Our team provides comprehensive consulting, and capital / operational project management in the nutraceutical, pharmaceutical, food and cannabis products industries. We deliver short turn-around times and cost-competitive solutions that help you complete your projects.
Comprehensive Consulting and Project Management Services
- NHP’s (Classes I, II and III)
- International Trade Certificates (ITC’s)
- Stability Studies
All natural health products (NHPs) require a product license before they can be marketed and legally sold in Canada. The licensing requirements of Natural Health Products Regulations (NHPR) apply to any person or company that manufactures, packages, labels and/or imports NHPs for commercial sale in Canada.
To obtain a product license, applicants must submit a detailed information about the product to Health Canada, including medicinal ingredients, dose, potency, non-medicinal ingredients, and recommended use(s). Also, depending upon the class of the application, additional information such as Evidence Reports, Safety Summary Reports, Quality Summary Reports are required to be submitted to Health Canada in order to justify the safety and efficacy of the product.
Once Health Canada reviews and approves the product for safety and efficacy, it issues the eight-digit Natural Product Number/ Product license number (NPN), which must appear on the product label. This eight-digit number indicates that the Natural health product has been approved by Health Canada for legal sale in the Canadian Market.
Classes of Product License Applications
There are three classes of applications, which are differentiated by their use of NNHPD monographs as follows:
- Class I applications are those that must comply with all the parameters of an individual NNHPD monograph.
- Class II applications are general and traditional applications supported by a combination of two or more NNHPD monographs.
- Class III applications are comprised of general, traditional and homeopathic applications requiring full assessment (not captured above in Class I or II) and include, but are not limited to, the following scenarios:
- Products with a novel preparation and/or dosage delivery system presenting unique safety and/or efficacy profiles
- Applications referencing a Master File to support safety, efficacy and/or quality.
- Products with ingredient combination issues (including those covered by a monograph) that may require safety assessment.
- Applications partially referencing monograph information but going beyond the parameters established in the relevant monograph(s).
- Homeopathic applications with specific claims.
Why Choose us?
Product license applications are one of our core competencies and we provide electronic Product license Application (e-PLA) submissions services for all the classes of Natural Health Products.
Our dedicated team of professionals can help you fast-track your Product license Application preparation and submission in the following steps:
- Free assessment of the initial proposed formulation to check if the product complies with the Natural Health Products Regulations (NHPR). We will review the product formulation and suggest some changes to the formulation if required to make the product compliant with the NHPR.
- Sending the written quotation once initial assessment has been completed.
- Signing the Designated Party Authorization Form.
- Preparing the Safety and Efficacy Summary Reports
- Preparing the Finished Product Specifications and Quality Summary Reports
- Preparing Product license applications in the electronic format (e-PLA) Preparing the draft labels
- After application submission, responding to all the Clarification requests and information request notices (IRNs) from Health Canada.
- Free amendment and notification to the Product licenses after NPN approval.
Solid Oral Dosage
Coated, chewable, enteric coated tablets
Capsules & Softgels
New Product Development and R&D
With extensive knowledge of both natural and conventional ingredients our Research and Development team can assist you in developing or reformulating a Natural Health Product.
We can develop a new formulation or optimize your existing formulation to ensure potency, efficacy and batch to batch consistency. Our R&D team will work closely with you to create a robust product formulation compliant with the regulations of target market and health standards.
How can we assist you with Product Development and commercialization?
- We specialize in developing in following dosage delivery formats and will assist you from product concept to commercialization including packaging and label development:
- Solid Oral dosage
- Coated, Enteric Coated, Effervescent, Chewable Tablets
- Hard Shell Capsules and Softgels
- Nano Emulsions
- Whey and plant based protein blends, meal replacements
- Amino acids
- Effervescent blends
- Organic Certification
- Vendor Qualification
Site Licensing (GMP Certificate)
All businesses in Canada that wish to manufacture, package, label or import natural health products for sale must hold a current site license. A site license issued by the NNHPD gives the licensee authorization to conduct the activities listed on the license. These activities must be carried out according to the good manufacturing practices (GMPs) outlined in the Natural Health Product Regulations (NHPR).
The site licensing system requires that all manufacturers, packagers, labelers, and importers be licensed. Sites must have procedures in place for distribution records and product recalls and for the handling, storage, and delivery of their products. They must also demonstrate that they meet good manufacturing practice (GMP) requirements.
Good manufacturing practices (GMP)
Good Manufacturing Practices or GMP is a system that consists of processes, procedures and documentation that ensures product safety and quality. This is achieved by setting appropriate standards and practices for the manufacturing, packaging, labeling, storing, and importing of NHPs intended for sale in Canada.
