Regulations Amending Certain Department of Health Regulations (Miscellaneous Program): SOR/2018-69

Canada Gazette, Part II: Volume 152, Number 8

Registration

April 4, 2018

FOOD AND DRUGS ACT RADIATION EMITTING DEVICES ACT CONTROLLED DRUGS AND SUBSTANCES ACT CANADA CONSUMER PRODUCT SAFETY ACT FINANCIAL ADMINISTRATION ACT

P.C. 2018-399 April 3, 2018

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health with respect to sections 1 to 81 and 86 of the annexed Regulations, and on the recommendation of the Treasury Board and the Minister of Health with respect to sections 82 to 85 and 87 of the annexed Regulations, makes the annexed Regulations Amending Certain Department of Health Regulations (Miscellaneous Program), pursuant to

• (a) subsection 30(1) ^footnotea of the Food and Drugs Act ^footnoteb;
• (b) paragraph 19.1(a) ^footnotec and subsection 23(2.1) ^footnoted of the Financial Administration Act ^footnotee;
• (c) subsection 13(1) ^footnotef of the Radiation Emitting Devices Act ^footnoteg;
• (d) subsection 55(1) ^footnoteh of the Controlled Drugs and Substances Act ^footnotei; and
• (e) subsection 37(1) ^footnotej of the Canada Consumer Product Safety Act ^footnotek.

Regulations Amending Certain Department of Health Regulations (Miscellaneous Program)

Food and Drugs Act

Food and Drug Regulations

1 The definition Director in section A.01.010 of the Food and Drug Regulations ^footnote1 is repealed.

2 Subsection A.01.061(3) of the Regulations is replaced by the following:

(3) The requirements of subsections (1) and (2) do not apply in relation to a drug or food if the Minister determines that the design of the container, the materials used in its construction or the incorporation of a safety device eliminate its potential hazard.

3 Paragraph B.01.466(1)(b) of the French version of the Regulations is replaced by the following:

• b) une notice d’accompagnement;

4 The portion of section B.14.009 of the French version of the Regulations before paragraph (a) is replaced by the following:

B.14.009 [N]. La marinade, la saumure et le mélange de salaison à sec employés dans le marinage des viandes conservées et des sous-produits de viande conservés peuvent renfermer :

5 The portion of section B.14.031 of the French version of the Regulations before paragraph (a) is replaced by the following:

B.14.031 [N]. La viande conservée et les sous-produits de viande conservés sont faits de viande crue ou cuite ou d’un sous-produit de viande crue ou cuite, qui ont été salés, asséchés, marinés, saumurés ou fumés et peuvent être garnis d’une glace et renfermer :

6 The portion of section B.21.006 of the Regulations before paragraph (a) is replaced by the following:

B.21.006 [S]. Prepared fish or prepared meat shall be the whole or minced food prepared from fresh or preserved fish or meat respectively, may be canned or cooked, and may,

7 Section B.21.007 of the French version of the Regulations is replaced by the following:

B.21.007 [N]. Le liant à poisson devant servir dans ou sur le poisson ou la chair préparés est du remplissage auquel on a ajouté n’importe quel mélange de sel, de sucre, de dextrose, de glucose, d’épices ou d’autres condiments.

8 The portion of section B.21.021 of the French version of the Regulations before paragraph (a) is replaced by the following:

B.21.021 [N]. Le poisson conservé et la chair conservée sont du poisson ou de la chair, à l’état cru ou cuit, qui ont été desséchés, salés, marinés, saumurés ou fumés, et peuvent renfermer un agent de conservation de la catégorie I, un agent de conservation de la catégorie II, du dextrose, du glucose, des épices, du sucre et du vinaigre, et :

9 Section B.22.016 of the French version of the Regulations is replaced by the following:

B.22.016 Aux fins des articles B.22.017 à B.22.019, viande de volaille pour ragoût s’entend de la viande de volaille cuite ou crue contenant au plus 15 % de gras, calculés d’après le poids de la viande crue.

10 The portion of section B.22.021 of the French version of the Regulations before paragraph (a) is replaced by the following:

B.22.021 [N]. La viande de volaille conservée et les sous-produits de viande de volaille conservés sont de la viande de volaille ou des sous-produits de viande de volaille crus ou cuits, qui ont été salés ou fumés et qui peuvent renfermer :

11 Subsection B.24.017(2) of the Regulations is replaced by the following:

(2) If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing.

12 Subsection B.25.060(2) of the Regulations is replaced by the following:

(2) If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing.

13 Paragraph C.01.004.02(6)(b) of the Regulations is replaced by the following:

• (b) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner; and

14 Section C.01.010 of the French version of the Regulations is replaced by the following:

C.01.010 S’il y a lieu de fournir le mode d’emploi approprié et sûr d’une drogue à usage parentéral ou d’une drogue sur ordonnance qui sert au traitement ou à la prophylaxie d’une maladie, d’un désordre ou d’un état physique anormal mentionnés à l’annexe A de la Loi, les étiquettes de la drogue, notamment toute notice d’accompagnement et toute documentation supplémentaire sur l’emploi de la drogue qui est fournie sur demande, peuvent faire mention de cette maladie, de ce désordre ou de cet état, et la drogue est exemptée à cet égard de l’application des paragraphes 3(1) et (2) de la Loi.

15 Subsection C.01.013(2) of the Regulations is replaced by the following:

(2) If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing.

