天然健康产品/保健品（NHP）许可服务

我们为您简化 NHP 许可申请流程，确保产品顺利符合加拿大卫生部的法规要求。
专业团队全程协作，让您把时间投入在品牌与业务成长上。

我们的NPN 申请服务和费用

我们坚持清晰、透明的收费结构，让您在每一步都放心。以下是我们根据不同申请种类提供的服务等级，您可以根据需求自由选择。

申请种类

适用范围

基础费用

加急服务

基础认证

适用于：一类NPN申请（1–4 个成分）

CA$375.00

+CA$75.00 (5 天→ 3 天)

标准认证

一类申请（5–10 个成分）或二类申请（3–8 个成分）

CA$675.00

+CA$150 (7 天→ 3 天)

复杂认证

三类NPN申请或复杂二类NPN申请（最多 15 个成分）

CA$1,075.00

+CA$300.00 (15 天→ 8 天)

联系我们讨论详情

如需了解关于费用、流程、修改（Amendments）和通知（Notifications）的详细信息，请参阅我们的流程 FAQ 或直接联系我们。

服务项目，为您的需求而设计

我们的专业团队通过科学验证与策略优化，为您的 NHP 申请提供更高的成功率。

01 新产品 NHP 申请服务

关于 NHP 许可您需要了解的一切：
NHP 是什么、如何申请NPN、为什么需要申请、以及我们如何帮助您快速通过审核。

开始初次申请

02 后续合规与维护服务

已经有 NHP 认证？
了解我们如何协助您在上市后持续保持合规，确保产品长期稳定、可持续经营。

查看后续合规服务

正在规划您的天然健康产品上市？

在什么情况下需要申请 NHP 许可？

在加拿大，天然健康产品（NHP）受到《天然健康产品法规》监管，以确保产品的安全性、功效和质量。含有特定活性成分、具有健康功效声称或具备特殊功能的产品，都不能按普通食品销售，必须取得 NHP 许可后才能上市。

获得 NHP 许可证（Natural Product Number, NPN）不仅符合加拿大卫生部的法规要求，更能显著提升产品的可信度，让您的品牌在竞争激烈的市场中脱颖而出。消费者普遍认为持证产品具有更严格的质量与法规保障，从而提升对产品安全性与专业度的信任。这也让品牌能够获得更稳固的市场定位与更高的溢价空间。

我们如何协助您的 NPN 申请

我们的团队以经验与法规专业为基础，帮助您的产品在首次递交时就具备最高的成功率。

01 策略咨询

为您的产品配方提供最可行、最具成本效益的审批路径建议。

从法规与市场双重角度出发，提供配方优化方向，让产品既合规又具备市场吸引力。

02 专业申报

为您的产品准备量身定制的申报材料，提升一次通过率。

根据加拿大卫生部的要求，整理完善的科学依据与配方支持文件。

03 专家标签审核

提供符合 NPN 要求的双语标签文本，区分必须项目与可选内容（包括用法用量、警示语、用途等）。

审核最终标签排版，确保字体大小、对比度与所有法规细节完全符合标准。

我们优化从配方到文件准备的每一步环节，帮助您的 NPN 申请顺利推进并高效通过审核。

获取免费报价

01

重大变更（Amendments）

重大变更指可能影响产品安全性、有效性或质量的调整。
此类变更必须在实施前获得加拿大卫生部批准，并更新产品许可证内容。

常见重大变更包括：

更改活性成分来源或效价
调整产品规格，如检验方法或纯度范围
修改推荐用量或使用时长
更新风险信息（移除、添加或修改警语/不良反应）

获取报价

02

一般通知（Notifications）

一般通知适用于不影响安全、有效性或质量的小幅更新。
这些通知需在变更后 60 天内提交。

常见通知包括：

增加或替换对安全性无影响的非药用成分
更改产品品牌名称
更新活性成分的通用名称
增补新的非严重不良反应或警语信息

获取报价

通过我们取得的新 NPN，可在 9 个月内享受 2 次免费通知服务。

了解我们如何协助您进行上市后的合规维护

无论是重大修改还是小幅更新，我们都能协助您完成后续合规流程，让产品持续保持合规状态。

为什么选择我们？

我们根据每位客户的实际情况制定合规策略，
在确保符合法规的同时，帮助您降低风险、稳健发展。

资深行业经验

全程准备申请文件并对接 Health Canada
1 个工作日内反馈进展，3 日内响应问题

高效顺畅的流程

由经验丰富的法规团队规划最优合规路径
确保业务计划按时推进

持续合规保障

获批后 9 个月内提供 2 次免费合规通知支持
让合规管理更省心

全面服务覆盖

提供 QTA 审核、IRN 回复及许可后审计支持
确保全面符合 Health Canada 要求

查看证书示例

加拿大卫生部 NHP 许可证示例

Ready To Get Started?

FAQ & Process Overview

We have streamlined the Natural Product License application process into 7 clear steps:

Step 1: Confidentiality Agreement

We begin by signing a Non-Disclosure Agreement (NDA) to ensure all discussions remain confidential. Required information will only be shared with Health Canada for the application process.

Step 2: Submit Formulations

Provide the following details for initial assessment:

Formula information, including the list and amounts of medicinal (active) and non-medicinal (excipient) ingredients.

Dosage directions and dosage form.

Designated selling country.

Designated claimed functions.

Step 3: Compliance Review

We review your documents to ensure your product meets Canadian regulations. If modifications are needed (e.g., dosage adjustments or ingredient changes), we will advise you. For non-compliant products, we will notify you of the likelihood of rejection.

Step 4: Quotation

Upon review, we provide an all-inclusive written quotation detailing the work and timeline required. The quoted amount is final—there are no hidden charges.

Step 5: Authorization and Application Submission

Once the quote is approved:

We will send you a Designated Party Authorization (DPA) Form for signature, allowing us to represent you with Health Canada.

A 70% deposit is required upon signing the DPA.

After receiving the deposit, we will provide you with a detailed Registration Information Checklist outlining the necessary details and documents needed for the application.

Upon receiving the deposit and all required information, we will submit the complete application package according to the timeline specified in the quotation.

Step 6: Responding to Health Canada

During Health Canada's assessment, additional information may be requested. We will collaborate with you to gather the required details and submit responses to Information Request Notices (IRNs) within the specified timeframe. This service is fully included in your package—no additional fees!

Step 7: Submission and Approval

Once the NPN is approved, we will notify you and issue the final invoice for the remaining 30%.
The following information is typically required for us to create your NPN application package:

NPN holder’s name and contact information.

Formula details, including all medicinal ingredients and excipients.

The dosage form and dosage.

Desired functional claims.

Other ingredient-specific information (if applicable).
Our team ensures your application is complete, accurate, and meets Health Canada’s standards. We provide:

Pre-submission meeting arrangements and preparation of pre-submission packages.

New company registration and obtaining a company code.

Completion of the Product Licence Applications (PLA) form.

Preparation of Finished Product Specifications.

Label text drafting in compliance with regulatory requirements.

Master File submissions.

Attestation to NNHPD monographs and/or preparation of Scientific Rationale.

Creation of a comprehensive Summary Report.

Assistance with completing the Animal Tissue Form, if applicable.
We assist in identifying and fulfilling all testing requirements to ensure your product meets compliance standards which could include:

Testing requirements depend on your product’s classification and ingredients. Common tests include assays on potency, microbial, and heavy metal contaminants.

Depending on the ingredients and extraction method, additional tests such as aflatoxins, solvent residues, or peroxide value may also be required.
Processing times vary by product complexity and Health Canada’s workload. Typical timelines are:

Class I: 60 calendar days.
Class II: 90 calendar days.
Class III: 180 calendar days for assessment, plus 210 calendar days for processing.

We work efficiently to prepare and submit your application to minimize delays.
Yes, all NHPs sold in Canada must have an NPN. Some platforms, such as Amazon, have stricter requirements, regularly auditing product compliance and flagging non-compliant products.
The NPN application process is complex, requiring navigation through detailed regulations. Our specialists streamline the process, helping you avoid costly errors, expedite review timelines, and maximize approval success.