The objective of this consultation document is to provide context and policy intent for the consumer health products framework (Framework) as outlined by the Minister of Health in her announcement in June 2014: "It is proposed that lower-risk products be separated from the framework for prescription drugs, and be moved under a new framework for consumer health products. The new Framework will take into account the potential risk of the product in order to ensure that the right level of oversight through regulations is applied."
Under this Framework, Health Canada will advance a new approach to the regulation of consumer health products. The key enabler of the approach is the proposal to create new regulations for non-prescription drugs, supported by ongoing operational improvements.
Throughout this document we will explain the importance of creating new non-prescription drug regulations to support the success of the overall consumer health products framework. We will also explain how the Framework and the proposed regulations are designed to ensure that the safety of Canadians always remains the priority.
As part of the Regulatory Transparency and Openness Framework, Health Canada is inviting all Canadians to be a part of the discussion on the future regulation of consumer health products. This document is intended for consultation with interested stakeholders.
The Framework seeks to modernize the oversight of consumer health products while continuing to ensure that Canadians have access to safe and effective products. As part of this modernization, Health Canada is establishing a consistent and aligned approach to the regulation of health products intended for consumer use (cosmetics, disinfectants, natural health products and non-prescription drug products). This approach includes providing Canadians with information that will help them to identify what products are regulated by Health Canada and enable them to make safe, informed choices about products and their use.
Consumer health products are products sold directly to consumers. Unlike prescription drugs, selection and use of consumer health products does not require the oversight of a health care practitioner. Health Canada has determined that with enough supporting information and instructions, consumers can safely select and use these products to maintain and improve their health.
Did you know?
Health Canada reviews consumer health products to make sure they are safe, effective and of high quality. You can tell a product has been reviewed and approved by Health Canada by the presence on a label of a DIN, NPN or DIN-HM.
Consumer health products cover a broad range of products that are defined and organized by Health Canada according to the Food and Drugs Act and various supporting policies.
Consumer health products include:
Did you know?
Health Canada has approved more than 85,000 consumer health products and there are databases on the Health Canada website that list these approved products. You can also enter a product's DIN, DIN-HM, or NPN into these databases to learn more details of Health Canada's approval of the product.
As Canadian consumers have access to more health information than ever before, they have been taking a bigger role in their own health care. This is particularly evident in the area of self-care where Canadians are making more decisions about how to improve and maintain their health with the use of products that they can chose and use on their own.
Meanwhile, the consumer health product market is growing and changing. These products are being sold in an increasingly wide range of locations from gas stations, to pharmacies, to health food stores, to supermarkets, and the range of products available is also increasing due to industry innovation and diversification. At the same time, the regulation of health professionals and what they can prescribe is changing such that more types of professionals are able to prescribe certain kinds of medications. Finally, there is an evolution in how non-prescription drugs are scheduled, which means in what types of stores they can be sold and whether they are available in front of or behind the counter.
Health Canada needs a regulatory approach that will be flexible and responsive enough to adapt to rapid innovation, shifts in the health professional sphere, and the ever-increasing demand from the consumer for more self-care options and information on how to use these products safely and effectively.
Consumer health products are regulated under several sets of regulations, each with its own requirements. Because some requirements are considerably more stringent than others, products of similar risk can be subject to very different requirements. This can result in disproportionate application. This is most evident in the case of non-prescription drugs, which are regulated using the same set of regulations as prescription drugs.
Products that have the health claim "sun protection factor (SPF)" or "helps prevent sunburn" on the label are natural health products or non-prescription drugs. This also includes those that may be perceived as cosmetics such as make-up and skin care products with SPF.
Under the Framework, the regulatory approach to sunscreens - regardless of their classification - would be aligned such that requirements are proportionate to the risk.
Further, many consumer health products border or sit at the interface of multiple product categories that are defined in regulation and policy. This means that a single product can have multiple features of different product categories at one time. For example, a cream could be a natural health product, a non-prescription drug, or a cosmetic depending on the product's ingredients, whether it claims to have an impact on the user's health, and other factors.
What is a health claim?
It is a statement on a health product about what the product does in relation to your health. Examples include: "relieves pain", "helps in the development of bones and teeth", "provides fast relief from allergies", "helps prevent tarter build-up".
Health Canada reviews the evidence behind these health claims to make sure that products do what they claim to do. Advertising preclearance agencies also play a role. These agencies, independent of government, work with advertisers to make sure that health product advertising for television, newspapers, etc. meets Health Canada's rules and standards.
