加拿大NNHPD
Natural and Non-prescription Health Products Directorate (NNHPD) 自然和非处方保健品管理局
以下方案旨在供目前不是保健品制造商的公司使用，但表示有兴趣在COVID-19大肆流行期间生产制造公众分发的洗手液企业。加拿大卫生部制定了一项临时办法，以支持这些公司在这一公共卫生紧急情况下获得所需的许可证。在此之后，加拿大卫生部会停止这一做法，并恢复常规许可证操作方法。
The below information is intended for the use of companies that are not currently manufacturers of health products, but have expressed interest in manufacturing hand sanitizers for public distribution during the COVID-19 pandemic. Health Canada is establishing an interim approach to support those companies in acquiring the needed licences during this public health emergency. Following this, Health Canada intends to discontinue this approach and returns to its regular licensing approach for hand sanitizers.
有意制造、包装、进口或贴上酒精洗手液标签的公司需要申请并获得产品授权（从而获得自然产品编号（NPN））和现场许可证。在COVID-19响应期间，本文件中概述的过程特别适用于加拿大洗手液制造商。
Companies interested in manufacturing, packaging, importing or labelling alcohol-based hand sanitizers need to apply for and receive a product authorization (resulting in the issuance of a Natural Product Number (NPN)) and a site licence. The process outlined in this document specifically applies to Canadian manufacturers of hand sanitizers during the COVID-19 response.
根据加拿大化妆品法规要求,化妆品制造商或进口商必须在产品第一次在加拿大境内销售的10天内向加拿大卫生部进行化妆品通报, 否则会导致产品拒绝进关,或从市场上召回.
通报人（Notifier）向加拿大卫生部提交化妆品通报表格Cosmetic Notification Form(CNF),CNF的信息主要包括产品品牌和名称，产品说明，通报人信息：（通报者可以是制造商、进口商或他们的代表人），名称,地址, 邮编,联系人名字,邮箱, 电话；产品成分等。CNF 的审核通过后，加拿大卫生部会发放化妆品号Cosmetic Number (CN)，和相关案例和提交编号Case and Submission numbers。
加拿大化妆品通报是不收官方费用的和年费的
化妆品：按规定，化妆品销售时必须通知卫生部，产品不得含有禁止成份，同时包装说明必须符合要求。总的来说，化妆品的要求不象保健品那么严格，如厂家无须通过GMP认证。不过如果化妆品具有一定疗效，同时含有医药成份，则会被归为保健品或药品监管，销售前需要申请NPN或DIN批号。这点可能很多人会忽略，以致带来不必要的麻烦。特别是有华人开发的中草药护肤品，具有一定疗效且含有中草药成份，很大可能需要按保健品申报，却仍然按化妆品销售，实际上已经违反卫生部规定。
1.化妆品中含有化妆品成分热表Cosmetic Ingredient Hotlist上的成分；如果化妆品中含有出现在热名单上的成分，加拿大卫生部可能会联系通报人以获取更多的信息，并可能会采取些合规行动化妆品含有影响产品分类的成分。种情况，化妆品通报将被转到到加拿大卫生部的另一个项目负责组跟进；
2.产品在产品名称、标签或网站上有治疗效果的描述。化妆品不能有与之相关的治疗效果的宣称。这种宣称可能导致产品被归类为药品或天然保健产品，根据《食品药品法》及其规定。这包括在产品名称、产品标签或在公司网站上找到的产品广告中的治疗效果的宣称。
3.成分浓度不正确；
4. 通报表里的化妆品名称或成分列表与提交的标签不一致;
本指令适用于三种不同的情况。它们是：
一. 申请人只有在其已获得生产、包装、标签和/或进口天然保健品的场所许可证，并在其产品线中添加洗手液（打算向公众出售）时，只需要产品许可证。
二. 当申请人目前正在制造、包装、贴标签或进口含酒精的洗手液，而不是将其分发给另一方或出售给公众，但有意这样做时，只需要现场许可证。
三. 不是生产或进口天然保健品（如酒厂）的公司，如果想向公众生产和销售含酒精的洗手液，则需要获得产品和现场许可证。
This directive applies to three separate scenarios. They are:
1. An applicant would require a Product Licence only if they already have a site licenced for manufacturing, packaging, labelling and/or importation of Natural Health Products and they are adding a hand sanitizer to their product line, which they intend to sell to the public.
2. An applicant would require a Site Licence only if they are currently manufacturing, packaging, labelling or importing alcohol-based hand sanitizers, and not distributing them to another party or selling them to the public but intends to do so.
3. Companies that do not manufacture or import Natural Health Products (e.g. a distillery) and would like to manufacture and sell alcohol-based hand sanitizers to the public would need to get a Product and Site Licence.
按以下所述，要求申请公司提供一份附信，说明它们是否正在申请产品许可证、现场许可证或两者兼而有之。
To proceed as described below, companies are asked to provide a cover letter indicating whether they are applying for a Product Licence, a Site Licence, or both.
本指令仅适用于含以下药物成分的酒精洗手液：
-乙醇（60-80%v/v），又称无水乙醇、乙醇、谷醇
-异丙醇（60-75%v/v），又称异丙醇，2-丙醇
This directive only applies to alcohol-based hand sanitizers containing the following medicinal ingredients:
- Ethanol (60-80% v/v), also known as anhydrous alcohol, ethyl alcohol, grain alcohol
- Isopropanol (60-75% v/v), also known as isopropanol, 2-propanol
公司必须持有自然产品编号（NPN）和现场许可证（SL），才能生产和向公众销售上述洗手液。请注意，生产天然保健品成品需要许可证，如果你只是生产原材料，则不需要许可证。
Companies must hold a natural product number (NPN) and a site licence (SL) before manufacturing and selling a hand sanitizer as described above to the public. Please note that a licence is required for the production of finished natural health products, and is not required if you are only producing raw materials.
