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Drugs and Health Products

Natural and Non-prescription Health Products Directorate (NNHPD) Upcoming activities: May 1, 2017 to September 30, 2017

The following is an overview of anticipated NNHPD consultations, review activities, publications, workshops and meetings, for the period covering May 1, 2017 to September 30, 2017.

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.

The NNHPD has created a new web page for Canadians which will act as a central hub for all information related to the regulation of self-care products. Stay in the know and take a few moments to visit this new page, available at: www.Canada.ca/selfcare-products.

Upcoming activities: May 1, 2017 to September 30, 2017

1. Consulting Canadians on the Regulation of Self-Care Products in Canada

Building on the fall 2016 online consultation, the NNHPD is further engaging consumers and other stakeholders on the development of a modernized approach to regulating self-care products during this activity period. This will include in-person and online consultation sessions on a refined policy proposal. For more information and to register for consultation sessions please visit: www.Canada.ca/selfcare-products.

2. Consulting Key Stakeholders on Updates to the Natural Health Products Online System

The NNHPD is exploring updating and enhancing its Natural Health Products Online System to release improved web enabled application forms. Between May and July 2017, NNHPD will put a call out through industry associations seeking key stakeholder participation in an engagement session to discuss end-user needs and updates to the online system. This engagement will assist in ensuring that any changes add value and meet the needs of end users while also satisfying the program's regulatory requirements.

3. Disinfectants/Sterilants/Sanitizers/Cleaners

The NNHPD is working collaboratively with the Pest Management Regulatory Agency (PMRA) and the Healthy Environments and Consumer Safety Branch (HECSB) to examine the oversight for disinfectants, and post-implementation of the proposed framework for self-care products. In the short-term, the NNHPD and the PMRA are exploring possible efficiencies in the pre-market review for dual-registration products. A progress update will be provided to interested stakeholders during upcoming bilateral and multilateral meetings.

4. Monograph Publication

The NNHPD is examining its strategic approaches to monograph development. This includes considerations for the finalization of monographs in draft, updates to existing monographs that improve clarity and comprehension, and development of new monographs to further support licensing efficiencies.

Stakeholders will continue to be consulted on newly published and anticipated revisions to existing monographs, as identified within the Calendar of Activities. However, unanticipated revisions, such as those identified through various pharmacovigilance activities, will continue to be published without consultation.

The following monographs are scheduled to be posted between May 1 and September 30, 2017.

  • Multi-Vitamin/Mineral Supplements
  • Antioxidant
  • Cognitive function products
  • Green Tea Extracts
  • Selenium
  • Chlorella
  • Devil’s Claw

Additionally, a number of monographs are being updated to reflect consistent recommendations on appropriate solid dosage forms for children less than 6 years of age.

5. Guidance Documents

The NNHPD will publish a Questions and Answers document on Plain Language Labelling for non-prescription drugs, which will include information on Brand Name Assessment. The intent is to publish this document in May 2017.

Similarly, the revised Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPPG) will be posted by May 31, 2017. In addition, draft guidance on URL naming conventions and web publishing standards is slated to be published within the same timeframe for consultation.

6. Bilateral and Multilateral Meetings

Bilateral meetings will be held to encourage dialogue between the NNHPD and its key industry and healthcare practitioner stakeholders. Where needed, bilateral meetings are being scheduled on the margins of the self-care products consultation process and should be held over the coming months.

The nine associations included in the NNHPD’s bilateral program will be invited to a multilateral meeting in the fall of 2017.

7. Chemicals Management Plan (CMP)

The CMP assesses environmental and human health risks posed by chemical substances, and develops and implements measures to prevent or manage those risks. Some substances that are assessed under the CMP are ingredients (medicinal or non-medicinal) in natural and non-prescription health products.

Draft screening assessments are published for a 60-day public comment period in the Canada Gazette. Information on how to submit comments will accompany the draft screening assessments. If you would like to be notified when draft screening assessments are published, you can subscribe to receive the latest news on the Government of Canada's chemical substances website.

8. Compliance Monitoring Projects

The Regulatory Operations and Regions Branch (RORB), in response to the evaluation of the Natural Health Products Program, implemented a pro-active compliance monitoring project that pilots on-site inspection of Good Manufacturing Practices (GMP) compliance for manufacturers and importers of natural health products. Follow-up based on the findings of the site visits is ongoing. Information on the project will be posted online later this year.

9. Additional Directions of Use for Children’s Dosage Forms

Natural health products with solid dosage forms, such as tablets and capsules, may not be suitable for children less than 6 years of age if the product label does not provide specific instructions of use. Between May and August 2017, NNHPD will determine whether licensed products have appropriate dosage forms for children and will request specific instructions for use in children to be added to the label of already licensed products. Additionally product monographs will be updated to include guidance on appropriate dosage forms for children.