16 Subsections C.01.014.2(2) and (3) of the Regulations are replaced by the following:

(2) Where the Minister believes on reasonable grounds that a product in respect of which an application referred to in section C.01.014.1 has been made

• (a) is not a drug, or
• (b) is a drug but that its sale would cause injury to the health of the consumer or purchaser or would be a violation of the Act or these Regulations,

he or she may refuse to issue the document referred to in subsection (1).

(3) Where the Minister, pursuant to subsection (2), refuses to issue the document, the applicant may submit additional information and request the Minister to reconsider his or her decision.

17 Subparagraph (a)(iv) of the definition drug in section C.01.014.8 of the Regulations is replaced by the following:

• (iv) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner; or

18 Section C.01.032 of the French version of the Regulations is amended by replacing, with any necessary modifications, “feuillet inséré dans son emballage” with “notice d’accompagnement”.

19 Subparagraph C.01.062(5)(e)(ii) of the French version of the Regulations is replaced by the following:

• (ii) qui possède bien les propriétés que les étiquettes, notamment toute notice d’accompagnement et toute documentation supplémentaire sur l’emploi de la drogue qui est fournie sur demande, s’y rapportant lui attribuent,

20 Section C.01.609 of the Regulations is replaced by the following:

C.01.609 Despite paragraph C.01.401(a), the potency of an antibiotic in amounts greater than 50 parts per million contained in a medicated feed registered under the Feeds Act may be declared in grams per tonne.

21 (1) The portion of subsection C.03.203(1) of the French version of the Regulations before paragraph (a) is replaced by the following:

C.03.203 (1) Un générateur de radionucléide porte sur son étiquette intérieure, à la fois :

(2) Paragraph C.03.203(1)(l) of the French version of the Regulations is replaced by the following:

• l) le mode d’emploi complet ou le renvoi à une notice d’accompagnement qui indique ces renseignements;

22 Subsection C.03.203(2) of the French version of the Regulations is replaced by the following:

(2) Les alinéas (1)i) et j) du présent article ne s’appliquent pas lorsque les renseignements qu’ils exigent apparaissent sur une notice d’accompagnement d’un générateur de radionucléide.

23 Paragraph C.03.207(g) of the French version of the Regulations is replaced by the following:

• g) le mode d’emploi approprié ou le renvoi à une notice d’accompagnement.

24 Paragraph C.03.312(b) of the French version of the Regulations is replaced by the following:

• b) dans la notice d’accompagnement de la drogue destinée à l’étude.

25 Subsection C.08.015(2) of the Regulations is replaced by the following:

(2) If, on receipt of the information and material submitted under section C.08.014, the Minister is not satisfied that the requirements of paragraphs (1)(a), (b) and (c) have been met, he or she shall refuse to issue an experimental studies certificate.

26 Subsection C.08.018(1) of the Regulations is replaced by the following:

C.08.018 (1) If the Minister determines that it is necessary in order to safeguard animal health or public health or to promote public safety, he or she may suspend for a definite or indefinite period or cancel an experimental studies certificate.

27 The Regulations are amended by replacing “Director” with “Minister” in the following provisions:

• (a) the definitions acceptable method and official method in section A.01.010;
• (b) sections A.01.011 and A.01.012;
• (c) subparagraph A.01.024(b)(i);
• (d) paragraphs A.01.044(2)(a) and (b);
• (e) section B.01.054;
• (f) paragraph B.16.002(c);
• (g) subsections B.24.017(1) and (3);
• (h) subsections B.24.305(1) and (3);
• (i) subsections B.24.306(1) and (3);
• (j) subsections B.25.046(1) and (3);
• (k) subsections B.25.048(1) and (3);
• (l) subsections B.25.060(1) and (3);
• (m) section B.26.005;
• (n) section B.27.004;
• (o) subsection B.28.002(1);
• (p) section B.28.003;
• (q) subsection C.01.005(1);
• (r) paragraph C.01.012(b);
• (s) subsections C.01.013(1) and (3);
• (t) the portion of subsection C.01.014.1(2) before paragraph (a);
• (u) subsections C.01.014.2(1) and (4);
• (v) sections C.01.014.4 to C.01.014.6;
• (w) paragraph C.01.036(1)(c);
• (x) the portion of section C.01.051 before paragraph (a);
• (y) paragraphs C.01.065(b) and (c);
• (z) subparagraph C.01.606(b)(i);
• (z.1) section C.01.611;
• (z.2) section C.02.006;
• (z.3) sections C.02.009 and C.02.010;
• (z.4) sections C.02.016 and C.02.017;
• (z.5) clauses C.02.019(1)(b)(i)(A) and (B);
• (z.6) subsection C.02.020(2);
• (z.7) section C.03.012;
• (z.8) section C.04.015;
• (z.9) paragraph C.04.070(a);
• (z.10) section C.04.102;
• (z.11) section C.04.127;
• (z.12) paragraph C.04.128(a);
• (z.13) sections C.04.131 and C.04.132;
• (z.14) section C.04.134;
• (z.15) paragraph C.04.555(1)(c);
• (z.16) paragraph C.04.561(1)(c);
• (z.17) paragraph C.04.567(1)(c);
• (z.18) paragraph C.04.573(1)(c);
• (z.19) paragraph C.04.580(1)(c);
• (z.20) paragraph C.04.588(1)(c);
• (z.21) paragraph C.04.595(1)(c);
• (z.22) paragraph C.04.601(1)(c);
• (z.23) section C.04.676;
• (z.24) paragraph C.08.005(1)(b), subparagraph (1)(e)(iii) and paragraphs (2)(a) and (b);
• (z.25) paragraph C.08.006(2)(f);
• (z.26) sections C.08.012 to C.08.014;
• (z.27) subsection C.08.015(1);
• (z.28) section C.08.017;
• (z.29) the portion of subsection C.08.018(2) before paragraph (a); and
• (z.30) paragraph D.02.011(b).

