Food and Drug Regulations (C.R.C., c. 870)
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Regulations are current to 2024-10-30 and last amended on 2024-06-17. Previous Versions
PART CDrugs (continued)
DIVISION 10Access to Drugs in Exceptional Circumstances (continued)
C.10.005 (1) The Minister may add a drug to the List of Drugs for Exceptional Importation and Sale only if the Minister has reasonable grounds to believe that
(a) there is a shortage or risk of shortage of another drug for which a notice of compliance has been issued under section C.08.004 or C.08.004.01 or for which a drug identification number has been assigned under subsection C.01.014.2(1); and
(b) the drug to be added to that list can be substituted for the drug referred to in paragraph (a).
(2) In subsection (1), shortage has the same meaning as in section C.01.014.8.
C.10.006 (1) A person who holds an establishment licence that authorizes the importation of a drug may import a designated drug if the following conditions are met:
(a) the licensee provides the Minister, electronically in a format specified by or acceptable to the Minister and not later than the third business day before the day on which the designated drug is imported, with a notification that contains the following information:
(i) the licensee’s name and contact information,
(ii) the name and contact information of each fabricator, packager/labeller and tester of the designated drug and the address of each building in which it is fabricated, packaged/labelled or tested,
(iii) in respect of the designated drug,
(A) its brand name,
(B) its medicinal ingredients,
(C) its dosage form,
(D) its strength,
(E) its route of administration,
(F) its identifying code or number, if any, assigned in the country in which it is authorized for sale, and
(G) a detailed description of its conditions of use,
(iv) the intended port of entry into Canada,
(v) the estimated date of arrival of the shipment of the designated drug, and
(vi) the total quantity of the designated drug that is intended to be imported on the date referred to in subparagraph (v);
(b) the designated drug is authorized to be sold by a foreign regulatory authority within its jurisdiction;
(c) the designated drug is in the same category as the category for which the establishment licence was issued;
(d) the following information is set out in the List of Drugs for Exceptional Importation and Sale in respect of the designated drug:
(i) the licensee’s name,
(ii) the information referred to in clauses (a)(iii)(A) to (F),
(iii) the name of the foreign regulatory authority referred to in paragraph (b), and
(iv) the date after which it may no longer be imported;
(e) the lot number of the designated drug is set out in the list referred to in paragraph (d), if applicable;
(f) the total quantity of the designated drug that the licensee imports does not exceed the maximum limit specified in the list referred to in paragraph (d) in respect of the drug, if applicable;
(g) the designated drug is imported on or before the date referred to in subparagraph (d)(iv); and
(h) the licensee has prepared a plan that specifies the measures to be taken in order for the licensee to comply with section C.10.011.
(2) In subsection (1), business day means a day other than
(a) a Saturday; or
(b) a Sunday or other holiday.
C.10.007 Sections A.01.040, A.01.044 and C.01.004.1 do not apply in respect of the importation, under section C.10.006, of a designated drug by a person who holds an establishment licence.
C.10.008 (1) Subject to sections C.10.009 and C.10.010, a sale of a designated drug that is imported under section C.10.006 is exempt from the following provisions:
(a) sections A.01.015, A.01.017 and A.01.051; and
(b) the provisions of Part C other than
(i) sections C.01.016, C.01.017, C.01.019 to C.01.020.1, C.01.040.3 to C.01.049.1 and C.01.051,
(ii) the provisions of Divisions 1A and 2, and
(iii) this section and sections C.10.009 to C.10.011.
(2) For greater certainty, for the purposes of section C.01.016, the manufacturer of a designated drug is required to comply only with the requirements set out in sections C.01.017 and C.01.019 in respect of the drug.
(3) Subsections (1) and (2) cease to apply in respect of the sale of a designated drug on its expiration date.
C.10.009 (1) Section C.02.019 does not apply to a person who holds an establishment licence in respect of a designated drug that they import under section C.10.006.
(2) The licensee shall perform the finished product testing on a sample of the designated drug that is taken either
(a) after receipt of each lot or batch of the designated drug on their premises in Canada; or
(b) before receipt of each lot or batch of the designated drug on their premises in Canada if the following conditions are met:
(i) the licensee has evidence satisfactory to the Minister to demonstrate that lots or batches of the designated drug sold to them by the vendor of the lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for that drug, and
(ii) the designated drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.
(3) In subsection (2), a reference to specifications is a reference to the specifications with which the designated drug is required to comply within the jurisdiction of the foreign regulatory authority referred to in paragraph C.10.006(1)(b).
(4) If the licensee receives on their premises in Canada a lot or batch of a designated drug whose useful life is more than 30 days, they shall visually inspect the lot or batch to confirm the identity of the product.
(5) Subsections (2) and (4) do not apply to the licensee if the designated drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and the following conditions are met:
(a) the address of the building is set out in their establishment licence; and
(b) they retain a copy of the batch certificate for each lot or batch of the designated drug that they receive for at least one year after the expiration date of the lot or batch.
