This is a topic of high interest to me, as it speaks to the free market access of health products in Canada. On Friday, Health Canada put out a consultation paper outlining their wish list of proposed regulatory changes in Canada. From what I can tell, no one likes this proposal. The proposal came out of left field. I am told that Health Canada had high level briefings with trade associations (including CHFA and CHPC), but this was not what I would call a “consultation”. In a nutshell, the proposal is seeking to combine the regulatory scheme for cosmetics, natural health products and OTC … [Read more...] about Proposed New Changes for NHP’s: Bad Idea?
With summer now fully underway, consumers’ attention has returned to sun protection and choosing from the many sunscreens available on the market today. There has been focus recently in social media on sunscreen ingredients, so if developing a new sunscreen is in your plans, what should you know? Let’s start with a simple multiple choice question: Sunscreens are: Over-the-counter (OTC) drugs Natural health products Cosmetics All of the above Did I say simple? That may not be completely accurate! The answer is actually (d) All of the above. Depending on where you market your … [Read more...] about Sunscreens: EU, Canada, USA
Foods supplemented with ingredients typically found in dietary supplements require special authorization in Canada. These can include vitamins, minerals, or amino acids in amounts outside of current fortification guidelines, or with novel herbal or bioactive ingredients (plant, fungal, algal, non-human animal material, fatty acids, non-nutrient ingredients). To date, only added supplemented nutrients (vitamins, minerals, and amino acids) as well as caffeine and related energy ingredients (taurine, glucoronolactone) have been allowed via the submission of Temporary Marketing Authorization … [Read more...] about “Supplemented Food” – A New Regulatory Approach in Canada
Good manufacturing practices, GMP for short, are measures and procedures designed to ensure consistent product quality and safety for all facilities manufacturing, processing, packaging, labeling and distributing products. In Canada, GMPs must be followed for all category of products: Drugs, Foods, Natural Health Products, Medical Devices, Cosmetics, Veterinary Products, Radiopharmaceuticals and Biological products. GMPs are similar across product categories, in that they address the following quality standards concerning: Premises, Equipment, Personnel, Sanitation, Raw Material Testing, … [Read more...] about Understanding GMP
On December 1, 2015 Health Canada’s Natural and Non-Prescription Health Products Directorate published a Notice to Stakeholders that formalized the long-anticipated updates to the Site Licensing (SL) process. The changes include a new QAR form, revised GMP and SL guidance documents, and new service standards, all of which have been implemented as of April 1, 2016. We’ve often heard clients comment that they think they may need a site license but aren’t sure what that really means. This article is designed to help clarify this area of the Regulations. First, let’s start by outlining the … [Read more...] about Do I Need a Site License?
We’re often asked whether or not to submit an application for a research licence or a licence to produce medical cannabis under the Marihuana for Medical Purposes Regulations (MMPR). Many people are under the impression that a research licence is faster to obtain, and that it is legal to sell cannabis to registered clients using this licence. Both assumptions are incorrect. NHP Consulting has experience submitting both types of licences, and the differences are night and day. For both types of applications the wait times are over a year, around the same timeframe for either. Also, any … [Read more...] about Licence to Research Cannabis in Canada