Regulations Amending the Food and Drug Regulations (Finished Product Testing): SOR/2020-73

Canada Gazette, Part II, Volume 154, Number 9

Registration

SOR/2020-73 April 7, 2020

FOOD AND DRUGS ACT

P.C. 2020-227 April 3, 2020

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) footnote a of the Food and Drugs Act footnote b, makes the annexed Regulations Amending the Food and Drug Regulations (Finished Product Testing).

Regulations Amending the Food and Drug Regulations (Finished Product Testing)

Amendments

1 (1) The portion of the definition batch certificate in subsection C.01A.001(1) of the Food and Drug Regulations footnote 1 before paragraph (a) is replaced by the following:

(2) Paragraph (e) of the definition batch certificate in subsection C.01A.001(1) of the Regulations is replaced by the following:

(3) Subsection C.01A.001(1) of the Regulations is amended by adding the following in alphabetical order:

2 Subsection C.02.019(4) of the Regulations is replaced by the following:

(4) Subsections (1) and (2) do not apply to a distributor or importer if the drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and they retain a copy of the batch certificate for each lot or batch of the drug that they receive.

(5) Subsections (1) and (2) do not apply to a distributor or importer of a drug that is not a prescription drug and that is part of a class of drugs that is set out in column 1 of the List of Non-prescription Drugs Not Subject to Certain Testing Requirements if all of the following conditions are met:

(6) A drug that is referred to in subsection (5) may be shipped directly to a person other than an importer if all of the following conditions are met:

Coming into Force

3 These Regulations come into force on the day on which section 7 of the Canada–United States–Mexico Agreement Implementation Act, chapter 1 of the Statutes of Canada, 2020, comes into force, but if they are registered after that day, they come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

These regulatory amendments address two main issues with respect to the regulation of drugs: (1) supporting Canadian businesses and innovation; and (2) supporting the implementation of the Canada-United States-Mexico Agreement (CUSMA).

(1) Supporting Canadian businesses and innovation

Since 2016, industry has consistently identified duplicative testing requirements for low-risk drug products as an irritant when these imported products have already been tested against good manufacturing practices (GMP) requirements in the exporting country. This is particularly true when these products are imported from establishments located in foreign jurisdictions with GMP requirements and compliance programs comparable to Canada’s. As outlined in the Health and Biosciences Sector Regulatory Review Roadmap, duplicative testing requirements create additional regulatory burdens and contribute to reducing Canada’s competitiveness in a global market. Regulatory amendments to the Food and Drug Regulations (FDR) are necessary to exempt importers of low-risk drug products from duplicative testing requirements when these products are imported directly from a GMP compliant establishment located in a jurisdiction having a comparable GMP compliance program, in a manner that permits timely updates to the list of products and exporting jurisdictions subject to these regulations when there are environmental changes or new evidence.

(2) Supporting implementation of the CUSMA

On November 30, 2018, Canada became a signatory to the CUSMA. On May 29, 2019, An Act to implement the Agreement between Canada, the United States of America and the United Mexican States was tabled in the House of Commons. The CUSMA creates a requirement for Canada to permit a set of low-risk drug products to be shipped directly to retailers, distributors or wholesalers, and to exempt those products from finished product testing requirements, provided they have already been tested prior to shipment and are imported from an establishment located in the United States (U.S.). footnote 2 These requirements do not align with the existing requirements under the FDR. In order for Canada to meet its international trade obligations under the CUSMA, regulatory amendments to the FDR are required.

Background

Existing regulatory requirements

Section C.02.019 of the FDR details testing requirements for finished products that must be met by Canadian packagers/labellers, distributors, and importers of drugs regulated under the FDR. Based on these requirements, drugs imported into Canada cannot be sold until they have been tested in Canada and found in conformity with the products’ specifications. Since importers are responsible for the quarantine of imported finished drugs until the results of those tests are available, they cannot arrange for direct shipment from the foreign establishments to the distributor, wholesaler or retailer in Canada.

These testing requirements are necessary for ensuring that finished drug products sold in Canada are safe, effective, and of good quality. However, when these requirements apply to products manufactured, packaged, labelled, and tested in a foreign GMP compliant establishment, they do not provide additional health or safety benefits, and needlessly increase regulatory burdens on industry while delaying retail sale unnecessarily.

The FDR already exempts Canadian importers from retesting requirements for any finished drug approved for sale in Canada that has been fabricated, packaged/labelled and tested, in countries having a Mutual Recognition Agreement (MRA) with Canada. This is because MRA countries are assessed as having GMP compliance programs comparable to Canada’s.

