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Drugs and Health Products

A Framework for Consumer Health Products

Table of Contents

Part 1

A. Introduction

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.

B. Objective of the Consumer Health Products Framework

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.

What is a Consumer Health Product?

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:

  • Non-prescription drugs (e.g., pain relievers, cold and allergy remedies, acne therapies);
  • Disinfectants (e.g., for use on countertops, contact lens solution);
  • Cosmetics (e.g., make-up, shampoos, deodorants); and
  • Natural health products (e.g., vitamin and mineral supplements, traditional and homeopathic medicines, probiotics, toothpastes).

Figure 1.0
Figure 1.0 - Examples of Products under the Consumer Health Products Framework

Did you know?

Health Canada has approved more than 85,000 consumer health products and there are Next link will take you to another Web site 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.

Why Develop the Framework?

Evolving Health Landscape

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.

Regulatory Challenges

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.

How are your sunscreens regulated?

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.

Table 1.0 - Consumer Health Product Classification and Interface
Consumer Health Product Cosmetic Natural Health Product Non-Prescription Drug
Sunscreen N/A Yes Yes
Basic Moisturizer Yes N/A N/A
Antiperspirants Yes Yes Yes
Deodorants Yes N/A N/A
Toothpastes Yes N/A N/A
Toothpastes with fluoride N/A Yes Yes
Regular Shampoo Yes N/A N/A
Anti-dandruff Shampoo N/A Yes Yes
Case Study: Toothpaste

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.

Why Develop New Regulations for Non-Prescription Drugs Under the Framework?

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.

How Does the Framework Benefit Consumers?

Transparency

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, Next link will take you to another Web site 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:

  • measures to ensure the product has not been rendered harmful through its manufacturing, packaging, labelling, importing or distributing;
  • understandable and complete information on product labels (e.g., dosing and side effect information); and
  • effective intervention from Health Canada when something goes wrong with the product and it poses harm.

On What Principles is the Framework Based?

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:

  • protecting the health and safety of Canadians;
  • a science-based approach;
  • transparency of important product information;
  • proportional oversight for products, both pre- and post-market;
  • flexibility to address varying risk profiles;
  • international alignment;
  • operational efficiency and sustainability;
  • responsive regulatory approach; and
  • reduction and prevention of regulatory barriers to small businesses.

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.

How are Consumer Health Products Currently Regulated?

Non-Prescription Drugs

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

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:

  • Disinfectants are generally exempt from establishment licensing and good manufacturing practices; however, the exemption does not apply to disinfectants that are used on invasive medical devices or on contact lenses.
  • While the guidance document for disinfectants has been revised to assist industry in complying with regulatory requirements, there are some regulatory requirements that pose challenges in proportionate regulation of the products.

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.

Natural Health Products

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

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.

  • Cosmetic Regulations
  • Natural Health Products Regulation
  • Food and Drug Regulations

What will Operational Improvements do to Achieve Alignment under the Framework?

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 development of a new advisory body that would provide expert views on consumer health products;
  • options for information technology modernization to support the streamlining of review activities, such as the automation of applications forms; and
  • an updated approach to sunscreens to be consulted on in winter 2015.

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 Next link will take you to another Web site 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.

Modernizing the Regulations

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.

Part 2 Proposed Non-Prescription Drug Regulations - Design Elements

Distinct from Prescription Drug Regulations

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 Next link will take you to another Web site 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.

Comprehensive 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.

Provisions for Disinfectants

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.

Flexible Instrument Choices to Support Proportional Oversight

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.

Market Authorization Holder Responsibilities

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.

Provisions for Good Manufacturing Practices and Establishment Licensing

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.

Safe Guards - Balancing Pre- and Post-Market Requirements

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.

Legislative Authorities

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.

Transparency

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.

Incorporation by Reference

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.

Part 3 Proposed Non-prescription Drug Regulations - Technical Description

The following sections are key parts of a new comprehensive set of regulations proposed for non-prescription drugs under the Next link will take you to another Web site Food and Drugs Act.

A. Application

The proposed regulations will apply to drugs for human use, including disinfectants. A definition of disinfectant may be required for greater clarity.