28 The French version of the Regulations is amended by replacing “râpage” with “broyage” in the following provisions:

• (a) subparagraphs B.08.040(1)(a)(i) and (ii);
• (b) subparagraph B.08.041(1)(a)(i);
• (c) subparagraph B.08.041.1(1)(a)(i);
• (d) subparagraph B.08.041.2(1)(a)(i);
• (e) subparagraph B.08.041.3(1)(a)(i);
• (f) subparagraph B.08.041.4(1)(a)(i);
• (g) subparagraphs B.08.041.5(1)(a)(i) and (ii);
• (h) subparagraph B.08.041.6(1)(a)(i);
• (i) subparagraph B.08.041.7(1)(a)(i); and
• (j) subparagraph B.08.041.8(1)(a)(i).

29 The French version of the Regulations is amended by replacing “feuillets à insérer dans l’emballage” with “notices d’accompagnement” in the following provisions:

• (a) paragraph B.24.305(2)(l); and
• (b) paragraph B.24.306(2)(f).

30 The French version of the Regulations is amended by replacing “feuillets insérés dans l’emballage” with “notices d’accompagnement” in the following provisions:

• (a) paragraph B.25.046(2)(l); and
• (b) paragraph B.25.048(2)(f).

31 The English version of the Regulations is amended by replacing “Director” with “Minister” in the following provisions:

• (a) subsection C.01.011(3);
• (b) paragraphs C.04.555(1)(a) and (b);
• (c) paragraphs C.04.561(1)(a) and (b);
• (d) paragraphs C.04.567(1)(a) and (b);
• (e) paragraphs C.04.573(1)(a) and (b);
• (f) section C.04.578;
• (g) paragraphs C.04.580(1)(a) and (b);
• (h) paragraphs C.04.588(1)(a) and (b);
• (i) section C.04.593;
• (j) paragraphs C.04.595(1)(a) and (b);
• (k) paragraphs C.04.601(1)(a) and (b); and
• (l) section C.08.010.

32 The French version of the Regulations is amended by replacing “Directeur général” with “ministre” in the following provisions:

• (a) subsection C.01.011(3);
• (b) paragraphs C.04.555(1)(a) and (b);
• (c) paragraphs C.04.561(1)(a) and (b);
• (d) paragraphs C.04.567(1)(a) and (b);
• (e) paragraphs C.04.573(1)(a) and (b);
• (f) section C.04.578;
• (g) paragraphs C.04.580(1)(a) and (b);
• (h) paragraphs C.04.588(1)(a) and (b);
• (i) section C.04.593;
• (j) paragraphs C.04.595(1)(a) and (b);
• (k) paragraphs C.04.601(1)(a) and (b); and
• (l) section C.08.010.

33 The French version of the Regulations is amended by replacing, with any necessary modifications, “dépliant” with “notice” in the following provisions:

• (a) paragraphs C.01.014.1(2)(m) and (m.1);
• (b) paragraphs C.08.002(2)(j) and (j.1); and
• (c) paragraph C.08.003(3.1)(a) and subparagraph (3.1)(b)(ii).

34 The French version of the Regulations is amended by replacing, with any necessary modifications, “dépliant compris dans l’emballage” with “notice d’accompagnement” in the following provisions:

• (a) paragraph C.01.131(b); and
• (b) section C.01.134.

35 The French version of the Regulations is amended by replacing, with any necessary modifications, “prospectus d’emballage” with “notice d’accompagnement” in the following provisions:

• (a) paragraph C.01.433(b);
• (b) subparagraph C.03.202(1)(b)(iv); and
• (c) subsection C.03.202(3).

36 The French version of the Regulations is amended by replacing, with any necessary modifications, “prospectus de conditionnement” with “notice d’accompagnement” in the following provisions:

• (a) paragraphs C.03.208(k) and (n); and
• (b) the portion of section C.03.209 before paragraph (a).

Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form)

37 (1) Subsection 5(1) of the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) ^footnote2 is amended by replacing the portion of the subsection C.01.014.2(1) before paragraph (a) that it enacts with the following:

C.01.014.2 (1) Subject to subsection (2), if a manufacturer has provided all the information and material described in subsection C.01.014.1(2) or section C.08.002, C.08.002.01 or C.08.002.1, as the case may be, in respect of a drug, the Minister shall issue to the manufacturer a document that

(2) Subsection 5(2) of the Regulations is amended by replacing the subparagraph C.01.014.2(1)(a)(ii) that it enacts with the following:

• (ii) if there are two or more brand names for the drug, the drug identification numbers assigned by the Minister for the drug, each of which pertains to one of the brand names and is preceded by the abbreviation “DIN”; and
  

(3) Subsection 5(3) of the Regulations is amended by replacing the portion of the subsection C.01.014.2(2) before paragraph (a) that it enacts with the following:

(2) The Minister may refuse to issue the document referred to in subsection (1) if he or she has reasonable grounds to believe that the product in respect of which an application referred to in section C.01.014.1 has been made

(4) Subsection 5(6) of the Regulations is amended by replacing the subsections C.01.014.2(3) and (4) that it enacts with the following:

(3) If the Minister refuses to issue the document under subsection (2), the manufacturer may submit additional information or material and request the Minister to reconsider his or her decision.

