By now, most stakeholders in the Natural Health Products Industry are aware that NHPs must be licenced in order to be sold in Canada. What is less widely known, however, is the requirement that all facilities involved in the manufacturing, packaging, labelling and importing of NHPs must also be licenced. In fact, the deadline for obtaining a site licence is fast approaching; December 31, 2005, to be exact.
What is a Site Licence? Simply stated, a site licence is documented proof that a facility is authorized to conduct certain activities at certain specified locations. In reality, a site licence is much more than that. A site licence is a declaration that a given facility is conducting their activities in accordance with the Good Manufacturing Practices or GMPs.
What are the GMPs? The GMPs are a set of mandated practices and measures intended to ensure that natural health products will meet their product specifications and that any associated risks are being minimized and managed. In order to obtain a site licence, a facility must prove to the government that they are complying with the GMPs and, in the case of importers, that their foreign manufacturers are also meeting the Canadian GMPs or their equivalent.
So who exactly is required to obtain a site licence? All domestic manufacturers, packagers, labelers, and importers of NHPs (including NHPs in bulk form) must possess a valid site licence. Perhaps just as informative, however, is the list of those who are not required to obtain a site licence: Domestic distributors, raw material suppliers, testing laboratories, persons manufacturing NHPs solely for use in clinical trials, and foreign sites do not require site licences. Nevertheless, the entire industry has a stake in the new site licencing regulations. As a retailer, you may ask, “If the regulations don’t apply to me, why should I care?” If you are a retailer, you may not be required to obtain a site licence, but if your vendors further up the supply chain are not compliant it could affect their ability to meet your demands and therefore your ability to meet your customer’s needs.
Of course, the concept of site licencing, while it may be relatively new to the NHP industry, is not entirely new to the health products industry as a whole. In fact, establishment licencing, which is very similar to site licencing, has been a requirement for the pharmaceutical industry in Canada for the past seven years. The new regulations will, however, require that businesses adopt an entirely new way of running their operations; in fact, it will require that they adopt an entirely new mindset. Ensuring that a product meets its specifications does not mean simply running a sample through a few standard tests – The GMPs are far more broad-based than basic lab work. They lay out proscribed standards for the equipment, premises, personnel, processes, procedures, and materials employed in the operations. Implementing a GMP system can take considerable time and resources and, at this late stage, businesses should have some sort of action plan in place in anticipation of the deadline.
So what will happen if, come 12:00a.m, January 1 2006, you do not have your site licence? Well, it is very unlikely that the Inspectorate is going to break down your door and shut down your facility. However, in terms of the letter of the law, you will be carrying out your operations illegally and down the road an inspector may very well show up at your site and take “enforcement action” (that’s a fancy term that refers to product seizures, injunctions, embargoes, prosecution, etc.) Moreover, you may be faced with increasingly nervous clients and distributors.
If you are as yet unfamiliar with the site licencing regulatory requirements, the place to start would be to pay a visit to the Natural Health Products Directorate’s website. Three documents posted on this site that are of particular relevance are The Site Licence Guidance Document, Site Licensing - A Step by Step Guide, and The Good Manufacturing Practices Guidance Document. Like most regulatory documents, they make for very dry reading. However, if you hold any sort of stake in the Natural Health Products Industry, you ought to be aware of the new regulatory requirements and the potential impact they may have on your business.
If you need help obtaining a Site License contact Dicentra Inc. We will certainly do our best to ensure that you are in full compliance prior to the fast approaching deadline. Contact us at 877-647-3279 or email us at [email protected].
Dicentra Inc. is Canada's leading consulting company whose prime directive is to develop the most impact and effective Natural Health Products solutions available today. Dicentra is an organization that designs and evaluates advanced natural health supplements for many of today's top brands. Their product licensing applications to the Natural Health Products Directorate of Health Canada are consistently successful in obtaining the most demanding health claims. By attracting top level consultants, Dicentra has defined itself as a leader in the Natural Health Products industry.