Regulatory cooperation and the Sunscreen Pilot Project

On May 5, 2016, the U.S. and Canadian regulatory officials conducted stakeholder engagement under the umbrella of the Canada-U.S. Regulatory Cooperation Council (RCC). At that time, concerns were raised about the need to retest imported finished products from the U.S. Industry representatives indicated that Canadian regulations required importers to perform the same finished product tests as were already required under U.S. law prior to export. These requirements were seen as duplicative since they increased the regulatory burden on industry without providing additional protection to the health and safety of Canadians. Since then, the self-care products industry has consistently identified duplicative testing requirements for finished products as an irritant. As well, removing duplicative testing requirements would align with Health Canada’s broader commitment since 2016 to update its approach to regulating self-care products in proportion to the risk they pose to the health and safety of Canadians. footnote 3

As part of the Canada-U.S. RCC Work Plan for Over-the-Counter Products, footnote 4 Canada committed to examining current legislation for the importation of sunscreens to Canada and exploring opportunities for a possible alignment of practices to lessen regulatory and administrative burdens related to duplicative testing requirements. On February 27, 2017, Health Canada launched the Sunscreen Pilot Project. The Sunscreen Pilot Project allowed qualifying Canadian importers of sunscreen products from the U.S. to rely on test results from U.S. fabricators or testers in order to meet Canadian GMP requirements prior to sale in Canada. The launch was supported by evidence that sunscreen products are low-risk compared to other drug products such as prescription drugs and they have well-established safety and efficacy profiles. In addition, U.S. testing requirements and the U.S.’s domestic GMP compliance program is comparable to Canada’s. Therefore, such an exemption would further promote both regulatory cooperation and integration of the North American market.

During interviews informing an internal review of the Sunscreen Pilot Project one year after implementation, Health Canada inspectors, businesses, and industry associations provided supportive feedback. They assessed the Pilot Project as innovative and risk-based. External stakeholders qualified the approach as “one of a kind” given that it provided a rapid response to industry’s concerns in advance of regulatory amendments. It also allowed the regulator to assess compliance and operational risks throughout implementation, which in turn would inform future regulatory amendments. Based on this success, the Sunscreen Pilot Project was expanded on February 14, 2019, to include sunscreen products imported from Mexico and Japan. The pilot project was also expanded to countries with whom Canada has an MRA to further operationalize the current regulatory exemption from duplicative testing requirements for products exported from those countries.

Authority to incorporate by reference

The Minister of Health has the authority to incorporate documents by ambulatory reference in the FDR. This can allow Health Canada to respond swiftly to any changes in environmental circumstances, to new evidence regarding health or safety risks, and to add (for example) any additional countries meeting PIC/S international instruments for GMP compliance programs or products assessed as lower risk. When a change to a document incorporated by ambulatory reference is contemplated, it is Health Canada practice to notify the public and stakeholders in order to provide an opportunity for sharing comments or concerns.

Objective

The primary objective is to align the current FDR with the provisions in the CUSMA and the Government’s commitment in the Health and Biosciences Sector Regulatory Review Roadmap as part of its regulatory modernization agenda. These amendments relieve the importer from implementing unnecessary duplicative testing requirements for a set of low-risk drug products and permit direct shipping to retailers, wholesalers or distributors when imported.

These amendments ensure that

An additional objective is to increase regulatory certainty for regulated parties hoping to benefit from the outcomes of the Sunscreen Pilot Project by providing appropriate regulatory authority to exempt importers from unnecessary duplicative testing requirements.

Description

New exemption from testing requirements and direct shipment

These regulations create a new exemption under section C.02.019 of the FDR, relieving Canadian importers and distributors from testing requirements for certain finished drug products imported from a GMP compliant establishment. This establishment needs to be located in a country which is on the list of recognized countries, i.e. a country that is a full participating regulatory authority to the Pharmaceutical Inspection Cooperation Scheme (PIC/S country). The exemption allows importers to ship qualifying products directly to retailers, wholesalers or distributors in Canada. Canadian manufacturers who have their finished products tested in a PIC/S country will similarly benefit from the exemption once the product is imported in Canada for sale.

The exemption is subject to the following conditions:

Canadian importers or distributors, as the case may be, are still required to retain a copy of the batch certificate for each lot or batch of the drug that they import. They remain responsible for the safety, efficacy, and quality of the finished products imported into Canada. The current prohibition against making finished products available for sale in Canada unless they comply with their specifications is maintained. Accordingly, importers are only able to authorize the release of any shipments once they are satisfied that testing requirements have been met in the exporting country. All prescribed requirements under the FDR related to the application for and the issuance of a drug establishment licence are unchanged and continue to apply.