Under the current system, the implications of a decision about what kind of product it is and the set of regulations that applies could be significant. If a product is a non-prescription drug instead of a natural health product or a cosmetic, the requirements that a company needs to meet may be disproportionate to the product's risk profile. Further, consumers' access to these products, which have been shown to be safe, could be unnecessarily delayed.
|Consumer Health Product||Cosmetic||Natural Health Product||Non-Prescription Drug|
|Toothpastes with fluoride||N/A||Yes||Yes|
In the chart above, you can see that toothpaste can be a natural health product, non-prescription drug, or a cosmetic. The two main factors that determine which of these three apply are the ingredients and the presence of a health claim. The health claim is particularly important because when there is one, the toothpaste must be a natural health product or a non-prescription drug. Cosmetics, however, cannot include claims about your health. Even though consumers use these toothpaste products in the same way, the classification is relevant for companies. How the product is categorized determines the regulatory requirements that must be met.
Regulated under the Food and Drug Regulations, non-prescription drugs are sold directly to consumers without a prescription and include a range of products such as pain relievers, cold and allergy remedies, acne therapies, anti-dandruff shampoos, toothpastes and disinfectants.
Currently, non-prescription drugs are regulated under various Divisions (e.g., 1, 1A, 2, 8 and 9) of Part C of the Food and Drug Regulations. Filing an application and obtaining an authorization is required for the sale and advertising of drug products, and also for establishments in which drugs are manufactured and distributed.
The general organization of the Divisions under Part C regulates both prescription drugs and non-prescription drugs together under the same provisions (from cold remedies to cancer drugs). The two major Divisions, 1 and 8, apply to the pre-market review of drugs and are not flexible enough to account for a drug's relative benefit, harm and uncertainty profile. This lack of flexibility in regulation has proven to be a less than an optimal means to determine the appropriate level of oversight and consistency between products of similar risk profiles for both their pre-approval data requirements and their post-approval monitoring requirements.
Without new regulations for non-prescription drugs, it will be very difficult to apply the aligned approach for consumer health products that is proposed in the Framework to non-prescription drugs. Also, non-prescription drugs would continue to be subject to disproportionate requirements.
By regulating consumer health products of similar risk profiles in a similar manner under the Framework, the regulatory process will be more consistent as will be the standards for safety. As a regulator, Health Canada will continue to focus on providing credible, timely information and greater openness and transparency about its health and safety decisions on consumer health products.
Want to know more?
Learn about Health Canada's commitment to transparency and openness.
As a result, Canadians will benefit from increased access to novel consumer health products and more tools (e.g., clear product labelling information, licensed health product databases for natural health products and non-prescription drugs) to support informed decision making on products available on the Canadian market.
Did you know?
The Government has created new rules for plain language labelling that will help improve the safe use of prescription and non-prescription drugs by making their labels and packaging information easier to read and understand.
The Framework aims to protect Canadians from the sale and advertising of unsafe consumer health products, while supporting their safe use. As Health Canada remains committed to the health and safety of Canadians, any updates to current regulations and any new regulatory approaches under the Framework will not compromise safety. The following must be included:
Health Canada recognizes that not all consumer health products have the same risk profile and therefore do not require the same level of oversight. The approach will be based on the management of benefits, harms and uncertainties by considering the nature, intended use and exposure of the product. This will support a regulatory system that is more open, predictable, transparent and does not compromise safety.
The new Framework is built on the following elements:
What does benefit, harm and uncertainty mean?
The regulation of consumer health products is based on the principle that the product's benefit must exceed any potential harm, with a reasonable degree of certainty. Benefit may be defined as any intended useful, positive effect obtained, whereas harm is any unintended effect that may cause injury or diminish human health in any way.
Benefit and harm are not absolute, and Health Canada recognizes that uncertainties exist with respect to both the benefit and harm that may result from being exposed to a food or health product.
Tolerance for harm and uncertainty is closely linked with the benefit that a product may provide.
While cosmetics fall under the Framework, how we assess what is in them is somewhat different. Ingredients are assessed for safety based on hazard and exposure. This means that Health Canada looks carefully at both the characteristics of the ingredients in a cosmetic as well as how consumers are exposed to those ingredients.
Of all the regulatory components in the Framework, the approach to natural health products represents the most modernized approach. Since the coming into force of the Natural Health Products Regulations in 2004, Health Canada has improved operational capacities, established effective, efficient licensing instruments (i.e., pre-cleared information or compendia of monographs), and created a three-class system for reviewing natural health products.
Want to know more?
Learn about natural health product regulation.
The Framework aims to build on recent natural health product best practices to provide consistent oversight, to the extent possible, for all consumer health products, while always making safety the priority.
Refer to the section entitled "Why develop new regulations for non-prescription drugs under the Framework?".
Did you know?
Canadians use many different non-prescription drugs to prevent and treat certain conditions, from protecting their skin from sun exposure to treating heartburn and acid indigestion.
