Recommendation Report from The Expert Advisory Committee for Regulation of Veterinary Natural Health Products

August 2010

Table of Contents

Part 1: General Overview of Regulation of Veterinary Natural Health Products

The Expert Advisory Committee on Veterinary Natural Health Products (EAC-vNHP or EAC) has been meeting with representatives of the Veterinary Drug Directorate (VDD) of Health Canada since November 2008. During these meetings, the Committee has reviewed information from other countries with regard to veterinary natural health products (vNHPs) and discussed the issues, goals, and priorities of both the Committee and the VDD with respect to vNHPs. Representatives from other directorates within Health Canada have provided relevant information that has enabled the Committee to better understand the process of regulation and identify any potential areas of difficulty with respect to the regulation of veterinary natural health products.

Although Committee deliberations are ongoing, the Committee feels that it is appropriate at this time to provide the VDD with an interim report. Part 1 of this interim report contains an overview of the overall goals and general recommendations of the Committee, while Part 2 contains specific recommendations with regard to presumed safe products, and Part 3 provides recommendations for implementation of the interim recommendations. The attached appendices contain additional information and/or definitions as recommended by the Committee. Specifically, Appendix A contains the working definition of a Veterinary Natural Health Product, Appendix B outlines what constitutes a presumed safe product, and Appendix C details the differences between a typical and an atypical presumed safe product.

1A. General Goals and Priorities

The long-term goal of VDD is to develop a well-defined regulatory process, including clear standards and guidelines (Standard Operating Procedures) for vNHPs so that the regulatory approach can be effective and efficient. The goal of the EAC is to advise the VDD with respect to these standards in order to protect the wellbeing of animals and the Canadian public. In order to accomplish these goals effectively, the EAC and VDD must ensure that the requirements and process for approval are not onerous, thereby minimizing regulatory backlogs, gaining the trust of the vNHP industry and the general public, and avoiding the creation of a black market for these products.

The short-term goal of the EAC is to advise the VDD on ways to facilitate the process of regulation of vNHPs. To meet this goal, the EAC recommends a 'fast track' process for products that are not likely to have a negative impact on the health of animals or the safety of the food supply and do not present any particular risk for humans (e.g. workplace exposure) or to the environment. The recommendation is to simplify the regulatory requirements for these presumed safe products to facilitate their approval in a timely manner. The emphasis for the fast track process for products that are presumed safe would be on a registration system that allows for efficient post-market surveillance and that allows the Health Canada to take immediate corrective action should a product be non-compliant or present an unacceptable health risk.

To meet both of these general goals, the EAC reviewed the requirements from other international jurisdictions with respect to veterinary natural health products. In addition, the EAC consulted with members of the Natural Health Products Directorate (NHPD) in order to benefit from their experience and to ensure that any recommended requirements for vNHPs do not exceed those currently in place for human NHPs in Canada. Finally, the EAC consulted with representatives of other related federal agencies, including representatives from the Canadian Food Inspection Agency (CFIA) and the Health Products and Food Branch Inspectorate (HPFBI) to ensure that EAC recommendations for vNHPs do not conflict with existing regulations within these agencies.

Based on these reviews and consultations, the Committee identified that the first priority with respect to regulation of vNHPs must be public safety, which means ensuring that safety standards for these products are developed. In particular, safety standards must be developed for all products that represent any risk, especially those products that are intended for use in food animals. Quality control standards should also be put into effect for the manufacture of vNHPs. These standards can reasonably parallel the current quality control standards required for human natural health products. Efficacy standards should only be required for products that make a specific claim on the label.

1B. Overview of Issues and Recommendations

  1. Definition of a vNHP. This issue was identified as the first priority of the Committee, since all other recommendations hinge upon this definition. It is critical that any definition should be comprehensive and should clearly exclude feed and drugs, both of which are regulated by other federal authorities. By clearly differentiating between veterinary natural health products, pharmaceutical products, and feeds, potential overlap will be avoided and manufacturers will be able to clearly identify which process to follow to obtain approval for their products.

