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 site will be one. If over, fee will depend on real site numbers.
**文件清單總覽（中英對照）
A1:
公司登記證明(Certificate of Incorporation);
內容重點為:加拿大註冊公司證書，含公司名稱、編號、註冊省份。
A2:
公司章程與董事名單(Articles of Incorporation & List of Directors);
內容重點為:確認公司法定負責人與營運權限。
A3:
加拿大地址證明(Proof of Canadian Address);
內容重點為:可為租約、帳單或商業登記地址。
A4:
母子公司關係聲明信(Letter of Association);
內容重點為:若由台灣母公司持股，附上控制聲明。
B1:
品質手冊(Quality Manual);
內容重點為:概述品質方針、責任分工、SOP 管理、風險控制架構。
B2:
標準作業程序(Standard Operating Procedures (SOPs));
內容重點為:含以下主題：
• 文件控制
• 供應商審查與認證
• 進口批次放行流程
• 投訴與召回處理
• CAPA 程序
• 儲存與運輸管理
B3:
紀錄表格範本(Record Forms & Logs);
內容重點為:批次檢查表、偏差報告、放行簽核表、訓練紀錄等。
B4:
QAP 簡歷與證明文件(QAP Curriculum Vitae & Certificates);
內容重點為:含教育背景、QA 經驗證明、訓練記錄。 B5:員工訓練紀錄(Training Records);內容重點為:QAP、倉管、文件管理人員等訓練紀錄。
C1:
外國製造廠清單(List of Foreign Manufacturers (Appendix C));
內容重點為:所有製造 / 包裝 / 標示廠商的名稱與地址。
C2:
外國 GMP 證明文件(GMP Evidence for Foreign Sites (Appendix D));
內容重點為:提供 ISO、TGA、FDA、EU GMP 證書（3 年內有效）。
C3:
供應商評估報告(Supplier Qualification Report);
內容重點為:顯示你已審核供應商的 GMP 合規狀況。
D1:
Site Licence 申請表(FRM-0034 Site Licence Application Form);
內容重點為:Health Canada 官方主表，列出 Importer 職能。
D2:
附件 A — Site Information(Appendix A — Site Information);
內容重點為:加拿大營運地址、儲存地點。
D3:
附件 B — QAP 資料(Appendix B — QAP Information);
內容重點為:詳列 QAP 姓名、職稱、資格、履歷。
D4
:附件 C — 外國製造廠名單(Appendix C — List of Foreign Manufacturers);
內容重點為:與 C1 重疊部分，但為官方格式。
D5:
附件 D — GMP 證明(Appendix D — GMP Evidence);
內容重點為:與 C2 對應。
E1:
Cover Letter（說明信）(Cover Letter);
內容重點為:概述申請範圍、產品類型、GMP 認可方式。
E2:
費用繳納證明（若適用）(Fee Payment Form / Receipt);
內容重點為:若費用制度生效，附付款證明。

**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 products will be two. If over or less, fee will depend on real product numbers.
**PSF 必須包含的內容（Health Canada 官方建議格式）:
PSF01:產品名稱(Product Name);文件內容為:英文商品名 + 通用名稱 (e.g. Hydrolyzed Collagen Drink)
PSF02:劑型(Dosage Form);文件內容為:Liquid / Capsule / Jelly Stick 等
PSF03:包裝形式(Packaging Type);文件內容為:例如：50 ml × 10 bottles / 15 g × 20 sticks
PSF04:成分表（藥用成分）(Medicinal Ingredients);文件內容為:每一成分名稱、來源、劑量、單位；符合 NHPID。
PSF05:成分表（非藥用成分）(Non-medicinal Ingredients);文件內容為:賦形劑、香料、甜味劑、防腐劑等。
PSF06:外觀說明(Description);文件內容為:顏色、氣味、味道、物理性狀。
PSF07:鑑別試驗(Identity Tests);文件內容為:針對主成分（例如膠原蛋白）之鑑定方法：如 FTIR / Peptide Profile。
PSF08:含量測試(Assay / Potency);文件內容為:含量測試方法、標準、允收範圍（±10%）。
PSF09:純度 / 污染物測試(Purity Tests);文件內容為:重金屬（Pb, Cd, As, Hg）、微生物限度、殘留溶劑等。
PSF10:物理 / 化學測試(Physical / Chemical Tests);文件內容為:pH、比重、黏度、外觀穩定性等。
PSF11:保存條件(Storage Conditions);文件內容為:“Store below 25 °C, protect from light and moisture.”
PSF12:有效期(Shelf Life / Expiry);文件內容為:例：2 years from manufacture date；附穩定性依據。
PSF13:測試方法參考(Test Methods Reference);文件內容為:USP / AOAC / In-house validated method。
PSF14:批次放行標準(Acceptance Criteria Summary);文件內容為:每項測試項目之允收範圍與合格/不合格標準。
PSF15:簽核欄位(Approval Signatures);文件內容為:QA / QAP / Technical Manager 簽名與日期。

**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 site will be one. If over, fee will depend on real site numbers.
**PSF 附屬支援文件（要放入產品檔案夾 Product File）
Health Canada 建議每個產品的「Product File」應包含以下文件（均與 PSF 關聯）： 文件名稱 目的 / 說明
1 Product Specification Sheet (PSF) 核心文件。
2 Master Formula Record (MFR) 描述配方組成、製程、填充、包裝步驟。
3 Product Licence (NPN Certificate) Health Canada 核准的產品許可證。
4 Stability Study Summary 穩定性研究摘要，用以支持有效期限。
5 Analytical Method Validation Summary 若使用內部方法，須提供驗證報告摘要。
6 Reference Standards List 用於分析的標準品清單與來源。
7 Lab Testing SOP / Method Sheet 每個測試項目的操作程序與儀器方法。
8 Sample COA (typical batch) 代表性批次的分析報告（COA）。
9 QAP Approval Record QAP 簽署文件，確認此 PSF 為現行版本。
10 Change Control Log 若配方或規格變更，紀錄版本號與修訂原因。
** 重點： 這一套文件整合起來即是 “Product Master File (PMF)” 或 “Product Dossier”。 PSF 是其中的品質核心文件，Health Canada 稽查時必查。

**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

More Cities and More Services please click  Sitemap