The Cannabis Act and Regulations contain numerous regulations and restrictions concerning cannabis products such as requirements for concentration, ingredients, and product testing.
The Cannabis Act and Regulations also outline the specific classes of cannabis that are legal in Canada (dried cannabis, cannabis extracts, cannabis topicals, edible cannabis, fresh cannabis, cannabis plants, and cannabis plant seeds).
NaturalSci can help you with these requirements by providing strategic guidance and consulting on the regulatory requirements for all classes of cannabis products. We provide consulting on all aspects of the Cannabis Act and Regulations related to cannabis products such as security, Good Production Practices (GPP), labelling, marketing, reporting, and access to medical cannabis.
NaturalSci can provide assistance with product formulation, product development, and conducting research with cannabis through our network of partners in the cannabis industry. We will also provide guidance to ensure your products meet all the regulatory requirements.
Our partners are licenced by Health Canada to conduct Research and Analytical Testing with cannabis and can help you formulate and develop your cannabis products at their licenced facilities.
The Cannabis Act and Regulations contain extensive labelling and packaging requirements for cannabis products including (but not limited to) warning messages, formatting requirements, design requirements, and promotional restrictions.
NaturalSci can help you navigate these requirements through compliance reviews of labelling and packaging for all classes of cannabis products. Our compliance reviews ensure that all regulatory requirements are met.
Almost every federal cannabis licence (i.e. cultivation, processing, etc.) requires the licence holder to have a Health Canada approved site/facility where the activities with cannabis will take place.
Similarly, in order to open a cannabis retail store in Ontario the owner of the store and store itself need to be licenced and approved by the AGCO.
NaturalSci can provide assistance with the acquisition and amending of all Federal Canadian cannabis licences and Ontario cannabis retail licences. We prepare all documentation needed for the submission of licence applications and we audit the site to ensure it is compliant with the regulations. We also provide access to our network of partners for all other site licencing needs such as design, construction, and security.
Cannabis Health Products (CHPs) are a class of cannabis products with potential therapeutic uses for minor ailments that Health Canada will be legalizing in the future.
Unlike other classes of cannabis, CHPs would be able to contain various medicinal and non-medicinal ingredients in addition to cannabis.
NaturalSci can provide assistance with the formulation of CHPs through access to our product development partners in the cannabis industry. We also provide strategic guidance on the evolving regulatory requirements for Cannabis Health Products.
NaturalSci can provide assistance with obtaining cannabis project funding through our extensive network of partners in the cannabis industry.
NaturalSci can also provide business and strategic advice to help you identify the best way to get your cannabis products onto the market.
Cosmetic Product Licensing
Health Canada must be notified of any cosmetic product sold in Canada. Cosmetic notification forms for your product must be sent to Health Canada at least 10-days prior to the date of first sale in Canada.
All cosmetic formulations must comply with Health Canada's Cosmetic Ingredient Hotlist. The Hotlist outlines ingredients that are both prohibited and restricted for use in Canadian cosmetic products.
International Trade Certificates
An international trade certificate (ITC) is a notarized document that provides information to foreign countries about the regulatory status of your natural health product and the regulatory status of the Canadian manufacturing, packaging, and/or labeling sites associated with it.
You are not required by the NHPR to have an ITC, but it helps speed up the process of bringing your product to a foreign market. Examples of foreign markets include Lebanon, Honduras, Iran, Indonesia, El Salvador.
There are 3 types of ITCs, the one you need depends on the product type:
- NHP site license only
- NHP with product license (NPN) and site license
- NHP with product license (DIN-HM) and site license (for homeopathic medicines)
ITCs are only provided through independent third parties. Health Canada does not provide ITCs. Companies/organizations who are “third-party issuance authorized” means they have met a list of criteria set out by Health Canada allowing them to issue ITCs.
The required information for NHP labels is based on ingredients and must indicate:
- Brand name
- Lot # and expiry
- Manufacturer contact
- Natural Product Number (NPN)
- Ingredient identity and amounts
- Medicinal use/purposes
- Direction and duration of use
- Risk information including: cautions, warnings, known adverse effects, and contraindications
- Non-medicinal ingredients
The required information for each category is based on the NNHPD Compendium of Monographs. Each monograph contains the proper statements which must appear on the label for the corresponding ingredient.
- Storage conditions
Yes, all NHPs sold in Canada must display all information in both English and French
Natural Health Product Licensing
All NHPs sold in Canada must adhere to the Canadian Natural Health Product Regulations (NHPR) - a subsection of the food and drugs act.
All NHP must be first approved for sale in Canada by the Natural and Non-prescription Drug Health Product Directorate (NNHPD).
When a product has been successfully reviewed and approved by the NNHPD it receives an 8-digit Natural Product Number (NPN). All NHPs must have an NPN to be sold in Canada including online sales for Canadian websites and companies (i.e. amazon.ca).
