Regulations Amending Certain Department of Health Regulations (Miscellaneous Program): SOR/2023-247

Canada Gazette, Part II, Volume 157, Number 25

Registration
SOR/2023-247 November 24, 2023

FOOD AND DRUGS ACT

CONTROLLED DRUGS AND SUBSTANCES ACT

TOBACCO AND VAPING PRODUCTS ACT

CANADA CONSUMER PRODUCT SAFETY ACT

P.C. 2023-1162 November 24, 2023

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health and the Minister of Mental Health and Addictions and Associate Minister of Health, makes the annexed Regulations Amending Certain Department of Health Regulations (Miscellaneous Program) under

(a) subsection 30(1)^{footnote a} of the Food and Drugs Act ^{footnote b};
(b) subsection 55(1)^{footnote c} of the Controlled Drugs and Substances Act ^{footnote d};
(c) sections 17^{footnote e} and 33^{footnote f} of the Tobacco and Vaping Products Act ^{footnote g}; and
(d) subsection 37(1)^{footnote h} of the Canada Consumer Product Safety Act ^{footnote i}.

Regulations Amending Certain Department of Health Regulations (Miscellaneous Program)

Food and Drugs Act

Food and Drug Regulations

1 The definition of Liste D in subsection C.01.001(1) of the French version of the Food and Drug Regulations ^{footnote 1} is replaced by the following:

Liste D: Document intitulé Liste de certaines drogues sans ordonnance pouvant être distribuées à titre d’échantillons publié par le gouvernement du Canada sur son site Web, avec ses modifications successives; (List D)

2 Paragraph C.01.004(5)(b) of the Regulations is replaced by the following:

(b) a drug dispensed pursuant to a prescription, if its label carries adequate directions for use and complies with the requirements of section C.01.005.

3 (1) Subsection C.08.011(2) of the Regulations is replaced by the following:

(2) In the case of the sale under subsection (1) of a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A and that was not imported under section C.08.011.2, an annual report identifying the total quantity of the new drug that was sold, including an estimate of the quantity sold in respect of each animal species for which the drug is intended, must be submitted to the Minister by the manufacturer, if the new drug was present in Canada at the time of sale, otherwise by the practitioner.

(2) Section C.08.011 of the Regulations is amended by adding the following after subsection (3):

(4) The annual report described in subsection (2) is for a period of one calendar year and must be submitted on or before March 31 of the year following the calendar year covered by the report, beginning with the first full calendar year during which the drug is first sold.

4 The portion of paragraph C.08.011.1(1)(a) before subparagraph (i) of the English version of the Regulations is replaced by the following:

(a) the manufacturer provides the following information to the Minister:

5 (1) Subsection C.08.011.3(2) of the Regulations is replaced by the following:

(2) The holder of an establishment licence who distributes to a practitioner, in accordance with subsection (1), a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A must submit to the Minister an annual report identifying the total quantity of the new drug that was distributed, including an estimate of the quantity distributed in respect of each animal species for which the drug is intended.

(2) Section C.08.011.3 of the Regulations is amended by adding the following after subsection (3):

6 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 determines that the requirements of paragraphs (1)(a), (b) and (c) have not been met, the Minister shall refuse to issue an experimental studies certificate.

7 (1) Subsection C.10.002(2) of the Regulations is amended by adding the following after paragraph (e):

(e.1) subsection C.02.021(1) as it applies to storage;

(2) Paragraph C.10.002(2)(f.1) of the Regulations is repealed.

Medical Devices Regulations

8 Section 18 of the French version of the Medical Devices Regulations ^{footnote 2} is replaced by the following:

18 L’instrument médical faisant partie d’un système doit être compatible avec les autres composants ou parties du système avec lesquels il interagit et ne doit pas nuire au rendement du système.

