Food and Drug Regulations
C.08.010 (1) The Minister may issue a letter of authorization to a manufacturer of a new drug authorizing the sale of a specified quantity of the new drug for human or veterinary use to a practitioner, for use in the emergency treatment of an animal or a person under the care of that practitioner, if
(a) the practitioner provides the following information to the Minister:
(i) the name of the new drug and details concerning the medical emergency for which the new drug is required,
(ii) the quantity of the new drug that is required,
(iii) subject to subsection (2), the information in the possession of the practitioner in respect of the use, safety and efficacy of the new drug,
(iv) the name and the civic address of the person to whom the new drug is to be shipped, and
(v) any other information the Minister may request to enable the Minister to determine whether to issue the letter of authorization;
(b) the practitioner agrees to
(i) provide a report to the manufacturer of the new drug and to the Minister describing the results obtained following the use of the new drug to address the medical emergency, including information respecting any adverse drug reactions observed by the practitioner, and
(ii) account to the Minister, on request, for all quantities of the new drug received;
(c) in the case of a new drug for human use, the person referred to in subparagraph (a)(iv) is a practitioner or a pharmacist; and
(d) in the case of a new drug for veterinary use, the person referred to in subparagraph (a)(iv) is a practitioner, a pharmacist or a person who may sell a medicated feed pursuant to section C.08.012.
(2) Subparagraph (1)(a)(iii) does not apply if the following conditions are met:
(a) the sale of the new drug has been authorized under subsection (1) to address the same medical emergency on at least one previous occasion;
(b) the European Medicines Agency or the United States Food and Drug Administration has authorized the sale of the new drug without terms or conditions, for the same use in its jurisdiction; and
(c) the Minister has not cancelled the assignment of a drug identification number for the new drug under paragraph C.01.014.6(2)(b) or (c) or subsection C.01.014.6(3).
(3) The Minister must not issue a letter of authorization for a new drug that is or that contains a restricted drug as defined in section J.01.001.
(4) The letter of authorization must contain the following information:
(a) the name of the practitioner to whom the new drug may be sold;
(b) the name and the civic address of the person to whom the new drug may be shipped;
(c) the name of the new drug and the medical emergency in respect of which it may be sold; and
(d) the quantity of the new drug that may be sold to the practitioner to address the medical emergency.
(5) For the purposes of this section, the practitioner is not required to know the identity of the animal or the person under the care of that practitioner at the time the letter of authorization is issued.
- SOR/2013-172, s. 11
- SOR/2018-69, ss. 31(E), 32(F)
- SOR/2020-212, s. 2
- Date modified: