PART CDrugs (continued)
DIVISION 8 (continued)
New Drugs (continued)
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.
- SOR/95-411, s. 11;
- SOR/95-521, s. 4;
- SOR/2014-125, s. 3;
- SOR/2018-84, s. 12.
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.
- SOR/2011-88, s. 20.
(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.
- SOR/95-411, s. 12;
- SOR/2001-203, s. 9;
- SOR/2011-88, s. 21.
Sale of New Drug for Emergency Treatment
C.08.010 (1) The Minister may issue a letter of authorization authorizing the sale of a quantity of a new drug for human or veterinary use to a practitioner named in the letter of authorization for use in the emergency treatment of a patient under the care of that practitioner, if
(a) the practitioner has supplied to the Minister information concerning
(b) the practitioner has agreed to
(1.1) The Minister shall not issue a letter of authorization under subsection (1) for a new drug that is or that contains a restricted drug as defined in section J.01.001.
(2) The Minister shall, in any letter of authorization issued pursuant to subsection (1), state
- SOR/2013-172, s. 11;
- SOR/2018-69, ss. 31(E), 32(F).
C.08.011 (1) Notwithstanding section C.08.002, a manufacturer may sell to a practitioner named in a letter of authorization issued pursuant to section C.08.010, a quantity of the new drug named in that letter that does not exceed the quantity specified in the letter.
(2) A sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations.
Sale of Medicated Feeds
(a) as regards the drug or drugs used as the medicating ingredient of the medicated feed,
(b) the medicated feed is for the treatment of animals under the direct care of the veterinary practitioner who signed the prescription;
(c) the medicated feed is for therapeutic purposes only; and
(d) the written prescription contains the following information:
(i) the name and address of the person named on the prescription as the person for whom the medicated feed is to be mixed,
(ii) the species, production type and age or weight of the animals to be treated with the medicated feed,
(iii) the type and amount of medicated feed to be mixed,
(iv) the proper name, or the common name if there is no proper name, of the drug or each of the drugs, as the case may be, to be used as medicating ingredients in the preparation of the medicated feed, and the dosage levels of those medicating ingredients,
(v) any special mixing instructions, and
(vi) labelling instructions including
(2) For the purpose of this section, medicated feed has the same meaning as in the Feeds Regulations.
- SOR/80-741, s. 1;
- SOR/92-130, s. 1;
- SOR/93-202, s. 27;
- SOR/2018-69, s. 27.
- Date modified: