After many years in the works, Canada’s regulations for Natural Health Products (NHP) were finally published in final form on Wednesday, June 18th. Products captured by the regulations include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines, probiotics, amino acids and essential fatty acids.
When Do The Regulations Come Into Effect?
Despite the fact that the regulations have been published, they will not actually be in effect until January 1st, 2004. In other words, it will not be possible to obtain a product licence for NHPs until early 2004.
For products already licensed as drugs (holding a Drug Identification Number ? DIN) the transition period will be six years from the time the regulations come into effect. The transition period will be four years for products that do not hold DINs. Requirements for Adverse Event Reporting come into effect as products obtain their NHP licences.
The transition period for good manufacturing practices (GMPs) and site licensing will be 2 years.
What Happens during the Transition Period?
Products currently holding drug licenses will continue to be regulated under the Food and Drug Regulations until they obtain NHP product licences.
Most products that fall within the NHP definition and do not hold drug licences are currently allowed to stay on the market as ?Products Subject to Special Measures?, even though they do not comply with the Food and Drug Regulations. It is expected that the Natural Health Products Directorate will introduce a new policy to allow these products to stay on the market throughout the transition period.
What are the Product Licensing provisions?
Essentially, the regulations state that an application for a product licence must include specific information about the NHP, for example, the quantity of the medicinal ingredients it contains, the specification it complies with, the recommended use or purpose for which the NHP is intended to be sold, and the supporting safety and efficacy data. Once a licence is granted, a natural product number (NPN) will be issued.
There is a ?default licensing? provision whereby products containing a single active ingredient for which Health Canada has created a monograph will be automatically granted a licence within 60 days.This provision does not come into effect until July 1st, 2004.The NHPD is working on a combination product policy that may allow products with multiple active ingredients to use this default licensing provision.
Products already licensed as drugs (with DINs) will be licensed through an abbreviated application process.
What are the Site Licensing Provisions?
A site licence is required for importers, manufacturers, packagers and labellers of NHPs. Distributors will not be required to hold a site licence, since their activities are usually limited to the handling of a finished, packaged product and do not involve manufacturing, packaging or labeling.
Adherence to GMPs is the main prerequisite that must be met before a site licence is issued. Site licence applicants must submit a report from a qualified quality assurance person – this individual can be an internal employee or a third-party auditor.
Those companies that already have an Establishment Licence (under the Canadian Food and Drug Regulations) will be able to apply through an abbreviated application form for an NHP site licence.
Foreign sites will not receive site licenses, due to jurisdictional issues, but they will be required to meet the same site licensing requirements in order to obtain a foreign site authority number.
New Opportunities for Industry?
Now that it will be possible to make health claims on all natural health products, something that has not been legal for those NHPs that did not hold DINs, some in the NHP industry are excited about new marketing opportunities.There will still be significant limitations on claims for certain disease states (eg. heart disease, arthritis, depression, etc.), however a working group recently established by Health Canada will make recommendations intended to address this regulatory impediment.
The new regulations are expected to hold industry to more uniform standards for the manufacturing and formulation of natural health products and it is hoped that this will have a positive impact on consumer confidence.
There are aspects about the implementation which remain unclear. One unknown is how long it will take for the NHPD to evaluate product licence applications and grant licences for new products and for products already on the market that do not hold DINs. Some in the Canadian NHP industry fear that Health Canada will not assign sufficient resources to product evaluation and licensing and that backlogs will result, particularly for new ingredients and for products with more than one active ingredient.This may hamper the ability of manufacturers to introduce innovative products.
While many in the Canadian NHP industry are cautiously optimistic about the new regulations, there will most likely be bumps along the road to implementation.
Kory McDonald is Executive Director of the Natural Health Products Manufacturers of Canada. She is based in Ottawa and has been working as an association manager and regulatory consultant to the NHP, food and beverage industries since 1997. Contact: firstname.lastname@example.org
This article was published in the June 27, 2003 issue of NPICenter.com e-newsletter, and is used with the permission of both the Kory McDonald and NPI Center.