The development of Natural Health Product (NHP) Regulations in Canada is having a significant impact in the way that manufacturers and distributors of Traditional Herbal Medicines and Homeopathic Medicines have been doing business.
These regulations provide a separate regulatory category for NHPs, and encompass herbal remedies, traditional and homeopathic medicines, vitamins, minerals, amino acids, essential fatty acids, and probiotics. Under these regulations, all NHPs will be required, under a pre-market review, to obtain a product license and a corresponding Natural Product Number (NPN) (in the case of homeopathic medicines, a DIN-HM would be required).
The Natural Health Product Regulations require the following elements:
- Product Licenses
- Packaging and Labeling Procedures
- Site Licenses
- Standards to support efficacy and safety
- Good Manufacturing Practices
- A Quality Assurance Unit
- Adverse Reaction Reporting
Nucro-Technics employs professional scientists with the expertise and experience necessary to facilitate the process of Product registration. We provide a turnkey service that includes:
- Professional management and coordination of all aspects of the submission process
- Effective needs assessment
- Preparation or pre-screening of regulatory submissions
- GMP-Compliant Analytical Chemistry & Microbiology Product Testing as required
- Ongoing Quality Assurance support
- Effective design and management of testing programs as required