9 The portion of paragraph 61(2)(c) of the Regulations before subparagraph (i) is replaced by the following:

(c) any actions taken as a result of the investigation referred to in paragraph 60(2)(h), which may include

Natural Health Products Regulations

10 (1) The portion of section 103.1 of the English version of the Natural Health Products Regulations ^{footnote 3} before paragraph (a) is replaced by the following:

103.1 Section C.08.010 and subsections C.08.011(1) and (3) of the Food and Drug Regulations apply in respect of natural health products with the following modifications:

(2) Paragraphs 103.1 (a) to (d) of the Regulations are replaced by the following:

(a) a reference to “new drug” is to be read as a reference to “natural health product”;
(b) the sale of a natural health product can only be authorized for human use;
(c) in subparagraph C.08.010(1)(b)(i), the reference to “adverse drug reactions” is to be read as a reference to “adverse reactions”;
(d) paragraph C.08.010(2)(c) is to be read as follows:
- (c) the Minister has not, in respect of a natural health product, suspended the product licence under subsection 18(1) or section 19 of the Natural Health Products Regulations or cancelled the product licence under paragraph 20(b) of those Regulations;
(e) in subsection C.08.011(1), the reference to “section C.08.002” is to be read as a reference to “subsection 4(1) of the Natural Health Products Regulations”; and
(f) in subsection C.08.011(3), the reference to “these Regulations” is to be read as a reference to the Natural Health Products Regulations.

Safety of Human Cells, Tissues and Organs for Transplantation Regulations

11 Sections 36 and 37 of the English version of the Safety of Human Cells, Tissues and Organs for Transplantation Regulations ^{footnote 4} are replaced by the following:

Storage location

36 An establishment that distributes cells, tissues or organs must store them in a location that has environmental conditions that maintain their safety and that is secure against the entry of unauthorized persons.

Storage during transportation

37 An establishment that ships cells, tissues or organs must ensure that they are stored during transportation in appropriate environmental conditions.

12 Paragraph 65(c) of the English version of the Regulations is replaced by the following:

(c) appropriate monitoring and control of environmental and microbiological conditions in all areas where its activities are carried out; and

Controlled Drugs and Substances Act

Precursor Control Regulations

13 The portion of item 23 of the schedule to the French version of the Precursor Control Regulations ^{footnote 5} in column 1 is replaced by the following:
Article	Colonne 1 Précurseur visé à la partie 1 de l’annexe VI de la Loi
23	Acide hypophosphoreux et ses sels et dérivés

Tobacco and Vaping Products Act

Vaping Products Labelling and Packaging Regulations

14 The French version of the Vaping Products Labelling and Packaging Regulations ^{footnote 6} is amended by replacing “mise en garde” and “mises en gardes” with “avertissement sanitaire” and “avertissements sanitaires”, respectively, with any necessary modifications, in the following provisions:

(a) the heading before section 13 and sections 13 to 16;
(b) subsections 17(1) and (2) and the portion of subsection 17(3) before paragraph (a);
(c) section 18;
(d) the portion of subsection 19(1) before paragraph (a) and the portion of paragraph 19(2) before paragraph (a);
(e) sections 20 and 21;
(f) section 25,
(g) the heading before section 32;
(h) the portion of section 32 before paragraph (a);
(i) sections 33 and 34;
(j) the portion of section 35 before paragraph (a);
(k) the portion of subsection 36(1) before paragraph (a) and paragraph 36(1)(b);
(l) paragraph 37(a);
(m) section 39; and
(n) subsections 42(1), the portion of subsection 42(2) before paragraph (a), paragraph 42(2)(c) and subsection 42(3).

Vaping Products Promotion Regulations

15 The French version of the Vaping Products Promotion Regulations ^{footnote 7} is amended by replacing “mise en garde” and “mises en gardes” with “avertissement sanitaire” and “avertissements sanitaires”, respectively, with any necessary modifications, in the following provisions:

(a) section 8 and the heading “Mise en garde” before it;
(b) paragraph 9(b);
(c) sections 10 to 12;
(d) subsection 17(2);
(e) sections 19 to 22;
(f) the portion of subsection 23(1) before paragraph (a), paragraph 23(1)(c) and subsection 23(3);
(g) section 27;
(h) subsections 28(1) and (2), the portion of subsection 28(3) before paragraph (a) and paragraph 28(3)(c);
(i) section 29;
(j) the portion of section 30 before paragraph (a) and paragraph (b);
(k) the portion of section 32 before paragraph (a);
(l) the portion of section 35 before paragraph (a); and
(m) section 36.

