All Veterinary Health Products sold in Canada require a Canadian representative regardless of where the VHP was manufactured ie. domestically or outside Canada. The Canadian representative must ensure the quality of the VHP while it’s sold in Canada. The obligations of the Canadian Representative are as follows::
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 VHP 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, labeling, 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.
Quality Smart Solutions can be your Canadian Representative for your VHPs. Our service is based on an annual basis structure. Contact us today to learn more about this convenient solution for your business.