SOR/2017-18: Regulations Amending Certain Department of Health Regulations (Miscellaneous Program)
REGISTRATION OF FEDERAL REGULATION - VIA OIC DATABASE, PRIOR TO PART II OF THE GAZETTE
February 13, 2017
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 t... (Click for more)
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Published on February 18, 2017
SOR/2017-18: Regulations Amending Certain Department of Health Regulations (Miscellaneous Program)
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: to correct references to section numbering; to correct a discrepancy between the French and English versions; to harmonize terms used in the regulations with those used in the enabling statute; to add clarity to a regulatory provision; to correct typographical or grammatical errors; and to repeal obsolete, spent or redundant regulatory provisions. Description Amendments to the FDR: 1. Correct typographical or grammatical errors: B.14.033, B.14.035 and B.14.037(1)(a): “hachée finement” will be changed to the correct tense of “hachée.” In Part B, the terms “preserve,” “preserved” and “preserves” appear in a total of 145 instances when referring to meat, poultry, and marine and fresh water animal products (e.g. fish). The Department has analyzed whether the French translation of each of these instances is using the correct tense of the verb “conserver.” In eight provisions the translations have been found to be incorrect and they will be changed to the proper tense. B.21.002(d): The French grammar inaccuracy “animaux marine” will be changed to “animaux marins.” 2. Add clarity to regulatory provisions: C.01.019(3): This provision will be amended to add the word “only” in the English version and “ne . . . que” in the French version to clarify intent. C.01.004.02(4): This provision will be amended to clarify the intent of the provision by adding the text in bold in both the English and French versions: “If the composition of a drug varies from one lot to another with respect to its non-medicinal ingredients.” 3. Harmonize terms used in the Regulations with those used in the enabling statute: C.01.010 and C.01.040.03(a): In the French version, the word “trouble” will be changed to “désordre” to align with terminology in the Food and Drugs Act. 4. Correct discrepancies between French and English versions noted by the SJCSR: B.08.040 to B.08.041.8: The French translation of “the product made by comminuting and mixing” (currently “produit du mélange et du malaxage”) will be changed to “produit du râpage et du mélange.” B.21.006[S], B.21.006(s) and B.21.021(e): When the terms are used to describe fish or seafood, all instances of “comminuted” will be changed to “minced” and all instances of “déchiquetés” will be changed to “hachés.” When “comminuted” and “déchiquetés” are used in reference to foods that are not fish or seafood, they will remain unchanged. This is consistent with the repeal of the term “comminuted” from the Canadian Food Inspection Agency’s Fish Inspection Regulations and will result in the same term used in the French translation (haché) for both “comminuted” and “minced.” As per the Department’s interpretation that “meat” is “chair” in French as it pertains to marine and fresh water animal products: B.21.005(b)(ii), B.21.020, B.21.021, B.21.021(c): “chair de poisson” will be changed to “chair.” B.21.006[S], B.21.006(n), B.21.007[S]: “viande” will be changed to “chair.” C.01.019(2): The French text “tout ou partie des réactions indésirables” will be changed to better align with the English “all or specified adverse drug reactions.” 5. Correct discrepancy between French and English versions identified by Health Canada: A.01.043: will be changed as follows: (EN) If an inspector, upon 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 …. (FR) L’inspecteur qui estime, après examen d’un échantillon de l’aliment ou de la drogue ou réception du rapport de l’analyste que la vente de l’aliment ou de la drogue serait contraire à la Loi ou au présent règlement, en avise …. B.21.003(b): The incorrect French translation of the word “glaze” (currently “lustre”) will be changed for “glaçure.” B.21.005: The words “d’animaux marins ou d’animaux d’eau douce ou leurs préparations” will be removed so that this section would simply refer to “chair.” 6. Correct section number referencing errors: There is an incorrect reference to adverse drug reporting requirements in the FDR that apply to drugs in clinical trials due to renumbering in Division 1 that came when C.01.018 to C.01.020 were added. The reference in subsection C.05.014(3) to “C.01.016 and C.01.017” will be changed to “C.01.016 to C.01.020” in the English version and from “C.01.016 et C.01.017” to “C.01.016 à C.01.020” in the French version. The reference in C.01A.013(a) to “subparagraphs C.01A.005(g)(i) and (ii)” is an error, given that paragraph (g) has been amended such that it no longer has subparagraphs. Paragraph C.01A.013(a) will be amended such that the reference is to C.01A.005(g). 