    The VDD team presented the Committee with a comprehensive definition of a vNHP that was similar to the definition developed for human NHPs. The approved working definition of a Veterinary Natural Health Product is attached as Appendix A.
  2. Health issues with respect to vNHPs. Any regulation of vNHPs must consider both whether the product could cause any health concerns for the animal receiving it, and whether there could be any potential human health concerns if a product is used in a food animal. In other words, the first concern for the VDD should be the safety and/or risk presented by a vNHP to either animals or humans.
  3. Risk classification. There is a need to classify vNHPs into categories based on their potential risk to health, and this classification should be based on scientific principles. There should be separate classes for products that are presumed safe, products that present unacceptable risks (i.e. products that are prohibited for use), products that are approved for use in certain species of animals (for example food animals, companion animals, horses), and products that are only available by prescription.
  4. Standards for safety, quality and effectiveness of vNHPs. The role of the VDD is to evaluate and monitor the safety, quality and effectiveness, to set standards and to promote the prudent use of veterinary drugs administered to food animals and companion animals. In order to facilitate the market authorization of vNHPs, appropriate standards for the evaluation of these products need to be developed. The Committee recommends that there should be general standards that apply to all vNHPs; products that present a higher risk should be required to meet higher standards, based on the potential risk.
  5. Review and monitoring. There is a clear need for post-market surveillance of these products, including a requirement that manufacturers report all adverse events to VDD. In addition, any product that is not categorized as presumed safe, especially those products intended for use in food animals, should undergo a pre-market review before being approved.
  6. Enforcement. Health Canada must have the ability to, at any time, inspect companies' records and facilities (including manufacturing plants and points of sale) and take compliance and enforcement action if necessary. In the case of a vNHP that was not manufactured in Canada, Health Canada could seek the cooperation of a 3rd party licensing authority (such as a licensing authority located in the country of manufacture) to assist in this process.

    Registration could be suspended or withdrawn in case of non-compliance.

Part 2: Specific Recommendations for Products that are Presumed Safe

In order to speed up the process of approval, the EAC recommends that VDD develop a 'fast track' process for products that are 'low risk', or presumed to be safe. Specific recommendations for the regulation of these presumed safe products are as follows:

  1. With respect to the definition of a vNHP, the Committee recommends that any definition should clearly differentiate between a vNHP and a pharmaceutical product so that a manufacturer or distributor can readily determine which submission/review process to follow.
  2. There should be a list of commonly used substances that are presumed safe in order to facilitate the approval process, allow fast track approval for these substances, and enhance clear communications with manufacturers and distributors. Appendix B outlines what the Committee defines as a presumed safe substance. The Committee recommends that VDD could reasonably use any relevant information available from National Animal Supplement Council (NASC), Mutual Recognition Agreements with other jurisdictions, or other credible sources to expedite this review process.
  3. There should be a defined process for adding new substances to the list referenced in Recommendation 2 in order to keep the list current. This process should include any procedures, requirements for safety and quality, and supporting data that would be necessary to add a substance that is not currently on the market, or to add a substance that was otherwise excluded from the original list.
  4. A natural health product that contains multiple natural health substances (i.e. a combination product) should also be eligible for 'fast tracking' as long as it contains only presumed safe substances as defined in Appendix B.
  5. If a product contains any substance that is not on the list of presumed safe substances, it can no longer be fast tracked. In this case, the process to be followed for approval will depend on the substance, but should be a specific and reasonable process that is based upon the relative safety of the substance. The recommendation is that this process does not need to be to the same level as that required for a drug; rather, that the manufacturer or distributor should be required to submit additional information such as data supporting the rationale for its inclusion in the product. The Committee will provide more detailed recommendations to the VDD as part of the next phase of deliberations.
  6. No conditions need to be stipulated for presumed safe substances as defined in Appendix B with respect to target species, maximum dose and/or formulation, unless proven concerns exist (see Recommendation 7, below).
  7. Several categories and/or lists of vNHPs should be developed (as outlined above in Part 1B.3.). For clarity, the presumed safe category should be further subdivided into 'typical' and 'atypical' substances as outlined in Appendix C of this report. In addition to the 'presumed safe' list, there should be a list of prohibited substances for all species and additional lists of substances that represent a concern to specific target species (such as food animals, cats, birds, etc, thus ensuring animal health and food safety. Any list of prohibited substances should be based on proven concerns.
  8. The approval process for fast tracking of presumed safe vNHPs should include 'Notification' and 'Registration' as defined by Health Canada.
  9. All labels for veterinary natural health products must comply with specific labelling regulations as established by Health Canada. For presumed safe products, it is sufficient for a senior official and/or the Canadian representative of the company to attest that the product label complies with Health Canada regulations. Proposed product labels should be submitted with the application for the substance or product; however, these labels do not need to be specifically reviewed by VDD as part of the fast track process.
    • 9.1 Background:
      • A product label contains information regarding the product's recommended usage, dosing, content (medicinal ingredients and non-medicinal ingredients), precautions or warnings, as well as the manufacturer's contact information.
      • The information on the label objectively describes the product to the consumer and provides the necessary information for its safe use.

