计划启动您的场所许可申请？
为什么需要 GMP 场所许可？
如果您的加拿大公司涉及生产、包装、贴标或进口天然健康产品，
依法必须持有天然健康产品场所许可（Site Licence）。
根据 Health Canada 要求，所有从事上述活动的企业，
必须取得由天然健康产品司（NHPD）签发的有效场所许可。
场所许可仅适用于加拿大境内的相关活动。
海外生产商、贴标商或包装商，需通过加拿大进口商的场所许可进行合规关联。
了解我们如何协助您的场所许可申请
我们通过专业指导与实操支持，简化 GMP 场所许可流程
01
业务活动界定
协助确认需纳入申请的具体活动范围，
包括生产、包装、贴标或进口等。
02
文件与资料支持
与您及相关合作方协作，准备并整理所有必要文件与证明材料，
用于场所许可申请、变更或续期。
03
合规准备与整改建议
提供针对性的合规建议，包括：
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SOP 的起草与修订
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产品检测要求说明
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设施与场地合规优化建议
准备开始了吗？立即联系我们，获取个性化报价，自信迈出取得 GMP 场所许可的第一步。
我们如何支持获得许可后的合规需求
我们持续为您提供专业支持，确保许可长期有效
01
续期服务：
Health Canada 要求场所许可最迟需在到期前 30 天提交续期申请，部分情况下需提前提交。
我们将协助判断合适的提交时间，并确保所有资料及时更新、按时递交。
02
许可变更申请：
部分变更事项需事先获得 Health Canada 批准，包括但不限于：
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新增业务活动（如新增生产或进口）
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新增生产、包装、贴标或仓储场所
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从非无菌剂型转为无菌剂型
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新增海外生产场所
03
变更通知：
部分变更无需提交变更申请，但需在60 个自然日内通知 NNHPD，例如：
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公司名称、通讯地址、电话、传真或邮箱变更
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对建筑、设备、操作或流程产生重大影响的调整
不确定需要续期、变更还是通知？欢迎联系我们，协助判断合适的申报类型及预计时间。
海外场所合规
什么是 FSRN？以及您为什么需要它？
海外场所参考编号（FSRN）由 NNHPD 向海外生产商、包装商或贴标商发放。
FSRN 用于证明海外场所符合加拿大 GMP 要求。
取得 FSRN 能为海外企业带来什么价值？
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
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全程准备申请文件并对接 Health Canada
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1 个工作日内反馈进展，3 日内响应问题
高效顺畅的流程
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由经验丰富的法规团队规划最优合规路径
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确保业务计划按时推进
持续合规保障
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获批后 9 个月内提供 2 次免费合规通知支持
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让合规管理更省心
全面服务覆盖
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提供 QTA 审核、IRN 回复及许可后审计支持
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确保全面符合 Health Canada 要求
查看证书示例
Health Canada 场所许可证示例
Ready To Get Started?
FAQ & Process Overview
Our streamlined process ensures efficient and effective management of your GMP site licence application:
Step 1: Initial Consultation
We assess your business needs and determine the activities to include in your application.
Step 2: Documentation Preparation
We collaborate with you to gather required documents, including SOPs, product testing records, and facility information, ensuring they meet Health Canada’s GMP standards.
Step 3: Facility Compliance Review
Our team evaluates your facility to identify and recommend updates needed for full compliance.
Step 4: Application Submission
We compile and submit the complete site licence application to Health Canada on your behalf.
Step 5: Communication with Health Canada
We handle all interactions with Health Canada, including responding to IRNs, ensuring timely and accurate replies to any additional requests.
Step 6: Approval and Ongoing Support
Once approved, we provide service for licence renewals, amendments, and maintaining compliance through regular audits or process updates.
This clear and efficient process ensures your GMP site licence is secured without unnecessary delays, allowing you to focus on growing your business.
The required documents depend on the activities included in the application (e.g., manufacturing, packaging, labelling, importing). Typically, you will need:
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A detailed description of the activities performed.
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Standard Operating Procedures (SOPs) for each GMP requirement (e.g., sanitation, personnel, quality assurance, product release).
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A site master file or facility documentation, including floor plans and equipment details.
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Records demonstrating product testing, stability data, and specifications.
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Evidence of compliance with personnel training requirements.
We assist in gathering and formatting all necessary documents to ensure compliance with Health Canada’s guidelines.
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The GMP assessment timeline depends on the number of sites and activities included in the application. Applications that meet all requirements and require no additional information typically take up to 90 days for Canadian sites, based on Health Canada’s Service Standards. However, recent high application volumes may cause delays.
We help identify pre-cleared GMP evidence and streamline the process to minimize delays and expedite approval.
Yes, if you are importing Natural Health Products (NHPs) for the purpose of sale in Canada, you must hold a valid GMP Site Licence. The importer is responsible for ensuring that the foreign manufacturing, packaging, and labelling sites comply with Canadian GMP standards. Importers must maintain proper documentation and oversight of their foreign suppliers.
