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

Additional Information

C.03.308 If the information submitted under section C.03.307 is insufficient to enable the Minister to determine whether the sale or importation of the study drug should be authorized, the Minister may, by notice in writing, request the sponsor to provide any additional information that is necessary to make the determination and that is relevant to the study drug, the study or the protocol, by the date specified in the notice.

Authorization

C.03.309 After examining the application and any additional information, the Minister shall authorize the sponsor to sell or import the study drug if she or he determines that the application complies with the requirements of section C.03.307, and shall send a notice of that decision to the sponsor that specifies the study sites in respect of which the sale or importation are authorized.

Notice

C.03.310 The sponsor shall notify the Minister in writing of the day on which the sale or importation of the study drug is intended to start in respect of each study site, not later than 15 days before that day.

Good Clinical Practices

C.03.311 A sponsor shall ensure that each study is conducted in accordance with good clinical practices and that

• (a) the study is scientifically sound and clearly described in its protocol;

• (b) the study is conducted, and the study drug is used, in accordance with the protocol and with these Regulations;

• (c) systems and procedures are implemented that assure the quality of every aspect of the study;

• (d) at each study site, there is only one qualified investigator;

• (e) at each study site, medical care and medical decisions, in respect of the study, are under the supervision of the qualified investigator;

• (f) each individual who is involved in the conduct of the study is qualified by their education, training and experience to perform their respective tasks;

• (g) before a study subject participates in the study, a copy of their signed consent form is included in the records for the study;

• (h) the requirements respecting information and records set out in section C.03.315 are met; and

• (i) the study drug is manufactured, handled and stored in accordance with Division 2, other than sections C.02.019, C.02.025 and C.02.026.

Labelling

C.03.312 Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the study drug

• (a) bears an inner label that sets out both of the following:

  • (i) the unique batch number for the study drug, and

  • (ii) the radiation warning symbol set out in Schedule 3 to the Radiation Protection Regulations and the words “RAYONNEMENT — DANGER — RADIATION”; and

• (b) is accompanied by a package insert that sets out all of the following information:

  • (i) a statement that indicates that the study drug is to be used only under the supervision of a qualified investigator,

  • (ii) the chemical or generic name of the active ingredients in the study drug,

  • (iii) the name and civic address of the manufacturer,

  • (iv) the name and civic address of the sponsor,

  • (v) the code or other identification of the protocol,

  • (vi) the warnings and precautions in respect of the use of the study drug, and

  • (vii) a list of the possible adverse reactions that are associated with the use of the study drug.

Submission of Information

• C.03.313 (1) On the Minister’s written request, a sponsor shall submit, within the period specified in the request, information to establish the safety of the study drug if the Minister has reason to believe any of the following:

  • (a) the use of the study drug may endanger the health of a study subject or other person;

  • (b) the study may be contrary to the best interests of the study subjects;

  • (c) a qualified investigator is not respecting their undertaking made under paragraph C.03.315(3)(f); or

  • (d) information submitted in respect of the study drug or study is false or misleading.

• (2) The Minister may, by notice in writing, require the sponsor to provide the Minister with any information or records referred to in subsection C.03.315(3) to assess the safety of the study drug or the health of the study subjects or other persons, by the date specified in the notice.

Adverse Reaction Reporting

• C.03.314 (1) During the course of a study, the sponsor shall notify the Minister of any serious adverse reaction or serious unexpected adverse reaction that occurs inside or outside Canada, within the following period:

  • (a) if the adverse reaction is fatal or life-threatening, within seven days after becoming aware of it; or

  • (b) if the adverse reaction is not fatal or life-threatening, within 15 days after becoming aware of it.

• (2) The sponsor shall, within eight days after having notified the Minister under subsection (1), file with the Minister a complete report in respect of the adverse reaction, including an assessment of the importance and implication of the findings.

• (3) Sections C.01.016 to C.01.020 do not apply to study drugs.

Records

• C.03.315 (1) The sponsor shall record, handle and store all information in respect of a study in a way that allows it to be reported completely and accurately and to be interpreted and verified.

• (2) The sponsor shall maintain complete and accurate records to establish that the study is conducted in accordance with these Regulations.

• (3) The sponsor shall maintain all of the following records in respect of the use of the study drug in each study:

  • (a) records respecting all adverse reactions that occur inside or outside Canada, including the indications for use and the dosage form of the study drug at the time of the adverse reaction;

  • (b) written procedures for subject monitoring and for the documentation and reporting of adverse reactions;

  • (c) articles from scientific journals or other publications that were used in support of the safety profile of the study drug in respect of humans;

  • (d) records in respect of each study subject, including respecting their enrolment, a copy of their signed consent form and sufficient information to enable them to be identified and contacted in the event that the sale of the study drug may endanger their health or that of another person;

  • (e) records respecting the shipment, receipt, sale, return and destruction or other disposition of the study drug;

  • (f) for each study site, an undertaking, dated and signed by the qualified investigator before the start of the study, that they will

    • (i) conduct the study in accordance with good clinical practices, and

    • (ii) on discontinuance of the study by the sponsor, for any reason related to health or safety, immediately inform both the study subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of study subjects or other persons;

  • (g) for each study site, a copy of the informed consent form; and

  • (h) for each study site, a copy of the certifying statement described in paragraph C.03.307(2)(q), of the protocol for the study and of the statement of the risks and anticipated benefits arising to the health of study subjects as a result of participating in the study that is set out in the informed consent form.