B. Non-application

The proposed regulations will not apply to:

  • Radiopharmaceuticals (Next link will take you to another Web site Schedule C of the Food and Drugs Act)
  • Biologic drugs (Next link will take you to another Web site Schedule D of the Food and Drugs Act)
  • Veterinary drugs
  • Drugs that are on the Prescription Drug List
  • Ethical drugs
  • Medical gases
  • Medical devices
  • Parenteral drugs (substances that are administered by puncturing the dermis)
  • Natural health products
  • Cosmetics

C. General Requirements

The following are some key general rules proposed for the oversight required for non-prescription drugs:

Labelling and Packaging

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:

  • label, package and brand name assessment review would be consistent with proposed licensing pathways (see below);
  • for disinfectants:
    • look-alike sound-alike brand name assessment would not be required;
    • exclusion from non-active ingredient declaration requirements on label would remain;
    • exemption from the requirement for a product fact table would be expanded to all disinfectants, except for contact lens solution, rather than being restricted to those represented solely for use as a disinfectant on hard non-porous surfaces;
    • requirements for hazard and precautionary statements would be provided to be in line with Canadian standards where applicable; and
  • for disinfectants and all non-prescription drugs, greater flexibility would be provided on how the designation of a lot number is presented on the label or package.

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.

Prohibited Substances and Coloring Agents

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:

  • for disinfectants used on inanimate objects, colouring agent requirements would not apply.

General Prohibitions on Sale and Advertising

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.

Record Keeping

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:

  • introduction of complaint trend reporting, which would require a market authorization holder to analyse, maintain and make available to Health Canada upon request a record of complaints and actions taken to address them.

Adverse Drug Reaction

The current adverse drug reaction reporting requirements in the Food and Drug Regulations (Next link will take you to another Web site sections C.01.016 to C.01.020) would be incorporated into the proposed regulations with the following key considerations:

  • for disinfectants, incident report obligations similar to section 14 of the Next link will take you to another Web site Canada Consumer Product Safety Act would be considered;
  • for disinfectants, requirements for preparing summary reports would not apply; and
  • for disinfectants, retention of records would be limited to 7 years (consistent with update to record keeping requirements under Division 7 and 8 of the Food and Drug Regulations).

Distribution of Samples

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).

Product- and Substance-Specific Requirements

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.

Expiration Dates, Specifications and Standards

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.

Other General Rules

All other relevant general rules in the Food and Drug Regulations would be consolidated and proposed in the new regulations.

D. Market Authorization

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.

Incorporation by Reference - Compendia of Monographs

The following are types of publicly available compendia of monographs for non-prescription drugs, including disinfectants:

  • Product-specific
  • Class-specific
  • Substance-specific (including active ingredients, non-active ingredients, colouring agents)
  • Test methods-specific (e.g., demonstration of efficacy for disinfectants)

Types of Market Authorization Application Pathways

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).

1. Full Compendial Filing

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:

  • Submission of an application is required and restricted to the established compendia of monographs.
  • No assessment would be required as the application would be based on pre-cleared information.
  • An applicant would conduct and attest to a brand name assessment.
  • A market authorization would be issued and drug identification number assigned automatically (full electronic filing to support this pathway will be considered).
  • Non-compliance with the Food and Drugs Act, regulations or compendia may lead to immediate regulatory action (see Post Market Section for further details).
  • Details on a process for the submission and review of non-prescription label and package mock-ups, including timing of submission, will be made available in guidance.

The application for the Full Compendial Filing proposes to require at a minimum the following information and documents:

  • a) name and contact information for the applicant;
  • b) if applicable, applicant's Canadian representatives' name and contact information;
  • c) quantitative list of active and non-active ingredients;
  • d) brand name(s);
  • e) recommended conditions of use;
  • f) dosage form;
  • g) strength;
  • h) route of administration;
  • i) supporting compendia;
  • j) confirmation that all requirements in the supporting compendia are met;
  • k) confirmation of completion of brand name assessment by applicant;
  • l) list of sites where the drug product and active ingredients are manufactured (sourced), packaged, labelled and corresponding Establishment Licence/Site Registration numbers; and
  • m) mock-ups of every package and label to be used in connection with the non-prescription drug.
2. Supplemented Compendial and Non-Compendial Filing

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:

