Site Licensing/Registration (Manufacturer/Importer/Distributor)
Depending on your planned activities in the Canadian market, the building you operate from (your “facility”) may need to obtain a government license or follow specific procedures. The 3 main licenses you may need to obtain in Canada are a Medical Device Establishment License (MDEL), a Drug Establishment License (DEL) or a Natural Health Product (NHP) Site Licence (SL). Additional licenses may also be required for facilities handling narcotics or precursors (Precursor A/B Licenses)). Food-related facilities require licenses from the Canadian Food Inspection Agency (CFIA) and cosmetic manufacturers must follow Good Manufacturing Practices (GMPs).
Each license allows different activities with different products. Our experienced team members will work with you to evaluate your business plan, including the products you will handle, and provide you with an assessment of the license(s) you require. We will then work with you to prepare and submit an application demonstrating compliance with Health Canada’s or the CFIA’s requirements, to ensure quick and cost-effective access for your products to the Canadian market.
Medical Device Establishment License
Most importers and distributors of medical devices in Canada need to obtain a unique business licence (a Medical Device Establishment License, MDEL) prior to importing or distributing medical device products in the Canadian market. Companies who manufacture their own Class 2-4 medical devices and hold a Medical Device License (MDL) for each of their products are exempt from the requirement for a MDEL, but MDEL licensing is required for companies selling their own Class I devices and also for businesses operating from outside of Canada who will sell medical devices in the country. For medical devices, the financial process of buying and selling is what Health Canada considers when evaluating what licenses are required, and our team will work with you to evaluate the type of application(s) you require.
Part of the MDEL licensing process for manufacturers includes a quality system assessment, and Health Canada requires medical device manufacturers to submit a quality system certificate issued by a recognized third-party auditing organization. Importers and distributors of medical devices are not required to have a registered quality system. NHP Consulting will work with you to refine your processes in light of Health Canada’s requirements, ensuring your company is set up to manage medical device products and their associated quality systems. Our quality system implementation and support services can help you design and implement the quality systems you need to obtain and maintain your MDEL though
Our experienced team members will review your business plan, provide customized feedback, and compile, submit, then support your application(s) to Health Canada, advocating and negotiating for you when necessary.
Drug Establishment License (DEL)
A Drug Establishment License (DEL) is required in Canada to manufacture, package, label, distribute, import, wholesale, or test a drug, and our experience consultants can evaluate your business plan and products to determine whether a DEL is required for your business.
Obtaining a DEL, then operating your licensed establishment requires the drafting and implementation of Good Manufacturing Practices (GMP), which ensure that drugs are produced to consistently high quality standards. Even if your specific business does not require a DEL, many auxiliary pharmaceutical enterprises are still required to follow GMP. Our team can create and customize GMP-compliant procedures required for doing business in Canada with pharmaceutical products, and ensure your facility, equipment, utilities, and technical reports are sufficient based on your product and activity.
If a DEL is required for your business, NHP Consulting can prepare and submit the DEL application to Health Canada on your behalf. Prior to issuing your DEL, Health Canada will complete an on-site audit of your facility. Our team members can help you prepare for the audit by conducting a mock audit for you to identify potential aspects of non-compliance and offer staff training to correct deficiencies. We can also be present during your Health Canada audit and act as your primary advocate for Health Canada throughout the application process. See our On-Site Facility Inspection section for further details.
In addition to a DEL, narcotics and controlled drugs must hold a valid license under the Narcotic Control Regulations. See our Precursor License section for further details.
Natural Health Product (NHP) Site License
Any Canadian company manufacturing, packaging, labeling and/or importing natural health products destined for the Canadian market must hold a Site License issued by the Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada. Licensed facilities must follow Good Manufacturing Practices (GMPs), and our team can help design, implement, and refine the standard operating procedures (SOPs) and GMP quality systems needed to obtain your site license and run a compliant facility. We help you confirm that your processes comply with Health Canada’s requirements by conducting a mock audit of your facility. See our Inspections and Audits page for further details. All Canadian companies wishing to import products from outside Canada are required to hold an importing site license from Health Canada, and each foreign manufacturer they receive product from is required to be included on the importing license. Demonstration of the foreign manufacturing site’s compliance with GMP is a requirement. In some cases, foreign facilities may opt to complete their own registration (a Foreign Site Reference Number, FSRN), which eases the process of addition to Canadian importer’s site license. NHP Consulting can compile and submit applications for a NHP Site Licenses and FSRNs to Health Canada. We can also work with importers and foreign suppliers to ensure a streamlined addition of foreign manufacturing sites to existing import licenses.
Precursor License (Class A/B)
Health Canada has published a short list of chemicals (called “precursor chemicals”) that can only be handled by a company holding a precursor license. Broadly speaking, precursors are chemicals used in the legitimate manufacture of legal drugs and health products, but precursors have the potential for diversion/conversion into illegal drugs. Ephedrine and pseudoephedrine, for example, are commonly used in cold and decongestant medicines, but they can also be used to produce methamphetamine. Due to the potential for precursor misuse, facilities handling precursor chemicals require specific approvals (Precursor Licence), and the Office of Controlled Substances (OCS) confirms that companies dealing with these types of products have certain controls in place. The license and controls are based on quality procedures and security protocols for the facility and personnel.
NHP Consulting will apply for the precursor license on your behalf, and your application compilation and submission will include evaluation, customization or creation of storage security measures, annual reporting processes, a completed paperwork package, and the required import/export permits.
Food Manufacturing (FSEP/HACCP)
Under the Safe Foods for Canadians Act (SCFA, 2015), every importer, distributor or manufacturer of food for export (or for inter-provincial trade within Canada) requires license from the Canadian Food Inspection Agency (CFIA). Part of the licensing requirements will be a written and implemented preventative control system such as HACCP (Hazard Analysis Critical Control Points), and high level details including a description of the facility’s equipment, preventative maintenance plans, sanitation programs, employee training, and traceability records/recall programs. HACCP is an internationally recognized, science-based food safety system, designed to manage food safety hazards. A HACCP plan must cover the manufacturing, storage, packaging, and labeling of a food, so the plan encompasses the products, people, processes, sanitation, pest control, hygiene, equipment, transportation, receiving, storage, investigations, complaints, and recall procedures.
Our experienced consultants can assist you with the CFIA licensing process as well as with design and implementation of HACCP quality systems.
All cosmetic products sold in Canada must be manufactured according to Good Manufacturing Practices (GMPs) to ensure that safety and quality standards are met.
According to the Canadian Cosmetic Regulations, all cosmetics for sale on the Canadian market must be manufactured according to Good Manufacturing Practices (GMPs). These standards include measures to ensure that all regulatory requirements are being met with regards to manufacturing, testing, storage, and handling and distribution.
In order to ensure that products are manufactured in a sanitary manner, GMPs pertaining to the manufacturing facility, equipment used, personnel qualifications, sanitation practices, laboratory controls, record maintenance, quality control procedures, and a system for complaints is in place. Adherence to GMPs is the most effective strategy to risk management, which in turn, mitigates most of the risk of contamination (and consumer adverse reactions).
NHP Consulting has helped many cosmetic manufacturers develop GMP’s, and can work with you to develop standards that are unique to your facility and products.