Watch for Updates to the Health Canada ePLA in the Spring of 2018!

Watch for Updates to the Health Canada ePLA in the Spring of 2018!

Health Canada is planning to update its process for completing electronic product license applications (ePLAs) for Natural Health Products (NHPs) in the spring of 2018.  These anticipated changes will impact processes for Class I, II and III product license applications, with a goal of improving operational efficiencies, wonderful news for Source and our clients!

For Class I applications, the updated web-based ePLA will only contain pre-populated statements, and will no longer contain an option to select “statement to the effect of” when attesting to pre-cleared monograph claims.  In order to maintain the 10-day review performance standard for Class I applications, if a PLA applicant wishes to use differing wording from the Health Canada pre-cleared monograph claim(s), this will prompt a shift to Class II review for the product.

New guidance on Class II and III applications, as well as updates to the Management of Product License Applications for Natural Health Products Policy, are anticipated for consultation (along with the release of the new ePLA) in the Spring of 2018.  Stay tuned for future issues of the reSOURCE for updates on the management of the ePLA process for Canadian NHP applications!

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