, the power in subsection (1) continues to apply in respect of an establishment licence until the licence is cancelled, even if the holder of the licence does not carry out activities in respect of the drug that formed the basis for the statement contained in the application that led to the issuance or amendment of the licence. SOR/2021-45, s. 9 SOR/2024-238, s. 12
Food and Drug Regulations — C.01A.012.2
C.01A.012.2 The Minister may, at any time, amend terms or conditions that are imposed on an establishment licence under subsection C.01A.012.1(1). SOR/2021-45, s. 9
Food and Drug Regulations — C.01A.013
C.01A.013 Every person who holds an establishment licence shall notify the Minister in writing within 15 days after (a) there is any change to the information referred to in any of paragraphs C.01A.005(1)(a), (b) and (e) to (i); or (b) an event occurs that results in their being in contravention of any of the applicable requirements set out in Divisions 2 to 4, if the event may affect the quality, safety or efficacy of a drug that they fabricate, package/label, test in accordance with the requirements set out in Division 2 or store, including during transportation. SOR/97-12, s. 5; SOR/2017-18, s. 15 SOR/2021-45, s. 10 SOR/2024-238, s. 13
Food and Drug Regulations — C.01A.014
C.01A.014 (1) No licensee shall carry on a licensed activity in respect of any category of drugs if a change referred to in subsection (2) has occurred in respect of that category, unless (a) they have filed with the Minister a notice that contains sufficient information to enable the Minister to assess the safety of the drug, taking into account the change; and (b) the Minister has issued to them a letter indicating that the information will be reviewed and has not, within 90 days after issuing the letter, sent them a notice indicating that the change is not acceptable. (2) Notification is required in respect of the following changes where they may affect whether a drug can be fabricated, packaged/labelled, tested or stored in accordance with the applicable requirements of Divisions 2 to 4: (a) changes to the plans and specifications of a building where a drug is fabricated, packaged/labelled, tested or stored; (b) changes to the equipment that is used in the fabrication, packaging/labelling or testing of a drug; (c) changes to the practices or procedures; and (d) in the case of an importer, other than an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building, any change referred to in paragraphs (a) to (c) that relates to the fabricator, packager/labeller or tester of the drug being imported. SOR/97-12, s. 5; SOR/2000-120, s. 5; SOR/2002-368, s. 6
Food and Drug Regulations — C.01A.015
C.01A.015 (1) An importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building shall immediately notify the Minister if the fabricator, packager/labeller or tester indicated in the importer’s establishment licence no longer holds a valid permit, licence or other authorization issued by the regulatory authority that recognized that building. (2) The Minister shall, on receiving a notification under subsection (1), amend the importer’s establishment licence by removing the name and address of that fabricator, packager/labeller or tester. SOR/97-12, s. 5; SOR/2000-120, s. 6; SOR/2002-368, s. 7
Food and Drug Regulations — C.01A.016
C.01A.016 (1) The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if he or she has reasonable grounds to believe that (a) the licensee has contravened any provision of the Act or these Regulations; or (b) the licensee has made a false or misleading statement in the application for the establishment licence. (2) Before suspending an establishment licence, the Minister shall consider (a) the licensee’s history of compliance with the Act and these Regulations; and (b) the risk that allowing the licence to continue in force would constitute for the health of the consumer. (3) The Minister shall not suspend an establishment licence until (a) the Minister has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken; (b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and (c) the licensee has been given an opportunity to be heard in respect of the suspension. SOR/97-12, s. 5; SOR/2018-84, s. 4 SOR/2021-46, s. 7
Food and Drug Regulations — C.01A.017
C.01A.017 (1) The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) without giving the licensee an opportunity to be heard if it is necessary to do so to prevent a risk to the health of consumers, by giving the licensee a notice that states the reason for the suspension. (2) A licensee may request of the Minister, in writing, that the suspension be reconsidered. (3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with the opportunity to be heard. SOR/97-12, s. 5; SOR/2018-84, s. 5
