Frequently Asked Questions about the Interim Notification Program
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  1. What is the INP?

    The Interim Notification Program (INP) for Low-Risk Veterinary Health Products (LRVHPs) allows LRVHPs to obtain a Notification Number if certain conditions are met. Given the INP safeguards, Health Canada considers it unlikely that a product satisfying all applicable requirements could present a significant health risk to the health of humans or animals.

    The Notification is valid for one year and can be renewed using a simplified procedure. Participation in the program is voluntary and industry members may instead prefer to obtain a Notice of Compliance (NOC) and Drug Identification Number (DIN).

    The notification process is administered by the Program Administrator, operating independently of Health Canada. The role of the Program Administrator is to process the notification applications to ensure that products notified under the INP meet the conditions established by Health Canada, and issue a unique product specific Notification Number (NN). The Program Administrator will recover costs by charging fees for new Notifications, annual renewals and amendments.

  2. What kinds of products are eligible? Is my shampoo or topical product eligible for the program?

    The INP applies to LRVHPs for sale in Canada that are for use in cats, dogs, and horses that are not intended for food. LRVHPs may only contain admissible substances that are found on the List of Substances including homeopathic medicines, botanicals, vitamins, minerals, fungi, bacteria, etc. Pet food products and veterinary health products intended for food producing animals, such as cows, swine and poultry are not covered under the INP.

    Products under the INP need to have a general health claim and identify the active ingredients that support that health claim. Therefore, a shampoo that contains essential fatty acids and has a general health claim of ‘Supplies essential fatty acids to support healthy skin and coat’ would be eligible for the program, whereas a shampoo that had no general health claim and no active ingredients would not.

  3. What are the fees?

    A $250 fee is payable to the Program Administrator when the Notification Form is submitted for review.

    If the product is admissible for the INP program, a $500 fee is payable before the Notification number is issued.

    The annual renewal fee is $250.

  4. Where can I see what products have been notified?

    A public list of Notified Products is maintained at lrvhp.ca.

    The list gives the following information about each Notified Product as it is entered on the Notification Form:

    • Product Brand Name
    • Notifier Name and contact information
    • Canadian Representative (if applicable) and contact information
    • Active Ingredients (Proper Name, Common Name, Quantity per Dosage Unit)
    • Intended Species
    • Dosage Form
    • Date of issuance for Notification Number
    • Date of upcoming renewal for Notification Number

     

  5. Does the Notifier need to be located in Canada?

    No. The Notifier can be a foreign manufacturer, etc. However, if the Notifier is not located in Canada, a person located in Canada must be designated as Canadian Representative.

  6. How many products can be included on a notification form?

    Products that have the same answers to Notification Form questions (ie. different presentation sizes of the same product, such as 30 capsules, 60 capsules and 90 capsules) can be included on a single Notification Form.

    Products with different answers to Notification Form questions (ie. different dosage forms of the same product, such as a capsule versus a powder) require different Notification Forms.

  7. Do products made in Canada require a NN?

    The INP program applies to products sold in Canada regardless of where they are manufactured.

  8. What is a Canadian Representative?

    The Canadian Representative is a person located in Canada who is responsible for the sale of the product in Canada and ensuring it meets the requirements of the Interim Notification Program (INP) as outlined in the Overview and other associated documents.

  9. Who needs to have a Canadian Representative?

    Notifiers located outside of Canada need to designate a Canadian Representative located in Canada, i.e. with a street address where a letter could be delivered in Canada.

  10. Can I have more than one Canadian Representatives for my product?

    No, there can only be one Canadian Representative for each product. This does not mean that the product has to be distributed through the Canadian Representative him/herself, as long as he/she is able to meet the obligations described in the attestation outlined in question 11.

  11. How do I inform NAC who is the Canadian Representative for my product?

    The name and coordinates of the Canadian representative for my product, if any, is required in section 2-4 of the electronic application form. The Canadian Representative will be required to attest to the following:

    • The attached notification form for a low risk veterinary health product has been submitted and you are designated as the Canadian Representative.

    • This is to confirm that you accept to be the Canadian Representative for this product.

