Natural and Non-prescription Health Products Directorate (NNHPD) six-month calendar of activities: July to December 2015

This calendar presents an overview of anticipated NNHPD review activities, publications, workshops and meetings for the period covering July to December 2015.

The Directorate will make every effort to complete the following list of activities within the timeline provided; however, projects may change or be delayed due to shifting priorities.

This document is intended to supplement other information on activities provided by the NNHPD. Visit us at What's New to find information on new and recent releases.

1.0 Consultations

Some of the documents listed below may be published in final form during the same six-month period, depending on the length and timing of consultations.

Consumer Health Products (CHP) Framework

Further to the Ministerial announcement on June 9, 2014, Health Canada consulted on a consumer health product framework. The consultation was launched on November 27, 2014, and closed on February 27, 2015. This framework seeks to establish a consistent and aligned approach to the regulation of health products intended for consumer use (disinfectants, natural health products, non-prescription drug products and cosmetics). The NNHPD continues to analyse the comments. A document summarizing what was heard during the consultation will be posted in the summer of 2015.

New Pre-cleared Information

• Origanum vulgare Leaf essential oil (oregano essential oil) Monograph (almost finalized)
• Ulmus rubra bark (Slippery elm bark) Monograph (almost finalized)
• Fiber Monograph
• Yellow dock - Rumex crispus Monograph
• Red clover - Trifolium pratense Monograph
• Yarrow - Achillea millefolium Monograph
• Pau d'Arco - Handroanthus heptaphyllus/impetiginosus Monograph
• Nasal rinse Monograph
• Topical Anesthetic/Analgesic/Antipruritic Labelling Standard (will be finalized based on comments received from consultation)
• Docusate Sodium Labelling Standard (will be finalized based on comments received from consultation)
• Dextromethorphan - Adult Labelling Standard (will be finalized based on comments received from consultation)
• Phenylephrine - Adult Decongestant Labelling Standard

Updates to existing Pre-cleared Information on:

• Antiseptic Skin Cleansers Monograph (will be finalized based on comments received from consultation)
• Acne Therapy Monograph

The NNHPD will be examining a new approach to monograph development. This may include updates to existing monographs beyond those listed above, based on publicly available information submitted in product licence applications.

Management of product licence applications for natural health products policy

As a result of the pilot project, announced via RSS feed in August of 2014, the NNHPD has been exploring an expansion of the Class II definition. Based on the pilot results the NNHPD will be consulting on an updated management policy which will include proposed class definitions as well as other updates.

Chemicals Management Plan (CMP)

The CMP is a Government of Canada initiative aimed at reducing environmental and human health risks posed by chemical substances listed on the Domestic Substances List, and develops and implements measures to manage those risks. Some substances that are assessed under the CMP are used as ingredients (medicinal or non-medicinal) in natural and non-prescription health products.

Notices containing the summary of the draft screening assessments are published for a 60-day public comment period in the Canada Gazette, Part I. The notices also provide information on how to submit comments following publication. For the latest news on actions being taken by the Government of Canada to assess and manage chemical substances, including notification that a draft screening assessment has been published, subscribe to the  Government's Chemical Substances.

Upcoming publications that may be of interest to the NNHPD stakeholders:

• Selenium and its compounds - summer 2015; and
• Boron-containing substances - fall 2015.

2.0 Final Publications

• Final versions of the site licensing documents (Site Licensing Guidance Document, Good Manufacturing Practices (GMP) Guidance Document and Quality Assurance Report (QAR) Form) that incorporate comments received during the 90-day consultation period held in 2014 will be posted in late summer/early fall 2015.

3.0 Workshops and meetings

• Ongoing bilateral meetings with stakeholder associations:
  Consumer Health Products Canada, Canadian Health Food Association, Canadian Homeopathic Pharmaceutical Association, Canadian Natural Products Association, Canadian Cosmetic, Toiletry and Fragrance Association, Canadian Consumer Specialty Products Association, Direct Sellers Association, Traditional Chinese Medicines Community
  
• Meeting of the Advisory Council on Traditional Chinese Medicines

4.0 Update from previous calendar

• Between January and June, 2014, Health Canada launched consultations on a revised approach to site licensing. Consultations on the final element of the approach ended September 2014. Feedback from this small pilot project will be considered as Health Canada advances initiatives related to the Consumer Health Products Framework.
  
• Since the Non-prescription Drug Monograph Attestation pilot project began in August 2014, a number of challenges have been identified. As such, the NNHPD will communicate some upcoming changes to the pilot with stakeholders in the near future. Until then, as previously noted, sponsors should continue to submit applications through the attestation process