Scope of products

The low-risk products now subject to this regulatory amendment are toothpastes, mouthwashes, personal care use antiseptic skin cleansers, sunscreens, anti-dandruff shampoos, diaper-rash creams, medicated skin care products (excluding antifungals, antivirals, antibiotics, corticosteroids, counter irritants, and analgesics), acne products, throat lozenges, and athlete’s foot creams.

Separate from the proposal to implement the CUSMA obligations around testing requirements and direct shipping, Health Canada is modernizing its approach to regulating self-care products (i.e. cosmetics, non-prescription drugs and natural health products) under the Self-Care Framework Initiative. An important step in advancing the Self-Care Framework Initiative was the publication in December 2018 of updated product monographs that establish a category of low-risk self-care products based on a technical review of a product’s conditions of use. This monograph review was supported by extensive consultations with key stakeholders from industry, academia, health professional organizations and patient groups. Health Canada develops these monographs based on pre-cleared information supporting the safety, efficacy and quality of medicinal ingredient(s) or drugs/natural health products that Health Canada has determined to be acceptable. Product monographs also outline the conditions of use based on a product category (e.g. medicated skin care products, antiseptic skin cleansers, etc.). Work to establish the initial list of products subject to an exemption from duplicative testing requirements on finished products relied on the low-risk categorization established through this monograph review.

When the CUSMA negotiations concluded, Health Canada had completed the review of the monographs pertaining to the following products: toothpastes; mouthwashes; personal care use antiseptic skin cleansers; sunscreens; anti-dandruff shampoos; diaper-rash creams; medicated skin care products (excluding antifungals, antivirals, antibiotics, corticosteroids, counter irritants, and analgesics); and acne products. This supported their inclusion under the CUSMA. As a result of continuous work on the monograph review post-CUSMA, throat lozenges and athlete’s foot creams are now included alongside the other products subject to Canada’s obligations under the CUSMA. The low-risk categorization of these products aligns with how the U.S. and other foreign regulators treat these products.

Scope of countries

Under the CUSMA, Canada has a unique bilateral commitment with the U.S. to relieve certain low-risk drug products from duplicative testing requirements and to permit shipments to be sent directly to retailers, wholesalers or distributors. This bilateral commitment is informed by the degree of assurance Health Canada has in the GMP compliance program in place in the U.S. given its participation to PIC/S along with Canada.

As a condition of receiving and maintaining their membership, participating authorities in PIC/S are subject to regular compliance assessments of their respective regulatory frameworks and GMP compliance programs according to internationally recognized PIC/S instruments. Canada recognizes that PIC/S countries, including the U.S., have comparable GMP compliance programs to Canada. Given the comparable situation between the U.S. and other PIC/S participating authorities, these regulations have been designed so as to be able to extend the exemption to all PIC/S countries.

Where a PIC/S authority has inspected one of its regulated establishments conducting activities in relation to a product subject to these regulations, Health Canada will recognize the foreign authority’s GMP inspection. Should a product subject to these regulations not be regulated as a drug in the exporting PIC/S country, however, it could be manufactured, packaged/labelled, or tested in a facility which was not subject to a GMP inspection. In such cases, the importer is still required under the FDR to demonstrate that the foreign establishment meets the FDR GMP standards for activities conducted in relation to the imported products.

These regulatory amendments align with Health Canada’s intention to further expand the Sunscreen Pilot Project and to leverage Canada’s efforts to advance regulatory harmonization and cooperation through its 20-year membership in PIC/S. This is to support the advancement of a consistent regulatory approach for similar products exported from countries with comparable regulatory requirements and compliance programs.

As such, finished products manufactured, packaged/labelled, tested, and exported from the following countries footnote 5 into Canada now qualify for direct shipment and relief from duplicative testing requirements:

Incorporation of the list of products and countries into the regulatory framework

Products and countries subject to these regulatory amendments will be set out in ambulatory lists incorporated by reference in the FDR. Both lists are published on Health Canada’s website and can be amended from time to time by the Minister.

Changes to the list of products could arise as a result of ongoing classification exercises under the Self-Care Framework Initiative, continued monograph reviews and safety, efficacy and quality assessments conducted at the time of a new product licence application. Prior to any changes to the ambulatory list of products incorporated by reference to the FDR, Health Canada will undertake a scientific review to consider if a product is of a low-risk nature.