    • 9.2 Rationale behind the Expert Advisory Committee Recommendation:
      • Product labels should be submitted as part of the registration process.
      • For products containing Presumed Safe Substances, Health Canada guidance documents should state that the label claim will not be specifically evaluated, but that Health Canada will keep the label on file for access in cases of regulatory compliance surveillance.
      • Since only general health claims are allowed on the labels of presumed safe products, the Committee felt that a label review was not required.
  10. All vNHPs should be identified as such on the label, using the term "natural health product" or "veterinary natural health products. With respect to label claims, the only claims allowed on presumed safe products should be general health claims. To facilitate the fast track process, Health Canada should issue a guidance document containing examples of allowable general health claims for presumed safe products. If a manufacturer wishes to have a specific therapeutic claim, the product or substance will not be eligible to be 'fast tracked' as a presumed safe product.
  11. Should a manufacturer wish to have a specific therapeutic claim on the label, the approval process should include a review of the specific claim, thus precluding the product from fast track approval. This review process should be conducted by third party reviewers who have expertise in the specific product or type of product being reviewed (i.e. claims for herbal products should be reviewed by reviewers with expertise in herbal therapy). Health Canada must be ultimately responsible for the integrity of the system of review.
    • 11.1 Background:
      • Manufacturers may want product-specific claims or recommended use statements on presumed safe products.

    • 11.2 Rationale behind the Expert Advisory Committee Recommendation:
      • Companies are entitled to add Recommended Use statements that are specific to their product.
      • If a company wishes to add a Recommended Use statement to a presumed safe product, there should be a regulatory review process to which the manufacturer can submit the data supporting the use of the product according to the specific recommended use.
      • In the opinion of the Committee, it would be reasonable for the VDD to use a third party to review the submitted labels and recommended use statements. These third party individuals need to possess the appropriate qualifications to conduct this review.
      • However, Health Canada must oversee the review process and ensure the integrity and transparency of the process.
      • A similar process could also be applied to other categories of veterinary natural health substances or products.
  12. With respect to the fast track approval process for presumed safe products, there should be no difference in the process between products intended for companion animal use and those intended for food animal use. However, the Committee does recommend that the distinction between food animal and companion animal groups be maintained for other categories of veterinary natural health products (i.e. for other categories developed under recommendation #7, above).
  13. With respect to quality of presumed safe vNHPs, attestation by a senior official or the Canadian representative of the company that the substance or product meets to pre-determined quality standards as established by Health Canada is sufficient for approval. Should there be a need for a quality review, a third party could reasonably conduct this review, as long as Health Canada is responsible for the integrity of the system.
  14. With respect to manufacturing facilities, attestation by a senior official or the Canadian representative of the company that the facility meets to pre-determined facility standards is sufficient for initial approval for a presumed safe product. However, Health Canada should establish that they have the ability to inspect manufacturing facilities if circumstances arise where an inspection would be warranted. Depending on the product category, more diligence may be required with respect to manufacturing data or site inspection, particularly in the case of food animals.
  15. With respect to the manufacturing of products containing highly purified plant extracts that are eligible to be included in the presumed safe category, there should be no requirement for the submission of more manufacturing data than is required for other presumed safe substances. In all cases attestation is sufficient, under the assumption that the manufacturer should be able to provide supporting information regarding purity and safety on request.
  16. A manufacturer could choose not to have a product treated as a presumed safe product, or could submit a registration request under a different approval/registration pathway for a product for which registration as a presumed safe product has been refused.
    • 16.1 Background:
      • Manufacturers may wish to make certain label claims that are not allowed for presumed safe products, or label claims that would facilitate exportation of the product.
      • Likewise, should a product be refused registration as a presumed safe product, the manufacturer may wish to apply for registration of the product under a different classification.

