Natural Health Products (NHPs) have gained significant popularity among consumers in Canada. However, manufacturers and distributors must comply with the Regulatory requirements set forth by Health Canada (HC) before launching and selling NHPs in the Canadian market. In this blog, we shall explore the process of launching and registering NHPs in Canada, outlining the essential steps involved.
Determining the NHP Status of a Product
The key initial step for launching an NHP is to determine whether the product qualifies as an NHP, according to HC’s definition of the term. NHPs are described as substances or combinations of substances used to maintain/promote health, prevent/treat diseases, and provide medicinal benefits. Examples of NHPs include vitamins, minerals, herbal remedies, and homeopathic medicines.
Registering the NHP with the NNHPD
Once it is determined that the product is indeed an NHP, the next step is to register it with the Natural and Non-prescription Health Products Directorate (NNHPD). The NNHPD is the Regulatory authority responsible for overseeing NHPs in Canada. The registration process involves submitting a complete and accurate application, which includes details about the ingredients and manufacturing processes, safety and efficacy data, and labeling and advertising materials.
Labeling and Advertising Requirements
HC imposes specific requirements for labeling and advertising NHPs. It is important to ensure that all labels and advertisements on the products are truthful, accurate, and not misleading in any way for consumers. The labeling should include essential information such as product name, medicinal ingredients, recommended use, and any cautionary statements. Adhering to these requirements is vital for maintaining transparency and providing accurate information to consumers.
In addition to the registration process, NHPs in Canada require a product license to be legally sold in the market. The product license outlines the specific conditions under which the product can be marketed, including indications, recommended dosage, and the route of administration. It is important to note that the product license is valid for five (05) years and must be renewed periodically to continue selling the NHP.
Working with Regulatory Consultants
Navigating the registration and licensing process for NHPs can be complex and time-consuming. To ensure compliance with the Regulatory requirements and streamline the launch process, working with experienced Regulatory consultants is highly recommended. Regulatory professionals, with their in-depth knowledge of the regulations and standards, can help manufacturers and distributors navigate the intricate steps involved in bringing an NHP to the market.
After successfully launching an NHP, you must fulfill the post-launch responsibilities. This includes monitoring product safety and efficacy, complying with any reporting requirements, and promptly addressing any safety concerns or adverse events that may arise. HC may conduct Post-marketing Surveillance (PMS) to ensure the ongoing safety and quality of NHPs in the Canadian market.
Launching and registering NHPs in Canada requires careful adherence to the Regulatory requirements of the HC. From determining the NHP status of the product to registering it with the NNHPD and obtaining the necessary product license, each step plays a crucial role in ensuring compliance and consumer safety.
Work with Regulatory consultants like Freyr to stay abreast of the latest regulations, bring your NHPs to the Canadian market, and offer your consumers safe and effective NHPs. Contact Freyr to find end-to-end Regulatory support for launching your NHPs in Canada. Stay informed! Stay compliant!