REGULATORY COMPLIANCE

Natural Health Products:

In Canada, the following products are regulated by the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada:

Vitamins and minerals
Herbs and plant extracts
Plant isolates and animal derived extracts
Homeopathic medicines
Prebiotics and probiotics
Amino acids and essential fatty acids
Traditional medicine (eg. Traditional Chinese Medicine)
Cosmetics

Our team of experts here at Stelioz offer regulatory compliance, scientific support and quality management solutions for various dosage forms of these products from conception to market launch and post-market product management.

Product Licenses (NPN)

Health Canada requires all Natural health products (NHPs) to have a pre-market approval in the form of a product license: Natural Product Number (NPN).

We can help you get your unique NPN number for any specific dosage form, formulation and health claim(s) approved by Health Canada (NNHPD).

At Stelioz, we have the extensive experience and expertise required to get an NPN product license for your product formulation and health claims efficiently so that you can launch your product. You can rely on our in-depth knowledge and strategic approach to navigate the complex regulatory framework and avoid delays in product licensing and refusals. Our services to help you successfully get your NPN include but not limited to:

Preparation of (product licensing applications) PLAs for Class I, II and III applications
Preparation of finished product specification (FPS) with recommendations on assay methods and tolerance limits
Preparation of safety and efficacy reports, claim substantiation and expert advice on getting evidence-based unique health claims
Submission of complete dossier to NNHPD
Response to Information Request Notices (IRNs) and follow-ups until product licensure
Post licensing amendments and notifications submission and management (ANFs)

Master File

Have a novel product/raw material with an interesting health claim or unique attributes? Health Canada (NNHPD) allows manufacturers/raw material suppliers of a medicinal ingredient to submit a dossier with proprietary information directly to NNHPD for review. Once a Master file (NHP-MF) is granted, it allows the Master file holder to:

Obtain NNHPD approved evidence based unique health claims by submitting a PLA- this permits you to strategically use these health claims to differentiate your raw material/product
Have their medicinal ingredient safety and efficacy reviewed and approved by Health Canada, which allows your clients to get NPN product licenses by simply referencing your master file number
Have the advantage of providing NHP-MF to your clients without sharing proprietary information

Services at Stelioz for Master files include:

Collection and review of research and documents to state and substantiate safety and efficacy claims in the application
Preparation of application submission, along with PLA for completion of Master file processing
Follow-ups and addressing of IRNs

Product Labels

Product label is the true representation of the product, the brand and the company. A well designed, accurate, and compliant label is an important step in positioning your brand and marketing. At Stelioz, we can help you make your label industry and market compliant with the following services:

Label design (including logo design and label graphics)
Label content preparation as per NNHPD regulations
Translation to French (or vice versa)
Final label checks prior to market launch

Site License

Health Canada ensures GMP compliance for all facilities involved in the handling of Natural health products by issuing a site license. A site license is required to manufacture, package, label or import a natural health product. The application, renewal and amendment for a site license requires submission of updated GMP evidence and a detailed overview of operations. Thus, the preparation of a site license application depends on activities that will be carried out at that site.

Our site license services include the following:

Review of site and intended operations and activities
Review of existing documentation and procedures to ensure GMP and Health Canada compliance
Preparation of documents to establish new procedures (including but not limited to: SOPs, formats for manufacturing records, product specification sheets and certificates of analysis, site sanitation and environmental monitoring documentation)
Verification of supplier and foreign site documentation
Compilation of final dossier (PLA, QAR, and associated evidence)
Follow ups, addressing of Information Request Notices (IRNs) and renewals

Site licensing requirements vary in each situation. Hence, we do perform site visits if required, to perform a complete survey of the facility and ensure regulatory and quality compliance

Foreign Site Registration (Foreign Site Reference Number)

For suppliers, manufacturers, packagers and labelers of natural health products outside of Canada, it can be quite challenging to navigate the system and collaborate with Canadian companies that import products from them. Health Canada requires GMP compliance evidence for all operations for sites located outside of the country. It can become difficult to provide this evidence to individual clients.
A foreign site reference number provides an easy one stop regulatory solution for sites located outside Canada. By obtaining a FSRN number, a foreign site can:

Communicate directly with Health Canada- get clarification and GMP validation while maintaining confidentiality in operations
Provide the FSRN authorization to any number of Canadian importers as proof of GMP compliance, thus improving market trust and visibility in Canada
Get annexed to an importers site license easily, since the FSRN is considered pre-cleared evidence for a foreign site

Stelioz is experienced with a wide variety of operations globally. By reviewing your current procedures and documentation, we can help you integrate your operations within Health Canada’s GMP compliance framework. Our FSRN procedure will take care of the following:

A complete review of GMP compliance and operations
Recommendations and assistance with preparation of GMP evidence documents (SOPs, certificates of analyses, technical documents etc.)
Preparation of FSRN application dossier for submission to Health Canada for review
Compilation of final application package (PLA, QAR, and associated evidence)
Follow ups, addressing of Information Request Notices (IRNs) and renewals

We do understand that each organization has its own operational methods. We believe in working with your quality and regulatory team, to understand your systems and help them seamlessly integrate with Health Canada’s platform.

Veterinary Health Products (VHP) and Supplements Application

The pet supplement industry is a rapidly growing market, and Health Canada has an evolving system for managing veterinary health products (VHPs) in Canada. All VHPs are subject to the GMP compliance requirements under the Natural Health Product Regulations. These include:

Vitamins and minerals
Plant and animal derived extracts and isolates
Prebiotics and probiotics
Amino acids and essential fatty acids
Traditional medicine

Although VHPs do not require a product license, they do require a notification to Health Canada 30 days prior to the sale of the product. The notification form sent to Health Canada is reviewed for safety, efficacy and quality of the VHP.