    • If the Notifier is not located in Canada, a person located in Canada must be designated as Canadian Representative. There can only be one Canadian Representative for each product. The Canadian Representative is responsible for the sale of the product in Canada and ensuring it meets the requirements of the Interim Notification Program (INP) as outlined in the Overview and other associated documents. The Canadian Representative must have systems in place to be able to effect a recall or take corrective actions in a timely manner for all products in Canada. This includes taking corrective action should Health Canada consider that the product does not meet the requirements of the INP and the relevant regulatory provisions or that it is unsafe or likely to cause the public to be deceived.

    • By clicking on this link, you confirm that you accept to act as the Canadian Representative for the product.

  12. What are the responsibilities of the Canadian Representative?

    The Canadian Representative must:

    i. have systems in place to be able to effect a recall or take corrective actions in a timely manner for all products in Canada. This includes taking corrective action should Health Canada consider that the product does not meet the requirements of the INP and the relevant regulatory provisions or that it is unsafe or likely to cause the public to be deceived.

    ii. satisfactorily implement the collection of distribution and sales data and channels  for each product in the case of a product recall;

    iii. attest to the safety of the product;

    iv. attest to the use of Good Manufacturing Practices (GMP) of the manufacturing, packaging, labelling, distribution and sale of the product.

    v. collect all adverse event reactions data and report serious adverse event reactions


    The Canadian Representative will have read access to the Notification Form. It is recommended that an agreement takes place between the Canadian Representative and the product sponsor to ensure that the Canadian Representative responsibilities and obligations can be met.

     

  13. How do I get started?

    Go to lrvhp.ca and select ‘Request a New Notifier Account’.  Once your account is active, you will be able to view guidance documents and complete the electronic Notification Form.

    Please review the Guidance Documents Before you begin.

  14. What if the substance in my product is not on the List of Substances?

    When you start filling out the Notification Form, you will be asked to select the product’s active and excipient ingredients from the List of Substances. Not all substances have been considered for admissibility. You can find out if Health Canada can make a quick decision about the substance or if an Application to Add a Substance will be required, by either emailing an inquiry to admin@lrvhp.ca or using the submit request option from within the application form.

  15. If the substance is admissible as a homeopathic, why isn’t it admissible in my product?

    Homeopathic products must be prepared following very specific methods of preparation identified in homeopathic pharmacopoeias that might include dilution of the substance until there is almost no trace of the original substance in the preparation. Therefore a substance that is not admissible in a ‘regular’ product may be admissible in a homeopathic product.

  16. My product has been sold for many years with no adverse events, why now do we have to prove safety?

    Some LRVHPs might have been sold on the market without having been authorized to do so by Health Canada. The INP has been developed to accommodate such products until a new regulatory framework is developed for veterinary drugs. Under the INP, the Notifier is entirely responsible for and attest to the safety of the product to be notified. One of the criteria for a product to be eligible for Notification is that all ingredients have to appear on the List of Substances that are admissible. This List has been developed taking into consideration a number of factors, including adverse event reports associated with products containing the ingredient.

  17. If my product is being safely used in humans, why can it not be assumed to be safe for use in animals?

    This statement may be true in many cases but not in every case. Humans, cats, dogs and horses have a different physiological make up and may metabolize products differently. For example, many painkillers commonly used in humans are toxic in cats, and the artificial sweetener xylitol is toxic in dogs.

  18. I have a proprietary blend or third party ingredient in my product. Will the information be kept confidential?

    proprietary blend is a list of ingredients that are part of a product formula specific to a particular manufacturer. Notifiers are required to list all the ingredients in a product on its label, along with the amount of each, unless the ingredients are part of a proprietary blend- then only the total amount of the blend and the minimum amount of each ingredient in the blend needs to be listed. The statement “contains not less than…xxxx.” for each ingredient must appear on the label. Note that proprietary flavouring and fragrance mixtures are discussed separately below.

    Not all substances can be included in a proprietary blend. For example, Traditional Chinese Medicine substances or homeopathics cannot be included in proprietary blends. Also, quantities of ingredients that should not exceed the recommended daily intake need to be declared on the label individually, for example such as Selenium. A more detailed list of ingredients that cannot be included in a proprietary blend will be published in the near future.

    Proprietary Flavouring mixture means a mixture of flavouring agents and flavour enhancers that are added as non-medicinal ingredients to enhance the existing taste and/or odor of a product. A Proprietary Fragrance mixture means a mixture of fragrance enhancers that are added as non-medicinal ingredients to enhance the existing scent and/or odor of a product.
    The components of mixtures have to be identified unless the flavourings or fragrances are part of a proprietary mixture - then the common name (e.g. Liver flavour #3) and quantity should be identified on the Notification Application. The ingredients of a proprietary flavouring mixture or proprietary fragrance mixture do not need to be provided to the Program Administrator or Health Canada but the Notifier may be required to submit to Health Canada, either themselves or via a third party (e.g. Master File) mechanism, information about the proprietary flavouring mixture or proprietary fragrance mixture. This information should be provided within 15 business days of the date of the request. Note that this does not apply to other proprietary excipient mixtures, such as preservative mixtures, where the components need to be identified on the Notification Form at the time of application.

    Table 1 represents a summary of the information requirements for different types of products

    Product type

    Item

    Notification Form

    [Confidential between Program Administrator, Health Canada, Notifier and Canadian Representative - if applicable]

    Product label

    Public Notified Product List

    For products containing Non-proprietary ingredients

    Ingredient identification  (active)

    Must be declared

    Must be displayed

    Listed

    Ingredient identification (Non-medicinal /excipients)

    Must be declared

    Not required

    Not listed

    For products containing Proprietary blends (except flavouring or fragrance mixtures)

    Ingredient identification proprietary blends (active)

    Must be declared

    Must be displayed

    Listed

    Total quantity of proprietary blend (active)

    Must be declared

    Must be displayed

    Listed

    Exact quantity of each blend ingredient (active)

    Must be declared

    Not required but must display: “Contains not less than xxx

    Not required but must display: “Contains not less than xxx

    Ingredient identification proprietary blends (non-medicinal/excipients)

    Must be declared

    Not required

    Not listed

    Exact quantity of each blend ingredient (non-medicinal/excipients)

    Must be declared

    Not required

    Not listed

    For products containing Proprietary Flavouring mixtures

    Identification of flavouring mixture

    Must be declared (e.g. Liver flavour #3)

    Not required

    Not listed

    Total quantity of flavouring mixture

    Must be declared

    Not required

    Not listed

    Identification and exact quantity of each ingredient in flavouring mixture

    Upon request by Health Canada only

    Not required

    Not listed

    For products containing Proprietary Fragrance mixtures

    Identification of fragrance mixture

    Must be declared (e.g. Fragrance #3)

    Not required

    Not listed

     

    Total quantity of fragrance mixture

    Must be declared

    Not required

    Not listed

     

    Identification and exact quantity of each ingredient in fragrance mixture

    Upon request by Health Canada only

    Not required

    Not listed

     

  19. How quickly will I know if my product has been accepted?

    If all of the information on the Notification Form can be evaluated without consulting with Health Canada, you should know within 2 weeks if the notification has been accepted.

    If consultation with Health Canada is required to evaluate the admissibility of information on the Notification Form (ie. a claim or ingredient), you should know within 2 - 3 weeks if the notification has been accepted.

  20. Once the Notification Form has been submitted or accepted, may I make changes to my original application?

    Yes. If the Notification Form has already been accepted, it may need to be re-evaluated if label information such as ingredients or claims change. If the change does not affect the Notified Product’s admissibility for the program, the change can be made and the Notifier or Canadian Representative (if applicable) will be required to complete the attestation step again.

    Should amendments be required, please review the Amendment Fee chart by clicking here 

    In order to make changes to your Notification Form after it has been submitted, you must email admin@lrvhp.ca with your Notification Form submission number and the Program Administrator will re-open the Notification Form for editing, or click on Manage, and select Create Amendment.

     

  21. Do I have to put my NN on the label?

    Yes, when a Notification Number is issued for a LRVHP, the Notifier must display it on the marketed product label.