(4) On the basis of the additional information or material submitted under subsection (3), the Minister shall reconsider the grounds on which the refusal to issue the document was made.

38 Section 6 of the Regulations is amended by replacing the section C.01.014.3 that it enacts with the following:

C.01.014.3 The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, within 30 days after the day on which the drug is first sold following the issuance by the Minister of the document, date and sign the document and return it to the Minister with a statement set out on it that the information it contains is correct and with an indication of the date of that first sale.

39 (1) Section 7 of the Regulations is amended by replacing the portion of the subsection C.01.014.5(1) before paragraph (a) that it enacts with the following:

C.01.014.5 (1) The manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for a drug shall, annually before the first day of October and in a form established by the Minister, provide the Minister with a notification that is signed by them and that

(2) Section 7 of the Regulations is amended by replacing the portion of the subsection C.01.014.6(1) before paragraph (a) that it enacts with the following:

C.01.014.6 (1) The Minister shall cancel the assignment of a drug identification number if

(3) Section 7 of the Regulations is amended by replacing the paragraph C.01.014.6(1)(c) that it enacts with the following:

• (c) the Minister determines that the product for which the drug identification number has been assigned is not a drug.

(4) Section 7 of the Regulations is amended by replacing the portion of the subsection C.01.014.6(2) before paragraph (a) that it enacts with the following:

(2) The Minister may cancel the assignment of a drug identification number if the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number

40 Section 8 of the Regulations is amended by replacing paragraph (d) of the definition drug in the section C.01.014.8 that it enacts with the following:

• (d) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner. (drogue)

Natural Health Products Regulations

41 Paragraph (a) of the definition expiry date in subsection 1(1) of the Natural Health Products Regulations ^footnote3 is replaced by the following:

• (a) the date, expressed at minimum as a year and month, that is the end of the stability period determined under section 52; and
  

42 Paragraph 2(1)(d) of the French version of the Regulations is replaced by the following:

• d) l’emmagasinage des produits de santé naturels dans le cadre de toute activité visée aux alinéas b) et c).

43 Paragraph 5(g) of the English version of the Regulations is replaced by the following:

• (g) information that demonstrates the safety and efficacy of the natural health product when it is used in accordance with the recommended conditions of use;

44 Subsection 8(2) of the English version of the Regulations is replaced by the following:

(2) In the case of a natural health product that is a drug for which a drug identification number is assigned in accordance with subsection C.01.014.2(1) of the Food and Drug Regulations, the product number assigned under subsection (1) shall be the drug identification number.

45 The portion of subsection 17(2) of the French version of the Regulations before paragraph (a) is replaced by the following:

(2) Le ministre lève l’ordre de cessation de vente lorsque le titulaire lui fournit les renseignements et documents montrant, selon le cas :

46 Paragraph 22(1)(e) of the French version of the Regulations is replaced by the following:

• e) dans le cas d’un produit de santé naturel importé, la preuve établissant que le produit de santé naturel sera fabriqué, emballé, étiqueté, importé, distribué et entreposé conformément aux exigences prévues à la partie 3 ou à des exigences équivalentes.

47 Paragraphs 32(1)(b) and (c) of the English version of the Regulations are replaced by the following:

• (b) if the licensee is authorized to manufacture, package or label a natural health product, conduct that activity in a building in which they are not authorized to do so;
• (c) if the licensee is authorized to import a natural health product, store a natural health product in a building in which they are not authorized to do so; or

48 The heading before section 45 of the French version of the Regulations is replaced by the following:

Lieux

49 The portion of subsection 45(1) of the French version of the Regulations before paragraph (a) is replaced by the following:

45 (1) Tout produit de santé naturel est fabriqué, emballé, étiqueté et entreposé dans des lieux qui sont conçus, construits et entretenus de manière à permettre l’exercice de ces activités dans des conditions hygiéniques, plus particulièrement de manière à :

50 Paragraph 48(a) of the French version of the Regulations is replaced by the following:

• a) les méthodes de nettoyage des lieux où l’activité est exercée;

51 Subparagraph 51(1)(a)(ii) of the English version of the Regulations is replaced by the following:

• (ii) has training, experience and technical knowledge relating to the activity conducted and the requirements of this Part; and

52 The heading before section 52 of the Regulations is replaced by the following:

Stability Period

53 The portion of section 52 of the Regulations before paragraph (a) is replaced by the following:

52 Every manufacturer and every importer shall determine the period of time during which, after being packaged for sale, the natural health product will maintain its purity and physical characteristics and its medicinal ingredients will maintain their quantity per dosage unit and their potency when

54 Subparagraph (b)(i) of the definition comité d’éthique de la recherche in section 63 of the French version of the Regulations is amended by replacing “soins de la santé” with “soins médicaux.

55 Subparagraphs 66(e)(iii) to (v) of the English version of the Regulations are replaced by the following:

• (iii) the pharmacological properties of the natural health product, if any, including its metabolites in all animal species tested,
• (iv) the pharmacokinetics of the natural health product and the natural health product metabolism, if any, including the biological transformation of the natural health product in all animal species tested,
• (v) the toxicological effects, if any, in any animal species tested under a single dose study, a repeated dose study or a special study in respect of the natural health product,

56 Subparagraph 67(1)(c)(i) of the French version of the Regulations is replaced by the following:

• (i) l’utilisation du produit de santé naturel destiné à l’essai clinique ne met pas en danger la santé d’aucun sujet d’essai clinique et celle d’aucune autre personne,
  

57 Section 69 of the English version of the Regulations is replaced by the following:

69 The sponsor shall notify the Minister of the date of the sale or importation of a natural health product for the purposes of a clinical trial at a clinic trial site at least 15 days before the date of that sale or importation.

58 (1) Subsection 71(2) of the French version of the Regulations is replaced by the following:

(2) Si l’une ou l’autre des modifications visées au paragraphe (1) est requise sur-le-champ parce que l’essai clinique ou l’utilisation du produit de santé naturel destiné à un essai clinique met en danger la santé de tout sujet d’essai clinique ou celle de toute autre personne, le promoteur peut l’apporter immédiatement; il fournit alors au ministre les renseignements exigés au paragraphe (3) dans les quinze jours qui suivent.

(2) Paragraph 71(4)(c) of the Regulations is amended by striking out “and” at the end of subparagraph (i), by adding “and” at the end of subparagraph (ii) and by adding the following after subparagraph (ii):

• (iii) the objectives of the clinical trial will be achieved.

59 Paragraph 74(f) of the French version of the Regulations is replaced by the following:

• f) à chaque lieu d’essai clinique, les soins médicaux et les décisions médicales dans le cadre de l’essai clinique relèvent du chercheur qualifié de ce lieu;

60 Paragraphs 77(1)(a) and (b) of the French version of the Regulations are replaced by the following:

• a) l’utilisation du produit de santé naturel destiné à l’essai clinique met en danger la santé de tout sujet d’essai clinique ou celle de toute autre personne;
• b) l’essai clinique va à l’encontre de l’intérêt de tout sujet d’essai clinique;

61 Section 81 of the French version of the Regulations is replaced by the following:

81 En toutes circonstances, le ministre suspend l’autorisation de vendre ou d’importer un produit de santé naturel destiné à un essai clinique, en totalité ou à l’égard d’un lieu d’essai clinique, avant d’avoir donné au promoteur la possibilité de se faire entendre, s’il a des motifs raisonnables de croire que cela est nécessaire pour prévenir un préjudice à la santé de tout sujet d’essai clinique ou à celle de toute autre personne.

62 The portion of subsection 93(1) of the Regulations before paragraph (a) is replaced by the following:

93 (1) Subject to section 94, the inner and outer labels shall show the following information in respect of a natural health product:

63 The portion of subsection 94(1) of the Regulations before paragraph (a) is replaced by the following:

94 (1) The natural health product shall be labelled as follows if the immediate container is not large enough to accommodate an inner label that complies with the requirements of section 93:

64 Section 100 of the Regulations is replaced by the following:

100 Sections A.01.040 to A.01.044 of the Food and Drug Regulations apply in respect of natural health products.

Controlled Drugs and Substances Act

Food and Drug Regulations

65 Paragraph G.03.014(c) of the Food and Drug Regulations ¹ is replaced by the following:

• (c) the Minister, sell or provide to or in accordance with his or her order any quantity of that drug, specified in the order, that is required by the Minister in connection with his or her duties; and

66 The portion of item 1 of Part II of the schedule to Part J of the Regulations before subitem (1) is replaced by the following:

• 1Salvia divinorum (S. divinorum), its preparations and derivatives, including

67 The Regulations are amended by replacing “agent” with “agent or mandatary” in the following provisions:

• (a) paragraph G.01.002(1)(f);
• (b) paragraph G.06.001(3)(b);
• (c) the portion of subsection G.06.001(4) before paragraph (b);
• (d) paragraph J.01.033(3)(b); and
• (e) the portion of subsection J.01.033(4) before paragraph (b).

68 The Regulations are amended by replacing “agent” with “agent or mandatary” in the following provisions:

• (a) subsection G.01.002(2); and
• (b) paragraph G.01.002(3)(a).

69 The Regulations are amended by replacing “Minister or his agent” with “Minister” in the following provisions:

• (a) paragraphs G.06.001(4)(b) and (5)(b); and
• (b) paragraph J.01.033(4)(b).

70 The Regulations are amended by replacing “Director” with “Minister” in the following provisions:

• (a) the portion of section G.06.002.2 before paragraph (a); and
• (b) the portion of section J.01.033.2 before paragraph (a).

Narcotic Control Regulations

71 Section 5 of the Narcotic Control Regulations ^footnote4 is replaced by the following:

5 The manufacturer of a test kit that contains a narcotic may apply for a registration number by submitting to the Minister an application containing

• (a) particulars of the design and construction of the test kit;
• (b) a detailed description of the narcotic and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component;
• (c) a statement of the proposed use of the test kit; and
• (d) any further information and material that the Minister may require to determine whether the test kit is one for which a registration number may be issued.
  