To facilitate the notification process and obtain the Notification Number, Health Canada has a List of Permitted substances. Any products containing ingredients on this list only require the notification for a pre-market approval. For new ingredients that are not on the list, a new substance application form can be used to explain the safety, efficacy and history of use of the ingredient with regards to its intended purpose in a particular species.

At Stelioz we can help you manage your VHP applications, and introduce new products and ingredients in the market. We have successfully prepared and submitted applications and added new substances to the List of Permitted Substances. Hence we understand the tailored and meticulous research required to demonstrate safety and efficacy of these ingredients specific to the species of the animal. Our VHP services include:

Preparation of notification for VHP products
Preparation of application for safety and efficacy for a new substance to be added to List of Permitted Substances
Label preparation and/or label review for VHP products
Post market follow up and regulatory support

Cosmetics and Personal Care

Cosmetic Notification

All cosmetics sold in Canada are subject to Health Canada’s Cosmetic Regulations. A cosmetic notification for a product must be submitted to Health Canada within 10 days of the first sale of the product. The cosmetic notification form (CNF) must be amended and submitted to Health Canada if there is a change in the formulation, name, or the company’s contact information.

Cosmetics and personal care products require careful planning not just at the pre-marketing stage, but from the conception of the formulation. At Stelioz, we provide support from the ground up, from conception to product launch, and post market support. We also help our clients identify their product classification within the cosmetic-NHP- drug framework. Our cosmetic and personal care regulatory and technical services include:

Formulation consulting (ingredient selection, sourcing, safety and efficacy compliance review, product categorization and classification)
Product testing and analytical report review, product specification development and guidance
Pre-marketing support- product claim substantiation and recommendations, marketing content review
Label services- product label review, French translation, label design

Our services are not limited to new products, we work with existing personal care products in the market. Whether it is regulatory compliance or marketing and consumer feedback, we can help you design your formulation and label to integrate these post market ideas and improve your product and brand.

Foods and Beverages

The food and beverage processing industry is one of the largest manufacturing industries in Canada. It is an exciting industry with new trends and innovative products being launched into the market every day, changing and even challenging the very definition of food and beverage. Stelioz provides regulatory and scientific consultation from product conception to post marketing research. Our services include:

Formulation review for regulatory compliance, review of intended use and health claims (if applicable)
Good manufacturing practices (GMP) compliance, including SOP development, manufacturing, quality and testing review
HACCP and Preventive Control Plan (PCP) Development
Preparation and submission of Safe Food for Canadians Regulations (SFCR) license application
Food manufacturing, safety and quality systems review and audit
Pre-submission consultation and preparation of Pre-market submissions to Health Canada’s Food Directorate
Temporary Market Authorization (TMA) applications
Assistance with product certifications- organic, gluten-free, non-GMO etc
Food label- design, creation and review (including label translation), nutrition facts table and health claims qualification
Submission of Novel Food Notification
Submission for Food additives
Food packaging submissions
Infant formula- labelling requirements, Infant formula and Human Milk Fortifier (HMF) pre-market submissions

Temporary Market Authorization (TMA)

The food and beverage industry is developing constantly to include more sophisticated products that offer fortification with vitamins and bioactive ingredients. In Canada, all food and beverage products must comply with the Food and Drugs Act (FDA) and the Food and Drugs Regulations (FDR). Products that fall outside the FDR requirements need additional evidence substantiating their health and efficacy, and safety claims. A rationale for such products is provided in the form of an amendment to FDR.

While the amendment is being reviewed, a Temporary Market Authorization (TMA) allows for the sale of the product interim, provided that a scientific risk assessment has been performed, which shows that the product is safe for consumers. With an assurance of safety, the purpose of a TMA is to collect post market data that would not otherwise be possible. This data is then used for assessing the amendment proposed to FDR.

Upon a TMA request, if approved, Health Canada will issue a Temporary Market Authorization letter (TMAL), which will allow for the product to be marketed within the specifications laid out in the TMA. Information gathered in this marketing phase will then be submitted to Health Canada.

Our expertise will help you navigate this process from submission to the completion of post market data collection and evidence compilation. Our services include:

Organize and coordinate pre-submission consultation with Health Canada
Preparation of TMA submission- review and compilation of application package
Preparation of product description and purpose of TMA
Review of proposed label
Preparation and review of proposed variation from FDR- Including safety evidence, quantity, period and area of sale, proposed data collection, proposed claim and scientific substantiation
Preparation of Letter of Agreement draft
Consultation with planning data collection and Temporary Marketing Research, submission of marketing research to Health Canada

Safe Food for Canadians Regulations (SFCR)

The Safe Food for Canadians Act regulated by the Canadian Food Inspection Agency (CFIA) was established to provide a framework for safe practices for handling, manufacturing, storage, import and distribution of food products. The Act specifies activities and products that require a SCFR license, and outlines steps to be taken for safe handling of these products/ingredients.

Our team can help you review your requirements under SCFR, and help you apply for a SCFR license if required. Our services include:

Perform a thorough review of operations and procedures to ensure compliance with SCFR regulations
Provide documentation consultation and draft SOPs where required
Identify areas where preventive control plans (PCPs) are essential and develop protocols according to Hazard Analysis and Critical Control Point (HACCP) principles
Aid in development of foreign supplier verification program
Perform assessment of operations to verify whether an SFCR license is required
Compile and submit SFCR license dossier for Health Canada approval in coordination with in-house quality and regulatory teams