FAQs
You’re what Canada’s looking for
485 Richmond Rd, Suite 603, Ottawa, ON, K2A 3W9
Copyright © 2024 PMK Federal Regulatory Consultants Inc.
NPN Consulting, NPN Licensing, and Natural Health Product Licensing with Health Canada
General Info:
Why is the Health & Wellness industry so lucrative?
The Health and Wellness Industry is growing steadily in Canada, and was estimated to be a $3.7 billion industry (CAD) in 2007. Canadians are not only large consumers of natural health products (roughly three-quarters of Canadians use them), they are also willing to pay premium prices for quality products. A focus on health and wellness by Canadian consumers has been reported as a key economic trend in Canada as more consumers look for ways to improve their well-being through nutrition and natural health products. Canada possesses a higher per-capita number of baby-boomers than the United States, and demographic research suggests that by 2020, the number of Canadians over the age of 65 will reach one in six. A healthy lifestyle and maintained vitality are essential to this group of consumers. In addition, a well-developed and welcoming business environment paired with a growing economy and relatively low corporate tax rates make Canada a prime location for successful Health and Wellness businesses, both now and in the future.
Why do I need a consulting service?
Entering a new market, developing a new product, or expanding an existing company can be a daunting task when dealing with complex regulatory systems and many competing players. Knowledge and expertise is a high value resource when crafting your company’s strategy and direction. For Instance, PMK Inc. understands Health Canada’s Natural Product Directorate, its expectations and demands, and can often reduce the need for extra communication and application changes, therefore, we can reduce the time and costs associated with NPN acquisitions.
Why are Natural Health Products (NPN) regulated?
Do you assist with new drug products (DINs) approvals?
Yes. Submitting a new drug product application (DIN) to Health Canada can be a complicated, detailed process. We can guide you.
What is the Import Corridor?
The Import Corridor is a feature unique to PMK Inc. Through this corridor, our clients can greatly reduce the time and costs of importing into the Canadian market. If you are an international manufacturer and you are interested in more information, feel free to contact us for further details.
What does DIN mean?
Health Canada issues Drug Identification Number (DIN) in order for any drug to be sold in Canada. Along with the requirement for all Schedule C drugs to have a DIN, the labelling requirements have also been updated to reflect this requirement. Instead of requiring the Establishment Licence Number to be on the label, there is now a requirement for the DIN to be on the label.
What does NPN mean?
The NPN is an eight-digit number that indicates the natural health product has been approved by Health Canada and is safe, works, and is of the high-quality. All products with a Natural Product Number are licensed for retail in Canada. The red circled area of the label is the Natural Product Number.
About PMK Federal Regulatory Consultants Inc.:
Why should I chose PMK?
We are located in Canada’s Capital Region and possess years of government experience, and are well-versed in government policies, processes and language. While the final decision always rests with Health Canada, we have successfully obtained over 1,000 licence applications. We are capable of making even the most complex licenses work. We believe strongly that while regulations exist, they should not be a burden to companies trying to provide consumers with options for their continued well-being. We also take pride in providing an excellent customer service model. Our executive team is directly involved with each and every file and is always available to you.
Are you a distributor?
While PMK Inc. is not a distributor, we are happy to help connect our clients with our distributing partners. We are constantly building our network of industry players in order to better serve you. Wide networks combined with strong, honest relationships are key to moving your product from the manufacturing floor to retail shelves.
What are the costs of your services?
Our costs vary depending on the service used and on whether we are providing a single service or a service package. NPN costs depend on the number and complexity of products requiring registration. We also offer our clients the option to lease a license, which can be more cost efficient than the standard registration fee(s), and ensures a client’s license portfolio is well maintained. We believe strongly that every contract should be beneficial and profit-generating for our clients’ long-term interests.
Do you work with start-ups?
Absolutely! We believe strongly in the right of consumers to have the widest choice possible when making decisions regarding their own well-being. New ideas and innovation are exciting possibilities for our industry. We will happily work with your start up to develop, produce and bring your new product to the market.
What are your ethics?
PMK Inc. firmly adheres to the principles of trust, integrity, honesty and fairness. We strive to provide you with not only a great service, but a fair and honest one as well. We know that a good reputation is intrinsically important, and we want ours to grow.
Interested In Our Services?