NPN approval timelines by the NNHPD are based upon a 3-tier risk classification system:
- Class I - 60-day review period (approx.)
- Class II - 90-day review period (approx.)
- Class III - 210-day review period (approx.)
Classification is based upon the NNHPID compendium of monographs. NPN submissions can attest to one or more ingredient monographs as a part of the application process. Classification of products based on formulations are as follows:
- Class I - Product attests to a single ingredient monograph
- Class II - Product attests to multiple ingredient monographs
- Class III - One or more ingredients cannot attest a Health Canada monograph. Supplemental safety and efficacy data required.
- You require a Drug Identification Number (DIN) which is an 8-digit designation.
- An Establishment License for the facility the product is being manufactured in.
- A Canadian compliant bilingual label, with Canadian Drugs Facts Table.
Depending on the type of application the Health Canada fee varies (Few examples):
- New Pharmaceutical DIN with Clinical or non-clinical data and chemistry and manufacturing data – $224,242.00.
- DIN submissions based on comparative studies - $55,737.00.
- Full Disinfectants Review - $7,126.00
- Category IV / Labelling Standards DIN application - $1,613.00
Timeline varies depending on the type of DIN application. Full list of Health Canada’s DIN performance standards can be found here.
- If your facility fabricates, packages, labels, distributes, imports, wholesales, or tests a drug you must apply to receive a Drug Establishment Licence (DEL).
- Hard Surface disinfectants do not need an Establishment licence.
The Health Canada fee depends on the activity and can range from as low as $2,560.00 CAD (Testing facility) to $41,626.00 CAD (Fabrications) and is subject to change every fiscal year.
A Site Licence is a 6-digit number that is given by Health Canada to a facility that demonstrates Good Manufacturing Practices according to the fabrication, packaging, labelling or importing of Natural Health products. A Site Licensed facility must uphold quality operations via the evaluation of its Places, People, Products and Processes.
Facilities that fabricate, package, label, or import a natural health product in Canada requires a Site Licence. To legally sell a Natural Health product in Canada, a Site Licenced facility must be associated with the product.
Health Canada’s performance standards depends on the type of GMP evidence provided and the number of sites. With precleared evidence the review is estimated 35 business days, while using other GMP evidence increases the time to 65 business days for up to 9 sites, and with greater than 9 sites would take 90 business days.
There is no Health Canada fee associated with a Site Licence application.
Yes, a site licence renewal is required. Once every year for years 1-3. Once every two years for years 4-8. Once every 3 years for 9 years+.
Yes, sports supplements containing ingredients such as protein isolates, amino acids, vitamins/minerals, or ergogenic aids (ex. caffeine) require an NPN to be sold in Canada.
Yes, Health Canada's Workout Supplements Monograph (August 5th, 2019) incorporates many of the compounds listed above. This allows for a single monograph attestation, keeping review & approval timelines by Health Canada to a minimum.
Veterinary Health Products
Yes, you need to register your product in Canada to receive a VHP notification number, which is a 4-digit alpha-numeric code.
Veterinary Health products need to be notified:
- At least 30 days before selling a VHP for the first time in Canada
- At least 30 days before making a change to a VHP that is already notified in Canada
- Before importing a VHP into Canada
Health Canada has a performance standard of 30 calendar days starting on filing date.
There is a $486 CAD fee associated with product notifications or major changes to products that have been previously notified to be paid directly to Health Canada.
The product can be notified if all ingredients are listed on the permitted substances database for their given purpose (active or excipient). If an ingredient is not found on the database or indicated for the intended dosage form or for specie; then the ingredient must be added or modified on the Permitted Substances Database before proceeding with the Notification.
You do not need a Site Licence or a Certified GMP Facility, however you are required to follow GMP at the site and ensure that the product meets quality requirements and is not adulterated or misleading.
Formulation & Research
We work with clients at every stage of formulating to ensure all ingredients and amounts in their formulations will be compliant with Health Canada regulations.
Our Formulation Review consultation serves as a valuable first step to advise clients of any recommended revisions or compliance issues with any given formulation.
Health Canada requires detailed information to be provided about each ingredient in a submitted product. The required information includes:
- Ingredient identity (Species & Genus for plant material)
- Ingredient quantity
- Dosage format (capsule, tablet, powder etc.)
- Source material
- Extract ratio and solvent (Dried Herb Equivalent for botanicals)
- Standardization of constituent ingredients
- Serving size and dosing recommendations
In certain circumstances, ingredients in a formulation fall outside of the published Health Canada monographs or have no monograph at all. NPN submissions with these ingredients must include additional safety evidence to be submitted. This is typically in the form of published clinical trials outlining safe use of the ingredient in question.
NaturalSci Regulatory offers safety & efficacy profiling services to ensure your ingredient has the proper supplemental data to be approved by Health Canada.