7. Repeal obsolete provisions or modernize obsolete references or archaic language: The archaic language in C.01.009 of the FDR will be modernized by replacing “statute of the Parliament of Canada” by “Act of Parliament” in the English version, and by replacing “un statut du Parlement du Canada” by “une loi fédérale” and “d’un statut” by “d’une telle loi” in the French version. Amendments to the MDR will: 1. Repeal obsolete provisions or modernize obsolete references or archaic language: Paragraphs 5(a) and 5(b) of the MDR will be repealed as they are obsolete standards. Medical gas pipelines will henceforth be regulated through national and provincial building codes, as they form part of the structure of a hospital. The Department’s regulatory authorities exempt medical gas pipelines that are built as part of the hospital structure from the MDR. 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. The Controlled Drugs and Substances Act (CDSA) and its regulations, including the NCR, provide a framework for the control of substances that can alter mental processes and that may cause harm to health or to society when diverted to an illicit market or used inappropriately. Within this context, subsection 28(1) of the NCR states that: “No licensed dealer shall sell or provide a narcotic that is not a drug within the meaning of section 2 of the Food and Drugs Act, unless the narcotic is labelled in accordance with the Food and Drug Regulations.” Subsection 28(1) was intended to ensure that narcotics in the form of active pharmaceutical ingredients (rather than only finished drug products) were labelled according to the FDR. Due to amendments made to the FDR in 2013, however, subsection 28(1) of the NCR is unnecessary as the raw materials (i.e. active pharmaceutical ingredients) are now subject to labelling requirements set out in the FDR. In accordance with section 59 of the NCR, the Minister may notify certain authorities (e.g. licensed producers, health care licensing authorities) if the Minister has reasonable grounds to believe that a health care practitioner has contravened certain provisions in the ACMPR. The provisions referenced in section 59 as belonging to the ACMPR (i.e. sections 128, 129 and 130) refer to provisions as they were numbered in the former Marihuana for Medical Purposes Regulations (MMPR). These former MMPR provisions are now found in sections 7, 8 and 9 of the ACMPR. The proposed amendment will correct the references in this section of the Regulations. Amendments to the ACMPR will correct numbering errors in: 1. Section 88 This section is intended to allow licensed producers to combine on one label product information and client information for all products. Specific product and client labelling requirements vary depending on the product being sold or provided: fresh or dried marihuana or cannabis oil, or marihuana seeds and plants. Product labelling requirements for marihuana seeds and plants are set out in sections 85 and 86 respectively. Section 87 sets out the labelling requirements for clients. As the Regulations are currently written, licensed producers may not combine on one label product information related to marihuana seeds and plants with information about the client (as it is the case for fresh or dried marihuana or cannabis oil) because section 88 does not reference sections 85 and 86; however, this is not the intent. The proposed amendments will enable licensed producers to combine, on one label, product information related to marihuana seeds and plants with client information. This will correct this inconsistency in the Regulations and will be similar to the case for fresh or dried marihuana and cannabis oil. 2. Section 90 This section of the ACMPR requires that all information on the product label for fresh and dried marihuana and cannabis oil and the client label for fresh and dried marihuana, cannabis oil, marihuana seeds and marihuana plants be in English and French, be clearly and prominently displayed on the label and be readily discernible under the customary conditions of use. The proposed amendments will enable these labelling requirements to also apply to information on the product label for marihuana seeds and plants, in addition to fresh and dried marihuana and cannabis oil, and correct this inconsistency among products. “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: [email protected] 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: [email protected] Amendments to the ACMPR: Office of Medical Cannabis Health Canada Address Locator: 0302B Ottawa, Ontario K1A 0K9 Email: [email protected] 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_ [email protected] Footnote a S.C. 2012, c. 19, s. 414 Footnote b R.S., c. F-27 Footnote c S.C. 2015, c. 22, s. 4(1) Footnote d S.C. 1996, c. 19 Footnote 1 C.R.C., c. 870 Footnote 2 SOR/98-282 Footnote 3 SOR/2014-158 Footnote 4 C.R.C., c. 1041 Footnote 5 SOR/2016-230
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