PART CDrugs (continued)
DIVISION 1 (continued)
Prescription Drugs (continued)
C.01.048 (1) If a physician, dentist, veterinary surgeon or pharmacist registered and entitled to practise their profession in a province has signed an order specifying the proper name or common name, the brand name and the quantity of a drug, other than the following, the person who receives the order may distribute the drug as a sample to the physician, dentist, veterinary surgeon or pharmacist if the drug is labelled in accordance with these Regulations:
(b) a controlled drug as defined in subsection G.01.001(1);
(c) a new drug in respect of which a notice of compliance has not been issued under section C.08.004; or
(2) An order referred to in subsection (1) may provide that the order be repeated at specified intervals during any period not exceeding six months.
- SOR/93-202, s. 9
- SOR/97-228, s. 2
- SOR/2018-144, s. 366
C.01.049 A person who, under section C.01.048, distributes a drug as a sample shall
(a) maintain records showing
(b) keep those records and all orders received for drugs in accordance with section C.01.048 for a period of not less than two years from the date upon which the distribution referred to in the records was made.
- SOR/93-202, s. 10
Information — Serious Risk of Injury to Human Health
(2) The holder of a therapeutic product authorization in respect of a drug that is part of a class of drugs set out in subsection (4) shall provide the Minister with information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the drug, regarding
(a) risks that have been communicated by any foreign regulatory authority that is set out in Part A of the List of Foreign Regulatory Authorities for the Purposes of Section C.01.050 of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a drug within the jurisdiction of such an authority, and the manner of the communication;
(b) changes that have been made to the labelling of any drug and that have been communicated to or requested by any foreign regulatory authority that is set out in Part B of the list referred to in paragraph (a); and
(c) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any drug, that have taken place within the jurisdiction of any foreign regulatory authority that is set out in Part C of the list referred to in paragraph (a).
(3) The information shall be provided to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.
(4) The classes of drugs are
(a) prescription drugs;
(b) drugs that are required to be sold under a prescription by Part G, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations; and
(c) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner.
(5) Despite subsection (2), a holder of a therapeutic product authorization who provided information in accordance with
(a) paragraph (2)(a) is not required to provide the same information again under that paragraph in the case where the holder receives or becomes aware of that information in respect of a foreign regulatory authority or person referred to in that paragraph; or
(b) paragraph (2)(b) or (c) is not required to provide the same information again under that paragraph in the case where the holder receives or becomes aware of that information in respect of a foreign regulatory authority referred to in that paragraph.
(6) In this section, 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.
- SOR/2018-84, s. 2
C.01.051 Where a manufacturer who sells a drug in dosage form or a person who imports into and sells in Canada a drug in dosage form commences a recall of the drug, the manufacturer or importer shall forthwith submit to the Minister the following information:
(a) the proper name of the drug, the common name of the drug if there is no proper name, the brand name of the drug and the lot number;
(b) in the case of an imported drug, the names of the manufacturer and importer;
(c) the quantity of the drug manufactured or imported;
(d) the quantity of the drug distributed;
(e) the quantity of the drug remaining on the premises of the manufacturer or importer;
(f) the reasons for initiating the recall; and
(g) a description of any other action taken by the manufacturer or importer with respect to the recall.
- SOR/82-524, s. 2
- SOR/93-202, s. 11
- SOR/2018-69, s. 27
Assessments Ordered Under Section 21.31 of the Act
(a) the order shall relate to a drug;
(b) the person to whom the order is made shall be the holder of one or more of the following therapeutic product authorizations in respect of the drug:
(c) the Minister shall have reasonable grounds to believe that
(i) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(i) or (iii), the benefits or risks of injury to health associated with the drug are significantly different than they were when the authorization was issued,
(ii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(ii) who is an importer, the manner in which one or more of the following activities is conducted may present a risk of injury to health associated with the drug:
(iii) in the case of a holder of a therapeutic product authorization referred to in subparagraph (b)(ii) other than an importer, the manner in which an activity that is authorized under the authorization is conducted may present a risk of injury to health associated with the drug.
(2) The Minister shall, after examining the results of an assessment that was ordered under section 21.31 of the Act,
(a) provide the holder of the therapeutic product authorization with the results of the examination; and
(b) ensure that a summary of the results of the examination, together with a description of any steps that the Minister has taken or may take as a consequence of the examination, is published on the Government of Canada website.
- SOR/2018-84, s. 3
- Date modified: