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Mojo Pet Supplements Veterinary Health Products (VHPs)

VHP (Veterinary Health Product) / NN (Notice of Notification)

 

A new notification program for veterinary health products (VHPs) came into effect on November 13, 2017.1


What You Need To Know

  • The new program formalizes the Interim Notification Pilot Program (INPP) for companion animal VHPs,2 extends its application to food animals, and creates a mandatory rather than voluntary notification framework.
  • It comes as part of Health Canada's effort to mitigate the health risks associated with antimicrobial resistance—VHP uses could potentially reduce the need to use antimicrobials.3
  • VHPs are low risk drugs in dosage form, used in managing animal health.
  • The logistics around the process of notification has now been finalized.

The Details

  • Law. This VHP program is a law, not a guidance. The mandatory reporting as part of the VHP program became law on November 13, 2017.
  • Transition period for labelling. Different transition periods apply for products that have received INPP approval to those products that do not have INPP approval.
    • Products with INPP notification number have an 18 month transition period and must comply with the new labeling requirements by May 13, 2019.
    • Products without INPP notification number have a 6 month transition period and must comply with the new labeling requirements by May 13, 2018.
  • Pre-notification before selling/importing. Companies are required to notify Health Canada at least 30 days before selling/importing a VHP or making a change to a marketed VHP. Upon accepting a notification application, Health Canada will issue a notification number for the VHP.
  • Renewal. Although there is no annual renewal requirement for VHP notification, companies must re-notify Health Canada if there are changes to the original notification.
  • Permitted substances. Compliant VHPs must only contain Health Canada approved medicinal and non-medicinal substances.
    • The list of permitted active, homeopathic, and traditional medicine substances are described on List C: Veterinary Health Products,4 provided for in the amended Food and Drug Regulations. The list also specifies limitations on each substance, such as the species and routes of administration permitted.
    • Health Canada also maintains a List of Permitted Substances,5 which includes non-medicinal ingredients, as well as the active, homeopathic, and traditional medicine substances described on List C.
       
    • Companies may submit requests to Health Canada to amend the List of Permitted Substances. This also includes requests to modify the limitations of a List C substance. There must be sufficient scientific data and information regarding the safety of use in target animals or humans. The length of time for approval will vary for medicinal versus non-medicinal ingredients.
  • Claims. VHPs are used for the maintenance and promotion of health and well being in food and companion animals. A VHP cannot claim use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms. Therefore, a product making general health claims supported by sufficient evidence would be acceptable.
  • Good manufacturing practices (GMPs). Manufacturers are required to meet the GMP requirements in the Natural Health Products Regulations (NHPR).
  • Labeling. In addition to complying with the Food and Drug Regulations labelling requirements, VHP labels must also include the statement "Veterinary Health Product" and any additional mandatory statements specified on List C.




What's Next

Companies that sell/import or intend to sell/import VHPs should sign up for an account on the new VHP notification program website. All notifications, requests, or reports are submitted online. Foreign manufacturers/distributors of VHPs will need a Canadian representative responsible for the product in Canada. Companies already marketing VHPs need to provide notification of the products to Health Canada and, depending on whether or not the product has an existing INPP notification number, take note of the labeling requirement compliance deadlines of May 13, 2018 or 2019, as applicable.

______________________________________________


See https://health-products.canada.ca/vhp-psa/en/home. See https://www.canada.ca/en/health-canada/services/drugs-health-products/veterinary-drugs/other-issues/interim-notification-pilot-program-low-risk-veterinary-health-products.html.


We reported on the 2017 amendments to the Food and Drug Regulations that address antimicrobial resistance from the veterinary use aspect, see "Rules Change for Veterinary use of Antimicrobials."


See https://www.canada.ca/en/public-health/services/antibiotic-antimicrobial-resistance/animals/veterinary-health-products/list-c.html. See https://health-products.canada.ca/vhp-psa/en/product-list. 


See http://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-196/.7


See https://health-products.canada.ca/vhp-psa/en/registe 

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International Trade Certificate (VHP/NN)

Additional Information

 As of September 2, 2013, Health Canada transferred the responsibility of International Trade Certificates (ITC) issuance to independent 3rd parties. It is standard practice among many countries to require an ITC to accompany any Natural Health Product (NHP) imported into their jurisdiction. An ITC is a document that provides information to the exporting country regarding the regulatory status of a Canadian NHP or Canadian manufacturer, packager and/or labeller and confirms that the product and/or site meets the strict Natural and Non-Prescription Health Product Directorate’s (NNHPD) regulatory requirements. 

Learn More

 

  • An International Trade Certificate for NHPs – This speaks specifically to products. Any product that holds a valid NPN or DIN-HM can obtain an ITC. Note: a separate application must be submitted for each product and country of destination.
  • An International Trade Certificate of Good Manufacturing Practices (GMPs) Compliance – This speaks specifically to domestic Canadian sites that possess a valid Site Licence. It is site, and not product specific and is essentially an attestation that a facility has been evaluated and found to comply with the Canadian NHP GMPs

Find out more

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