Changes to the list of countries may arise when new health authorities acquire full membership to PIC/S or new information reveals a risk to health or safety, should a category of products exported from a listed country be exempted from retesting requirements in Canada.

When changes to the lists are contemplated, a transparent and consultative approach will be used to make changes to either list based on established federal practices. Health Canada will consult Canadians through a Notice of Proposal and will consider all feedback provided during the 60-day consultation period prior to implementing changes to either of the lists entitled

Regulatory development

Consultation

Consultations on the proposal supporting these amendments have been conducted since 2016 with representatives of all impacted stakeholder groups. Stakeholders impacted by these amendments include associations representing healthcare professionals and industry, patient safety and consumer interest groups, and businesses involved in the self-care products sector. Consultations informing these regulations were conducted as part of the RCC, the Canada-European Union Regulatory Cooperation Forum (RCF), the Self-Care Framework initiative, the Health and Biosciences Regulatory Review, and the Sunscreen Pilot Project.

During consultations by the U.S. and Canadian regulatory officials under the RCC beginning on May 5, 2016, stakeholders raised concerns regarding duplicative retesting requirements for finished products imported from the U.S. Stakeholders indicated that these requirements imposed an unnecessary regulatory burden on industry without providing additional protection for the health and safety of Canadians.

Before and during implementation of the Sunscreen Pilot Project, consultations were conducted with industry through Drug Establishment License (DEL) Bulletins, webinars, and various workshops and bilateral meetings from December 2016 to October 2018. When canvassed as part of an internal review of the Sunscreen Pilot Project in summer 2018, stakeholders uniformly agreed that it was an improvement from previous requirements. They wished to see it further extended and expanded to new products and exporting jurisdictions.

Consultations under the Self-Care Framework held in 2019 canvassed stakeholders for input on a proposal to regularize the Sunscreen Pilot Project and expand it to other countries and products. Stakeholders approved of both an expansion to other low-risk drug products as well as including PIC/S members in the scope of countries where exported products could be exempted from duplicative testing requirements. The consultations confirmed stakeholders’ support for the proposed amendments.

In particular, a leading industry association and principal voice of the cosmetics and personal care products industry in Canada voiced its support for incorporating the lists of qualifying countries and products by reference, to allow for the Minister to update either list from time to time, given the flexibility this approach provides to respond to risk and future evidence.

Furthermore, during consultations related to the Health and Biosciences Regulatory Review, stakeholders indicated the need for a risk-based and consistent approach to regulating self-care products. Stakeholders specifically noted the need for reduced regulatory burden in the management of low-risk drug products. footnote 6

Finally, consultations were led by Global Affairs Canada (GAC) throughout the CUSMA negotiation process, and were supported by Health Canada. Consultations solicited views from the Canadian public, as well as businesses, unions, civil society, and Indigenous groups. In particular, input informing Canada’s CUSMA commitment regarding duplicative testing and direct shipment for low-risk drug products was provided by the Cosmetics Alliance of Canada (CAC), which was engaged throughout the negotiation of the CUSMA.

Cost-benefit consultations

Health Canada’s Office of Audit and Evaluation conducted a review of the Sunscreen Pilot Project over spring/summer 2018 to assess whether intended outcomes were being met and to identify areas for improvement. The review covered the period of fall 2016 to spring 2018, and focused primarily on program effectiveness determined through interviews with 31 key informants (namely, 12 internal representatives from the Government of Canada and 13 external representatives, including sunscreen importers and industry associations).

During these consultations, industry participants in the Pilot Project provided information on costs and benefits encountered during implementation. Based on stakeholder feedback and further analysis, a qualitative analysis was undertaken as these amendments are expected to be low impact in nature.

Prepublication

Exemption from prepublication in Canada Gazette, Part I, is supported by the following:

(1) Alignment with existing practices and stakeholder input: These regulatory amendments align with Health Canada’s practices under the Sunscreen Pilot Project, which has covered a subset of the products included in this proposal since its launch in February 2017. In addition, the regulatory amendments align with Health Canada’s objectives under other initiatives on which stakeholders have been extensively consulted over a three-year period, including the Sunscreen Pilot Project, the CUSMA negotiations, the RCC, the RCF, the Health and Biosciences Regulatory Review, and the Self-Care Framework, for which feedback received was consistently supportive.

