Vol. 151, No. 4 — February 22, 2017

Registration

SOR/2017-18 February 13, 2017

FOOD AND DRUGS ACT
CONTROLLED DRUGS AND SUBSTANCES ACT

Regulations Amending Certain Department of Health Regulations (Miscellaneous Program)

P.C. 2017-113 February 13, 2017

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending Certain Department of Health Regulations (Miscellaneous Program), pursuant to

Regulations Amending Certain Department of Health Regulations (Miscellaneous Program)

Food and Drugs Act

Food and Drug Regulations

1 Section A.01.042 of the English version of the Food and Drug Regulations (see footnote 1) is replaced by the following:

A.01.042 If an inspector examines or takes a sample of a food or drug under section A.01.041, the inspector may submit it to an analyst for analysis or examination.

2 Section A.01.043 of the Regulations is replaced by the following:

A.01.043 If an inspector, on examination of a sample of a food or drug or on receipt of a report of an analyst of the result of an analysis or examination of the sample, is of the opinion that the sale of the food or drug in Canada would constitute a violation of the Act or these Regulations, the inspector shall so notify in writing the collector of customs concerned and the importer.

3 Paragraphs B.14.007(a) and (b) of the French version of the Regulations are replaced by the following:

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 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 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 Paragraph B.21.003(b) of the French version of the Regulations is replaced by the following:

7 The portion of section B.21.005 of the French version of the Regulations before paragraph (a) is replaced by the following:

B.21.005 Le poisson, à l’exception des protéines de poisson, les produits de chair ou leurs préparations sont falsifiées si l’une des substances ci-après ou une substance de l’une des catégories ci-après s’y trouve ou y a été ajoutée :

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

B.21.006 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,

9 Paragraph B.21.006(n) of the French version of the Regulations is replaced by the following:

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

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

11 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 Le poisson conservé et la chair conservée doivent être du poisson ou de la chair, à l’état cru ou cuit, qui ont été desséchés, salés, marinés, saumurés ou fumés; ils 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 :

12 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 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 :

13 Section C.01.009 of the Regulations is replaced by the following:

C.01.009 If any Act of Parliament or any of its regulations prescribes a standard or grade for a drug and that standard or grade is given a name or designation in the Act or regulation, no person shall, on a label of or in any advertisement for that drug, use that name or designation unless the drug conforms with the standard or grade.

14 (1) Subsection C.01.019(2) of the French version of the Regulations is replaced by the following:

(2) Le rapport comprend une analyse critique et concise des réactions indésirables à la drogue et des réactions indésirables graves à la drogue, ainsi que les fiches d’observation portant sur toutes les réactions indésirables à la drogue et les réactions indésirables graves à la drogue — ou celles qui sont précisées par le ministre — qui sont connues du fabricant et qui sont associées au sujet de préoccupation que le ministre a demandé à celui-ci d’analyser dans le rapport.

(2) Subsection C.01.019(3) of the Regulations is replaced by the following:

(3) The Minister shall, after giving the manufacturer an opportunity to be heard, specify a period for the submission of the report that is reasonable in the circumstances. The Minister may only specify a period that is less than 30 days if the Minister needs the information in the report to determine whether the drug poses a serious and imminent risk to human health.

15 Paragraph C.01A.013(a) of the Regulations is replaced by the following:

16 Subsection C.05.014(3) of the Regulations is replaced by the following:

(3) Sections C.01.016 to C.01.020 do not apply to drugs used for the purposes of a clinical trial.

17 The Regulations are amended by replacing “comminuted” with “minced” in the following provisions:

18 The French version of the Regulations is amended by replacing “produit du mélange et du malaxage” with “produit du râpage et du mélange” in the following provisions:

19 The French version of the Regulations is amended by replacing “hachée finement” with “hachée” in the following provisions:

20 The French version of the Regulations is amended by replacing “chair de poisson” with “chair” in the following provisions:

21 The French version of the Regulations is amended by replacing “trouble” with “désordre” in the following provisions:

Medical Devices Regulations

22 Section 5 of the Medical Devices Regulations (see footnote 2) is replaced by the following:

5 These Regulations do not apply to a medical gas piping system that is assembled on site at a health care facility and permanently built into the structure of the facility.

Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use)

23 Section 5 of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) (see footnote 3) is amended by replacing the portion of subsection C.01.004.02(4) before paragraph (a) that it enacts with the following:

(4) If the composition of the drug varies from one lot to another with respect to its non-medicinal ingredients,

Controlled Drugs and Substances Act

Narcotic Control Regulations

24 Section 28 of the Narcotic Control Regulations (see footnote 4) is replaced by the following:

28 A licensed dealer must not sell or provide a narcotic, other than a preparation described in section 36, unless the narcotic is securely packed in its immediate container. The container must be sealed in such a manner that it cannot be opened without breaking the seal.