Disinfectants are currently regulated under various Divisions of the Food and Drug Regulations alongside prescription drugs and non-prescription drugs. Disinfectants have the same requirements as non-prescription drugs with some notable exceptions:
Certain disinfectants (e.g., for use in swimming pools and spas) will continue to be regulated under the Pest Control Products Act.
Did you know?
Around the home, disinfectants can be used on things like garbage cans, cutting boards, shower stalls, doorknobs, toilets and kitchen counters.
Regulated under the Natural Health Products Regulations, natural health products include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics and other products like amino acids and essential fatty acids. Similar to non-prescription drugs, natural health products also include products such as pain relievers, toothpastes and anti-dandruff shampoos.
Elements of the Natural Health Products Regulations,in effect since 2004, have proven to be an effective means to achieve a flexible, risk-based regulatory approach to consumer health products. The desirable elements of the Natural Health Products Regulations, combined with the experience gained over the last ten years, will inform the creation of a modern, comprehensive and risk-based framework for consumer health products.
Did you know?
Your daily vitamin and mineral supplement is actually a natural health product.
Cosmetics are regulated under the Cosmetic Regulations. It is important to note that products that look like cosmetics at retail may actually be regulated as non-prescription drugs or natural health products because of what they contain and the claims they make about what they do. Under the Framework, the approach to cosmetics will be better aligned; as a result, Canadians can continue to access safe products and industry will see more proportionate application of requirements.
Multiple Product Regulations
Depending on their representation for use and composition, consumer health products are regulated under three different sets of regulations administered by two different Branches within Health Canada.
While the Department is proposing to create new regulations for non-prescription drugs, it is making many improvements to its regulatory approach to consumer health products. Efforts are focused on examining current policy, guidance and operational processes to support the alignment of consumer health products, including the approach outlined in this discussion paper.
Health Canada has identified a group of lower-risk products for which companies may provide their applications in a more efficient way through the non-prescription drug monograph attestation pilot. This pilot, informed by natural health product best practices, enables applicants to fully attest to established monographs (such as those for sunscreens and throat lozenges, among others) in order to obtain approval to market a product. Operational improvements like this one remove unnecessary burden from the process. What remains constant is that companies must always meet safety standards.
Other work includes:
The Consumer Health Products Framework envisions an integrated governance approach to consumer health products that brings together the Health Portfolio, the provincial and territorial governments, and relevant stakeholder associations such as the National Association of Pharmacy Regulatory Authorities (NAPRA). The development of this governance will help to address issues around Canadians' access to safe consumer health products, point of sale issues, informed use of self-care, and the need to reduce overall health care system costs by promoting self-care options.
What is the Health Portfolio?
Health Canada, the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Patented Medicine Prices Review Board and the Canadian Food Inspection Agency are all part of the Health Portfolio.
As outlined in the Health Products and Food Branch Regulatory Roadmap, updated regulations were envisioned for drugs: aligning products of similar benefit, risk and uncertainty profiles. The first step under the Framework will be to propose the creation of new regulations for non-prescription drugs. Desirable elements of the Food and Drug Regulations combined with experience gained from administering regulations such as the Natural Health Products Regulations will inform the creation of a modern, comprehensive and risk-based set of regulations for non-prescription drugs. Furthermore, this will create fluidity between regulations such as the Natural Health Products Regulations and the Cosmetic Regulations. This approach will continue to ensure Canadians can have confidence in the safety of health products they use.
Part 2 of this document will outline the regulatory design elements for the proposed non-prescription drug regulations found in Part 3. Once these regulations are adopted, non-prescription drugs would no longer be regulated under the Food and Drug Regulations.
Did you know?
Health Canada publishes a bi-annual calendar of review activities, publications, workshops and meetings related to natural health products and non-prescription drugs.
The proposed non-prescription drug regulations will be separated from the regulations for prescription drugs; however, the proposed regulations will be designed to work together to address gaps or issues, such as switching the status of drugs from prescription to non-prescription and interfaces with other commodities and regulations. In addition, the Prescription Drug List currently established in Division 1 of Part C of the Food and Drug Regulations, provides clarity regarding the drugs to which the proposed non-prescription drug regulations will not apply.
For all consumer health products, the benefit of the product must outweigh the harm. The level of oversight will be proportional, and in the proposed regulations, the type and amount of evidence that a company must submit will depend upon the nature of the product, its intended use and exposure. It is recognized that a greater variety of evidence types will exist for these products, as they range from well-established and understood products to new chemical entities. Safety, efficacy and quality will remain central to these principles as they guide the development of the provisions or requirements within the proposed regulations.
The provisions in these regulations will reflect the life-cycle approach and will include pre- and post-marketing oversight, such as requirements for product authorization and site licensing, good manufacturing practices, clinical trials and post-market surveillance.
Given their unique nature of intended use, the approach to regulating disinfectants should be somewhat different than the approach required for other non-prescription drugs intended for direct human use. The proposed regulations for non-prescription drugs will be designed to include distinct provisions for disinfectants that are tailored appropriately.
More responsive regulatory instruments and licensing models for the proportional oversight of non-prescription drugs are proposed. These instruments and licensing models will take into consideration the type and amount of evidence required for products depending upon their nature, intended use and exposure, as well as information the regulator already knows about the product. The licensing models for product and site will be developed based on this approach. Other provisions of the proposed regulations will carry this approach as well and provide flexibility to address the difference in the risk profile of products. Flexibility will be further established by using instruments such as guidance documents that will support the regulations and provide details on complying with the requirements.
In addition, the approach will be informed by the Natural Health Products Regulations and operational efforts to apply a risk-based approach to achieve efficiency and proportional oversight, as well as international best practices.
Health Canada recognizes that over the last several years, the drug manufacturing industry, like many others, has evolved a complex, networked approach to manufacturing. Parties who obtain authorization to market a non-prescription drug will continue to be ultimately responsible for their authorized products. In addition to ensuring the safety, efficacy and quality of products, market authorization holders will continue to be responsible for receiving, maintaining and submitting adverse reaction reports and keeping sufficient records to enable the complete recall of a product.
As a result, although the market authorization holder still has legal responsibility for the drug, in practice, that company may find it a challenge to obtain sufficient knowledge or control of manufacturing operations and distribution of the product through the supply chain. Currently, there are no regulatory requirements on a company, such as a retail chain, that is not a market authorization holder but sells a non-prescription drug under its brand name ("brand owner"). In the proposed regulations, these "brand owners" would be required to have a market authorization with associated rights and obligations.
Most of the changes to good manufacturing practices proposed in the regulations for non-prescription drugs are already widely implemented on a voluntary or interpretative basis. The regulations would establish a general good manufacturing practice standard that would be expected for all non-prescription drugs, regardless of their risk profile; however, the interpretation of each good manufacturing practice requirement would be further supported in guidance documents and tailored to the nature of the drug, the activity being conducted and the associated risks.
The current establishment licensing and good manufacturing practice requirements taken together ensure the production of high quality drug products and facilitate their export to other jurisdictions with equivalent regulatory requirements and inspection programs (e.g., Canada's Mutual Recognition Agreement partners and the participating authorities of the Pharmaceutical Inspection Co-operation Scheme).
It is proposed that the current establishment licensing model be maintained for parties carrying out regulated activities for most non-prescription products and supplemented with a risk-based approach to include a site registration model for certain lower-risk activities and products.
The objective of the proposed non-prescription drug regulations is to continue to provide oversight that does not compromise safety, efficacy and product quality. For example, advancing a pre-market licensing scheme to support flexibility and proportionality will be balanced with a robust and stringent post-market scheme that allows for responsive regulatory action for non-compliance, such as licence suspension and/or mandatory recall. Further, the life-cycle approach and post-market surveillance system will be tailored to the levels of uncertainties associated with the product. This approach will provide on-going information which, if the benefit, harm, uncertainty profile changes, may result in immediate regulatory action, such as reclassification of a product.
The proposed regulations to modernize the oversight of non-prescription drugs will be developed within the existing legislative authorities and new authorities under Protecting Canadians from Unsafe Drugs Act (Vanessa's Law). This will enable the design of regulations that would allow for the stratification of risk-based requirements for pre-market and post-market.
The new authorities in Vanessa's Law (e.g., incorporation by reference) will be used to incorporate lists of documents such as product, class or substance-specific monographs, allowing for more efficient product approval through the use of compendia. This streamlined application process would be balanced by the new post-market authorities (e.g., mandatory label change or recall) in Vanessa's Law that give Health Canada the ability to respond rapidly to safety issues.
Health Canada has committed to providing greater and more meaningful transparency by enabling easy access to information, as well as providing information in a format that is easy to understand and provides value to the end user - the Canadian public, patient, health care provider, domestic or international partner, or regulated party. Through Vanessa's Law, new transparency measures will be adopted in the non-prescription drug regulations, including the following: making Health Canada decisions and reasons for them publicly available; requiring disclosure of clinical trial information; and allowing for disclosure of confidential business information when there is a serious risk to human health.
It is a term used to describe a mechanism which allows a document or list that is not in the text of the regulations to be made a part of the regulations. Vanessa's Law will give the Governor in Council the authority to make regulations to incorporate by reference documents into regulations made under the Food and Drugs Act. This will allow Health Canada to administratively update documents from time to time without a regulatory amendment, such as compendia with new information once a scientific review of that information has been made. Being publically available, these compendia can be used to support a market authorization application, thus reducing burden on the applicant and bringing efficiencies to Health Canada's review process.
