Canada Natural Health Products Regulatory Affairs Application Services

Evershine Canada, together with its foreign affiliates, provides comprehensive Natural Health Products Regulatory Affairs Application Services  to support your Canada subsidiary..
Email：yto4ww.food@evershinecpa.com

Pre-Market Review (PRA-F-PMA)

a. We assume products will be two. If over or less, fee will depend on real product numbers.
b. We will review the documents and let you know if the product is eligible to obtain the license.
C. In order to assess the formula and provide a further quote on class 1 or Class 2 or class 3, we will require the following information:
•The official brand name of the product;
• Dosage directions and dosage form;
• The formula with the amounts of each medicinal ingredient and the non-medicinal ingredients. Please include the source materials (ie. leaf, root) for your medicinal ingredients.
• For extracts, please ensure that they have a ratio (e.g. 4:1), and for standardized extracts, please ensure they have constituents and potencies.

Product Licence application Class 1 (PRA-F-PLA-1)

a. We assume products will be two. If over or less, fee will depend on real product numbers.
b. Only After Passing PRA-F-PMA Pre-Market Review, and being judged as Class I,this process will go ahead.
c. Class I Product fully attested to existing NHP monographs in the Natural Health Products Ingredients Database (NHPID) with no deviations (ingredients, dose, source, route, claims).
d. From application to gaining approval , it might spend around 60 working days

Product Licence Application Class 2 (PRA-F-PLA-2)

a.We assume products will be two. If over or less, fee will depend on real product numbers.
b.Only After Passing PRA-F-PMA Pre-Market Review, and being judged as Class II,this process will go ahead.
c, Class II Product partially attested to monographs or has minor deviations (e.g. claim wording, combination of ingredients). Requires summary evidence or scientific literature support.
d.From application to gaining approval , it might spend around 96 working days

Product Licence Application Class 3 (PRA-F-PLA-3)

a. We assume products will be two. If over or less, fee will depend on real product numbers.
b. Only After Passing PRA-F-PMA Pre-Market Review, this process will go ahead.
C Class III Product not fully supported by monographs, new ingredients, new delivery forms, or new claims. Requires full scientific evidence package.
d.From application to gaining approval , it might spend around 210 working days

Label Compliance Review (PRA-F-LCR)

a.We assume products will be two. If over or less, fee will depend on real product numbers.
b. After getting Natural Product Number (NPN) through Product Licence Application (PLA), next step is Label Compliance Review.
c. Verify that the label content, format, language, warnings, font size, and all required statutory information are fully compliant with applicable regulations.
d. Importation, manufacturing, and sales may only commence after the label has been confirmed as compliant.

Site Licensing SL# application (PRA-F-SL)

**We assume there will be one site. If additional sites are involved, the fees will be adjusted based on the actual number of sites.
**Document Checklist Overview
A1:
Certificate of Incorporation;
Key content: Canadian company registration certificate, including company name, registration number, and province of incorporation.
A2:
Articles of Incorporation & List of Directors;
Key content: Identification of legal representatives and operational authority of the company.
A3:
Proof of Canadian Address;
Key content: May include lease agreement, utility bill, or registered business address.
A4:
Letter of Association;
Key content: If owned by a Taiwan parent company, include a statement of control relationship.
B1:
Quality Manual;
Key content: Overview of quality policy, responsibilities, SOP management, and risk control framework.
B2:
Standard Operating Procedures (SOPs);
Key content includes the following topics:
• Document control
• Supplier qualification and approval
• Import batch release procedures
• Complaint and recall handling
• CAPA procedures
• Storage and distribution management
B3:
Record Forms & Logs;
Key content: Batch checklists, deviation reports, release approval forms, training records, etc.
B4:
QAP Curriculum Vitae & Certificates;
Key content: Educational background, QA experience, and training records.
B5:
Training Records;
Key content: Training records for QAP, warehouse personnel, and document control staff.
C1:
List of Foreign Manufacturers (Appendix C);
Key content: Names and addresses of all manufacturers, packagers, and labeling entities.
C2:
GMP Evidence for Foreign Sites (Appendix D);
Key content: Valid GMP-related certifications (e.g., ISO, TGA, FDA, EU GMP) issued within the past 3 years.
C3:
Supplier Qualification Report;
Key content: Demonstrates GMP compliance evaluation of suppliers.
D1:
FRM-0034 Site Licence Application Form;
Key content: Official Health Canada application form indicating importer activities.
D2:
Appendix A — Site Information;
Key content: Canadian operating address and storage locations.
D3:
Appendix B — QAP Information;
Key content: Detailed information on QAP, including name, title, qualifications, and CV.
D4:
Appendix C — List of Foreign Manufacturers;
Key content: Official format corresponding to C1.
D5:
Appendix D — GMP Evidence;
Key content: Corresponds to C2.
E1:
Cover Letter;
Key content: Summary of application scope, product types, and GMP recognition approach.
E2:
Fee Payment Form / Receipt (if applicable);
Key content: Proof of payment if fee requirements apply.