25 Paragraphs 59(4)(a.1) and (a.2) of the Regulations are replaced by the following:

Access to Cannabis for Medical Purposes Regulations

26 Section 88 of the Access to Cannabis for Medical Purposes Regulations (see footnote 5) is replaced by the following:

88 In the case of fresh or dried marihuana, cannabis oil or marihuana plants or seeds to be sold or provided to a client or an individual who is responsible for the client, the information required under section 84, 85 or 86 and under paragraph 87(1)(a) or subsection 87(2) or (3), as applicable, may be set out on one label.

27 The portion of subsection 90(1) of the Regulations before paragraph (a) is replaced by the following:

90(1) All information that is required under section 84, 85 or 86 and under paragraph 87(1)(a) or subsection 87(2) or (3), as applicable, to appear on a label must be

Coming into Force

28 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.)

Issues

Health Canada (the Department) and the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) identified miscellaneous minor amendments required for the Food and Drug Regulations (FDR), Medical Devices Regulations (MDR) and Narcotics Control Regulations (NCR). Further, the SJCSR indicated that the repeal of a redundant subsection to the NCR should be made. In addition, Health Canada identified the need to correct minor provision numbering errors in the Access to Cannabis for Medical Purposes Regulations (ACMPR).

These amendments, which are being brought forward by the Department of Health, have been collected in this omnibus Regulatory Impact Analysis Statement (RIAS).

Objective

These amendments have the following objectives:

Description

Amendments to the FDR:

1. Correct typographical or grammatical errors:

2. Add clarity to regulatory provisions:

3. Harmonize terms used in the Regulations with those used in the enabling statute:

4. Correct discrepancies between French and English versions noted by the SJCSR:

5. Correct discrepancy between French and English versions identified by Health Canada:

6. Correct section number referencing errors:

7. Repeal obsolete provisions or modernize obsolete references or archaic language:

Amendments to the MDR will:

1. Repeal obsolete provisions or modernize obsolete references or archaic language:

Amendments to the NCR will:

1. Repeal subsection 28(1) as its labelling requirements have been rendered redundant due to amendments in the FDR in 2013.

Amendments to the ACMPR will correct numbering errors in:

1. Section 88

2. Section 90

“One-for-One” Rule

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

Small business lens

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

Rationale

Some of the amendments to the FDR are in response to the SJCSR’s review of the Regulations. The need for a number of other minor technical amendments to the FDR (correction of language discrepancies, and referencing and typographical errors, modernizing obsolete references or archaic language) and to the MDR (repeal of obsolete provisions) have also been identified by the Department. The amendments help to correct or improve the regulatory base and do not impose any costs on the government or stakeholders.

The repeal of subsection 28(1) of the NCR responds to a concern raised by the SJCSR. This provision is no longer required after the coming into force of the Regulations Amending the Food and Drug Regulations (1475 — Good Manufacturing Practices) published in May 2013. With the 2013 amendments, certain provisions under the FDR pertaining to labelling requirements were extended to be applicable for both active ingredients and finished products. The labelling requirements of subsection 28(1) of the NCR are no longer required.

The amendments to the ACMRP and other amendments to the NCR correct regulatory drafting errors, ensure consistency and clarity in the regulatory framework for cannabis for medical purposes, and do not impose any costs on the government or stakeholders.

Contacts

Nancy Maguire
Manager
Departmental Regulatory Affairs
Regulatory Operations and Regions Branch
Health Canada
Address Locator: 3005A
Holland Cross, Tower B, 5th Floor
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Email: DRA-ARM@hc-sc.gc.ca

Amendments to the FDR and MDR:

Bruno Rodrigue
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Address Locator: 3000A
Holland Cross, Tower A, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Email: LRM_MLR_consultations@hc-sc.gc.ca

Amendments to the ACMPR:

Office of Medical Cannabis
Health Canada
Address Locator: 0302B
Ottawa, Ontario
K1A 0K9
Email: OMC-Engagement-BCM@hc-sc.gc.ca

Amendments to the NCR:

Denis Arsenault
Manager
Healthy Environments and Consumer Safety Branch
Health Canada
Main Stats Building
150 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Email: OCS_regulatorypolicy-BSC_ politiquereglementaire@hc-sc.gc.ca