What are compendia?
It is a body of well-established safety, quality and efficacy knowledge compiled together in the form of monographs, labelling standards, acceptable ingredient lists and other information.
The proposed non-prescription drug regulations will enable information that has already been used to support market authorization to be referenced in an application thus bringing efficiencies to the review process.
The following sections are key parts of a new comprehensive set of regulations proposed for non-prescription drugs under the Food and Drugs Act.
The proposed regulations will apply to drugs for human use, including disinfectants. A definition of disinfectant may be required for greater clarity.
The proposed regulations will not apply to:
The following are some key general rules proposed for the oversight required for non-prescription drugs:
The current labelling and packaging rules in Part A and Division I of the Food and Drug Regulations would be incorporated into the proposed regulations with the following key considerations:
Under the Plain Language Labelling Initiative, product labels must contain clear, accurate, and easily understandable information as well as minimize opportunities for confusion with labels, packages or names. Health Canada is currently developing the Good Label and Package Practices Guide that will provide more detailed information about the design of safe health product labels and packages. This guide will be available for consultation in winter 2015.
The current prohibitions in the Food and Drug Regulations regarding substances and colouring agents would apply to the proposed regulations using new efficient rule-making tools, such as incorporation by reference and with the following key consideration:
There would be a prohibition on the sale and advertising on a non-prescription drug unless a market authorization has been issued and not suspended or revoked in respect of that drug. This will replace the current prohibition linked to drug identification number issuance under section C.01.014 of the Food and Drug Regulations. Under this approach, more than one drug identification number may be assigned to a single market authorization to account for different strengths, dosage forms and routes of administration. The market authorization structure would allow for amendments, rather than the filing of a new drug identification number application as currently required under Division 1 of the Food and Drug Regulations.
The current record keeping requirements in the Food and Drug Regulations would be consolidated and incorporated into the proposed regulations with the following key considerations:
The current adverse drug reaction reporting requirements in the Food and Drug Regulations ( sections C.01.016 to C.01.020) would be incorporated into the proposed regulations with the following key considerations:
The regulations would propose sampling rules that allow the distribution of samples of any authorized non-prescription drugs to any person (i.e., exempt non-prescription drugs from the prohibitions in section 14 of the Food and Drugs Act).
Existing requirements, such as those found in both Divisions 1 and 9 of the Food and Drug Regulations, will be assessed for relevance and incorporated into the Compendia of Monographs maintained by the Minister. For example, section C.09.020 to C.09.022 specific to acetaminophen would be replaced and instead incorporated by reference into a product-specific monograph.
Existing general rules regarding expiration dates and standards would be incorporated in individual monographs as applicable. For example, an expiry date may not be necessary in all instances for disinfectants. In addition, specifications can be included in a monograph for the upper maximum limit for an active ingredient, among other things.
All other relevant general rules in the Food and Drug Regulations would be consolidated and proposed in the new regulations.
The modernized product licensing scheme for non-prescription drugs will be based on proportionality and moves away from the old application of Divisions 1 and 8 of the Food and Drug Regulations, which are based on whether the drug falls under the definition of "new" drug or not. This has proven to be a less than optimal means to determine the level of oversight both pre- and post-approval. Under the new market authorization scheme in the regulations, various pathways are proposed and based not only on the exposure, intended use and nature of the product, but whether Health Canada has previously reviewed the benefit, harm and uncertainly profile of the product. Based on this approach, Health Canada would establish the compendia of monographs that would provide an efficient means to seek approval of products that follow a monograph. Health Canada would develop the compendia of monographs through its review of products and on-going assessment of the benefit, harm and uncertainty profile of those products.
This scheme incorporates the current abilities for innovative drugs to apply for a market authorization under the proposed "Innovative non-prescription drug Filling" pathway (see below) and to seek data protection for their innovative drug under provisions similar to section C.08.004.1 of the Food and Drug Regulations. Once a monograph has been established it would provide the basis for an indirect comparison to the innovative drug, which will allow for an abbreviated filing under the appropriate pathway.
In addition, the proposed market authorization scheme for non-prescription drugs will be supported by instruments such as incorporation by reference. This approach is similar to the incorporation of the Compendium of Monographs published by Health Canada, referred to in section 6 of the Natural Health Products Regulations.
The following are types of publicly available compendia of monographs for non-prescription drugs, including disinfectants:
An applicant may apply for a market authorization using the pathways proposed below that would index evidence requirements. These pathways reflect when there is a need to assess new information about the drugs benefits, harms and uncertainties, or when previously assessed information can be relied on (i.e., pre-cleared information in the compendia of monographs).