    • 16.2 Rationale behind the Expert Advisory Committee recommendation:
      • Manufacturers should be allowed to choose whether their product is fast tracked for approval with a general label claim or undergoes a review to allow a specific therapeutic claim.
      • Health Canada could assess a fee for review of data for a specific therapeutic claim.
      • By defining criteria, thresholds and research requirements for specific therapeutic claims, Health Canada would encourage industry research for natural health products.
  17. Homeopathic medicines for use in animals should be treated in essentially the same way as all other vNHPs with respect to fast track approval or allowable claims and the requirements for homeopathic medicines for use in animals should not exceed those currently in place for homeopathic medicines with the NHPD. Medicines listed in a homeopathic pharmacopoeia would be eligible for the fast track approval process only if the manufacturer or the manufacturer's Canadian representative attests to adherence to strict manufacturing standards that relate specifically to the preparation of homeopathic medicines (i.e. in accordance with homeopathic standards for preparation of mother tinctures and potencies). If a homeopathic medicine is not listed in a homeopathic pharmacopoeia, it is not eligible for fast track approval. The Committee noted that no homeopathic product could technically be considered safe, based on the potential for aggravations when misapplied.
  18. With respect to "Systems of Traditional Medicines" such as Ayurvedic, Traditional Chinese Medicine, or other 'healing paradigms', the Committee recommends that the veterinary use of these systems of medicine should be under the jurisdiction of a knowledgeable practitioner. As far as the individual substances or products are concerned, if all of the individual ingredients are on the presumed safe list, these products may meet the requirements for fast track approval. If not, these products should be labelled 'to be used under the supervision of a qualified practitioner."
    • 18.1 Background:
      • Traditional medicines, such as Traditional Chinese Medicine, Canadian First Nations Traditional Medicines, Ayurvedic Medicines and African Traditional medicines, are systems of medicines based on cultural belief systems or healing paradigms. Their use is guided by the principles of these healing paradigms, usually under the supervision of specialized practitioners.
      • Traditional use means that the use is well-documented according to the accumulated experience of many traditional health care practitioners over an extended period of time and accords with well-established procedures of preparation, application and dosage. In some cases, there may be a history of use in animal species.

    • 18.2 Rationale behind the Expert Advisory Committee recommendation:
      • Many products used in these systems of traditional medicine could not be registered as veterinary presumed safe products, not because they are considered unsafe but because they cannot be evaluated as veterinary products the same way as they are on the human side.

    As is already the case, the fact that traditional medicines would not be registered as veterinary drugs would not prevent the veterinary extra-label drug use of products approved by the NHPD under the supervision of qualified practitioners.

Part 3: General Implementation, Monitoring and Enforcement

Implementation of the regulations should be in a stepwise fashion, as follows:

  1. Request all vNHP manufacturers and distributors in Canada to voluntarily register with Health Canada if they are marketing products in Canada. This will allow the VDD to gain information on the current Canadian market and to allow the VDD to generate a catalogue of ingredients and/or products being used.

