NATURAL HEALTH PRODUCTS
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.
The Natural Health Product 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 the new regulations, all NHPs will be required, under a premarket review, to obtain a product licence and a corresponding Natural Product Number (NPN) or, in the case of homeopathic medicines, a DIN-HM.
The Natural Health Product Regulations require the following elements:
- Product Licences
- Packaging and Labelling Procedures
- Site Licences
- 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 services that include:
- Professional management and coordination of all aspects of the submission process
- Effective needs assessment
- Preparation or pre-screening of regulatory submissions
- Ongoing Quality Assurance support
- Effective design and management of testing programs as required