  • Health Canada will conduct an assessment of new information respecting the drug's benefits, harms and uncertainties.
  • Submission of an application will be required - where there is reliance on compendia, but additional information is required to be assessed (e.g., active ingredient in a class-specific monograph with a new dosage form or new indication).
  • An ability to impose conditions on the market authorization (e.g., requiring further information prior to incorporation of new information in monograph).
  • A market authorization may be issued and drug identification number may be assigned.
  • Health Canada may update compendia as appropriate (e.g., based on assessment of data or a condition imposed that provides new data).
  • Regulatory action may result from non-compliance with the Food and Drugs Act, regulations or compendia (e.g., require reassessment of the drug's benefits, harms and uncertainties) (see Post Market Section for further details)

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:

  • n) information to assess the harms, benefits and uncertainties associated with the non-prescription drug as it relates to the differences from the existing compendia;
  • o) where none exist in the compendia, specifications and test methods for ingredients and finished product;
  • p) results of bioequivalence studies as necessary (e.g., new dosage form); and
  • q) detailed method of manufacturing for the finished product.

The following are key elements of the Non-Compendial Filing pathway:

  • Health Canada will conduct an assessment of new information respecting the drug's benefits, harms and uncertainty of the product.
  • Submission of an application is required.
  • An ability to impose conditions on the market authorization (e.g., requiring further information prior to a monograph being created).
  • A market authorization may be issued and drug identification may be assigned.
  • Health Canada may create compendia as appropriate (e.g., based on assessment of new safety data or a condition imposed that provides new safety data).
  • Regulatory action may result from non-compliance with the Food and Drugs Act or regulations (see Post Market Section for further details).

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:

  • r) information to assess the harms, benefits and uncertainties associated with the drug.
3. Administrative Filings

The following are types of administrative filings:

  • Private label
  • Manufacturer name change
  • Product name change
  • Additional product name
  • Licensing Agreement between two companies
  • Transfer of market authorization
  • Merger/Buyout

The application for the Administrative Filing would include the following type of information:

  1. Confirmation that all aspects of the product and labelling material will remain the same except for the name change(s) in the labelling material.
  2. Labelling material with new name or the manufacturer and/or product name.
  3. For product name changes, confirmation of completion of brand name assessment by applicant (applicant's brand name assessment may be requested for review by Health Canada under certain circumstance, e.g., umbrella branding).
  4. For transfer of market authorization, confirmation of change from original market authorization holder and the authorization to access the original submission and if any licensing agreement is terminated between market authorization holders, notify Health Canada of its cessation date. Health Canada may suspend or cancel the market authorization.
  5. A list of sites where the drug product and active ingredients are manufactured (sourced), packaged, labelled and corresponding Establishment Licence/Site Registration numbers.
4. Prescription Status Switch Filing (full or partial switch)

The following are key elements of the Prescription Status Switch Filing pathway:

  • Submission of an application is required (i.e., to remove from Prescription Drug List and to obtain a non-prescription drug market authorization).
  • Health Canada would conduct an assessment of benefits, harms and uncertainties.
  • An ability to impose conditions (e.g., requiring further information).
  • A market authorization may be amended with existing drug identification number.
  • Health Canada may update compendia as appropriate (e.g., based on assessment of new safety data or a condition imposed that provides new safety data).

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:

  • information to assess the harms, benefits and uncertainties associated with the drug as it relates to self-selection and use by the consumer; and
  • evidence that demonstrates that Prescription Drug List factors no longer apply.
5. Innovative Non-Prescription Drug Filing

The following are key elements of the Innovative non-prescription drug Filing pathway:

  • Submission of an application is required.
  • Full assessment of the drug's benefits, harms and uncertainties would be conducted.
  • Applicable to new substances (i.e., for drugs that meet the definition of "innovative drug" under C.08.004.1 of the Food and Drug Regulations).
  • An ability for Health Canada to impose conditions.
  • Health Canada would establish a monograph as appropriate (e.g., based on assessment of the safety data or a condition imposed that provides new safety data).
  • Regulatory action would be based on injury to health and safety.

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:

  • r) information to assess the harms, benefits and uncertainties associated with the drug.
Request for Additional Information or Samples

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.

Issuance of a Market Authorization and Assessment of an Amendment

The Minister may issue or amend a market authorization if the following conditions are met:

  1. The applicant submits an application in accordance with the appropriate licensing or amendment pathways and meets the requirements;
  2. The applicant submits all additional information or samples requested;
  3. The Minister determines that the benefits associated with the non-prescription drug outweigh the harms having regard to the nature and extent of the uncertainties associated with the benefits and harms; and
  4. The applicant does not make any false or misleading statements in the application.
Refusal to Issue or Amend a Market Authorization

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.