(6) In this section, specifications has the same meaning as in section C.02.002.
C.10.010 (1) A person who holds an establishment license and who imports a designated drug under section C.10.006 is required to comply with paragraphs C.02.020(1)(a), (b) and (d) in respect of the drug but is not required to maintain the records referred to in those paragraphs on their premises in Canada.
(2) The Minister may request that the licensee provide to the Minister any of the records referred to in paragraphs C.02.020(1)(a), (b) or (d) in respect of the designated drug.
(3) The licensee shall provide the requested records electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister.
C.10.011 (1) A person who holds an establishment licence shall not sell a designated drug that they imported under section C.10.006 unless they ensure that the information referred to in clause C.10.006(1)(a)(iii)(G) is available in English and French and in a manner that permits the safe use of the drug.
(2) The licensee shall ensure that the information is available in accordance with subsection (1) until at least the end of the day on the latest expiration date of the designated drug that they imported.
DIVISION 11Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling
C.11.001 (1) The following definitions apply in this Division.
- foreign regulatory authority
foreign regulatory authority has the same meaning as in subsection C.10.001(1). (autorité réglementaire étrangère)
- initial public health official
initial public health official means the public health official named in an authorization issued under subsection C.11.003(1). (responsable de la santé publique initial)
- public health official
public health official means
(a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act;
(b) the Chief Medical Officer of Health, or equivalent, of a province;
(c) the Medical Officer of Health, or equivalent, of a municipality;
(d) the Surgeon General of the Canadian Armed Forces; or
(e) the Chief Medical Officer of Public Health for the Department of Indigenous Services. (responsable de la santé publique)
- subsequent public health official
subsequent public health official means any public health official, other than the initial public health official, who obtains the quantity of a drug, or a portion of the quantity, that is specified in an authorization issued under subsection C.11.003(1). (responsable de la santé publique subséquent)
(2) This Division applies to a drug for human use in dosage form for which a drug identification number has not been assigned under subsection C.01.014.2(1) or for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01, including drugs that have ceased to be considered to be natural health products by virtue of subsection 103.15(2) of the Natural Health Products Regulations.
C.11.002 (1) In order to address an actual, imminent or potential emergency, event or incident affecting public health or the health of members of the Canadian Armed Forces, a public health official may, on application to the Minister, obtain an authorization that permits a drug manufacturer to sell a specified quantity of a drug to the public health official, for immediate use or stockpiling or both.
(2) The application must
(a) set out the name of the public health official and include information setting out how they may be contacted at any time;
(b) set out the name of the manufacturer and include information setting out how they may be contacted at any time;
(c) describe the emergency, event or incident;
(d) state whether the drug is for immediate use or stockpiling or both;
(e) describe the use of the drug that is intended to address the emergency, event or incident;
(f) set out the civic address of the place to which the drug is to be shipped by the manufacturer;
(g) set out the following information about the drug:
(i) its brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark,
(ii) its medicinal ingredients,
(iii) its strength,
(iv) its dosage form,
(v) the recommended dosage for the use described under paragraph (e),
(vi) its recommended route of administration,
(vii) the indications that have been approved by any foreign regulatory authority, if applicable,
(viii) its contraindications,
(ix) a summary of its safety profile, and
(x) the recommended storage conditions for the drug;
(h) specify the quantity of the drug required to address the emergency, event or incident;
(i) include a statement by the public health official, accompanied by supporting information or documents, attesting that
(i) there is an actual, imminent or potential emergency, event or incident affecting public health or the health of the members of the Canadian Armed Forces that is likely to result, in humans, in a serious or life-threatening disease, disorder or abnormal physical state,
(ii) immediate action is or would likely be required to diagnose, treat, mitigate or prevent the disease, disorder or abnormal physical state or its symptoms,
(iii) conventional therapies, if any, have failed, are unsuitable or are unavailable in Canada at the time the application is made, and
(iv) the known and potential benefits associated with the use of the drug described under paragraph (e) outweigh the known and potential risks associated with that use;
(j) include any information or document available to the public health official concerning the safety, efficacy and quality of the drug in respect of the use described under paragraph (e), including information published in a medical or scientific journal; and
(k) set out the following information, if known by the public health official:
(i) the names of the foreign regulatory authorities that have authorized the sale of the drug in their jurisdictions for the same use as that described under paragraph (e),
(ii) the names of the foreign regulatory authorities that have received an application for authorization to sell the drug in their jurisdictions for the use described under paragraph (e) but that have not yet made a decision in respect of that application at the time the public health official makes the application under subsection (1), and
(iii) the names of the foreign regulatory authorities that have refused to authorize the sale of the drug in their jurisdictions for any use, as well as the reason for the refusal.
(3) The public health official must provide the Minister with any additional information or document that the Minister determines is necessary for the purpose of reviewing the application, by the date specified by the Minister.
- Date modified: