Current NHPD Regulations
Natural Health Product Regulations
New “Natural Health Product Regulations” created by Health Canada as of January 1, 2004 apply to all natural health products (NHPs) in regards to the production, packaging/labeling, distribution, storage and sale of NHPs.
Rationale
The Natural Health Product Directorate (NHPD) of Canada has developed their approach to implementation and compliance of the regulations while being aware of consumer’s desire to have access to NHPs, balanced with The Directorate’s insistence that the NHPs are safe and effective.
The NHPD assists Health Canada in ensuring that quality natural products are sold to the public and that quick and effective product recalls can be undertaken when necessary.
To this end the Regulations include circumstances for refusing, suspending or canceling a NHP licence.
A Closer Look at the Regulations
Natural Health Product Regulations include provisions on: definitions, product licensing, site licensing, good manufacturing practices, clinical trials, labeling and packaging requirements and adverse reaction reporting.
• The NHP must be granted a Product License by the NHP Directorate; The efficacy and safety of a NHP must be supported by the Standards of Evidence established by the NHPD and be submitted for government approval before a Product Licence will be granted; The manufacturer is responsible for recording and reporting adverse reactions to the NHP.
• Each site that manufactures, stores, packages, labels or otherwise distributes a NHP must be in compliance with the NHPD’s Good Manufacturing Practices and must be granted a Site Licence by the NHPD ;
The Regulations having come into force January 1, 2004 is followed by a transitional period that will span from two (2) to six (6) years – 2 years for site licensing and 6 years for products with Drug Identification Numbers
(DINs).