Full Compendial Filing means that all information necessary to support the safe and effective use of the drug has already been pre-cleared by Health Canada. The compendial product monograph would detail such items as acceptable indications, ingredients, strengths, dosage forms, routes of administration, and text of any label instructions for use, contra-indications and other warnings.
The following are key elements of the Full Compendial Filing pathway:
The application for the Full Compendial Filing proposes to require at a minimum the following information and documents:
Supplemented Compendial Filings would allow for additional information (e.g., new dosage form) to be added to the compendia as well as to the terms of a market authorization.
The following are key elements of the Supplemented Compendial Filing pathway:
The application for the Supplemented Compendial Filing would require the same information and documents detailed above in Full Compendial Filing from (a) to (m), as well as the following:
The following are key elements of the Non-Compendial Filing pathway:
The application for the Non-Compendial Filing would require the following information and documents, as set out in the Full Compendial Filing in (a) to (h), (k) to (m), (o) and (q), as well as the following:
The following are types of administrative filings:
The application for the Administrative Filing would include the following type of information:
The following are key elements of the Prescription Status Switch Filing pathway:
The application for the Prescription Status Switch Filing would require the same information and documents detailed above from the Full Compendial Filing (a) to (h) and (m), as well as the following:
The following are key elements of the Innovative non-prescription drug Filing pathway:
The application for the Innovative non-prescription drug Filing would require the following information and documents as set out in the Full Compendial Filing in (a) to (h), (k) to (m), (o) and (q), as well as the following:
If the information and material provided in respect of an application for a market authorization or application for amendment are insufficient to enable the Minister to determine whether to issue or amend the market authorization, the Minister may request the applicant to provide any additional information or material or sample that is necessary to make the determination.
The Minister may issue or amend a market authorization if the following conditions are met:
The Minister may refuse to issue or amend a market authorization with notice to the applicant that sets out the reasons for the refusal. The applicant may choose to request reconsideration of the application with an opportunity to be heard. After reconsidering the application, the Minister may issue or amend the market authorization based on the conditions set out for the Issuance of a Market Authorization and Amendment (above) or uphold the refusal.
The Minister may assign a drug identification number to a non-prescription drug that has been assigned a market authorization. A unique drug identification number will be issued for each strength, dosage form, and route of administration associated with the market authorization.
The market authorization may contain the following information:
The market authorization holder must notify the Minister of any information set out in the market authorization that the market authorization holder knows to be incorrect.
The Minister may impose terms and conditions on a market authorization respecting measures to be taken by the market authorization holder post authorization to:
In deciding whether to issue or amend a market authorization with terms and conditions, the Minister must consider the following:
If the market authorization holder makes a change in respect of the non-prescription drug, pathways are proposed based on the urgency and type of change. Unless otherwise exempted (see "notification" below), an amendment application is required for any significant changes to information and material previously submitted in connection with the market authorization.
Any other significant change in relation to the information and material that was previously provided in connection with the market authorization that is likely to have a significant effect on an assessment of the harms or benefits associated with the non-prescription drug or the uncertainties related to those harms and benefits.
A market authorization holder would be exempted from filing an amendment application for significant changes that appear in a document that is incorporated by reference in the regulations that is maintained by the Minister.
In identifying those changes that would be exempt from amendment filing, the Minister must consider:
The market authorization holder would be required to notify the Minister of any changes that are set out in the document, within a set period of time specified in the regulations from the date the change was implemented.
The market authorization holder would also be required to retain a record of information supporting such a change and make it available to the Minister upon request (for the purposes of auditing).
The regulations propose to modernize the current regulatory provisions regarding good manufacturing practices in the Food and Drug Regulations to include the following:
The proposed quality management components would comprise explicit requirements, similar to those implemented in other jurisdictions. Manufacturers would be required to have quality systems (which comprise components that already exist in regulations such as quality control, components which have long been interpreted into good manufacturing practices such as validation, as well as newer components such as quality assurance, corrective action and preventive action, and management review) in place, and to enter into quality agreements with other parties involved in the manufacturing process to describe and document the responsibilities of each party to ensure full good manufacturing practices compliance. Both of these components have been recommended in Health Canada guidance and are widely applied in industry on a voluntary basis. They have been implemented in jurisdictions such as the United States, European Union, Japan and Australia.
Good Distribution Practices requirements address environmental control, but also include qualification of suppliers and customers, registration requirements for brokers, better security in transport and storage, and tracking and traceability requirements
Health Canada proposes that the modernization of the good manufacturing practices regulations include explicit inclusion of environmental control and supplier qualification requirements to better ensure the quality of products, ingredients and packaging materials. The new regulations may also include strengthened requirements for the segregation of substandard or falsified products if they appear in the legitimate supply chain.