    Although notification (registration) process is proposed to be voluntary, Health Canada will ultimately need ways to enforce compliance with manufacturers. Manufacturers who voluntarily register should not be subject to compliance action. Manufacturers who do not voluntarily register may be those in need of being investigated and/or targeted for enforcement actions due to lack of compliance.
  2. Classify vNHPs into schedules similar to the CFIA feed schedules, enabling the assignment of registration numbers. Priority should be placed on developing a schedule or list of presumed safe substances and an exclusionary list of toxic substances. Products that are presumed safe would then qualify for fast tracking, as outlined above in Part 2.
  3. Develop a procedure for monitoring of all vNHPs. There should be post-market monitoring of all products, with a requirement to report ALL adverse events, not just serious adverse events. In order to implement monitoring, it will be necessary to define what is considered to be an adverse event, and to determine when adverse events should be reported. In addition to the post-market monitoring, a pre-market review should be required for any high-risk products intended for use in food animals. With products intended for use in horses, it will be necessary to identify whether the product can be used in horses that are destined for human consumption.
    • 3.1 Background:
      • Post-market monitoring is critical to protect the wellbeing of animals and the public.

    • 3.2 Rationale behind the Expert Advisory Committee recommendation:
      • The Committee's primary concern is the safety of any veterinary natural health product that is approved for use by the Canadian public. To ensure this, manufacturers should be required to record all adverse incidents and retain the information in a systematic manner, to immediately report any serious incidents as defined in the regulations, and to report any significant changes in the risk-benefit profile of substances or products. In addition, the manufacturer should be required to provide all information regarding adverse incidents on request.

    To facilitate reporting and achieve consistency throughout the industry, Health Canada should develop a standardized form or method for recording and reporting adverse events. Any post-market surveillance process should be overseen by a health professional capable of judging the significance of any adverse events, especially since this reporting system will play a large role in the classification of a product as low risk. It would be reasonable for Health Canada to accomplish this proposal by adapting a model in use by another third party agency.
  4. Develop a public campaign to educate both the public and the industry on the intent of Health Canada with respect to the reasons behind notification to lessen any concerns, especially those regarding over-regulation. Ensure that all public campaigns are non-threatening and that the process remains transparent. Also, emphasize to the public that Health Canada's intent is to oversee vNHPs to ensure public safety, retain accessibility to vNHPs and ensure that the vNHP industry is credible and responsible.
  5. Initiate discussions with manufacturers in an effort to develop a voluntary quality certification system. Health Canada should establish the basic criteria for this certification system, which could reasonably be modelled upon the system currently in place in the United States, namely the NASC model.

Appendix A: Working Definition of a Veterinary Natural Health Product

A veterinary Natural Health Product is a substance or mixture of substances administered across mucous membranes or applied topically and that is manufactured, sold, or represented for use in:

  1. the diagnosis, treatment or prevention of a disease, disorder or abnormal physical state or its symptoms in animals; or
  2. restoring, correcting or modifying organic functions in animals; or
  3. articles intended to affect structure or function of the body in animals.

AND

All medicinal ingredients of a veterinary Natural Health Product are substances set out in Schedule 1, and do not include substances set out in Schedule 2.

Schedule 1: List of Included substances

  1. A plant or plant material, an alga, a bacterium, a fungus or a non-human animal material
  2. An extract or isolate of a substance described in item 1, the primary molecular structure of which is functionally equivalent to that which it had prior to its extraction or isolation
  3. A vitamin
  4. An amino acid
  5. A fatty acid
  6. A synthetic duplicate of a substance described in any of the items 2 to 5
  7. A mineral
  8. A probiotic
  9. An enzyme
  10. A homeopathic medicine
  11. Any combination product whose medicinal ingredients consist entirely of things referred to in any of the items 1 to 9.

Schedule 2: List of Excluded substances

  1. Any substance set out in the Feeds Act and Regulations
  2. A substance set out in Schedule C of the Food and Drugs Act
  3. A substance set out in the Health of Animals Act or Schedule D of the Food and Drugs Act, except for the following:
    1. A drug that is prepared from any of the following micro-organism, namely, an alga, a bacterium or a fungus; and
    2. Any substance set in Schedule D when it is prepared in accordance with the practice of homeopathic pharmacy
  4. Substances listed in Schedule F (part 1) of the Food and Drugs Act, except for homeopathic medicines manufactured from Schedule F ingredients
  5. A substance set out in any of the Schedules I to V of the Controlled Drugs and Substances Act
  6. A substance that is administered by puncturing the dermis
  7. Chemically synthesized allopathic drugs
  8. Antibiotics prepared from an alga, bacterium or fungus or a synthetic duplicate of that antibiotic, except for homeopathic medicines manufactured from these ingredients
  9. Synthetically produced or isolated hormones, not including homeopathic medicines manufactured from these ingredients.