Canada Consumer Product Safety Act

Glazed Ceramics and Glassware Regulations

16 The portion of section 1 of the schedule to the Glazed Ceramics and Glassware Regulations ^{footnote 8} before paragraph (a) is replaced by the following:

1 The following method, which is based on the International Organization for Standardization standard ISO 6486-1:2019, entitled Ceramic ware, glass ceramic ware and glass dinnerware in contact with food — Release of lead and cadmium — Part 1: Test Method, third edition, August 2019, is to be used to determine whether a product releases lead or cadmium:

17 The portion of section 2 of the schedule to the Regulations before paragraph (a) is amended by replacing "ASTM C927-80 (2004)" with "ASTM C927-80 (2019)e1".

Vaping Products Labelling and Packaging Regulations

18 Subsection 48(3) of the Vaping Products Labelling and Packaging Regulations ^{footnote 6} is replaced by the following:

Exception — small immediate container

(3) If the immediate container has a small size, the list of ingredients must be displayed

(a) if the main display panel of the immediate container has an area of greater than 15 cm² but less than 45 cm², on the display surface of the exterior package, on the display surface of the immediate container or on a tag attached to the immediate container; and
(b) if the main display panel of the immediate container has an area equal to or less than 15 cm², on the display surface of the exterior package or on a tag attached to the immediate container.

19 Subsection 56(5) of the Regulations is replaced by the following:

Exception — small immediate container that is not packaged

(5) If the immediate container has a small size and is not packaged, the statement must be displayed

(a) if the main display panel has an area greater than 15 cm² but less than 45 cm², on the display surface of the immediate container or on a tag attached to the immediate container; and
(b) if the main display panel of the immediate container has an area equal to or less than 15 cm², on a tag attached to the immediate container.

Coming into Force

20 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 or the Order.)

Issues

Between 2016 and 2021, the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) identified a number of administrative and technical issues with the Food and Drug Regulations and the Natural Health Products Regulations. Health Canada has committed to addressing certain issues raised by the SJCSR through these miscellaneous amendments regulations.

Health Canada officials have also identified a number of minor issues in regulations it administers through departmental review processes completed as part of Health Canada’s good regulatory stewardship practices. Health Canada is proactively addressing these non-substantive issues through these miscellaneous amendments regulations. Amendments to the Food and Drug Regulations, the Glazed Ceramics and Glassware Regulations, the Medical Devices Regulations, the Schedule to the Precursor Control Regulations and Schedule VI to the Controlled Drugs and Substances Act, the Safety of Human Cells, Tissues and Organs for Transplantation Regulations, the Vaping Products Labelling and Packaging Regulations, and the Vaping Products Promotion Regulations are being made to address the identified issues.

Objective

The amendments have the following objectives:

To clarify a cross-reference to section numbering to reduce confusion and enable regulated parties to easily find the corresponding requirements;
To correct discrepancies between the French and English text of the regulations to improve clarity and reduce the risk of inconsistent interpretation;
To correct typographical or grammatical errors to improve readability of the regulations;
To harmonize terms with those used in related regulations to improve alignment and clarity;
To correct discrepancies between the use of certain terms to increase consistency in interpretation;
To improve clarity for various provisions to facilitate consistent interpretation;
To renumber sections to improve readability of the regulations; and
To update references to standards and other documents incorporated by reference (where the change is non-substantive).

Description and rationale

1. Clarifying a cross-reference

The following amendment clarifies a cross-reference to section numbering to reduce confusion and enable regulated parties to find the corresponding requirements easily.