(2) Reduction of regulatory burden: The amendments reduce regulatory burdens for industry, improve consumer access to qualifying products, and maintain existing levels and mechanisms of oversight to address risks posed to the health and safety of Canadians. During consultations informing Health Canada’s review of the Sunscreen Pilot Project, some industry participants expressed an interest in joining the Sunscreen Pilot Project, but required more regulatory certainty prior to changing their current distribution practices.

(3) International regulatory harmonization: These regulatory amendments fully leverage Canada’s efforts to enhance regulatory harmonization and cooperation among PIC/S members. Given that maintaining a GMP inspection regime equivalent to PIC/S instruments is an ongoing obligation on PIC/S members, all PIC/S countries have been assessed as having a GMP compliance program comparable to Canada’s.

(4) Exemption from World Trade Organization (WTO) notification: Given that the amendments apply to products already authorized for sale in Canada, and do not impose any new or modified technical requirements on new or existing products or regulated parties, a notification to WTO is not required.

Modern treaty obligations and Indigenous engagement and consultation

These amendments do not impact Government obligations in relation to rights protected by section 35 of the Constitution Act, 1982, modern treaties or international human rights obligations.

Instrument choice

These regulatory amendments are necessary for Canada to implement the CUSMA and stabilize the Sunscreen Pilot Project for stakeholders and the Government. The ongoing Sunscreen Pilot Project only provides exemptions for sunscreen products approved for sale in Canada and does not cover the full scope of products listed under Annex 12-B of the CUSMA. This does not provide sufficient authority for exempting importers from complying with existing regulatory requirements. Therefore, the status quo (i.e. taking no action) was not a viable option. Non-regulatory options are also not viable as the Food and Drugs Act permits exceptions to the FDR requirements only in accordance with the regulations.

Several industry representatives also indicated a need for increased regulatory certainty. The current policy approach adopted under the Sunscreen Pilot Project does not provide sufficient assurance that it will remain long lasting and worth investing in new business processes in order to benefit from this exemption.

Regulatory analysis

Benefits and costs

Benefits and costs for industry

Based on the feedback received on the implementation of the Sunscreen Pilot Project, industry representatives confirmed that these amendments respond to a long-standing barrier to the trade of low-risk products. The savings and efficiencies offered by the relief from duplicative testing and the ability to ship products directly from a foreign manufacturer to retailers, distributors or wholesalers in Canada provide two sets of positive incremental impacts for businesses taking advantage of these amendments.

First, importers of low-risk drug products will save costs associated with unnecessary duplicative testing requirements, ranging from the costs directly associated with testing of finished products to any fines imposed by retailers unable to fulfil purchase orders due to duplicative testing-related delays. Second, businesses will save on supply chain administration and logistics-related costs. Industry stakeholders participating in the Sunscreen Pilot Project noted they were able to move products from import to retail approximately two to four weeks faster when not subject to duplicative testing requirements.

Although it is expected that importers will seek to take advantage of the flexibility provided by these amendments, uptake will depend on business decisions that importers would make according to their individual commercial positions and supply chain arrangements. Importers and distributors opting to ship finished products directly to retailers, distributors or wholesalers in Canada are required to ensure that controls are in place to maintain the safety, efficacy, and quality of products when activities are conducted on their behalf with respect to the imported product. For example, this requirement can be satisfied by entering into Quality Agreements with third parties responsible for the distribution and sale of the product. Quality Agreements are a well-established practice in the pharmaceutical industry when regulated parties share or delegate activities in order to continue to ensure compliance with GMP regulatory requirements.

Costs associated with putting such controls in place to maintain the safety, efficacy and quality of products are not taken into account under these regulations, as they are the result of business decisions to opt for direct shipment based on each company’s preferred approach. Furthermore, their complexity and cost would vary according to the supply chain arrangements, sizes, and business practices of each party.

Benefits for Canadians

These regulatory amendments provide Canadians with faster access to exempted products, and may allow businesses to pass savings on to Canadian consumers should they choose to do so. Furthermore, the safety, efficacy, and quality of imported products are not compromised by these amendments. Importers and distributors will remain responsible for existing regulatory requirements, including ensuring that finished products are tested in accordance with GMP requirements and meet their approved specifications prior to being released for export to Canada, regardless of any arrangements made for direct shipping.