• (4) The sponsor shall maintain all records for five years after the day on which the study ends.

Discontinuance of a Study

• C.03.316 (1) If a sponsor discontinues a study in its entirety or at a study site, the sponsor shall notify all qualified investigators of the discontinuance as soon as possible in writing, and include in the notice the reasons for the discontinuance and whether the study presented any risks to the health of study subjects or other persons.

• (2) If the discontinuance is for reasons that would affect the health or safety of study subjects or other persons, the sponsor shall notify the Minister in writing within 15 days after the discontinuance, and include in the notice the reasons for the discontinuance and whether it will have an impact on any proposed or ongoing studies in respect of the study drug in Canada by the sponsor.

Suspension

• C.03.317 (1) The Minister shall suspend an authorization to sell or import a study drug, in its entirety or in respect of a study site, in any of the following circumstances:

  • (a) information provided by the sponsor under section C.03.307, C.03.308 or C.03.313 proves to be inaccurate or incomplete;

  • (b) the sponsor fails to provide the Minister with sufficient information to establish the safety of the study drug pursuant to a written request under section C.03.313, by the date specified in the request;

  • (c) the sponsor fails to notify the Minister of an adverse reaction or file a report in respect of an adverse reaction in accordance with section C.03.314; or

  • (d) the sponsor contravenes a provision of these Regulations or any provision of the Act in relation to the study drug.

• (2) In determining whether to suspend an authorization in its entirety or in respect of a study site, the Minister shall consider whether the reason for the suspension affects the study in its entirety or affects only a certain study site.

• (3) Before suspending an authorization, the Minister shall send the sponsor a notice that

  • (a) specifies whether the suspension is of the study authorization in its entirety or in respect of a study site and sets out the reasons for the proposed suspension and the effective date;

  • (b) if applicable, specifies the corrective action that the sponsor must take and the period within which it must be taken; and

  • (c) gives the sponsor a reasonable opportunity to be heard in writing concerning the proposed suspension.

• (4) Despite subsection (3), the Minister shall immediately suspend an authorization if she or he has reason to believe that it is necessary to do so to prevent injury to the health of a study subject or any other person.

• (5) When the Minister suspends an authorization under subsection (4), the Minister must send the sponsor a notice that

  • (a) sets out the reasons for the suspension;

  • (b) if applicable, specifies the corrective action that the sponsor must take and the period within which it must be taken; and

  • (c) gives the sponsor a reasonable opportunity to be heard in writing concerning the suspension.

Reinstatement

• C.03.318 (1) Subject to subsection (2), the Minister shall reinstate the authorization if the sponsor provides the Minister with sufficient evidence to establish that the study does not present a risk of injury to the health of study subjects or other persons, within the following periods:

  • (a) in the case of a suspension under subsection C.03.317(1), 30 days after the day on which the suspension is effective; or

  • (b) in the case of a suspension under subsection C.03.317(4), the period specified in the notice sent under subsection C.03.317(5).

• (2) If the Minister does not reinstate any part of an authorization that was suspended, the Minister shall amend the authorization to remove that part.

Cancellation

• C.03.319 (1) The Minister shall cancel an authorization, in its entirety or in respect of a study site, in either of the following circumstances:

  • (a) the study is discontinued in its entirety or at that study site by the sponsor under section C.03.316; or

  • (b) the sponsor fails to provide the Minister with the evidence required by subsection C.03.318(1) within the specified period.

• (2) When the Minister cancels all or part of an authorization, she or he shall send the sponsor a notice that sets out the reasons for the cancellation and the effective date.

DIVISION 4

Schedule D Drugs

C.04.001 In this Division,

date of manufacture

date of manufacture means

• (a) in the case of a product for which a standard of potency exists, the date it satisfactorily passes a potency test,

• (b) in the case of an animal product for which no standard of potency exists, the date of its removal from the animal, and

• (c) in the case of a product other than an animal product for which no standard of potency exists, the date of cessation of growth; (date de fabrication)

drug

drug means a drug that is listed in Schedule D to the Act that is in dosage form or a drug that is an active ingredient that can be used in the preparation of a drug listed in that Schedule; (drogue)

licence

licence or Canadian licence[Repealed, SOR/97-12, s. 31]

manufacturer

manufacturer [Repealed, SOR/97-12, s. 31]

C.04.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division.

C.04.002 This Division does not apply to a drug in oral dosage form that contains micro-organisms if the drug is recommended solely for restoring, normalizing or stabilizing the intestinal flora.

C.04.003 The date of issue of a drug shall be the date on which the finished product is removed from cold storage but in any case shall be, not later than

• (a) six months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 10°C;

• (b) 12 months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 5°C; or

• (c) two years after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 0°C.

C.04.004 to C.04.006 [Repealed, SOR/97-12, s. 34]

C.04.007 [Repealed, SOR/97-12, s. 67]

C.04.008 to C.04.012 [Repealed, SOR/97-12, s. 36]