72 The portion of item 1 of the schedule to the Regulations before subitem (1) is replaced by the following:

• 1Opium Poppy (Papaver somniferum), its preparations, derivatives, alkaloids and salts, including:

73 The portion of item 2 of the schedule to the Regulations before subitem (1) is replaced by the following:

• 2Coca (Erythroxylum), its preparations, derivatives, alkaloids and salts, including:

74 Subitem 4(4) of the schedule to the French version of the Regulations is replaced by the following:

• (4) métheptazine (ester méthylique de l’acide hexahydro diméthyl-1,2 phénylazépine-4 carboxylique-4) et ses sels

75 The Regulations are amended by replacing “agent” with “agent or mandatary” in the following provisions:

• (a) paragraph 3(1)(f);
• (b) paragraph 68(3)(b);
• (c) the portion of subsection 68(5) before paragraph (b);
• (d) the portion of subsection 68(6) before paragraph (a); and
• (e) the portion of section 69 before paragraph (a).

76 The Regulations are amended by replacing “agent” with “agent or mandatary” in the following provisions:

• (a) subsection 3(2); and
• (b) paragraph 3(2.1)(a).

77 The Regulations are amended by replacing “Minister or his agent” with “Minister” in the following provisions:

• (a) paragraph 68(4)(b);
• (b) paragraph 68(5)(b); and
• (c) paragraph 68(6)(b).

Benzodiazepines and Other Targeted Substances Regulations

78 The English version of the Benzodiazepines and Other Targeted Substances Regulations ^footnote5 is amended by replacing “agent” with “agent or mandatary” in the following provisions:

• (a) subsections 4(3) and (4);
• (b) sections 59 to 61; and
• (c) subsection 77(1) and paragraph (3)(a).

Precursor Control Regulations

79 The English version of the Precursor Control Regulations ^footnote6 is amended by replacing, with any necessary modifications, “representative” with “agent or mandatary” in the following provisions:

• (a) paragraph 9(1)(b); and
• (b) paragraph 9(1)(d).

80 The English version of the Regulations is amended by replacing “agent” with “agent or mandatary” in the following provisions:

• (a) the portion of subsection 39(1) before paragraph (a); and
• (b) paragraph 39(3)(a).

Canada Consumer Product Safety Act

Administrative Monetary Penalties (Consumer Products) Regulations

81 Subsections 9(1) and (2) of the French version of the Administrative Monetary Penalties (Consumer Products) Regulations ^footnote7 are replaced with the following:

Individu

9 (1) La notification de tout document visé par le présent règlement, sauf l’ordre donné en application des articles 31 ou 32 de la Loi, à un individu qui y est nommé, autre que le ministre, se fait selon l’une des modalités suivantes :

• a) par la remise du document à l’individu, en tout lieu;
• b) si une tentative de remise du document aux termes de l’alinéa a) échoue pour quelque raison que ce soit, par l’envoi du document par un service postal ou de messagerie qui délivre un document faisant foi de la date de livraison à l’expéditeur et au destinataire, à la dernière adresse connue ou au lieu de résidence habituel de l’individu.

Personne autre qu’un individu

(2) La notification de tout document visé par le présent règlement, sauf l’ordre donné en application des articles 31 ou 32 de la Loi, à une personne qui n’est pas un individu et qui y est nommée se fait selon l’une des modalités suivantes :

• a) par l’envoi du document par un service postal ou de messagerie qui délivre un document faisant foi de la date de livraison à l’expéditeur et au destinataire, à l’attention de la personne, au siège ou à l’établissement de la personne ou de son mandataire;
• b) par la remise du document au siège ou à l’établissement de la personne ou de son mandataire, à un dirigeant ou à un autre individu qui semble diriger ou gérer le siège ou l’établissement.

Financial Administration Act

Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations

82 The definition site in section 1 of the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations ^footnote8 is replaced by the following:

site means

• (a) a building specified in a dealer’s licence and located more than one kilometre from any other building specified in the licence; or
• (b) more than one building specified in a dealer’s licence, all of which are located within one kilometre of each other. (site)
  

83 (1) Subsection 4(1) of the Regulations is replaced by the following:

Remission

4 (1) Subject to subsection 6(2), if the fee is greater than an amount equal to 1.5% of the applicant’s actual gross revenue from the sale, testing and packaging/labelling of controlled drugs and narcotics for the previous calendar year, remission is granted of the difference between those amounts if the applicant provides with their application for the renewal of their dealer’s licence a statement signed by the individual responsible for the applicant’s financial affairs that sets out the actual gross revenue.

(2) Subsection 4(2) of the French version of the Regulations is replaced by the following:

État — première année d’activités

(2) Au cours de la première année civile d’activités exercées au titre de la licence de distributeur autorisé, le demandeur fournit l’état dans les quatre-vingt-dix jours qui suivent la fin de cette première année civile d’activités pour avoir droit à la remise.

84 (1) Subsection 5(1) of the Regulations is replaced by the following:

Timing of payment

5 (1) Subject to subsection (2), the fee is payable on the day on which the dealer’s licence is issued.

(2) Subsection 5(2) of the Regulations is replaced by the following:

Timing of deferred payment

(2) In the case of an applicant referred to in subsection 4(2), the fee is payable on the expiry of the 90-day period if the renewed dealer’s licence is issued.

