Food and Drug Regulations (C.R.C., c. 870)

• C.08.007 (1) Where a manufacturer has received a notice of compliance issued in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, the manufacturer shall establish and maintain records, in a manner that enables an audit to be made, respecting

  • (a) animal or clinical experience, studies, investigations and tests conducted by the manufacturer or reported to him by any person concerning that new drug;

  • (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that new drug;

  • (c) experience, investigations, studies and tests involving the chemical or physical properties or any other properties of that new drug;

  • (d) any substitution of another substance for that new drug or any mixing of another substance with that new drug;

  • (e) any error in the labelling of that new drug or in the use of the labels designed for that new drug;

  • (f) any bacteriological or any significant chemical or physical or other change or deterioration in any lot of that new drug;

  • (g) any failure of one or more distributed lots of the new drug to meet the specifications established for that new drug in the submission or supplement; and

  • (h) any unusual failure in efficacy of that new drug.

  • (i) [Repealed, SOR/95-521, s. 3]

• (1.1) The manufacturer shall retain the records respecting the information referred to in subsection (1) for at least seven years from the day on which they were established.

• (2) A manufacturer or importer who sells a new drug for extraordinary use in accordance with section C.08.002.02 shall retain the written order for at least 15 years from the day on which the order was filled.

C.08.008 No manufacturer shall sell a new drug unless the manufacturer has, with respect to all the manufacturer’s previous sales of that new drug, furnished to the Minister

• (a) a summary of a record respecting any information referred to in paragraphs C.08.007(1)(a) to (c), on receipt of a request from the Minister for the summary;

• (b) a summary of a record respecting any information referred to in paragraph C.08.007(1)(d) to (f), immediately on the manufacturer establishing the record; and

• (c) a summary of a record respecting any information referred to in paragraph C.08.007(1)(g) or (h), within 15 days after the day on which the manufacturer established the record.

C.08.008.1 Where a manufacturer has received a notice of compliance issued in respect of an extraordinary use new drug submission, an abbreviated extraordinary use new drug submission or a supplement to either of those submissions, the manufacturer

• (a) shall adhere to the plan referred to in subparagraph C.08.002.01(2)(b)(ix); and

• (b) shall, before the first day of October in each year and whenever requested to do so by the Minister for the purposes of assessing the safety and effectiveness of the drug to which the notice of compliance relates, provide a report on the use of the drug, including a critical analysis of any available updated information respecting the drug’s safety and effectiveness.

• C.08.009 (1) Where the Minister has decided

  • (a) to notify the manufacturer of a new drug for veterinary use that the sale of that drug to qualified investigators is prohibited, or

  • (b) to suspend a notice of compliance issued under section C.08.004 or C.08.004.01,

  the manufacturer, if dissatisfied with that decision, may require the Minister to provide him with the reasons for the decision.

• (2) Where the manufacturer has received the reasons for a decision of the Minister pursuant to subsection (1), he may require the Minister to refer that decision to a New Drug Committee and thereupon shall provide the Minister with a statement of the reasons for his dissatisfaction and any information and material upon which he relies in support of those reasons.

• (3) Where the Minister has been required to refer a decision to a New Drug Committee pursuant to subsection (2), he shall appoint a member of the New Drug Committee, the dissatisfied manufacturer shall appoint a member of the New Drug Committee and the two members so appointed shall appoint a third member of the New Drug Committee who shall be chairman, or, if they are unable to do so within a reasonable time, the Minister shall appoint a third member of the New Drug Committee who shall be chairman.

• (4) Any person who is in the full-time employment of the Department or in the full-time employment of the dissatisfied manufacturer shall not be appointed a member of a New Drug Committee.

• (4.1) A member of a New Drug Committee shall, on appointment, sign an undertaking not to disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

• (5) The Minister shall pay the reasonable fees and costs incurred by the member of the New Drug Committee appointed by the Minister, and the dissatisfied manufacturer shall pay the reasonable fees and costs incurred by the member appointed by the dissatisfied manufacturer, and the Minister and the dissatisfied manufacturer shall each pay half of the reasonable fees and costs incurred by the chairman.

• (6) The New Drug Committee formed pursuant to subsection (3) shall consider the reasons for the decision of the Minister, the reasons for the dissatisfaction of the dissatisfied manufacturer and any information or material in support of the reasons of the Minister or the dissatisfied manufacturer and may consider other evidence, material, information or representations.

• (7) The New Drug Committee formed pursuant to subsection (3) shall report its findings and recommendations to the Minister.

• (7.1) No member of a New Drug Committee shall disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

• (8) Where the Minister has received the findings and recommendations of a New Drug Committee, he may reconsider the decision to which those findings and recommendations relate.

Pre-positioning of Public Health Emergency Drugs

C.08.009.01 The following definitions apply in sections C.08.009.03 to C.08.009.05.

Chief Public Health Officer

Chief Public Health Officer means the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act. (administrateur en chef de la santé publique)

dosage form class

dosage form class has the same meaning as in subsection C.01A.001(1). (classe de forme posologique)

fabricate

fabricate has the same meaning as in subsection C.01A.001(1). (manufacturer)

foreign regulatory authority

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 and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with the applicable legal requirements. (autorité réglementaire étrangère)

package/label

package/label has the same meaning as in subsection C.01A.001(1). (emballer-étiqueter)

C.08.009.02 Sections C.08.009.03 to C.08.009.05 apply in respect of a public health emergency drug if

• (a) a notice of compliance has not been issued in respect of the drug under section C.08.004 or C.08.004.01; and

• (b) His Majesty in right of Canada has entered into a contract for the procurement of the drug.