Food and Drug Regulations — C.01A.017.1
C.01A.017.1 The Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if, after the Minister has, under section 21.31 of the Act, ordered the licensee to conduct an assessment in order to provide evidence establishing that the licensee’s buildings, equipment or practices and procedures, as the case may be, continue to meet the requirements referred to in paragraph C.01A.005(1)(l), subparagraph C.01A.005(1)(m)(ii) or (iii) or paragraph C.01A.005(1)(o), (a) the licensee fails to comply with the order; or (b) the licensee complies with the order but the Minister determines that the results of the assessment are not sufficient to establish that those requirements continue to be met. SOR/2018-84, s. 6 SOR/2021-45, s. 11
Food and Drug Regulations — C.01A.018
C.01A.018 The Minister shall reinstate an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) that are the subject of the suspension if, within 12 months after the effective date of the suspension, the licensee provides the Minister with sufficient evidence demonstrating that (a) the situation on which the suspension was based has been corrected; or (b) the situation on which the suspension was based did not exist. SOR/97-12, s. 5; SOR/2018-84, s. 6
Food and Drug Regulations — C.01A.018.1
C.01A.018.1 The Minister shall cancel an establishment licence if the licensee has failed to submit an application for the review of the licence in accordance with subsection C.01A.009(1). SOR/2011-81, s. 6; SOR/2018-84, s. 7
Food and Drug Regulations — C.01A.018.2
C.01A.018.2 (1) If the Minister has suspended an establishment licence in respect of all matters indicated in subsection C.01A.008(2) and the suspension is still in effect 12 months after the effective date of the suspension, the Minister shall cancel the licence. (2) If the Minister has suspended an establishment licence in respect of one or more of the matters indicated in subsection C.01A.008(2) and the suspension is still in effect 12 months after the effective date of the suspension, the Minister shall cancel the licence only in respect of the matters that are the subject of the suspension. SOR/2018-84, s. 7
Food and Drug Regulations — C.01A.019
C.01A.019 (1) For the purposes of this Division and Divisions 2 to 4, a regulatory authority that is set out in column 1 of the List of Regulatory Authorities for the Purposes of Section C.01A.019 of the Food and Drug Regulations , published by the Government of Canada on its website, as amended from time to time, is designated in respect of the activities set out in column 3 for the drugs or category of drugs set out in column 2. (2) Whole blood and its components are excluded from the drugs and categories of drugs that are set out in column 2 of the List. (3) The lot release of drugs listed in Schedule D to the Act is excluded from the activity of testing set out in column 3 of the List. SOR/97-12, s. 5; SOR/2000-120, s. 7; SOR/2002-368, s. 8 SOR/2024-136, s. 2
Food and Drug Regulations — C.02.002
C.02.002 In this Division, drug [Repealed, SOR/97-12, s. 6] importer [Repealed, SOR/97-12, s. 6] medical gas means any gas or mixture of gases manufactured, sold or represented for use as a drug; ( gaz médical ) packaging material includes a label; ( matériel d’emballage ) produce [Repealed, SOR/97-12, s. 6] quality control department [Repealed, SOR/2010-95, s. 1] specifications means a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes (a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material, (b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and (c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. ( spécifications ) SOR/82-524, s. 3; SOR/85-754, s. 1; SOR/89-174, s. 1; SOR/97-12, s. 6; SOR/2010-95, s. 1
Food and Drug Regulations — Food and Drug Regulations
medical gas means any gas or mixture of gases manufactured, sold or represented for use as a drug; ( gaz médical )
Food and Drug Regulations — Food and Drug Regulations
packaging material includes a label; ( matériel d’emballage )
Food and Drug Regulations — Food and Drug Regulations
quality control department [Repealed, SOR/2010-95, s. 1]
Food and Drug Regulations — (a)
specifications means a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes (a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material, (b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and (c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. ( spécifications )
Food and Drug Regulations — C.02.002.1
C.02.002.1 This Division does not apply to fabricating, packaging/labelling, testing, storing and importing of antimicrobial agents. SOR/2004-282, s. 3
Food and Drug Regulations — C.02.002.2
