Natural Health Products/Dietary Supplements    

If your company manufactures, distributes, imports or sells Natural Health Products (NHPs) in Canada, you must comply with the "Natural Health Product Regulations". These Regulations came into force on January 1, 2004 and are administered by the Natural Health Product Directorate of Health Canada.

A Closer Look at the Regulations

Under the regulations, a NHP includes: vitamins, minerals, lipids and amino acids, non-human animal material, and homeopathic preparations. Cosmetic preparations containing one or more of these natural health substances also fall under the regulations. The following are required before production/distribution/sale of a NHP:

• Standards of Evidence to support the efficacy, safety and quality of the product must be submitted for governmental approval before a Product License will be granted;
• The product must be granted a Product License by the NHP Directorate;
• Each site of manufacture/storage/packaging and/or labeling/and distribution must be granted a Site License by the NHP Directorate;
• The production, packaging/labeling, distribution and storage of NHPs must be in compliance with the NHP Directorate's Good Manufacturing Practices; and
• The manufacturer is responsible for recording and reporting adverse reactions to the product.

These Regulations provide Health Canada with widespread authority with regards to the issuance, suspension or cancellation of licenses for NHPs and sites, as well as the ability to issue to a stop sale directive under the appropriate circumstances.

GLOBALTOX can assist with meeting these requirements through the following services:

• Efficacy assessment of a NHP;
• Safety assessment of a NHP;
• Quality summary development together with assistance on determining the appropriate testing and product specifications;
• Assistance with product label compliance;
• Compilation of a product license application;
• SOP (Standard Operating Procedure) development for all aspects of the manufacturing/packaging/labeling, distribution etc. of the supply chain of the NHP;
• Assistance in meeting all Good Manufacturing Practice (GMP) requirements;
• Compilation of a site license application; and,
• Liaison with regulatory agencies including assistance in preparing responses to Processing Deficiency Notices (PDNs) and Information Request Notices (IRNs)./li>