Medical Devices Regulations:

The English version of paragraph 61(2)(c) of the Medical Devices Regulations is amended to clarify that the “investigation” referenced in paragraph 61(2)(c) is the “investigation referred to in paragraph 60(2)(h).” The French version of paragraph 61(2)c) of the Medical Devices Regulations is amended to clarify that the “enquête” referenced in paragraph 61(2)c) is the “enquête visée à l’alinéa 60(2)h).” This reduces confusion, as there are many other references to “investigation” in the Medical Devices Regulations.

2. Correcting discrepancies between French and English versions

The following amendments correct discrepancies between the French and English versions of the regulations to improve clarity and reduce the risk of inconsistent interpretation.

Medical Devices Regulations:

The French version of section 18 of the Medical Devices Regulations is amended to replace “or” with “ou” to align with the English version and correct a typographical error.

The Schedule to the Precursor Control Regulations and Schedule VI to the Controlled Drugs and Substances Act:

The French versions of item 23 in the Schedule to the Precursor Control Regulations (PCR) and of item 22 in Schedule VI to the Controlled Drugs and Substances Act (CDSA) are amended to reflect the correct name of the precursor chemical “hypophosphorous acid” in French (“acide hypophosphoreux” rather than “acide hydrophosphoreux”), thereby aligning the English and French versions. As hypophosphorous acid is listed under both Schedule VI to the CDSA and the Schedule to the PCR, this amendment must be made to both Schedules to ensure alignment.

Safety of Human Cells, Tissues and Organs for Transplantation Regulations:

The English version of section 36 of the Safety of Human Cells, Tissues and Organs for Transplantation Regulations is amended to delete the word “appropriate.” This resolves the inconsistency between the English and French versions of this provision.

The English version of section 37 of the Safety of Human Cells, Tissues and Organs for Transplantation Regulations is amended to change an amendment made by Regulations SOR/2022-197. This amendment reverts section 37 back to the pre-SOR/2022-197 English version by removing “and adequate packaging materials.” This amendment improves alignment between the English and French versions of this section as it relates to conditions.

The English version of paragraph 65(c) of the Safety of Human Cells, Tissues and Organs for Transplantation Regulations is amended to add the concept of conditions. This resolves the inconsistency between the English and French versions.

3. Correcting typographical or grammatical errors

The following amendments correct typographical or grammatical errors to improve readability of the affected regulations.

Food and Drug Regulations:

The English version of paragraph C.10.002(2)(f.1) of the Food and Drug Regulations is amended to remove the comma after “subsection C.02.021(1).” The French version of paragraph C.10.002(2)(f.1) of the Food and Drug Regulations is amended to remove the comma after “l’article C.02.021(1).” Removing the commas corrects the typographical errors and does not change the original intent.

The French version of the definition of “Liste D” of subsection C.01.001(1) of the Food and Drug Regulations is amended by removing the comma between the words “d’échantillons” and “publié” in the phrase “à titre d’échantillons, publié par le gouvernement du Canada” so it reads as “à titre d’échantillons publié par le gouvernement du Canada.” Removing the comma corrects the typographical error and does not change the original intent.

4. Harmonizing terms with those used in related regulations

The following amendments harmonize terms with those used in the enabling statute and/or related regulations to improve alignment and clarity.

Food and Drug Regulations:

The English and French versions of sections C.08.011 and C.08.011.3 of the Food and Drug Regulations are amended to include the time frame indicating when an annual report must be provided for drugs for veterinary use that contain an active pharmaceutical ingredient on the List of Certain Antimicrobial Active Pharmaceutical Ingredients (List A) that have been authorized under the provisions by the Emergency Drug Release program. The time frame for the annual report will align with the annual reporting time frame for authorized veterinary drugs in dosage form that contain an active pharmaceutical ingredient that is set out in List A. This addresses the concern raised by the SJCSR.