Industry compliance with product specification requirements was verified during a 2017–2018 compliance monitoring exercise under the Sunscreen Pilot Project, which tested 27 sunscreen products sold in Canada and found that those products met their approved specifications. footnote 7 Of the sunscreens tested, all 27 had a pH range close to the skin’s natural level and contained the amount of active ingredient listed on their labels, and none had preservatives known to cause skin irritation or microbial contaminants above permitted levels. Low-risk non-compliance incidents with record-keeping requirements were detected, but did not directly affect the safety, efficacy and quality of the products. This will be addressed further as part of Health Canada’s compliance and enforcement implementation strategy.

Benefits and costs for Health Canada

Health Canada benefits from strengthened regulatory cooperation with international partners by leveraging the outcomes of long-standing regulatory harmonization initiatives through PIC/S.

Costs and savings related to compliance and enforcement resources are neutral. These amendments do not include changes to the regulatory requirements applicable to importers and distributors or Health Canada’s approach to oversight for these products. However, should the Self-Care Framework come into force, Health Canada expects to be able to tailor its oversight approach for low-risk products in a manner permitting reallocation of resources to high-risk products.

Small business lens

Importers

These regulatory amendments will result in an overall positive impact for small businesses involved in importing low-risk health products, given the savings associated with the removal of duplicative testing and the ability to streamline supply chains through direct shipping. Uptake of the flexibility created by these amendments is contingent on business decisions, which importers will make according to their individual commercial positions and supply chain arrangements.

Testers

Although any business licensed to perform testing on low-risk finished drug products could be impacted by these amendments, the degree of impact will vary according to how reliant each business is on testing the low-risk finished drug products included under these regulatory amendments, which form a very small subset of self-care products in Canada. Businesses licensed by Health Canada to perform testing on low-risk drug products are likely to be the most impacted by these regulatory amendments, given the potential for importers to have testing performed in other PIC/S countries rather than in Canada. Based on internal establishment licence data, Health Canada found that of the 34 licensed regulated parties performing testing on finished dosage form drug products, six are only licensed to conduct testing activities on low-risk drug products. Of that subset of licensed regulated parties, none of the six met the definition of “small business” under the Policy on Limiting Regulatory Burden on Business. footnote 8

One-for-one rule

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

Regulatory cooperation and alignment

Concerns regarding unnecessary duplicative testing requirements were initially raised in the context of the Canada-U.S. RCC, following which solutions were pursued as part of the negotiations for the CUSMA. By fully leveraging PIC/S regulatory harmonization efforts and international cooperation to monitor regulatory compliance with GMP requirements, these regulatory amendments address these concerns and fulfil several elements of the Canada-U.S. RCC Work Plan for Over-the-Counter Products.

Regulatory cooperation and alignment are at the core of these amendments. They rely on the degree of assurance Health Canada has built over the years, through PIC/S member assessments, in the GMP compliance programs of foreign jurisdictions and the GMP compliance culture of regulated establishments located in those countries when it relates to drugs.

Implementation of these regulatory amendments will be further coordinated with existing efforts to address several interrelated issues under the first work plan of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) RCF, including classification of products. footnote 9

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan was conducted and concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for this proposal.

Implementation, compliance and enforcement, and service standards

These regulations will come into force on the day that the Canada–United States–Mexico Agreement Implementation Act comes into force, but if they are registered after that day, they will come into force on the day they are registered.

Implementation activities to support these regulations, such as staff training and compliance promotion, are minimal given that these regulatory amendments are removing existing requirements and Health Canada developed operational expertise during the implementation of the Sunscreen Pilot Project. Departmental guidance further clarifying these amendments for stakeholders are published on Health Canada’s website.

Importers, distributors and wholesalers will continue to be inspected based on risk and complaints received respecting quality, efficacy and safety issues, and in order to assess compliance with GMP requirements. This approach could also be accompanied by other targeted compliance monitoring activities conducted to verify the compliance of a sample of products on the market tested in a PIC/S country.

There is also no change in the implementation and enforcement of the current drug establishment licensing (DEL) program. Regulated parties will be charged appropriate service fees to cover costs associated with the delivery of a DEL under the cost recovery framework for health products. The current performance standard of 120 days associated with the issuance of a decision on an application for a DEL remains unchanged.

Should Health Canada consider updating the lists in the future as part of other ongoing initiatives, this will be based on safety, efficacy and quality considerations, as well as changes in the GMP certification of countries (e.g. changes in PIC/S membership status). Health Canada will also consider risks associated with non-compliance with GMP standards. Any changes will be supported by a transparent and consultative approach as outlined above.

Contact

Catherine Hudon
Director
Compliance Policy and Regulatory Affairs
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Telephone: 613‑954‑6785
Email: hc.prsd-questionsdspr.sc@canada.ca