The LRVHP administered by North American Compendiums (NAC) is now closed.
Registered users have read-only access to their applications.
For any questions, contact VHP-PSA@hc-sc.gc.ca.
For additional information about Health Canada’s Notification Program for veterinary health products (VHPs): https://www.canada.ca/en/public-health/services/antibiotic-antimicrobial-resistance/animals/veterinary-health-products.html
This is further to Health Canada’s regulatory changes related to Veterinary Health Products (VHPs) that will come into force on November 13, 2017 (See recent news). The new VHP Notification Program will be administered by Health Canada and replace our existing LRVHP Program.
Please note the following dates related to the transition to the new system:
Until October 13th, NAC will continue to administer the LRVHP.ca system and handle questions and concerns.
Between October 13, 2017 and November 13, 2017 Health Canada will be preparing the new Notification Program for VHPs.
All products that have a valid Notification Number as of October 13th, 2017 will have extra time to transition to the new system (18 months extra beyond November 13, 2017 coming into force - which is May 13, 2019).
October 13, 2017 is the last day that NAC will administer the LRVHP.ca
September 8, 2017 is the last day to submit new Notification applications under the existing program.
October 13, 2017 is the last day to renew Notification applications.
October 13, 2017 is the last day that the LRVHP.ca system will be able to receive any adverse events.
The current AER phone number will continue to operate until May 13, 2019.
Admissible Substance Applications currently in review which have not been completed will transition to the new system.
We will be automatically transferring all the files for your company to Health Canada. If for any reason you do not wish us to do this please advise Health Canada by August 25th.
If you have any questions please contact the LRVHP administrator at Health Canada.
Please note: Important Message from Health Canada
This email provides you with additional information about Health Canada’s Notification Program for veterinary health products (VHPs), which are low risk products such as vitamins, minerals, traditional and homeopathic medicines for companion and food-producing animals that are intended to help maintain animal health and welfare.
In 2012, Health Canada, in collaboration with the independent third party, North American Compendiums (NAC - www.lrvhp.ca) and the Canadian Animal Health Institute, launched a voluntary pilot program aimed at creating a flexible and risk appropriate mechanism for manufacturers and importers to access low risk products for use in companion animals. The pilot program was intended as a temporary mechanism to assess the effectiveness of a streamlined approach to oversee low risk veterinary health products with a view to informing the development of a new regulatory framework for these products. Since that time, nearly 1000 products have been notified by this program and are available for sale in Canada.
The May 17, 2017 final publication in the Canada Gazette, Part II of the Regulations Amending the Food and Drug Regulations (Veterinary Drugs – Antimicrobial Resistance) includes provisions that build on the successes of the pilot program and introduces a similar notification pathway in the regulations for VHPs for use in both companion and food-producing animals.
With the new rules, Health Canada will regulate VHPs through a Notification Program administered by the Veterinary Drugs Directorate. The new Notification Program is intended to be similar in functionality to the pilot program’s current system (www.lrvhp.ca), including the notification of VHPs, the requirements for VHP substances or ingredients as included on List C: Veterinary Health Products, and the reporting of adverse events.
The following information is intended to enable a smooth and efficient transition:
Current www.lrvhp.ca users:
· For companies with valid notifications (via www.lrvhp.ca), we are working with NAC to facilitate the transition to the new Notification Program, which will include an additional 18 months for companies to update their labels, or sooner at the next labelling cycle.
· For companies that do not want their files to be automatically transferred to the new Health Canada system should inform NAC (firstname.lastname@example.org) by August 25, 2017.
· For companies interested in notifying additional VHPs (via www.lrvhp.ca) before the new rules apply, you have until October 13, 2017.
· You will receive additional details from NAC shortly, and for any questions, contact email@example.com.
Potential new www.lrvhp.ca users:
· For companies who have not notified their VHPs (via www.lrvhp.ca) and are interested in doing so before the new rules apply, you have until October 13, 2017. For any questions, contact firstname.lastname@example.org.
For companies who do not notify their VHPs (via www.lrvhp.ca), all VHPs will be required to comply with the new rules as of November 13, 2017.
We will be engaging stakeholders in September 2017 to provide additional information about the new VHP rules and Notification Program, proposed processes and timelines for implementation. For any questions, contact VHP-PSA@hc-sc.gc.ca.
We want to thank the NAC for their collaboration and administration of the highly effective and innovative approach to oversee VHPs.
Mary Jane Ireland
Veterinary Drugs Directorate
In collaboration with Health Canada’s Veterinary Drugs Directorate (VDD), the Notification Program is expanding the scope to a limited group of low risk veterinary health products (LRVHPs), including oral Calcium supplements and udder creams and lotions for dairy cattle. These products present minimal risk to animals and food safety and are important tools to maintain animal health and welfare.
As of March 23, 2017, products eligible for this expansion can be notified through the Health Canada.. Additional information can be found on the websites of
Health Canada has permitted an abbreviation of the mandatory horse warning statement from “Not for use in horses intended for food as a withdrawal period has not been established” to “Not for use in horses intended for food”.
This change is effective immediately. The option will be presented at the Warning section when horses are selected as intended species. Notifiers may also choose to continue using the existing non-abbreviated Warning.
Further to our recent software upgrade to the Low Risk Veterinary Health Products Interim Notification Pilot Program (INPP) on May 26th, 2014, we are pleased to announce an amendment to the access rights of the Canadian Representative. Prior to May 26th, the Canadian Representative had full viewing access of the form. As of May 26th, the Canadian Representative can no longer view the quantities of all non-medicinal ingredients.
If you have any questions or comments, please send an email to email@example.com.
North American Compendiums is pleased to announce a software upgrade to the Interim Notification Pilot Program for Low Risk Veterinary Health Products.
Access to the Low Risk Veterinary Health Products website will be disabled for implementation from May 21st, 2014 at 12:01am ET (Eastern Time) to May 26th, 2014 at 8:00am ET.
The Notified Products List will be accessible during this time, however Application Form access will not.
What are some of the key improvements?
Health Canada has provided a clarification in the Interim Notification Program for Low Risk Veterinary Health Products (INPP) regarding the Canadian Representative. These clarifications can also be found in the FAQ section of the website lrvhp.ca, points 8 through 13.
If you have any comments or questions, please send an email to firstname.lastname@example.org.
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.
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.
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.
How do I inform North American Compendiums 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 D of the electronic application form. The Canadian Representative will be required to attest to the following:
What are the responsibilities of the Canadian Representative?
The Canadian Representative must:
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.
Health Canada and North American Compendiums are pleased to announce that products containing certain substances produced by genetically modified (GM) microorganisms will be added to the scope of products admissible under the Interim Notification Pilot Program (INPP) for Low Risk Veterinary Health Products on November 25, 2013.
This approach is not expected to impact the safety of notified products as GM microorganisms themselves or their altered genetic material are not permitted in products eligible for notification.
What are GM microorganisms?
For the purpose of the INPP, GM microorganisms include genetically modified bacteria, fungi, yeasts, protozoa and microalgae, but do not include tissue cultures of plant or animal cells or viruses. "Genetically modified" refers to altered genetic material in a way that does not occur naturally by mating and/or natural recombination.
Which GM microorganisms are permitted to be used for production of admissible substances?
GM microorganisms used for this purpose must belong to well-characterized microbial species with a history of safe use in food or feed, and the traits introduced must also be well characterized. A sufficient body of knowledge must exist to have established an acceptable risk profile in humans, animals and the environment (such as the absence of endogenous toxins and unwanted secondary metabolites in the GM microorganism or its product). If the microbial species (conventional counterpart) to which the novel traits have been introduced still exists, it should have a well-established history of safe use in production or processing the substance (such as Qualified Presumption of Safety status in the European Union).
What substances are affected?
Chemically-defined, purified substances and their mixtures in which both GM microorganisms and newly introduced genes have been removed. This can include crystallized vitamins, amino acids, polysaccharides and other highly purified molecules that are synthesized with the use of GM microorganisms as "biofactories".
Complex products in which both GM microorganisms and newly introduced genes are no longer present. This can include enzyme preparations and cell extracts.
What products are out of the scope of the INPP?
Products that contain GM microorganisms themselves (viable or nonviable) or their recombinant genes are out of the scope of the INPP. Examples are products containing genetically modified probiotics and microbial biomasses.
Do I need to disclose that the substances are produced by GM microorganisms?
When entering the source material for an ingredient produced by a GM microorganism on the Notification Form, the word "synthetic" should be entered.
What happens if Health Canada requires information on GM microorganisms used in production of substances?
Health Canada may require details about the identification of the GM microorganisms used, production process/preparation and other details as warranted for example in response to a safety concern or complaint. The Notifier is responsible for providing information on all ingredients and their respective production process(es) to Health Canada upon request. It is expected that the Notifier will provide the information within 15 business days of the request.
Health Canada and North American Compendiums are pleased to announce that otic products will be added to the scope of products admissible under the Interim Notification Pilot Program for Low Risk Veterinary Health Products on September 30, 2013.
Like oral and topical products, only those otic products containing ingredients determined by Health Canada not likely to represent a significant health risk to animals or humans when used appropriately and in doses at generally accepted safe levels will be eligible for notification under the program.
How do I know which ingredients are approved for otic products?
Substances will be individually evaluated for otic use. Once approved, the route of administration “Otic” will be added to the respective entry on the List of Substances.
What types of claims can be made?
Claims will be limited to statements to the effect of:
For the maintenance of healthy ears only.
Claims relating to cleaning the ears and/or removing excessive wax.
What type of cautions will need to be displayed on the label?
Products for otic use would need to display the following Cautions/Contraindications on the product label:
For use in healthy ears only unless recommended by a veterinarian.
Discontinue use if there is discharge, discomfort, redness or irritation and consult your veterinarian.
Not for use in pregnant or lactating animals.
Avoid getting into eyes.
Health Canada and NAC are pleased to announce an amendment to the information requirements for the Interim Notification Pilot Program for Low Risk Veterinary Health Products. Previously, full disclosure on all proprietary flavouring mixtures was required as part of the application. To further streamline the notification process, an attestation confirming all ingredients included in the flavouring mixtures are safe for use in cats, dogs and horses that are not intended for food, and are compliant with the general principles on the use of flavourings, will be required in lieu of providing detailed information from third party flavouring providers. This approach is not expected to impact the safety of the product as all ingredients in flavouring mixtures must be included on selected lists of substances previously determined to be safe for such use. Notifiers must also agree to provide detailed information to Health Canada within 15 business days in the event that this information is requested by Health Canada.
How does this affect previously notified products?
If you have already notified a product that contains a proprietary flavouring mixture, you will not need to make any changes at this time. When it is time to renew your product, you will be asked to attest to the safety of the ingredients in your product.
What if you are in the process of notification now?
If you have a product that you are currently notifying, you will not need to disclose the ingredients of the proprietary flavouring mixture identified. You will be asked to identify the proprietary flavouring name and provide attestation to the safety of your product. Please note that you are attesting to the safety of all ingredients in the product, including the proprietary flavouring mixture.
What happens if Health Canada requires information on the flavouring mixtures in the future?
Health Canada may require ingredient identification and other details in response to a safety concern or complaint. The Notifier is responsible for providing information on all ingredients included within the proprietary flavouring blends to Health Canada when requested. It is expected that the Notifier will provide the information within 15 business days of the request.
Please review your active application(s) to identify if this amendment will expedite the notification process.
Helpful answers to over twenty 'Frequently Asked Questions' can be found under the new FAQ tab.
Admissible Substance Application Form - this form helps to guide you, the Notifier, through the process of submitting an application to have a substance approved for use in the Low Risk Veterinary Health Products program.
Reaction Reporting Form - this form makes reporting adverse reactions simple and easy to submit.
This is a reminder that as of September 17th, 2012 all Notified Low Risk Veterinary Health Products (LRHVP) should bear a label stating a Notification Number (NN) and the claims, warnings and contraindications as stated in the notification form.
Changes to Labeling Requirements for Canadian Representative and Adverse Event Reporting
The following changes have been made to the Labeling Requirements and the Adverse Event Reporting structure:
1. The name of the Canadian Representative does not have to appear on the product label.
2. The Adverse Event Reporting structure has now been centralized to a 1-800 number and website, which will be printed on product labels and administrated by NAC. We will pass them on immediately to the manufacturer and the Canadian Representative, if applicable.
Please review the following documents for more information:
1. Interim Notification Labeling Requirements June 15th, 2012 - see page three re: Adverse Event Reporting.
2. Sample Label June 15th, 2012.
Please note that copies of the Adverse Event Form and the Substance Application Form can now be found on lrvhp.naccvp.com, under 'Other Forms'. Both forms can be completed and submitted electronically.
Notifiers can now copy an entire application and then edit it. This will be helpful to those submitting several (similar) products.
Beginning March 19, 2012, products which have met the conditions of the program and issued a Notification Number will be posted on the public pages at http://lrvhp.naccvp.com.
When completing a notification form, note that a substance may still be admissible even if it does not appear on the List of Substances, and will be submitted to Health Canada as they are received. Health Canada evaluates whether the substance can be added immediately or whether further information is required to make a decision. This applies to both active and excipient substances. Therefore, notifiers are encouraged to include a substance on their notification form even if it does not appear on the List of Substances.
Previously, products containing glucosamine required the “Caution with diabetic animals” to be included on the label. More recent studies show that glucosamine does not appear to affect blood glucose levels, and therefore Health Canada no longer requires the inclusion of this statement.
Notifiers are reminded to regularly review the approved List of Substances as this may be updated daily.
Health Canada has revised the Labelling Guidance document (shown on Guidance Document tab) to reflect the change discussed in item 1.
Health Canada will now accept the statement “For Animal Use Only” or “For Animal Use” as well as “For Veterinary Use Only” or “For Veterinary Use”. If the “For Animal Use” or “Animal Use Only” statements are used, the species for which the product is intended must be stated, e.g. “For Cats and Dogs”.