27 NNHPD Monograph Updates, Deadlines & Performance Standards Changes

27 NNHPD Monograph Updates, Deadlines & Performance Standards Changes

September 21, 2018 By

In this report—27 monograph updates + a notice of extended licence processing timelines from Health Canada  

1. Green Tea Extract Monograph Update

 

In November 2017, the NNHPD made revisions to risk information for the Green Tea Extract monograph, based on a Health Canada safety summary review for products containing Green Tea extract that identified the need for more cautionary statements for this ingredient.

The changes applicable for this ingredient were indicated in bold as follows, in order to enhance the previous risk information:

 

  • If you have a liver disorder, consult a healthcare practitioner prior to use. Stop use if you develop symptoms of liver trouble such as yellowing of the skin/eyes (jaundice), stomach pain, dark urine, sweating, nausea, unusual tiredness and/or loss of appetite and consult a healthcare practitioner.

 

Plus, addition of the following risk information:

 

  • Rare, unpredictable cases of liver injury associated with green tea extract-containing products have been reported (in Canada and internationally).

 

Submitting a Green Tea Monograph Attestation Form and labelling of the revised green tea extract risk statements is required for all marketed products with this medicinal ingredient—and has a deadline of November 14, 2018.  The attestation is to be signed by the Senior Official of the licence holder/company to confirm awareness of making the above noted updates to the product licence and label. The attestation form requests the quantity per dosage unit of green tea extract and of the Epigallocatechin gallate (EGCG) provided from the green tea extract. If the attestation form is not submitted, or product labels are not updated by this date, further compliance and enforcement action may be initiated by the NNHPD (i.e. section 16 notice).

 

3. More NNHPD Monograph Updates

The NNHPD has revised 26 of their monographs by making various changes for each, including changes to the “statements to the effect of” for claims, warnings and other product statements. Please see the following list of monograph updates for any new submissions you may be compiling or for any updates you are looking to make for your existing product licence/s:

 

3. Updates for Licence Application Performance Standards

In June 2018, the NNHPD communicated a Notice to Industry regarding improving the efficiency and predictability of the management process for Natural Health Product Licence Applications. This decision to revise the standards was based on various considerations, such as higher application volumes, deficient applications, increased paper submission, etc… In the Notice, the NNHPD indicated updates to their review timelines as follows, notably affecting the Class 1 and Class 2 submissions timelines:

      • Class 1 Application – 60 day review period (previously 10 days)
      • Class 2 Application – 90 day review period (previously 30 days)
      • Class 3 Application – 210 day review period (no change)

 

For more assistance in determining if your product requires label updates, or if you are interested in filing an amendment to your existing licence based on the updated NNHPD monographs, contact dicentra for assistance and for more information.

 

dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products. We can be reached at 1-866-647-3279 or info@dicentra.com.