  22. If a product has a NN, is it guaranteed to be okay for sale in Canada?

    Given the INP safeguards, Health Canada considers it unlikely that a product satisfying all applicable requirements could present a significant risk to the health of humans or animals.

    Consequently, in the case of a product that meets all conditions of the INP and has been assigned a notification number, Health Canada would not prioritize the enforcement of the regulatory requirements related to the importation, manufacture, or sale of those veterinary drugs falling within the program and would not normally seek to prevent the importation, manufacture, or sale of such a product, unless a health risk is identified.

    Health Canada may take enforcement action should it have reasons to believe that a product is not compliant with the requirements of the INP, is unsafe or causes the public to be deceived.

    The issuance of a Notification number does not exempt any product from the application of legislation administered by other entities such as the Canadian Food Inspection Agency (CFIA), the Pest Management Regulatory Agency (PMRA) or other government regulatory authorities. For example, if the product includes animal derived ingredients, it may be subject to the importation requirements of the Health of Animals Act. The Notifier is responsible for ensuring compliance with applicable legislation.

  23. How can I report an adverse event?

    There are three ways to do this. An adverse event can be reported to the Notifier (or Canadian representative if applicable), to the Program Administrator or directly to Health Canada. Contact information of the Notifier can be found on the product label or the Program Administrator’s website under the Notified Product List tab. The Program Administrator can be contacted at 1-877-203-3313 and an Adverse Event Report Form can be electronically filed at lrvhp.ca. The Notifier (or the Canadian Representative if applicable) as well as the Program Administrator are to forward any serious event reports to Health Canada within 15 days so that Health Canada can take appropriate action if necessary. Health Canada can also be directly contacted through the Veterinary Drugs Directorate at http://www.hc-sc.gc.ca/dhp-mps/vet/advers-react-neg/adr-rim_fyi-pvi-eng.php#a9

  24. Where can I get more information?

    Please review all of the guidance documents available at lrvhp.ca.

    Questions can be emailed to admin@lrvhp.ca.

    The Program Administrator can be contacted at 1-888-328-6228.

  25. Are there additional import requirements before I import my Notified product?

    CFIA import conditions for terrestrial animal commodities, by type, can be found here:
    http://inspection.gc.ca/animals/terrestrial-animals/imports/policies/animal-products-and-by-products/2001-8/eng/1321130887830/1321131057471

    Import conditions should be confirmed using the commodity specific import procedural directives and Automated Import Reference Systems (AIRS) on the CFIA website:
    http://inspection.gc.ca/plants/imports/airs/eng/1300127512994/1300127627409

    Notified products containing animal derived substances such as gelatin, phospholipids, glycerol, amino acids etc., may require additional documents, such as an importer permit and/or official zoosanitary export certificate from the central competent veterinary authority or other competent authority of the country of origin, for import into Canada. 

    HS codes (Harmonized System) have a standardized component (6 digits) and a more unique component (4 digits). The standardized component could be taken from the pharmaceutical products section (30):
    http://www.wcoomd.org/en/topics/nomenclature/instrument-andtools/hs_nomenclature_2012/~/media/A5AB85D497324DABA8F6548337A16C07.ashx

    Tariff Classification of Medicaments Including Natural Health Products:
    http://www.cbsa-asfc.gc.ca/publications/dm-md/d10/d10-14-30-eng.pdf

    Additional information on the HS system can be found here:
    http://www.wcoomd.org/en/topics/nomenclature/overview.aspx

    If you have questions regarding tariff classification, rates of duty, permits or other CBSA programs please contact the CBSA's computerized, 24-hour telephone service (Border Information Service) at 1-800-461-9999, available free of charge throughout Canada; press "0" to speak directly with an agent during regular business hours, Monday to Friday (08:00 to 16:00 local time except holidays).
     
    From outside Canada call 204-983-3500 or 506-636-5064, long distance charges will apply. TTY is also available within Canada: 1-866-335-3237. 

    The CBSA also offers advance rulings for tariff classification which provide binding, written advice as to the classification of a product.