Appendix B: Working Definition of a Presumed Safe Product

This class would cover products that are not likely to have a negative impact on the health of animals or the safety of the food supply and do not present any particular risk for humans (e.g. workplace exposure) or the environment.

A. Products which would be presumed safe would include:

  1. Any homeopathic preparation that conforms to one of the recognized pharmacopoeias and is diluted below a certain level of potency (to be determined).
  2. Pre-identified botanicals and botanically derived substances.
  3. Pre-identified health supplements (e.g. vitamins, minerals, glucosamine, chondroitin, MSM, etc.).
  4. Pre-identified probiotics.
  5. Pre-identified fungi
  6. Pre-identified bacteria.
  7. Any product whose ingredients are a normal/ natural component of human or animal food*
    *Conditions could apply to various types of products. For example, point 7 could allow the inclusion of garlic in the organic dairy industry. If there is a concern in another species of animal, such as garlic use in cats, a condition could be applied.

B. Products which would not be presumed safe:

  • Related To Route of Administration:
    • 1. Implants;
    • 2. Injectable;
    • 3. Intra-mammary;
    • 4. Ophthalmic;
    • 5. Transdermal patches.

  • Related To Product Type:
    • 6. Radiopharmaceuticals;
    • 7. Biologics, except in:
      1. homeopathic medicines; and
      2. colostrum;
    • 8. Chemically synthesized antibiotics and hormones, except for plants and whole herb extracts with antimicrobial or definitive hormonal activity; (mild hormonal activity should be allowed - for example, estrogen responsive incontinence in dogs may be helped by wild yam);
    • 9. General anesthetics - drugs involving loss of consciousness;
    • 10. Tranquilizers, except for products having mild calming effects;
    • 11. Non-natural substances unless they yield the original substance after digestion or absorption;
    • 12. Isolates and extracts that involve a complicated and delicate manufacturing process (to be defined);

  • Related To Exclusions:
    • 13. Prescription substances listed in Schedule F, except in homeopathic medicines;
    • 14. Substances covered under the Controlled Drugs and Substances Act;
    • 15. Products used in relation to a reportable disease listed in the Health of Animals Act;
    • 16. Substances (whether used as active pharmaceutical ingredients or excipients) listed in a schedule (to be developed), using the following criteria:
      1. Is it a substance known to cause serious adverse health consequences?
      2. Is there an unusual risk of dangerous interaction with other substances?
      3. Is it a mutagenic, teratogenic or carcinogenic substance?
      4. Does the substance have the potential to have detrimental effects on certain population groups, such as growing animals and pregnant animals?
      5. Is there a potential for topical preparations to be inappropriately ingested and therefore result in serious adverse health consequences (e.g. licking off topical creams/oils by animals)?
      6. How probable is it that a product can be confused with another toxic product?
      7. Is there a likelihood of contamination with a toxic ingredient?
      8. Is there a narrow margin of safety (e.g. Is it easy to reach toxic levels when inappropriate higher doses are used?)? This may be species dependent - for example, cats are highly sensitive to certain ingredients because of lack of certain enzyme systems.
      9. Is there insufficient information available to be able to evaluate its health risk potential and should its use therefore be avoided?
      10. Does the product contain a substance that originates from a Bovine Spongiform Encephalopathy (BSE) infected animal (Specified Risk Materials - SRMs)?
      11. Can the use of the substance result in possible transmission of diseases to humans?
      12. Is there the potential for harmful drug residues in meat, eggs, honey, of parent substance and/or active metabolites?
      13. Is there a possibility of bioaccumulation of substances ingested by humans from sources in addition to edible animal products?
      14. Can the substance have a harmful environmental impact?
      15. Is there evidence that residues of the drug in animal products have a harmful effect on human gut flora?
      16. Could residues negatively affect technological processes used in food processing?
    • 17. Label claims that the product is effective for the treatment of serious conditions listed in a schedule to be developed, using the following criteria - A condition that:
      1. is associated with significant morbidity or mortality;
      2. is associated with severe pain (NB: should not exclude products such as MSM, chondroitin, glucosamine, meadowsweet, Boswellia and other plants with anti-inflammatory activity used for chronic pain associated with osteoarthritis);
      3. is a zoonotic disease;
      4. can be highly contagious to other animals; or
      5. has anti-microbial resistance potential;