• C.08.009.03 (1) The holder of an establishment licence may import a public health emergency drug if

  • (a) the Chief Public Health Officer provides the Minister with

    • (i) the name and contact information of the holder,

    • (ii) the name and contact information of the public health emergency drug’s manufacturer,

    • (iii) the name of the public health emergency drug and a description of it,

    • (iv) information indicating that the public health emergency drug is the subject of a new drug submission, a supplement to a new drug submission or an application made to a foreign regulatory authority to authorize its sale,

    • (v) information specifying the quantity of the public health emergency drug to be imported, and

    • (vi) the civic address of the place where the public health emergency drug will be stored after it is imported;

  • (b) the holder provides the Minister with

    • (i) the name and contact information of each fabricator, packager/labeller and tester of the public health emergency drug and the civic address of each building at which the drug will be fabricated, packaged/labelled or tested, specifying for each building

      • (A) the activities referred to in Table I to section C.01A.008 that apply to the public health emergency drug,

      • (B) the categories referred to in Table II to that section that apply to the public health emergency drug, and

      • (C) for each of those categories, the dosage form classes, if any, and, in the case of a public health emergency drug that will be sterile, an indication to that effect, and

    • (ii) a certificate from an inspector indicating that the buildings, equipment, practices and procedures of each fabricator, packager/labeller and tester meet the applicable requirements set out in Divisions 2 to 4 or, alternatively, other evidence establishing that those requirements are met; and

  • (c) the public health emergency drug belongs to a category of drugs that are authorized to be imported under the establishment licence.

• (2) Paragraph (1)(b) does not apply to the holder of an establishment licence in respect of a building referred to in subparagraph (1)(b)(i) if

  • (a) the building is listed in the licence; and

  • (b) the information referred to in clauses (1)(b)(i)(A) to (C) that the holder submitted in respect of the building in their application for the licence under section C.01A.005 or in an application to amend the licence under section C.01A.006, has not changed.

• (3) If the conditions set out in subsection (1) are met, the Minister shall send a letter to the Chief Public Health Officer to that effect.

C.08.009.04 Sections A.01.040, C.01.004.1 and C.01A.006 and Divisions 2 to 4 of this Part, other than the following provisions, do not apply in respect of the importation of a public health emergency drug under section C.08.009.03 by the holder of an establishment licence:

• (a) sections C.02.003.1, C.02.004 and C.02.006, as they apply to the storage of the public health emergency drug by the holder;

• (b) subsection C.02.012(1);

• (c) section C.02.012.1, as it applies to the storage of the public health emergency drug by the holder;

• (d) sections C.02.013 and C.02.014;

• (e) section C.02.015, as it applies to the storage and transportation of the public health emergency drug by the holder;

• (f) subsection C.02.021(1), as it applies to the storage of the public health emergency drug by the holder;

• (g) subsection C.02.022(1);

• (h) section C.02.023;

• (i) subsection C.02.024(1); and

• (j) section C.03.013.

C.08.009.05 Despite anything in these Regulations, the holder of an establishment licence may distribute a public health emergency drug that they have imported under section C.08.009.03 if

• (a) the Chief Public Health Officer provides the Minister with the name of the public health emergency drug and the civic address of the place where it will be stored after distribution; and

• (b) the public health emergency drug is distributed to a person who will store it at that place.

Disclosure of Information in Respect of Clinical Trials

• C.08.009.1 (1) In sections C.08.009.2 and C.08.009.3, information in respect of a clinical trial means information in respect of a clinical trial, within the meaning of section C.05.001, that is contained in a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for a new drug for human use filed under section C.08.002, C.08.002.01 or C.08.002.1 or in a supplement to any of those submissions filed under section C.08.003.

• (2) For greater certainty, the definition information in respect of a clinical trial includes information that is contained in a submission or supplement referred to in that definition and that is in respect of clinical testing involving human subjects in regards to which an application was filed under this Division before September 1, 2001.

• C.08.009.2 (1) Information in respect of a clinical trial that is confidential business information ceases to be confidential business information when one of the following circumstances occurs with respect to the submission or supplement:

  • (a) the Minister issues a notice of compliance under section C.08.004 or C.08.004.01;

  • (b) in the case where the Minister issues a notice to the manufacturer under paragraph C.08.004(1)(b) or C.08.004.01(1)(b) and the manufacturer does not amend the submission or supplement under subsection C.08.004(2) or C.08.004.01(2), the applicable period referred to in the relevant subsection expires;

  • (c) the Minister issues a notice to the manufacturer under paragraph C.08.004(3)(b) or C.08.004.01(3)(b).

• (2) Subsection (1) does not apply to information in respect of a clinical trial that

  • (a) was not used by the manufacturer in the submission or supplement to support the proposed conditions of use for the new drug or the purpose for which the new drug is recommended; or

  • (b) describes tests, methods or assays that are used exclusively by the manufacturer.