85 The heading before section 12 and sections 12 and 13 of the Regulations are repealed.

Radiation Emitting Devices Act

Radiation Emitting Devices Regulations

86 Paragraphs 4(c) and (d) of Part VII of Schedule II to the Radiation Emitting Devices Regulations ^footnote9 are replaced by the following:

• (c) during any time interval of greater than 10 seconds but less than or equal to 1.0 × 10⁴ seconds, an integrated irradiance of 1.0 × 10^–2 joules per square centimetre; and
• (d) during any time interval of greater than 1.0 × 10⁴ seconds, an irradiance of 1.0 × 10^–6 watts per square centimetre.

Coming into Force

87 These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations and the Order.)

Issues

The Standing Joint Committee for the Scrutiny of Regulations (SJCSR) identified inconsistencies in the drafting of the following act and regulations:

• Administrative Monetary Penalties (Consumer Products) Regulations (AMPR);
• Schedule to the Controlled Drugs and Substances Act (CDSA);
• Food and Drug Regulations (FDR);
• Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations (LDCDNFR);
• Narcotics Control Regulations (NCR); and
• Natural Health Product Regulations (NHPR).

In addition, Health Canada identified the need to make minor amendments to the following regulations:

• Benzodiazepines and Other Targeted Substances Regulations (BOTSR);
• Precursor Control Regulations (PCR); and
• Radiation Emitting Devices Regulations (REDR).

Objectives

These amendments have the following objectives:

• to correct discrepancies between the French and English versions;
• to correct typographical or grammatical errors;
• to modernize obsolete references and archaic language; and,
• to add clarity to regulatory provisions.

Description

Amendments to the AMPR

1. The SJCSR identified inconsistencies between the language used in section 9 of the French version of the AMPR and the French version of the Canada Consumer Product Safety Act (CCPSA):
   • Section 9 of the French version of the AMPR is amended to align with the language used in the French version of the CCPSA.

Amendments to the Schedules to the CDSA, FDR and NCR

1. Correcting typographical or grammatical errors:
   • In Schedule I to the CDSA and the Schedule to the NCR, the French chemical description for “métheptazine” is incorrect, as identified by the SJCSR. Thus, the term “éthylique” is replaced with the term “méthylique” in order to read “Métheptazine (ester méthylique de l’acide hexahydro diméthyl–1,2 phénylazépine–4 carboxylique–4)”.
   • Several plant names are not correctly italicized. Amendments are made to the following genus and species names of plants to italicize them: Opium Poppy (Papaver somniferum) and Coca (Erythroxylum) in Schedule I to the CDSA and the Schedule to the NCR; and Salvia divinorum (S. divinorum) in Schedule IV to the CDSA and the Schedule to Part J of the FDR.
   • Amendments are made to the NCR to replace the term “the Minister or his agent” with “the Minister”. Since a reference to “the Minister” implicitly includes a reference to an agent of the Minister, it is unnecessary to include an express reference to the agent.

Amendments to the BOTSR, FDR, NCR and PCR

1. Correcting discrepancies between the French and English versions:
   • Amendments are made to the NCR, Parts G and J of the FDR, the BOTSR and the PCR to ensure that the correct terms have been used in French and English to express the notion of “agent or mandatary” in English and “mandataire” in French.

Amendments to the FDR

1. Responding to discrepancies between French and English versions identified by the SJCSR:
   • The FDR presently has various French translations of the English term “package insert”. These various French translations are replaced with the words “notice d’accompagnement” to align with the English term “package insert” in several provisions in Part C of the FDR.
2. Responding to discrepancies between French and English versions identified by Health Canada:
   • The term “malaxage” was changed to “râpage” in various provisions in 2017 ^footnote10 to address comments made by the SJCSR. However, the word “râpage” does not express the proper intent of the provision in the context of manufacturing processed cheese. The term is replaced by “broyage”.
   • In the French version of B.22.016, the words “cuite ou crue” are inserted to harmonize with the English version, which includes the words “cooked or uncooked”.
   • The weight reference in the English version of C.01.609 is amended to refer to “tonne” (i.e. metric) instead of “ton” (i.e. imperial) to align with the French text.
3. Correcting typographical errors:
   • The French version of several provisions in Part B is missing the [N] that would designate it as a standard. These provisions have the corresponding [S] in the English version.
   • The standards reference [S] was omitted from B.21.006 as part of amendments made in 2017. ^footnote11 It was not the Department’s intention to remove the standardization of this provision, and so the notation is reinserted.
4. Correcting obsolete provisions or modernizing obsolete references or archaic language:
   • In line with current drafting conventions, references to the “Director” are replaced with “Minister” where appropriate. Subsection 24(2) of the Interpretation Act provides for the possibility of appropriate officials acting on behalf of the “Minister”, but it is silent on powers of other officials being exercised by persons other than the named official. Amending these provisions would not have any policy or operational implications. As a result, the definition of “Director” is repealed.
   • In certain provisions where “Director” is replaced with “Minister”, obsolete regulatory language has also been modernized (e.g. “is of the opinion” replaced with “determines”).
   • The position of the Minister of Consumer and Corporate Affairs is obsolete. As such, paragraphs A.01.061(a) and (b) are amalgamated into a single sentence and will reference “Minister” (in line with the amendment above).
5. Responding to issues of lack of clarity identified by the SJCSR, by adding clarity to regulatory provisions:
   • In C.01.004.02(6)(b) and C.01.014.8(a)(iv), the reference to “administered” is amended to “to be administered” to make it clearer to regulated parties which products are being regulated in these provisions.