  • Related To Safety of Food:
    • 18. When used on food animals:
      1. Substances listed in Division 6 of Part C of the Food and Drug Regulations - conjugated estrogens, digitoxin, digoxin, esterified estrogens, gelatine (except from vegetable origin), thyroid (except in homeopathic medicine);
      2. Substances banned in food under B.01.048-C.01.610.1 (e.g. clenbuterol);
      3. Preparation having estrogenic activity (banned in poultry B.22.009);
      4. Substance listed in Table 1 (B.15.001) of the food regulations (arsenic, fluoride, lead, tin), except in homeopathic medicines.

C. Adding products to the list:

Health Canada could add products or classes of products to those listed in the schedule or allow for variations in the attached conditions, in consideration of the following factors:

  1. International post-market surveillance has shown a low rate of serious adverse drug reactions for this product (or similar products);
  2. There exists within the public domain a scientifically recognized body of evidence that demonstrates that the product (or similar products) does not present significant risks in humans or animals
  3. The product (or similar products) has a significant history of safe use in the same or related species;
  4. There is no known toxicity;
  5. There is no particular reason to fear negative consequences resulting from interaction with other drugs;
  6. The product contains substances of endogenous origin;
  7. The product is normally used in a small number of individual animals on an infrequent or irregular basis (although this product should still be proven safe in the target species);
  8. Residues from dietary or parenteral administration results in tissue residues which are within normal physiological range;
  9. Tolerance by humans is high;
  10. Absorption from the gastrointestinal tract or from sites of local application (e.g. Skin) is poor or absent;
  11. The substance is rapidly and extensively detoxified or excreted;
  12. The product is used with respect to restrictions such as a particular route of administration, or particular species;
  13. Animals are unlikely to be sent for slaughter during or immediately after treatment; with any food animal, due consideration should be made for a withdrawal period.

D. Withdrawal of products from the list:

Health Canada could remove a product or a class of products from the list of presumed safe products, or impose additional conditions, if evidence shows that such products may present significant health risks which were not previously known (using the same criteria as above but in reverse). In this case, manufacturers having a product already registered would be provided an opportunity to be heard before a decision is made.

Appendix C: Typical and Atypical Presumed Safe Products

Definitions

A. Typical presumed safe products

In order to obtain a market authorization, the manufacturer of a product meeting all the criteria established in Appendix B would not have to demonstrate that the product is safe and efficacious. In a sense, Health Canada would have already indicated that it would authorize the sale of products meeting those conditions and what is left to do is register each individual product.

B. Atypical presumed safe products

Homeopathic preparations, botanicals, health supplements, probiotics, fungi and bacteria could still be treated as presumed safe products, although not meeting all the conditions described in Appendix B. In these cases, the review process would include some additional requirements to allow Health Canada to satisfy itself that the product is indeed a low risk product.

Premarket Requirements

A. Typical presumed safe products

  1. In order to be authorized to sell a "typical presumed safe product", an applicant would have to complete and submit a form (ideally, this should be available in electronic format) that would include the following information:
    • Contact information for the Canadian representative (who will be the point of contact for Health Canada)
    • Information about the manufacturer;
    • Location of manufacturing sites;
    • Information necessary to determine whether the product is covered under and meets the conditions of Appendix B;
    • Information necessary to ensure traceability.