The new regulations propose that all parties will be required to maintain quality agreements with business partners to ensure that clear roles and responsibilities are established. For example, if a recall is initiated, each party throughout the supply chain must be aware of its own responsibilities to facilitate a recall.
It is proposed that terminology be modernized and that the good manufacturing practice-related provisions in the current Food and Drug Regulations be re-ordered in a logical and consistent manner for ease of reference and understanding.
This section should continue to specify non-application to certain products and activities as listed in the current Food and Drug Regulations. For example, good manufacturing practices requirements do not apply to disinfectants, other than those used on invasive medical devices or on contact lenses (referred to in the current Food and Drug Regulations as "antimicrobial agents").
The regulations would continue to prohibit the sale of a drug that does not meet the good manufacturing practice requirements.
The regulations would propose new requirements for general quality systems (including specific mention of quality assurance, corrective action, preventive action, management review and internal audit program components), quality agreements between all parties involved in the manufacturing and distribution of a drug, supplier qualification, and related record-keeping requirements.
For the following sections, the existing requirements in the Food and Drug Regulations would be maintained. Terminology would be updated where necessary and explicit qualification and/or validation requirements would be added where appropriate:
For the following sections, the existing requirements in the Food and Drug Regulations (regarding specifications, raw material testing, packaging materials testing, labelling materials testing, manufacturing control, packaging control and labelling control) would be maintained and grouped together for ease of reference and understanding. New validation, quality assurance/quality control and environmental control requirements would be added and clarified. Amendments to clarify which parties are responsible for the good manufacturing practice compliance of the drug would also be added:
This section would include specific requirements regarding a stability program similar to those which currently exist in the Food and Drug Regulations. Exemptions from stability requirements would be provided for products where stability has been well established (e.g., disinfectants).
Specific requirements regarding complaints, returns, and recalls, similar to those which currently exist in the Food and Drug Regulations, will be provided. In addition, new requirements would be added for corrective action and preventive action, the segregation of substandard or falsified product, and notification to Health Canada of health risk investigations.
The good manufacturing practice requirements as proposed would be applicable to all non-prescription drugs, as they comprise general principles of good manufacturing. However, there are non-prescription products where different levels or types of oversight may be more appropriate given their risk profile. These products may also be subject to different levels of oversight in other countries, such flexibility would still respect the Mutual Recognition Agreements and Pharmaceutical Inspection Co-operation Scheme for export purposes.
The proposal to modernize the current Food and Drug Regulations requirements related to establishment licensing includes the following:
It is proposed that the current establishment licensing requirement be revised with a risk based approach:
Parties subject to the establishment licensing requirement would continue to require an establishment licence prior to carrying out a regulated activity, would continue to be subject to the existing two- or three-year inspection cycle, and would continue to be eligible to export their products under Canada's Mutual Recognition Agreements or pursuant to Pharmaceutical Inspection Co-operation Scheme protocols. The good manufacturing practice regulations, establishment licensing requirement and inspection program would continue to be maintained in equivalence with our international partners, as required by treaty.
The Site Registration Eligibility List would be incorporated by reference into regulation and be maintained administratively by Health Canada. Criteria for determining whether a product or activity should be on the list would include:
Parties who carry out regulated activities for products and/or activities on the Site Registration Eligibility List would be required to register the sites at which their activities are conducted. Regulatory oversight over these products and activities could include longer inspection cycles, alternation with evidence-based assessments, some reliance on third party audits, issue-specific inspections, random spot checks, or some combination of these.
These parties would be subject to the same general good manufacturing practice requirements as establishment licence holders.
Parties who carry out regulated activities for products and/or activities on the Site Registration Eligibility List may apply for an establishment licence for the purposes of facilitating export of their product. The switch would be considered irrevocable for a term of three years, in line with expiry dates used under the Mutual Recognition Agreements and Scheme protocols.
Currently, as part of the establishment licence application process, importers are required to provide to Health Canada, information pertaining to the foreign sites which have manufactured and tested the drugs to be imported, including evidence of those sites' compliance with good manufacturing practice requirements. This requirement ensures that imported drugs available to Canadians meet the same quality standards as drugs manufactured in Canada.
Drug importers that are applying for an establishment licence, and site registrants undergoing post-registration compliance verification, would continue to be subject to the requirement to demonstrate the good manufacturing practice compliance of their foreign sites. As part of the modernization of the overall regulatory framework pertaining to non-prescription drugs, Health Canada, through the development of guidance would tailor the amount and type of information to be submitted, and the interval at which the information must be updated.
Health Canada would establish a publicly disclosed list of approved foreign sites, similar in concept to the foreign site reference number system used for natural health products. The regulation would include provisions to support the approved foreign site list and use incorporation by reference to capture all Mutual Recognition Agreement provisions.
