Regulations governing Natural Health Product (NHPs) came into effect January 1, 2004. There is a transition period, however, all products which currently have a Drug Identification Number (DIN) must comply with the NHP regulations by January 1, 2010. There are a number of requirements which must be met if you are a manufacturer, packager, distributor or tester of natural health products. Non-compliance of these requirements can result in a stop sale being issued by Health Canada.

How do the changes affect you if you are a manufacturer, importer, packager or labeler? Let Keller Consulting assist you with the requirements.

Below is a brief summary of some of the components which make up the new NHP regs:



Product License (Part 1 of the Regulations)

All natural health products must have a product license in order to be sold. There is a 6 year transition period for products which currently have a DIN. A product license will enable Health Canada to assess and manage the benefits and risks associated with the use of NHPs. Each NHP sold in Canada will go through a pre-market review process before it is authorized for sale by the Minister of Health.

The product license holder is responsible in ensuring Good Manufacturing Practices (GMPs) are followed throughout all stages of manufacturing and distribution.

A product licence applicant is required to attest that the product is manufactured, packaged, labelled, distributed and imported in accordance with good manufacturing practices.

Product license applications are intended to support product safety and efficacy.

For products that are imported for sale the applicant is required to submit evidence of compliance.



Site License (Part 2 of the Regulations)

If you are a manufacturer, packager, labeller or importer of natural health products you are required to have a site license. Until a site license is obtained, the Food and Drug Regulations apply for products which currently have a DIN (Drug Identification Number).

GMPs are one of the main prerequisites that must be met before a site licence is issued.



GMPs (Part 3 of the Regulations)

The GMPs apply to manufacturers, packagers, labellers, importers and distributors. NHPs can only be sold once it has been established they have been manufactured, packaged, labelled and stored in accordance with the GMPs. Keller Consulting can help you meet these requirements.

In many cases the Regulations specify the requirements, however, do not outline how these requirements must be met. For this reason, it is advantageous to work with Keller Consulting, who through industry experience and contacts can interpret these requirements and assist you meeting them in a timely and cost effective manner.

GMP requirements come into effect on the earlier of the following: (i) the date a site licence is issued, or (ii) the end of the transition period for site licensing, December 31, 2005. Current GMP requirements in Division 2 of the Food and Drug Regulations continue to apply to NHPs in the interim period.