Natural Product Number 是全天然保健品通过验证的证明号码
按照加拿大卫生部(Health Canada)规定，2014年9月1号起，所有加拿大进口、生产、销售的自然保健品 (Natural Health Products, NHPs)都需要获得加拿大卫生部的自然产品批号(Natural Product Number, NPN)或者顺势疗法药品批号(Homeopathic Medicine Number, DIN-HM)。除NPN及DIN-HM批号外，加拿大卫生部同时要求所有自然保健品生产、进口、贴标、包装、运输及存储的地点都需要符合加拿大优良生产标准Canadian Good Manufacturing Practices (GMPs) for NHPs。
加拿大自然保健品批号Natural Product Number(NPN)认证
加拿大优良生产标准Canadian Good Manufacturing Practices (GMPs)认证
Applying for NPN vs DIN
In order to sell a topical hand antiseptic in Canada, market authorization from Health Canada is required. The NNHPD Antiseptic Skin Cleansers (Personal Domestic Use) monograph (2018)<http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=antiseptic_antiseptique&lang=eng> describes the requirements necessary to receive market authorization for topical antiseptic hand cleansers intended for domestic personal use only (i.e. not commercial use).
Hand antiseptic products are regulated under the Food and Drugs Act <https://laws-lois.justice.gc.ca/eng/acts/f-27/> as either natural health products (NHPs) or non-prescription drugs (NPDs), depending on the active ingredients they contain. If all of the active ingredients in the health product are classified as NHP ingredients (e.g. ethanol, isopropanol), then the product is subject to the Natural Health Products Regulations<http://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-196/> (NHPR), where a Natural Product Number (NPN) is required for sale in Canada. If the product contains an active ingredient that is classified as a drug (e.g. benzalkonium chloride, chlorhexidine gluconate, benzethonium chloride, chloroxylenol, triclosan), then it is subject to the Food and Drug Regulations<https://laws-lois.justice.gc.ca/eng/regulations/c.r.c.%2C_c._870/index.html>, where a Drug Identification Number (DIN) is required for sale in Canada. Please note that a hand sanitizer cannot hold an NPN and DIN simultaneously.
Please see below information regarding how to apply for market authorization should your product meet the definition of either an NHP or NPD.
NATURAL HEALTH PRODUCTS
The Natural Health Products Management of Applications Policy<https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-health-products/legislation-guidelines/guidance-documents/management-product-licence-applications-attestations.html> (NHP MAP) outlines the process applied by NNHPD to manage Product Licence Applications (PLA) for NHPs submitted in accordance with the Natural Health Products Regulations<http://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-196/> (NHPR).
As indicated above, applicants may refer to the NNHPD Antiseptic Skin Cleansers (Personal Domestic Use) monograph (2018)<http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=antiseptic_antiseptique&lang=eng> for topical hand sanitizer NHPs that are intended for domestic personal use.
To proceed with the Expedited Access process, follow the steps outlined in the Guide on Health Canada’s interim expedited licensing approach for the production and distribution of alcohol-based hand sanitizers<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/covid-19-expediated-licensing-alcohol-hand-sanitizer.html>.
Applications that go beyond the parameters of the monograph (such as making additional or differently worded claims, missing risk information or directions for use) or applications which are not compliant to the monograph will be prioritized but are not eligible for the expedited licensing process described in the Guide<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/covid-19-expediated-licensing-alcohol-hand-sanitizer.html> referred to above. As such, provide supporting evidence of safety, efficacy and quality (including a Finished Products Specification form<https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/forms-templates/finished-product-specifications-form.html>) in order to proceed for further review. For more information on the requirements for these types of applications, please refer to Health Canada’s NHP Management of Applications Policy<https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-health-products/legislation-guidelines/guidance-documents/management-product-licence-applications-attestations.html> (NHP-MAP, 2019).
For products that are classified as NHPs and are intended for personal use in a commercial or institutional setting (e.g. workplaces, washrooms in public buildings), applicants can apply for market authorization outside of the monograph stream (i.e. Class III). Please refer to Section 3-Classes of Applications<https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-health-products/legislation-guidelines/guidance-documents/management-product-licence-applications-attestations.html#3> of the NHP MAP for more information on the classes of NHP applications and the application process.
A site licence is required to manufacture, package, label, or import a NHP for sale in Canada. Please refer to the Site Licensing Guidance Document<https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/site-licensing-guidance-document.html#a1.4> for additional information.
Should you require more guidance on how to apply for an NHP licence, please see attached document titled “Natural Health Product Application Steps”
Finally, for applicants who are unsure if their product is a natural health product (NHP), please refer to section 4.4 Product Classification Request<https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-health-products/legislation-guidelines/guidance-documents/management-product-licence-applications-attestations.html#4.4> of the NHP-MAP.
As Health Canada is prioritizing COVID-19 related applications (for both product and site), when submitting your application through ePost please clearly identify that your application is COVID-19 related. Please ensure that you completely meet our product licence application requirements prior to submitting, in order to facilitate an expedited review. Please note that information regarding the expedited performance standard for these submissions will be made available shortly (e.g. for Class I, 10 days).
For natural health products applications:
NNHPD will issue a decision for product and site license applications within four business days after the application is deemed complete (e.g., after the final Information Request Notice response has been reviewed). Applications or requests received after close of business on Fridays will be processed on the following Monday.
Non-alcohol based hand sanitizers
In order to sell a non-prescription (commonly referred to as over-the-counter, OTC) drug in Canada, a Drug Identification Number (DIN) is required. The Food and Drug Regulations set out requirements for approval for sale and issuance of a DIN for a drug in Canada. Additionally, as a standard requirement, a drug establishment licence<https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establishment-licences-drug-establishment-licensing-fees-0002/GUI-0002-ENG.pdf> is required to conduct licensable activities (e.g., fabricate, package, label, test, import, distribute, or wholesale) related to a drug. However, Health Canada is currently exempting the requirement for a drug establishment license for hand sanitizers and disinfectants, as an interim measure during the COVID-19 crisis. But hand sanitizers with a DIN must be manufactured under the good manufacturing practices (GMP) conditions - as described in Section C.02 of the Food and Drug Regulations<https://laws-lois.justice.gc.ca/eng/regulations/c.r.c.,_c._870/index.html>.
Please refer to the following information including the steps, requirements, review timelines and fees for a DIN application for hand sanitizers.
Companies that wish to manufacture, package, label or import non alcohol hand sanitizers need to obtain DIN. The process outlined below only applies to domestic manufacturers of hand sanitizers related to the COVID-19 response and does not alter the regulatory process currently in place for other types of health products.
To manufacture hand sanitizer drug products during the COVID-19 crisis
Hand sanitizers containing the following single ingredients must apply for a Drug Identification Number (DIN):
- Benzalkonium chloride (0.1-0.15%)
- Benzethonium chloride (0.05-0.5%)
- Chlorhexidine gluconate (2-4%)
- Chloroxylenol (0.5-3%)
- Triclosan (0.1-1%)
To obtain a Drug Identification Number (DIN), the following steps must be completed:
For hand sanitizers for personal domestic use containing drug ingredients, a submission attesting to the Antiseptic Skin Cleansers (Personal Domestic Use) monograph (2018)<http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=antiseptic_antiseptique&lang=eng> can be submitted if the ingredients, claims and conditions of use comply with those specified in the monograph. Health Canada will expedite review of these submissions. No additional claims outside the monograph are permitted through this filing stream (e.g. antiviral efficacy, organism specific claims).
To apply for a DIN attesting to the Monograph, include the following:
- A completed drug application form (HC3011) found here<https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/applications-submissions/hc3011_sc3011-2020-eng.pdf>
- A certificate attesting to a Category IV drug monograph submission found here<https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/attestation-eng.pdf>
- Labels and Packages certification form for non-prescription drugs found here<https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/forms/labels-packages-certification-form-non-prescription-drugs.pdf>
- A completed fee form<https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/forms/drug-submission-application-fee-form-human-and-disinfectant-drugs-eng.pdf> and necessary fees (currently $1,616 as of April 1, 2020)
- Label mock-ups for the product.
- A cover letter that highlights COVID-19 in the subject line.
Please see the Management of Drug Submissions<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/management-drug-applications-2019/document.html#a90> Guidance Document outlining the submission process. Application are accepted on media as defined in the Guidance or you can submit your application electronically, please refer to Filing Submissions Electronically<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/filing-submissions-electronically.html>
In addition, please consult the Common Electronic Submissions Gateway guidance<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/common-electronic-submissions-gateway.html>, and FAQs<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/common-electronic-submissions-gateway/frequently-asked-questions.html>. Please see the current and revised fees<https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/pharmaceutical-submission-application-review-funding-fees-drugs-health-products.html> effective April 1, 2020.
For non-eCTD electronic submissions, courier your application on an acceptable media format as indicated in the Guidance Document: Preparation of Drug Regulatory Activities in the 'Non-eCTD Electronic-Only' Format<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/common-technical-document/updated-guidance-document-preparation-regulatory-activities-non-ectd-electronic-only-format.html> to the address below:
Office of Submissions and Intellectual Property
HPFB, Address Locator 0201A1
Finance Building, Loading Dock 3
101 Tunney’s Pasture Driveway,
Ottawa, Ontario K1A 0K9
Questions regarding DIN applications outside of the submission process should be sent to NNHPD at email@example.com<mailto:firstname.lastname@example.org>
***Drug submissions are not accepted via email***
Ingredients listed above are included in Health Canada’s Antiseptic Skin Cleansers (Personal Domestic Use) monograph<http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=antiseptic_antiseptique&lang=eng>. A monograph sets out pre-cleared information for a product, including ingredients and including permissible uses, and is used to support the licensing of certain drugs. A product that matches the conditions described in this monograph can submit an application attesting to the Monograph. If the ingredients or their concentrations, or use conditions do not match, an application should be filed outside the monograph with supporting data.
Applications that are administratively complete and that fully comply with the monograph will receive an expedited review within 10 business days, assuming responses to clarification requests are received within 24 hours. For all other applications that fall outside of the monograph, an expedited review of 52 days will be applied for applications associated with COVID-19 that require a full evidence package.
Should you require more guidance on how to apply for DINs, please contact the Office of Submissions and Intellectual Property (OSIP) at:
If the proposed product does not align with the Monograph (e.g., different ingredients, different concentration of medicinal ingredients than allowed in the Monograph, making pathogen specific claims, different use conditions such as commercial or institutional use etc.), a submission outside the Monograph stream is required. If the product contains ingredients not listed in the Monograph, seeks certain efficacy requirements, or is intended for use in healthcare settings or food-handling facilities, the submission requires additional data to demonstrate safety and efficacy of the product under the proposed conditions of use. Data requirements for such applications are outlined in the Human-Use Antiseptic Drugs guidance document<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/human-use-antiseptic-drugs.html>. Applicants interested in getting authorization outside the scope of the Monograph are encouraged to get product specific advice by contacting NNHPD general inquiries at:<mailto:hcXXXXXXc@XXXXXXa>
Drug Establishment Licences
Under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19<https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/covid19-interim-order-drugs-medical-devices-special-foods.html>, Drug establishment licences in respect of drugs that are not pest control products and that are intended to reduce or inactivate pathogenic microorganisms on human skin do not apply.
While hard surface sanitizers for food industry are assessed by the Food Directorate, Hard Surface Disinfectants, with claims, are assessed by the Natural and Non-Prescription Health Products Directorate. Please see the information below regarding the application process for such products.
To seek market authorization for hard-surface disinfectants, the following options apply:
1. If the product is NOT currently marketed, but the sponsor has data to support indirect or direct claims against coronavirus in accordance with the efficacy requirements of the Guidance Document – Disinfectant Drugs<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/disinfectant-drugs.html#a232>, then an application must be submitted for full review (DIND with data or NDS depending on the ingredients and claims – fee = $XXXXX). A full review must demonstrate the minimum bacterial efficacy prior to any other claims. These applications will be subject to an expedited review for COVID-19 associated claims. If the DIN application contains claims against other pathogens, they may be reviewed at a later date.
1. If the ingredients are in accordance with the Hard Surface Disinfectants Monograph<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/hard-surface-disinfectants-monograph-revised.html>, then a DIND application attesting to the monograph will be submitted. No broad spectrum virucide, direct or indirect COVID-19 claims are permitted in the absence of data, and such your product will not be added to Health Canada’s list of hard-surface disinfectants for use against coronavirus (COVID-19)<https://www.canada.ca/en/health-canada/services/drugs-health-products/disinfectants/covid-19/list.html> – if this is desired you must use the full review option above
* For monograph submissions you will require:
i. A completed drug application form (HC3011) Health Canada 3011: Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation<https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/applications-submissions/hc3011_sc3011-2020-eng.pdf> (Guidance for Completing the Drug Submission Application Form<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/forms/guidance-completing-drug-submission-application-form-2019.html>), and follow the guidance<https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/for