Some areas that can influence the safety and quality of products that GMP guideline and regulation address are the following:
- specifications (product)
- sanitation program
- quality assurance
- sterile products
- lot or batch samples
- recall reporting
Site license for Importers and Retailers
Any business or individual that imports into Canada a finished Natural Health Product (NHP) for the purpose of sale is considered to be an importer as per the Natural Health Product Regulations (NHPR)
Importers that ship a product directly to the retailer without first storing the product require a site license and must comply with all the GMP requirements outlined by the Natural Health Product Regulations (NHPR)
Also, retailers selling imported NHPs are considered the importers and require a valid site license.
How to obtain the site license?
To apply for a site licence, applicants must provide to the NNHPD, a site licence application which includes the following forms and documents:
- Site Licence Application (SLA) Form: The Site Licence Application Form captures all of the information outlined in the GMP Regulations.
- Designated Party Authorization (DPA) Form (when applicable): Applicants/licensees who have designated a third party person to file a submission with the NNHPD on their behalf must submit a Designated Party Authorization Form.
- Evidence of GMP compliance for each site. When NHPs are imported from foreign manufacturers, packagers and/or labelers, a foreign site reference number (FSRN) must be provided to demonstrate the GMP compliance of foreign sites.
Foreign Site Reference Number (FSRN)
The NNHPD may issue a FSRN to a foreign site that has demonstrated compliance the Regulations via a separate FSRN application process. Once issued a FSRN, foreign site owners may authorize Canadian importers to reference their FSRN as an alternative to providing GMP evidence for their site.
This process protects confidential manufacturing information and helps to expedite the review process. The FSRN is valid for a period of one or three years from the date of issuance, depending on the type of supporting GMP evidence provided in support of the foreign site.
How can we help you meet the quality standard (GMP) and obtain a site license and/or foreign site Reference Number (FSRN)?
We will help your facility to meet the GMP requirements by establishing a quality system, generating Standard Operating procedures (SOPs), evaluating the documentation and records on site for completeness and accuracy. If required, provide proper training to the QA department on site.
Once the quality system is in place, we will complete the site license application or FSRN application with supporting documentation and records. Also, after application submission, respond to all the Clarification requests and information request notices (IRNs) from Health Canada.
Also, after license approval we can assist you with annual renewal.
- Process Design
- Setup & Optimization
Facility Layout and Design
Design, construction, and commercialization of a nutraceutical, pharmaceutical and cannabis manufacturing facilities requires detailed project planning and assignment of significant technical resources. It also dictates the quality and compliance of products that are to be manufactured. Therefore, these activities must be planned in detail with respect to the local, national and international regulatory requirements to establish a strong starting base to grow upon.
A manufacturing plant must be an integrated design that satisfies the following:
- Process requirements
- Personnel flows
- Material flows (product, component, and raw material movements)
- Equipment layout requirements
- Operational access requirements
- Maintenance access requirements
The advantages of a good manufacturing plant layout include but are not limited to:
- Optimum use of available floor space for production operations
- Improved product quality with minimized loss due to waste and spoilage
- Efficient arrangement for receipt, storage, delivery and release of raw material and finished goods.
How can we help you?
Out Team can provide comprehensive consulting services to you including the detailed initial planning of production facilities. With more two decades of experience in nutraceutical, pharmaceutical and cannabis industries, backed by a thorough understanding in manufacturing of all oral delivery dosage formats, we have a great depth of experience in the construction of systems, and you will be assured of the highest degree of safety and competence right from the start.
- CR Metered dosing
- Blister packaging
Packaging Design and Development
Packaging is an important component in the new product development, as it can greatly affect the stability and safety of product. Packaging material is chosen based on its efficacy and other characteristics that enable it to preserve the quality, potency, and safety of the product.
Packaging for nutraceuticals and pharmaceuticals is also essential for identification purposes, for marketing and promoting different brands. There are several different types of packaging, which are classified as primary, secondary, and tertiary.
Primary product packaging is the material that surrounds the nutraceutical/pharmaceutical product. Types of common primary packaging types are:
- Plastic Bottles (PET: polyethylene terephthalate, HDPE: high-density polyethylene, PP: polypropylene)
- Glass Bottles
- Blister packs: PVC/PVDC-ALU, ALU-ALU
- Gusseted Bags
Secondary packaging is the exterior packaging of the primary packaging that groups packages and further protects or labels the Nutra/Pharma product. Some examples of secondary packaging are as follows:
Tertiary packaging is used for bulk handling, storage, and distribution. Tertiary packaging is required to protect both the product and the packaging from external forces during transportation from one destination to another.
The most popular tertiary packaging used is cardboard boxes.
- Please contact us, we’d love to hear about your project!
- Please contact us, we’d love to hear about your project!