Assignment of Drug Identification Number

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.

Contents of Market Authorization

The market authorization may contain the following information:

  1. Name and address of the market authorization holder.
  2. Drug identification number(s) that have been assigned in respect of the non-prescription drug and the strength, dosage forms and routes of administration associated with each drug identification number.
  3. Brand name of the non-prescription drug.
  4. Non-prescription drug's proper name or if there is no proper name its common name.
  5. Conditions of use that are authorized for the non-prescription drug, such as dose, use, route of administration, duration or use, any contraindications or other warnings, recommended use or purpose.
  6. In respect of each active ingredient of the non-prescription drug, its authorized quantity per dosage unit, potency and source material.
  7. Any terms and conditions imposed by the Minister.
  8. Date on which the market authorization was issued.

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.

Terms and Conditions on Market Authorizations

The Minister may impose terms and conditions on a market authorization respecting measures to be taken by the market authorization holder post authorization to:

  1. optimize the benefits, minimize the harms and manage the uncertainties related to the benefits and harms of the non-prescription drug; and
  2. collect information to enable the assessment of the benefits and harms of the non-prescription drug to determine any change to its benefits and harms and to resolve uncertainties.

In deciding whether to issue or amend a market authorization with terms and conditions, the Minister must consider the following:

  • The applicable requirements set out in the regulations (e.g., adverse drug reaction reporting) will not be sufficient to meet the objectives described in a. and b. above.
  • It is feasible that the measures to be imposed as terms and conditions may meet the objectives described in a. and b. above.
  • No other less burdensome means of achieving the objectives described in a. and b. above have been identified.
  • There are significant uncertainties with respect to the benefits or harms associated with the non-prescription drug and information is not otherwise available to address the uncertainties.

Changes to Market Authorizations - Amendment Application Pathways

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.

1. Priority amendments (expedited review)
  • Changes intended to mitigate the risk of serious and imminent injury to health; or changes requested by the Minister, including pursuant to an order (label change, tests, studies, etc.)
2. Non-priority amendments
Administrative changes
  • Change to the name and contact information of the market authorization holder and, in the case of a foreign holder, the name and contact information of its Canadian representative;
  • Transferring the ownership of a non-prescription drug from one market authorization holder to another;
  • Change to the brand name of the non-prescription drug.
Other significant changes
  • Change to the products that are authorized under the market authorization (e.g., addition or removal of strengths, dosage forms and routes of administration).
  • Change to the conditions of use (labelling) that are authorized for the non-prescription drug, including:
    • dose,
    • use, or
    • any contraindications or warnings.
  • Change to the terms and conditions on the authorization (additions, modifications or removal).

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.

3. Notifications (exemptions from filing an amendment application)

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 level of risk associated with the change.
  • The existence of well-established means of ensuring that the change does not have a negative impact on the benefits, harms and uncertainties associated with the drug or its manufacture.

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).

E. Good Manufacturing Practices

The regulations propose to modernize the current regulatory provisions regarding good manufacturing practices in the Food and Drug Regulations to include the following:

  • The addition of quality management components;
  • The addition of some Good Distribution Practices components;
  • More clarity around appropriate division of Good Manufacturing Practices responsibilities between regulated parties; and
  • The updating of terminology, clarification of existing requirements, and restructuring of regulatory provisions for readability of application.

Quality Management

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

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.

Appropriate Responsibilities of Regulated Parties

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.

Updating of Terminology, Clarification of Existing Requirements, and Restructuring of Regulatory Provisions for Readability

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.

General
  • The definition of "manufacturer" be amended to reflect the commonly understood meaning ("one who makes things").
  • The definition of "distributor" be amended to reflect the commonly understood meaning ("one who distributes things") without reference to the name which may be on the label.
  • The definitions of the various activities subject to good manufacturing practices be adjusted where necessary to better reflect modern manufacturing practices (e.g., the separation of "packaging/labelling" into the activities of "packaging" and "labelling", as some parties now perform one activity but not the other).

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").

Prohibitions

The regulations would continue to prohibit the sale of a drug that does not meet the good manufacturing practice requirements.

Quality Management

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.

