Regulatory
Compliance
Services

Product/Formula
Review

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Label Review
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Translation
Services

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Natural Health
Product Licensing

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Cosmetic
Notification

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Site Licensing
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International Trade
Certificates

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Product/Formula Review

Canada’s Natural Health Product Regulations require all natural health products to be licensed before they are sold in Canada. Unlicensed products may be removed from the market.

To help clients achieve compliance with the Natural Health Product Regulations, Imperia offers a “product/formula review” service which assesses the licensability of the client’s products and provides corrective recommendations.

The client’s natural health products will be reviewed in terms of product classification, type of natural health product, risk factors, manufacturing site requirements, medicinal ingredient requirements, health hazard evaluation, non-medicinal ingredient requirements and animal tissue form requirements.

Based on the product/formula review, Imperia will generate a Product Compliance Report for the client that will include the analysis and one of three conclusions:

  1. Highly probable that product is licensable “as is”
  2. Highly probable that product may be licensed after minor modifications not involving product reformulation
  3. Product may be licensed after major modifications involving product reformulation

Due to its experience and expertise, Imperia recommends itself as the service provider to assist with the product licensing submission and/or product reformulation, as required.

Please note that Imperia cannot guarantee that any NHP will be licensed by NHPD. This depends on the quality of the evidence for product efficacy and safety in support of a product license submission.

Need help with licensing?

Filing a Product License Application in Canada for a natural health product (NHP) can be a complex, time-consuming process. Multi-ingredient products may require dozens of documents (supporting safety, efficacy and quality) and hundreds of pages. Imperia can assist your licensing efforts using PhD medicinal chemistry expertise and a decade of regulatory experience to speed the process and maximize success. Imperia’s own portfolio of 500+ licenses shows its success. Consider Imperia as the best NHP licensing firm to help you with your NHP licensing needs. For assistance, please contact Imperia today.

 

 

 

 

 

 

 

 

 

 


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