Vaping Products Labelling and Packaging Regulations:

The French version of the Vaping Products Labelling and Packaging Regulations is amended to replace the term “mise en garde” and “mises en garde” with “avertissement sanitaire” and “avertissements sanitaires” to align with the term used in the Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance) in the following provisions:
- (a) Part 1: Heading prior to section 13;
- (b) Subheadings for section 14, section 15, subsection 20(2), section 25 and section 32;
- (c) Text in sections 13, 14, 15, 16, 21, 25, 32, 33, 34, 35, and 39;
- (d) Text in subsections 17(1), 17(2), 17(3), 18(1), 18(2), 18(3), 19(1), 19(2), 20(1), 20(2), 36(1), 42(1), 42(2) and 42(3);
- (e) Text in paragraphs 36(1)b), 37a) and 42(2)c); and
- (f) Title of the document incorporated by reference: sections 14 and 15 (to be amended to “Liste des avertissements sanitaires concernant les produits de vapotage”).

Vaping Products Promotion Regulations:

The French version of the Vaping Products Promotion Regulations is amended to replace every instance of the term “mise en garde” with “avertissement sanitaire” to align with the term used in the Regulations Amending the Tobacco Products Regulations (Plain and Standardized Appearance).

5. Correcting terminology discrepancies

The following amendment corrects a discrepancy between the use of certain terms to increase consistency in interpretation.

Food and Drug Regulations:

The English version of paragraph C.01.004(5)(b) of the Food and Drug Regulations is amended to replace “suitable” with “adequate.” The French version is amended to replace “convenable” with “approprié.” This amendment creates consistent terminology with respect to label directions within section C.01.004. This addresses the concern raised by the SJCSR.

6. Improving clarity

The following amendments improve clarity for various provisions to facilitate consistent interpretation of the regulations.

Food and Drug Regulations:

The English version of paragraph C.10.002(2)(f.1) of the Food and Drug Regulations is amended to replace “subsection C.02.021(1), in respect of storage;” with “subsection C.02.021(1) as it applies to storage;”. Replacing “in respect of” with “as it applies to” improves the clarity of the rule.

The English version of subsection C.08.015(2) of the Food and Drug Regulations is amended to replace the words “is not satisfied” by “determines” and to also replace “paragraphs (1)(a), (b) and (c) have been met,” by “paragraphs (1)(a), (b) and (c) have not been met,”. The French version is amended to replace the words “n’est pas convaincu” by “conclut” and to also replace “alinéas (1)a), b) et c) ont été satisfaites,” by “alinéas (1)a), b) et c) n’ont pas été satisfaites,”. This amendment resolves the potential subjectivity introduced by the use of the words “is not satisfied/n’est pas convaincu” into the decision-making process for the issuance of experimental studies certificate by the Minister in subsection C.08.015(2). This addresses the concern raised by the SJCSR.

The English and French versions of subsections C.08.011(2) and C.08.011.3(2) of the Food and Drug Regulations are amended to remove the words “in the form established by the Minister” in the English version and “en la forme établie par celui-ci” in the French version, as it is not essential for the Minister to have the authority to establish the form of the annual report. This addresses the concern raised by the SJCSR.

The English version of paragraph C.08.011.1(1)(a) of the Food and Drug Regulations is amended to remove the word “concerning” from the opening words of the paragraph, as it is unnecessary. The amendment improves the clarity of the rule and addresses the concern raised by the SJCSR.

Medical Devices Regulations:

The French version of section 18 of the Medical Devices Regulations is amended to replace “de celui-ci” with “du système” to align with the English version.

Natural Health Products Regulations:

The English and French versions of section 103.1 of the Natural Health Products Regulations are amended in three ways to clarify how the emergency provisions of the Food and Drug Regulations apply for the purposes of the Natural Health Products Regulations. Specifically, the amendments clarify that (1) natural health products can only be authorized for human use; (2) the reference to “adverse drug reactions” in the English version of the emergency provisions is a reference to “adverse reactions,” and the reference to “réaction indésirable à la drogue” in the French version of the emergency provisions is a reference to “réaction indésirable,” the terms used in the Natural Health Products Regulations; and (3) the terms “these Regulations” and “présent règlement” are to be interpreted as the Natural Health Products Regulations, meaning that the sale of a natural health product made in accordance with the emergency provisions is exempt from the Natural Health Products Regulations. These amendments address the concerns raised by the SJCSR.