Substantially unchanged provisions

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:

  • Personnel
  • Premises
  • Equipment
  • Sanitation
  • Sterile Products
  • Finished Product Testing
  • Records
  • Samples
Substantially unchanged but regrouped provisions

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:

  • Fabrication Operations
  • Packaging Operations
  • Labelling Operations
  • Importation Operations
  • Storage, Transport and Sale Operations
Stability Program

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).

Complaints, Returns, Suspect Products, Recalls

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.

F. Establishment Licence / Site Registration

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:

  • introduction of a risk based establishment licensing/site registration oversight scheme;
  • changes to the foreign site review process; and
  • modernization of terminology and provisions to ensure clarity, to better reflect policy intent, and to facilitate enforcement.

Risk-Based Approach to Establishment Licensing

It is proposed that the current establishment licensing requirement be revised with a risk based approach:

  • The existing, internationally aligned establishment licence requirement for parties carrying out regulated activities for most non-prescription products; and
  • An option for site registration for certain lower-risk activities and products as set out on a Site Registration Eligibility List.
Establishment Licence

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.

Site Registration

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:

  • The complexity of the manufacturing process or other activity being conducted;
  • The degree of health risk likely to be posed by quality failures such as contamination, imprecise measurement or lack of temperature control;
  • The maturity, approach to quality and/or compliance history of the industry under consideration as a whole; and
  • The regulatory approach applied to the product or activity by other comparable jurisdictions.

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.

Switching Between the Licensing and Registration Pathways

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.

Foreign Site Review Process

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.

Specific Requirements for Establishment Licence and Site Registration

Application and Prohibition

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.

Establishment Licence Application / Site Registration Process Requirement

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.

Issuance of an Establishment Licence or Listing on the Site Registration

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.

Refusal to Issue or Amend Establishment Licence and Listing on the Site Registration

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.

Additional Information

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.

Terms and Conditions

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).

Amendment

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.

Linkages to Market Authorization

The Minister may reconsider issuance of an establishment licence or site registration based on status of a market authorization.

Relinquishment of 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.

Suspension and Cancellation

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.

G. Clinical Trials

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:

  • Implicit ability for the Minister to issue and authorize for sale non-prescription drugs for the purpose of clinical trials (e.g., remove opportunity for "default" authorization consistent with Vanessa's Law);
  • Ability for the Minister to impose terms and conditions on authorizations;
  • Improvements regarding data integrity and quality and patient safety as they relate to Good Clinical Practices and sponsors' obligations, based on updates to the International Conference on Harmonization - ICH-E6: Good Clinical Practices; and
  • Clinical trial registration and disclosure of results (consistent with the transparency measures in Vanessa's Law).

H. Post-Market - Market Authorization Holder's Obligations

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:

  • implementation and maintenance of any terms or conditions under a market authorization;
  • recall reporting; and
  • reporting of adverse drug reactions.

New requirements would include:

  • Maintenance of complaint records and requirement to review/investigate them for health risk trends, including lack of efficacy, and preparation of annual summary reports to be made available upon request.
  • Notification of label change and status changes in other jurisdictions.
  • Good pharmacovigilance practices including systems and procedures to assess changes in the benefit, harm and uncertainty profile of the product by qualified personnel.
  • Recall notification timeline starting at the risk identification stage, full recall plan and reporting on recall effectiveness.

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:

  • To compel information;
  • To order the recall of unsafe drugs;
  • To impose tougher fines and penalties;
  • To order a reassessment;
  • To order a change to a label or package;
  • To order test and studies; and
  • To impose terms and conditions on an authorization.

Appendix A - Consultation Questions

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 Next link will take you to another Web site 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:

Optional*

Please choose one of the following options:

  • (Indicate all that apply.)

Part 1 : Consumer Health Products Framework

Part 1 : Consumer Health Products Framework

1. Are there any gaps that may not have been addressed?






Part 2: Proposed Non-Prescription Drug Regulations - Design Elements

Part 2: Proposed Non-Prescription Drug Regulations - Design Elements


Product Licensing




Site Registration




Post-Market



Part 3: Proposed Non-Prescription Drug Regulations - Technical Description

Part 3: Proposed Non-Prescription Drug Regulations - Technical Description

Product Licensing






Site Registration


6. Are there any additional post-licence elements to consider in the notification, amendment, licence expiry or yearly renewal?




Clinical Trials

9. Should all product lines be subject to clinical trial provisions?


10. Should distinct provisions be considered for certain products?



Post-Market