Whether you need assistance in licensing
.......... or ..........
- HC Natural Health Products
- USA Pre-Market Notification
You will find QMRS services, unique and matchless
Product Licensing
Whether You Need assistance in licensing Natural Health Products, Cosmetics, or USA New Dietary Ingredients Pre-Market Notification, You Will Find QMRS Services Unique and Matchless
HEALTH CANADA REGULATIONS
Health Products and Food Branch(HPFB) is an organization within Health Canada that regulates products; including Pharmaceuticals, Medical Devices, Natural Health Products and Food.
In Canada, Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use.
Prior to being given market authorization, a manufacturer must present scientific evidence of a product’s safety, efficacy, and quality as required by the Regulations.
1. Natural Health Products(NHPS)
In Canada, Natural Health Products (NHPs) are subject to the Food and Drugs Act and Regulations. Products that fall within these Regulations include Herbal Remedies, Homeopathic Medicines, Vitamins, Minerals, Traditional Medicines, Probiotics, Amino Acids, and essential Fatty Acids.
NHPs require a product license before they can be sold in Canada. Obtaining a license will require submitting detailed information on the product to Health Canada (HC), including Medicinal Ingredients Quantity, Potency, and Recommended Use. Once a product has been assessed for Safety and Efficacy and granted Market Authorization, the product label will bear an eight-digit product license number preceded by the distinct letters NPN, or in the case of a homeopathic medicine, by the letters DIN-HM.
2. USA: New Dietary Ingredients (NDI) Notification
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market Dietary Supplement (DS) that contain “new dietary ingredients” notify the FDA about these ingredients.
In brief;
The objective is to provide adequate assurance that the product offered for sale is safe and effective. Therefore, it is the responsibility of the applicant (producer) to provide a complete product license application, with evidence demonstrating that safety (risk) has been established and sufficiently mitigated; and the efficacy (benefit) has been demonstrated.
QMRS CONSULTING SERVICES
As QMRS led by a Ph. D. holder in life sciences (London), we do write a well referenced scientific summary reports on the product safety and efficacy. During the last fifteen years, QMRS helped many clients throughout the world to license their products with Health Canada. In fact, our success rate could be the highest among other companies. Certainly, You Will Find QMRS Services Unique and Matchless.
If you have any questions, please, contact us by phone at 613 695 1967 or by email at: jalal@qmrs.com
