NHPD Issues Proposed Changes to the existing Compendium of Monographs Guidance Document, seeks Stakeholder Feedback

September 16, 2013 By

NHPD has released a revised Compendium of Monographs Guidance Document. This document is open for comment until October 26, 2013.

The NHPD has issued a revision to its Compendium of Monographs Guidance Document. The revision was based on changes resulting from the final Quality of Natural Health Products Guide (see our previous news item from July 15, 2013). The Compendium of Monographs, version 2.1 (November 2007) is being replaced by the revised draft guidance document Compendium of Monographs, version3.0 (June 2013). The revised document is available on the NHPD web site. This consultation is open for comment from August 28, 2013 until October 26, 2013.

Stakeholders are urged to review the draft guidance document and provide NHPD with comments. There are several changes incorporated into the new document, including a new listing of the types of monographs available to industry when filing new Product Licence Applications. It is important to provide feedback during these consultations so that NHPD can gauge the impact to industry of any proposed changes. Dicentra’s staff of regulatory experts can assist you with completing your compendial applications and advise when a compendial application is the correct choice.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or info@dicentra.com