Vaping Products Labelling and Packaging Regulations:

The English and French versions of subsections 48(3) and 56(5) of the Vaping Products Labelling and Packaging Regulations are amended to modify the information display requirements a regulated party must satisfy in subsections 48(3) and 56(5) for a small immediate container. Subsection 48(3) requires an immediate container with a main display panel that has an area less than 45 cm² to display the information on the display surface of the exterior package or a tag attached to the immediate container and, in subsection 56(5), for the information to be displayed on a tag. The current requirements contain a discrepancy between Part 1 and Part 2 that may restrict or limit the flexibility available to a regulated party to label appropriately on a small immediate container. The amendments increase alignment with certain flexibilities in Part 1 by including the option for the information to be displayed on the display surface of the immediate container, in the case where a small immediate container has a main display panel greater than 15 cm² but less than 45 cm². These amendments align labelling flexibilities and allow the information to be available on the immediate container, thus addressing an unintended gap in flexibilities between Parts 1 and 2.

7. Renumbering sections

The following amendment renumbers paragraphs to align the provisions in the correct alphanumeric order.

Food and Drug Regulations:

The English and French versions of subsection C.10.002(2) of the Food and Drug Regulations are amended to rename paragraph (f.1) as (e.1) and move it up by one line so it features between paragraphs (e) and (f) to align the provisions in the correct alphanumeric order.

8. Updating incorporations by reference

The following amendment updates references to documents incorporated by reference where the changes are non-substantive.

Glazed Ceramics and Glassware Regulations:

The English and French versions of sections 1 and 2 of the Schedule of the Glazed Ceramics and Glassware Regulations are amended to replace the reference to ISO 6486-1:1999 and ASTM C927-80 (2004) with their latest versions, ISO 6486-1:2019 and ASTM C927-80 (2019). Updating the references to the standards does not affect the test methods outlined in the Schedule and does not have any impact on the requirements of the Regulations.

Regulatory analysis

One-for-one rule and small business lens

The one-for-one rule does not apply to these amendments, as there is no change in administrative costs or burden to businesses.

Analysis under the small business lens determined that the amendments will not impact small businesses in Canada.

Administrative amendment of marginal notes

Marginal notes in the French version of the Cannabis Regulations are amended administratively under paragraph 27(b) of the Legislation Revision and Consolidation Act. Marginal notes are not part of the body of the Regulations (Interpretation Act, section 14).

The marginal notes that accompany the following provisions will be administratively amended in the consolidated version of the Cannabis Regulations available on the Justice Laws website:

(a) Subsections 88.94(3), 146(7), 173(4);
(b) Sections 179, 187, 195; and
(c) Subsections 225(3), 226(2), 226.1(2), 227(3), 228(2), 231(2), 235(2), 244(2), 246(2), 247(6), 301(2), 302(2), 304(2), 305(2), 331(3), 340(5), 351(2).

In these marginal notes, the expression “durée de conservation” will be replaced by “période de conservation.” The expression “durée de conservation” is defined in the Cannabis Regulations; however, the above provisions do not refer to this defined term, but rather to a different retention period, as reflected in the English version. Amending these marginal notes administratively by replacing the words “durée de conservation” with “période de conservation” aims to avoid potential confusion with the defined term.

Contact

Jillian Andrews
Acting Director
Compliance Policy and Regulatory Affairs Division
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada
200 Eglantine Driveway
Jeanne Mance Building, 7th Floor
Tunney’s Pasture
Ottawa, Ontario
K1A 0K9
Telephone: 343‑553‑1188
Email: dra-arm@hc-sc.gc.ca