Amendments to the LDCDNFR

1. Correcting typographical errors:
   • Amend subsection 5(2) in the English version to replace the dash in “90–day period” with a hyphen (“90-day period”).
2. Adding clarity to regulatory provisions:
   • In paragraphs 1(a) and (b) (with respect to the definition of “site”), and subsections 4(1), 4(2), 5(1), and 5(2) the terms “dealer’s licence for controlled drugs”, “dealer’s licence for narcotics”, “licence”, and “relevant licence” are replaced with the term “dealer’s licence.” This amendment addresses SJCSR concerns as well as inconsistencies identified by Health Canada.
3. Correcting obsolete provisions or modernizing obsolete references or archaic language:
   • Transitional provisions (sections 12 and 13) are repealed as these provisions were limited to a specific period of time that is now completely lapsed.

Amendments to the NHPR

1. Responding to discrepancies between French and English versions identified by the SJCSR:
   • Subparagraph (b)(i) of the definition of “comité d’éthique de la recherche” found in section 63 is amended by replacing “soins de la santé” with “soins médicaux” in order to harmonize with the English version.
   • The clause “if any” in subparagraphs 66(e)(iii) to (v) is rearranged to harmonize with the French term “le cas échéant”.
   • The French words “des sujets d’essai clinique ou celle d’autres personnes” in provisions 67(1)(c)(i), 71(2), 77(1)(a) are changed to harmonize with the English version.
   • The French phrase “des sujets d’essai clinique” in paragraph 77(1)(b) is amended to harmonize with the English.
   • Section 69 is amended to harmonize with the French version and clarify that it is the clinical trial that is taking place at the clinical trial site and not the sale or importation.
   • The French words “soins de santé” in paragraph 74(f) are replaced with “soins médicaux” to harmonize with the English version.
   • Section 81 is amended to harmonize with the English version that refers to the singular form of individuals while the French version refers to the plural form (i.e. la santé des sujets d’essai clinique ou à celle d’autres personnes).
   • Section 81 is amended to provide a more accurate translation of “prévenir que soit causé un préjudice à la santé” to harmonize with the English version.
   • Provisions 5(g), 17(2), and 22(1)(e) are amended to allow for a more consistent use of terminology, specifically dealing with the terms “supports”, “demonstrating”, and “evidence demonstrating”.
   • Paragraph 5(g): Change the word “supports” to “demonstrating” to maintain consistency with the French version.
   • Subsection 17(2): “montrant” (instead of “établissant”) is used with respect to “renseignements et documents”.
   • Paragraph 22(1)(e): “preuve” is replaced with “preuve établissant”.
   • Amend subsection 8(2) from “required under subsection (1)” to “assigned under subsection (1)” to align with the French version.
   • English version of paragraphs 32(1)(b) and (c) are revised to harmonize with the French version, which is more specific.
   • In the French version of subsection 45(1) (heading and text) and paragraph 48(a) “locaux et terrains attenants” is replaced with “lieux” to harmonize with the English version.
2. Responding to the SJCSR, to correct typographical errors:
   • The word “the” in the clause “has the training, experience and technical knowledge” is removed from the English version of subparagraph 51(1)(a)(ii) to correct the grammatical error.
3. Correcting obsolete provisions or modernizing obsolete references or archaic language:
   • In paragraph 2(1)(d), the term “entreposage” is replaced by “emmagasinage” to be consistent with the terminology of the Food and Drugs Act.
4. Responding to issues of lack of clarity identified by the SJCSR, by adding clarity to regulatory provisions:
   • The definition of “expiry date” in the subsection 1(1) is amended to reference the “end of the period determined under section 52” to provide additional clarity.
   • The heading before section 52 is replaced by “Stability Period”.
   • Section 52 is amended to replace “will continue to comply with its specifications” with “will maintain its purity and physical characteristics” to provide additional clarity, as well as add the following text, “and its medicinal ingredients, their quantity per dosage unit and their potency”.
   • Subsection 71(4) is revised to add a further condition for the amendment to the authorization to sell or import a natural health product (i.e. that the Minister has reasonable grounds to believe that the objective of the clinical trial will be achieved). This amendment will align the subsection with subparagraph 67(1)(c)(iii) that outlines the conditions for the initial authorization.
   • In subsections 93(1) and 94(1), the words “section 3 of the Act” and “subject to section 3 of the Act”, respectively, are removed as they are unnecessary and misleading. Section 100 is amended to remove the clause “in addition to these Regulations” to provide clarification of the provision.

Amendments to REDR

1. Correcting typographical errors
   • Subparagraphs 4(c) and (d) of Schedule II, Part VII – Laser Scanners are amended to remove the negative sign from the exponent in the expression 1.0 × 10^-4 so it will read 1.0 × 10⁴.

“One-for-One” Rule

The “One-for-One” Rule does not apply to these amendments, as there is no change in administrative costs to business.

Small business lens

The small business lens does not apply to these amendments, as there are no costs to small business.

Rationale

Many of the amendments are in response to the SJCSR’s review of the regulations. The need for a number of other minor technical amendments has also been identified by the department. The amendments help to correct or improve the regulatory base and do not impose any costs on government or stakeholders.

Contacts

Amendments to the FDR and NHPR

Amendments to the AMPR

Amendments to the BOTSR, FDR (Parts G and J), NCR, PCR and Schedules to the CDSA

Amendments to the LDCDNFR

Amendments to the REDR