Any site assessed by Health Canada as good manufacturing practice-compliant would be added to the list. Importers importing from a listed foreign site would not be required to provide further good manufacturing practice evidence as part of its establishment licence application or post- registration compliance verification.
Similar application and prohibitions as found in existing Food and Drug Regulations requirements will be proposed for establishment licence and site registration (e.g., may not conduct fabrication unless licensed or registered, whichever is applicable), including exemptions for disinfectants, other than those used on invasive medical devices or on contact lenses.
For the establishment licence application, similar requirements to provisions under Division 1A of the Food and Drug Regulations with modernization, for example more flexibility on specific requirements, like contact information.
The site registration application would be similar to the establishment licence application but would not require foreign site good manufacturing practice evidence.
For establishment licence applications, the regulations would propose similar provisions as under Division 1A of the Food and Drug Regulations for issuance, with consideration regarding: modernization of the format and content of the licence or registration; and specify that the Minister may issue an establishment licence or permit a site to be registered based on a determination related to health and safety.
The regulations would propose similar provisions as under Division 1A of the Food and Drug Regulations for refusal to issue or amend an establishment licence and listing for site registration, with clarification that the Minister may refuse if incomplete or inaccurate information has been submitted by the applicant.
The regulations will propose an ability for the Minister to request additional information demonstrating compliance with requirements at any time and within a specified time for both establishment licence and site registration.
The terms and condition in the existing provision under Division 1A of the Food and Drug Regulations would be incorporated for both establishment licence and site registration, except with the addition that the Minister can add terms and conditions immediately if necessary to prevent injury to health and with opportunity to be heard after necessary action is taken (e.g., unlike current requirement to wait 15 days after notice is provided).
The regulation would propose, similar to section 32 of the Natural Health Products Regulation, that activities may not be undertaken until an amendment application has been filed and approved for an establishment licence or a notification has been made for a change related to site registration information.
The Minister may reconsider issuance of an establishment licence or site registration based on status of a market authorization.
For both establishment licence and site registration, the regulations would propose similar to section 38 of the Natural Health Products Regulation, a requirement to notify Health Canada within 30 days of ceasing an activity.
The regulations propose similar provisions to the Food and Drug Regulations regarding suspension and cancellation with the addition of the following: the Minister may suspend or cancel if: corrective actions or mitigation efforts have not been taken or have been unsuccessful; or the holder/registrant has failed to provide requested evidence of compliance by a specified date or compliance history of the holder/registrant demonstrates an inability to consistently conduct its activities in accordance with the regulations.
An establishment licence holder would be required to notify the Minister when an activity is commenced. If an activity has not commenced within two years of receiving the licence, the Minister may suspend the licence pending reassessment.
The proposed regulatory requirements for non-prescription drugs subject to clinical trials will reflect a modernized version of Division 5 of the Food and Drug Regulations. This will include the following:
The proposed post-market interventions support balancing pre- and post-market oversight with regulatory abilities and requirements that allow for responsive and decisive action tailored to the issue and the product. The new regulations are a continuum of proportionality, where the post-market requirements and authorities logically link and tailor to all aspects of the regulations (i.e., product licensing, establishment licensing and site registration). Health Canada would also have the power to intervene for identified safety issues under all pathways.
Post-market obligations that would apply to all market authorization holders will mirror existing provisions in the Food and Drug Regulations as follows:
New requirements would include:
The proposals for post-market will include the authorities under Vanessa's Law related to new measures required to enhance patient safety and strengthen safety oversight throughout the lifecycle of products, such as improvements to Health Canada's ability to collect post-market safety information and take appropriate action when a serious risk to health is identified.
The following new authorities under Vanessa's Law, and the corresponding obligations on the market authorization holder, would apply to all pathways. Health Canada's abilities would be discretionary and could be utilized based on the risk associated with the product and the type of action required.
The new authorities for the Minister include the following abilities:
This discussion paper seeks views from all stakeholders on elements that could strengthen a framework for consumer health products and seeks input on key policy issues. Respondents are encouraged to respond directly to the proposed questions highlighted below.
Health Canada will use the consultation feedback received in the development of the Consumer Health Products Framework.
*The personal information being collected under this process is for the purpose of obtaining your feedback on the Consumer Health Products Framework. If contact information is provided, it would only be used for the purpose of arranging a potential follow-up discussion on your feedback.
The personal information you provide is protected under the provisions of the Privacy Act. That Act also includes the right of access to and correction of your personal information. This collection is described in the Standard Personal Information Bank on Outreach Activities (PSU 938). Should you require clarification about this Statement, contact our Access to Information and Privacy Coordinator.
Health Canada is seeking views on the following key areas, summarized as follows: