FDA 510(k) Pre-Submission: Steps for Medical Device Approval
Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new to the regulatory landscape, find
... Read moreLeverage our expertise for Veterinary Health Registration, VHP Package Compliance, French Translation, and obtaining a Notification Number.
🌟 Your journey begins with ensuring your products meet the stringent Veterinary Health Product (VHP) regulations in Canada.
📋 Navigate Regulatory Labyrinths with Ease: The VHP landscape can be complex and ever-changing. Our experts are well-versed in the latest regulations, saving you time and stress.
🧪 Ensure Safety and Efficacy: Canadian pet owners demand the best for their furry friends. Compliance guarantees that your products are safe, effective, and trustworthy.
Canadian Market Access: With our guidance, you’ll seamlessly access a booming Canadian pet market, opening doors to new customers and growth opportunities.
📦 Get Your Products to Shelves Faster: Compliance delays can be costly. We streamline the process, so your products can start enriching pets’ lives sooner.
🐶 Gain Trust and Credibility: Compliance reassures customers that your products are backed by science and adhere to the highest quality standards.
Don’t let regulatory hurdles hold you back! Invest in Veterinary Health Product compliance assistance today and watch your pet products thrive in Canada. Tail wagging and purring customers await! 🐕🐈
At Quality Smart Solutions, we are committed to offering quality support for those who manufacture, import, distribute, or sell Veterinary Health Products in Canada so that a profitable business can be established. Contact us for the following Veterinary Health Products regulatory compliance solutions in Canada.
With extensive experience in Veterinary Health Products registration, our VHP compliance officers will help register your VHPs by preparing VHP applications, ensuring your VHP label meets language requirements and VHP regulations.
We take care of everything, such as helping you obtain a Veterinary Health Product Notification Number, ensuring all required information is available on the principal display panel, providing labeling in English and French language.
We have the ability to serve as your Canadian Representative for your Veterinary Health Product needs. Our service is designed based on an annual basis structure. Contact us to learn more about this convenient solution.
There are certain rules set by Health Canada to sell Veterinary Health Products in the Canadian marketplace. Anyone planning to manufacture, distribute, import, or sell Veterinary Health Products in Canada must abide by the labeling rules of the Food and Drug Regulations. They must notify Health Canada at least 30 days before selling or importing VHPs in the country, or making any changes to their products. It is recommended that the Veterinary Health Product application be submitted 3 to 6 months prior to sale. When a VHP is registered, a Notification Number (NN) is issued. Health Canada can stop the sale of a Veterinary Health Product if the product is found to be unsafe or misleading.
All ingredients contained in a Veterinary Health Product must be found in the Permitted Substances List (PSL). If ingredients are not found in the PSL, you need to prepare a New Substance Application.
Any company that manufactures, packages, imports, distributes, or stores VHPs must follow Good Manufacturing Practices (GMPs).
Companies must report serious drug reactions to Health Canada as well as submit extensive evidence to support the safety of any new ingredients to be used in animals.
Every Veterinary Health Product application undergoes an initial administrative stage and then an information verification stage for review.
Veterinary Health Products are low-risk health products in oral dosage form for animal consumption. They are used to maintain and promote the health and wellness of certain animals. However, these products are not recommended for treating, preventing, or curing diseases. VHPs contain ingredients such as minerals, vitamins, and traditional medicines.
The Veterinary Services industry in Canada has performed strongly over the last few years. The market is projected to grow due to animal diseases, people’s love for animal adoption, and their awareness about companion animals and livestock. More than 40% of homes in Canada have at least one dog and 38% have at least one cat, according to the Canadian Animal Health Institute (CAHI)’s 2018 report.
In Canada, pet food labeling is governed by the Consumer Packaging and Labeling Act under Industry Canada’s administration. Additionally, the Competition Bureau oversees a voluntary code of conduct for pet food labeling and advertising, ensuring that product labels include feeding instructions and prevent misleading business claims or endorsements.
AAFCO has developed two nutrient profiles for dogs, one for growth and reproduction and another for adult maintenance, with the latter having lower nutrient levels to avoid excessive amounts. However, it’s the Center for Veterinary Medicine (CVM) within the FDA that regulates dog food production. The CVM evaluates health claims on labels related to specific nutrient profiles, such as those for managing chronic renal disease. Additionally, the USDA ensures that pet food is labeled distinctly from human food and conducts inspections to ensure proper ingredient handling.
When assessing pet food, ingredient lists are helpful but have limitations. Ingredients are listed by weight, which can be manipulated by manufacturers to appear more appealing.
Another crucial aspect on a pet food label is the nutritional adequacy/life-stage statement. AAFCO permits companies to create foods meeting canine nutrient profiles through formulation, a less expensive method than feeding trials. However, formulation doesn’t prove nutrient availability or palatability. Alternatively, companies can conduct AAFCO protocol feeding trials, which are more comprehensive but costlier, offering insights into palatability and nutrient bioavailability.
We have licensed a wide range of Veterinary Health Products, including but not limited to below
Proven Expertise. Companies who have Trusted Us to Become Compliant with Health Canada Regulations.
I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.
Health Canada’s Notification Program for Veterinary Health Products (VHPs) provides a process to help companies meet the rules for importing and selling VHPs in Canada. VHPs must be notified to Health Canada:
Yes. Labelling rules for drugs (including VHPs) are outlined in the Food and Drugs Act and Regulations. The label text must be identical to the information provided in the authorized VHP Notification Form. Furthermore, VHP labels must:
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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.