  2. Both a senior official of the company and the Canadian representative would also have to attest that:
    • there is objective evidence demonstrating that the product is safe;
    • there is objective evidence to support a "reasonable expectation of effectiveness";
    • the quality plan complies with the Good Manufacturing Practices requirements as determined by Health Canada;
    • the excipients conform with the list of non-medicinal ingredients generally recognized as safe established by Health Canada for natural health products on the human side (other than substances identified as presenting a health risk for some species);
    • legislative requirements, including those relating to health claims and labelling, will be complied with; and
    • they will inform Health Canada of any relevant or significant change in the substance or product.

      The Committee has recommended that safety and quality are paramount to the approval process for presumed safe products and has placed less emphasis on efficacy of this class of products. However, manufacturers must attest that there is objective evidence for a reasonable expectation of effectiveness because the company must ultimately take responsibility that it is selling something that works. In this way, the recommendations for vNHPs will conform with requirements for other presumed safe products in other directorates.

  3. Health Canada would rely on the information provided in the form unless it has reasons to believe that it is misleading or that the product presents a health risk, in which case it could ask for any additional information deemed necessary to establish that the product is safe, has a reasonable expectation of providing a benefit consistent with labelling claims and is of good quality.

  4. For certain products, the applicant would have to provide additional information (e.g. complete an animal tissue form for products of animal origin). Health Canada would review this documentation.

  5. After having determined that the product is indeed a "typical presumed safe product" based on the information provided in the form, and assuming that everything is in order, Health Canada would then issue a registration number that indicates that the product is a veterinary natural health product (e.g. VN 1234567).

  6. The same submission could cover several variations of the same product (e.g. different dosages) provided that the relevant conditions are met, but different registration numbers would be issued for each version of the product.

  7. Registration would be valid for two to five years.

  8. The fee charged for registration would be proportional to the amount of resources required to administer the whole program, and should be based on cost-recovery.

  9. Should the Canadian representative for the manufacturer sever their relationship with the company, then the company will need to appoint a new Canadian representative, and the company may need to reapply for registration.

B. Atypical presumed safe products

  1. For any variation from what would constitute a "typical presumed safe products", the pre-market requirements for a manufacturer of an "atypical presumed safe product" would, in addition to the above, also have to provide (depending on what the variation consists in):
    • a summary assessment of the safety of the product;
    • a credible rationale for a reasonable expectation of effectiveness; and/or
    • a plan demonstrating that the product will be of good quality.

  2. With regard to safety and efficacy, those would normally be expected to include at least references to recognized monographs or pharmacopoeias, scientific literature, or an evaluation conducted by another trusted regulatory agency that has approved the product.

  3. While registration would be more or less automatic (and fast tracked) in the case of "typical presumed safe products" that meet the relevant conditions, Health Canada should only approve the sale of an "atypical presumed safe product" once reasonably satisfied that the product is safe, has expected benefits consistent with labelling claims and is of good quality. The burden of proof would be on the applicant. Moreover, Health Canada could attach conditions to the registration (e.g. conditions of use, claims, product information). The delay to obtain a registration number would likely be longer in these cases.

As an example, say that Glucosamine, Chondroitin and MSM would be listed in the schedule of ingredients that are presumed safe, and Tansy would not because Tansy contains toxic active components such as Thujone. A product for dogs containing Glucosamine, Chondroitin and MSM would qualify as a "typical presumed safe product" and would be fast tracked. A product for dogs containing Glucosamine, Chondroitin and Tansy would not. However if the manufacturer could show that all toxic compounds of Tansy have been removed from its product, it could ask Health Canada to review the additional evidence in order to have this "atypical presumed safe product" authorized for sale.

Manufacturing Requirements

Typical and atypical presumed safe products

Establishment licenses would not be required for manufacturing presumed safe products.

However, the manufacturer would have to comply with basic Good Manufacturing Practices (established in the regulations or adopted by referencing other existing standards from another credible 3rd party licensing authority should the facility be in another international location). There should be harmonization between the requirements from Health Canada and those of other jurisdictions whenever possible.

It may also have to comply with additional requirements for specific types of products (e.g. specific chemistry and manufacturing requirements for highly concentrated botanicals).

Health Canada should have the ability to inspect the facilities and processes at any time and the manufacturer would have the obligation to notify Health Canada whenever there is a change in manufacturing sites.

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