C.02.002.2 In this Division, (a) a reference to specifications is — in respect of a drug intended for consumption or use outside Canada, the raw material used in such a drug or the packaging material for such a drug — a reference to the specifications with which the drug, raw material or packaging material is required to comply in the country in which the drug is intended to be consumed or used; and (b) the definition expiration date in subsection C.01.001(1) does not apply in respect of a drug intended for consumption or use outside Canada. SOR/2022-100, s. 5
Food and Drug Regulations — C.02.003
C.02.003 No distributor referred to in paragraph C.01A.003(b) and no importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored, including during transportation, in accordance with the requirements set out in this Division. SOR/82-524, s. 3; SOR/97-12, s. 7; SOR/2000-120, s. 8; SOR/2010-95, s. 2(F) SOR/2024-238, s. 14
Food and Drug Regulations — C.02.003.1
C.02.003.1 No person shall sell a drug that they have fabricated, packaged/labelled, tested or stored unless they have fabricated, packaged/labelled, tested or stored the drug, including during transportation, in accordance with the requirements set out in this Division. SOR/2013-74, s. 7 SOR/2024-238, s. 14
Food and Drug Regulations — C.02.003.2
C.02.003.2 (1) No person shall import an active ingredient into Canada for the purpose of sale unless they have in Canada a person who is responsible for its sale. (2) No person who imports an active ingredient into Canada shall sell any lot or batch of it unless the following appear on its label: (a) the name and civic address of the person who imports it; and (b) the name and address of the principal place of business in Canada of the person who is responsible for its sale. SOR/2013-74, s. 7
Food and Drug Regulations — C.02.003.3
C.02.003.3 No person shall use an active ingredient in the fabrication of a drug unless the ingredient has been fabricated, packaged/labelled, tested and stored, including during transportation, in accordance with the requirements set out in this Division. SOR/2013-74, s. 7 SOR/2024-238, s. 15
Food and Drug Regulations — C.02.004
C.02.004 The premises in which a lot or batch of a drug is fabricated, packaged/labelled or stored shall be designed, constructed and maintained in a manner that (a) permits the operations therein to be performed under clean, sanitary and orderly conditions; (b) permits the effective cleaning of all surfaces therein; and (c) prevents the contamination of the drug and the addition of extraneous material to the drug. SOR/82-524, s. 3; SOR/97-12, s. 8; SOR/2010-95, s. 3
Food and Drug Regulations — C.02.005
C.02.005 The equipment with which a lot or batch of a drug is fabricated, packaged/labelled or tested shall be designed, constructed, maintained, operated and arranged in a manner that (a) permits the effective cleaning of its surfaces; (b) prevents the contamination of the drug and the addition of extraneous material to the drug; and (c) permits it to function in accordance with its intended use. SOR/82-524, s. 3; SOR/97-12, s. 9
Food and Drug Regulations — C.02.006
C.02.006 Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored, including during transportation, under the supervision of personnel who, having regard to the duties and responsibilities involved, have had any technical, academic or other training that the Minister considers satisfactory in the interests of the health of the consumer or purchaser. SOR/82-524, s. 3; SOR/85-754, s. 2; SOR/97-12, s. 52; SOR/2018-69, s. 27 SOR/2024-238, s. 16
Food and Drug Regulations — C.02.007
C.02.007 (1) Every person who fabricates or packages/labels a drug shall have a written sanitation program that shall be implemented under the supervision of qualified personnel. (2) The sanitation program referred to in subsection (1) shall include (a) cleaning procedures for the premises where the drug is fabricated or packaged/labelled and for the equipment used in the fabrication or packaging/labelling; and (b) instructions on the sanitary fabrication and packaging/labelling of drugs and the handling of materials used in the fabrication and packaging/labelling of drugs. SOR/82-524, s. 3; SOR/97-12, ss. 10, 53
Food and Drug Regulations — C.02.008
C.02.008 (1) Every person who fabricates or packages/labels a drug shall have, in writing, minimum requirements for the health and the hygienic behaviour and clothing of personnel to ensure the clean and sanitary fabrication and packaging/labelling of the drug. (2) No person shall have access to any area where a drug is exposed during its fabrication or packaging/labelling if the person (a) is affected with or is a carrier of a disease in a communicable form; or (b) has an open lesion on any exposed surface of the body. SOR/82-524, s. 3; SOR/97-12, s. 11