Product Specification (PRA-F-Spec)

**We assume there will be two products. If the actual number of products differs, the fees will be adjusted accordingly based on the actual product count.
**PSF Required Contents (Health Canada Recommended Format):
PSF01: Product Name;
Content: English product name + common name (e.g., Hydrolyzed Collagen Drink).
PSF02: Dosage Form;
Content: Liquid / Capsule / Jelly Stick, etc.
PSF03: Packaging Type;
Content: e.g., 50 ml × 10 bottles / 15 g × 20 sticks.
PSF04: Medicinal Ingredients;
Content: Name, source, dosage, and unit of each ingredient, in compliance with NHPID.
PSF05: Non-medicinal Ingredients;
Content: Excipients, flavorings, sweeteners, preservatives, etc.
PSF06: Description;
Content: Color, odor, taste, and physical characteristics.
PSF07: Identity Tests;
Content: Identification methods for key ingredients (e.g., collagen), such as FTIR or peptide profile.
PSF08: Assay / Potency;
Content: Testing methods, standards, and acceptable range (e.g., ±10%).
PSF09: Purity Tests;
Content: Heavy metals (Pb, Cd, As, Hg), microbial limits, residual solvents, etc.
PSF10: Physical / Chemical Tests;
Content: pH, specific gravity, viscosity, appearance stability, etc.
PSF11: Storage Conditions;
Content: e.g., “Store below 25°C, protect from light and moisture.”
PSF12: Shelf Life / Expiry;
Content: e.g., 2 years from the date of manufacture, supported by stability data.
PSF13: Test Methods Reference;
Content: USP / AOAC / in-house validated methods.
PSF14: Acceptance Criteria Summary;
Content: Acceptable ranges and pass/fail criteria for each test item.
PSF15: Approval Signatures;
Content: Signatures and dates of QA / QAP / Technical Manager.

Certificate of Analysis (PRA-F-COA)

**We assume you will execute 6 batches per year. If More than 6 batches, will charge USD1300 per batch.
**COA Certificate of Analysis Format:
Header :
Product name, batch/lot number, manufacture date, expiry date
Test parameters :
Identity, purity, potency, microbial limits, heavy metals, etc.
Specifications :
Accepted limits / criteria
Results :
Measured values with pass/fail
Test method reference :
e.g. USP, AOAC, in-house validated method
Analyst / QA signature :
Name, position, signature, date Laboratory information:Lab name, address, contact
QAP approval:
Final sign-off before release

Annual Site Compliance Maintenance (PRA-F-SCM)

**We assume there will be one site. If additional sites are involved, the fees will be adjusted based on the actual number of sites.
**PSF Supporting Documents (to be included in the Product File)
Health Canada recommends that each product’s “Product File” should include the following documents (all linked to the PSF):
1. Document Name Purpose / Description
2. Product Specification Sheet (PSF) — Core document.
3.Master Formula Record (MFR) — Describes formulation composition, manufacturing process, filling, and packaging steps.
4.P.roduct Licence (NPN Certificate) — Product license approved by Health Canada.
5.Stability Study Summary — Summary of stability studies supporting shelf life.
6.Analytical Method Validation Summary — Validation summary required if in-house methods are used.
7.Reference Standards List — List and sources of standards used for analysis.
8.Lab Testing SOP / Method Sheet — Procedures and analytical methods for each test item.
9.Sample COA (typical batch) — Certificate of Analysis for a representative batch.
10.QAP Approval Record — Signed record confirming the PSF is the current approved version.
11.Change Control Log — Records of version changes and reasons if formulation or specifications are updated.
**Key Point:
Together, these documents form the “Product Master File (PMF)” or “Product Dossier.”
The PSF serves as the core quality document and is a primary focus during Health Canada inspections.

Government FEE (PRA-F-GF)

**This fee will be paid to the relevant Canadian government authorities or designated entities.
**We will make the payment on your behalf and be reimbursed upon providing the official receipt issued by the Canadian government or its authorized entities.
**When the prepaid amount exceeds USD 500, we will request advance payment from you.

Contact Us

Email: yto4ww.food@evershinecpa.com
Or
Eveshine Canada , One of Evershine affiliates
Manager Ian Lin Speak in English, and Chinese.

For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4yto@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable for your case.
Linkedin address: Dale Chen

Additional Information
Evershine has 100% affiliates in the following cities:
Headquarter, Taipei, Xiamen, Beijing, Shanghai, Shanghai,
Shenzhen, New York, San Francisco, Houston, Phoenix Tokyo,
Seoul, Hanoi, Ho Chi Minh, Bangkok, Singapore, Kuala Lumpur,
Manila, Dubai, New Delhi, Mumbai, Dhaka, Jakarta, Frankfurt,
Paris, London, Amsterdam, Milan, Barcelona, Bucharest,
Melbourne, Sydney, Toronto, Mexico

Other cities with existent clients:
Miami, Atlanta, Oklahoma, Michigan, Seattle, Delaware;
Berlin, Stuttgart; Prague; Czech Republic; Bangalore; Surabaya;
Kaohsiung, Hong Kong, Shenzhen, Donguan, Guangzhou, Qingyuan, Yongkang, Hangzhou, Suzhou, Kunshan, Nanjing, Chongqing, Xuchang, Qingdao, Tianjin.

Evershine Potential Serviceable City (2 months preparatory period):
Evershine CPAs Firm is an IAPA member firm headquartered in London, with 300 member offices worldwide and approximately 10,000 employees.
Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people.
Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)

Please send email to HQ4yto@evershinecpa.com

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