Food and Drug Regulations (C.R.C., c. 870)
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Regulations are current to 2023-05-17 and last amended on 2022-03-02. 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.
PART DVitamins, Minerals and Amino Acids
D.01.001 (1) In this Part,
advertise means to advertise to the general public; (faire de la publicité)
- brand name
brand name means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,
(a) that is assigned to the drug by its manufacturer,
(b) under which the drug is sold or advertised, and
(c) that is used to distinguish the drug; (marque nominative)
- common name
common name means, with reference to a salt or derivative of a vitamin, the name in English or French by which the salt or derivative is
(a) commonly known, and
(b) designated in scientific or technical journals; (nom usuel)
- human milk fortifier
human milk fortifier has the same meaning as in section B.25.001; (fortifiant pour lait humain)
- human milk substitute
human milk substitute has the same meaning as in section B.25.001; (succédané de lait humain)
- prepackaged product
prepackaged product means any food that is contained in a package in the manner in which it is ordinarily sold to, or used or purchased by, a person; (produit préemballé)
- reasonable daily intake
reasonable daily intake, in respect of a food named in an item in Column I of Schedule K, means the amount of that food set out in Column II of that item; (ration quotidienne normale)
- recommended daily intake
recommended daily intake[Repealed, SOR/2016-305, s. 61]
- supplemental ingredient
supplemental ingredient has the same meaning as in section B.01.001; (ingrédient supplémentaire)
- supplemented food
supplemented food has the same meaning as in section B.01.001; (aliment supplémenté)
- supplemented food facts table
supplemented food facts table has the same meaning as in subsection B.01.001(1); (tableau des renseignements sur les aliments supplémentés)
- Table of Daily Values
Table of Daily Values has the same meaning as in subsection B.01.001(1); (Tableau des valeurs quotidiennes)
- Table of Reference Amounts
Table of Reference Amounts has the same meaning as in subsection B.01.001(1); (Tableau des quantités de référence)
testimonial, with respect to a food or drug that is represented as containing a vitamin, mineral nutrient or mineral, means any dramatized or undramatized pictorial, written or oral representation as to the result that is, has been or may be produced by the addition to a person’s diet of that vitamin, mineral nutrient or mineral, as the case may be; (témoignage)
- weighted recommended nutrient intake
weighted recommended nutrient intake means, in respect of a vitamin or mineral nutrient, the amount of the vitamin or mineral nutrient set out in Table II to Division 1 and Table II to Division 2. (apport nutritionnel recommandé pondéré)
(2) For the purposes of this Part, a serving of stated size of a food shall be
(a) based on the food as offered for sale;
(b) in either of the following cases, the net quantity of the food in the package:
(i) if the quantity of food in the package can reasonably be consumed by one person at a single eating occasion, or
(ii) if the package contains less than 200% of the reference amount for the food; and
(c) in all other cases, the amount indicated for the food according to the criteria set out in column 3A of the Table of Reference Amounts.
(3) A serving of stated size of a food shall be expressed as follows:
(a) in the case of a single-serving prepackaged product to which paragraph (2)(b) applies, per package and using the following units:
(i) in grams, if the net quantity of the food is shown on the label by weight or by count, and
(ii) in millilitres, if the net quantity of the food is shown on the label by volume; and
(b) in the case of a multiple-serving prepackaged product to which paragraph (2)(c) applies, according to the following units set out in column 3B of the Table of Reference Amounts and according to the manner set out in that column:
(i) the household measure that applies to the product, and
(ii) the metric measure that applies to the product.
- SOR/88-559, s. 31
- SOR/93-202, s. 31
- SOR/96-259, s. 3
- SOR/2003-11, s. 27
- SOR/2016-305, s. 61
- SOR/2021-57, s. 17
- SOR/2022-169, s. 22
- Date modified: