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    • Introduction
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      • Requirements of Health Authorities
      • Drug Application Process
      • Meeting with Health Authorities
      • Electronic Common Technical Document (eCTD)
      • Register of Innovative Drugs
      • Submissions Comparing to Innovative Drugs
      • Product Monograph
      • Drug Label Compliance
      • Filing of Information and Material to Health Authorities
      • Evaluation of Submissions
      • Pharmacovigilance
    • Natural Health Products
      • NHP Documentation Review
      • NHP Product Registration Submissions
      • Natural Health Product Site Licence
    • Medical Device
      • Medical Devices Services
      • Medical Device Application Process
      • Medical Device class II, III and IV
  • Market Expansion Services
  • Contact Us
Atinza Canada Inc.Atinza Canada Inc.
  • Home
  • Global Regulatory Affairs Services
    • Introduction
    • Pharmaceutical
      • Requirements of Health Authorities
      • Drug Application Process
      • Meeting with Health Authorities
      • Electronic Common Technical Document (eCTD)
      • Register of Innovative Drugs
      • Submissions Comparing to Innovative Drugs
      • Product Monograph
      • Drug Label Compliance
      • Filing of Information and Material to Health Authorities
      • Evaluation of Submissions
      • Pharmacovigilance
    • Natural Health Products
      • NHP Documentation Review
      • NHP Product Registration Submissions
      • Natural Health Product Site Licence
    • Medical Device
      • Medical Devices Services
      • Medical Device Application Process
      • Medical Device class II, III and IV
  • Market Expansion Services
  • Contact Us

Natural Health Products

Home Natural Health Products
What are Natural Health Products?

Under the Natural Health Products Regulations, which came into effect on January 1, 2004, natural health products (NHPs) are defined as:

  • Vitamins and minerals
  • Herbal remedies
  • Homeopathic medicines
  • Traditional medicines such as traditional Chinese medicines
  • Probiotics
  • Other products like amino acids and essential fatty acids

NHPs must be safe to use as over-the-counter products and not need a prescription to be sold. Products needing a prescription are regulated as drugs under the Food and Drug Regulations.

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NATURAL HEALTH PRODUCT LICENSING
All NHPs must be licensed by Health Canada before they are allowed to be legally sold to Canadians. The application must include sufficient evidence to support the safety, efficacy and quality of the NHP.

Atinza will assist you at every stage of the complex and often confusing product licensing process, from conducting scientific literature reviews to support safety and efficacy to completing, submitting and managing the application through liaison with the NNHPD on your behalf.Read More

TECHNICAL LABEL REVIEW
Labelling of natural health products is strictly controlled by Health Canada and is indispensable content of Product Licence Application. It must include but not limited to ingredient nomenclature, dosing and risk information, substantiated health claims and bilingual labeling in English and French. To ensure your label is favored for marketing but at the same time totally complies with current regulation is what we strive for.Read More
SIMPLIFIED PROCEDURES FOR OBTAINING LICENCE
After both parties sign mutual CDA, we will review the formulation of the products that is being prepared to license in Canada as NHP. If the formulation is satisfactory, we will send you quotation for our services. Once the quote is accepted, you will send us signed DPA – Designated Party Authorization form for which Atinza can contact Health Canada on your behalf. Application for the NHP will be submitted to Health Canada. Natural Product Number (NPN) has been granted, we will complete a label compliance review to complete our service.Read More

SITE LICENCES

Site Licence is required for importers, manufacturers, packagers and labellers in Canada who involves in any step of life cycle of Natural Health Products. Atinza support clients to provide required evidence that their facilities have proper processes in place; including receiving natural health products, a clean premises with a good sanitation program, an up to date recall system in place. All activities are recorded according to current GMP procedures.

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Identify your Canadian importer

Your Canadian Importer also needs to have Site Licence. If they do not currently have one, we will provide service to obtain them a Site Licence.  Standard Operating Procedures (SOPs) and executed records is required to submit to Health Canada. We will work with your importer to ensure proper documents are arranged and meet Canadian’s regulation.

Manufacturers & Warehouses

All other entities that involves with the product should also provide documents evidencing their compliance with GMP standards. These entities include, but not limited to, foreign manufacturers, warehouses. Atinza will work with these facilities to ensure proper documents are arranged as they are part of the application for importer’s site licence with Health Canada.

Obtaining approval from NNHPD

We will submit application to Natural and Non-Prescription Health Products Directorate (NNHPD) for assessment. We will follow and inform you for any inquiry raised by NNHPD. We will work with your sites to ensure you understand and meet requirement of NNHPD. After the application is granted, your Canadian importer is eligible to receive your licensed NHPs.

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Please let us know if you have any inquiries.

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