The 6 month calendar of NNHPD activities for natural health products provides updates on new monographs and guidance documents.

The Natural and Non-Prescription Health Products Directorate (NNHPD) has released its current and upcoming calendar of activities and updates for the first half of 2015. As one of the major changes, the NNHPD has highlighted its relatively new role in review of non-prescription (or over-the-counter) and disinfectant drugs, and is working on this alignment over the coming months. Several items for Consultation are expected to be published and are outlined below.

Consumer Health Products (CHP) Framework

Health Canada is consulting on a new framework in order to establish an aligned approach to the regulation of health products for consumer use. The consultation took place from Nov. 27, 2014 – Feb. 27, 2015. The consultation is a result of the Ministerial Notice to Stakeholders in June 2014 which focuses on streamlining certain lower-risk health products (for example, cosmetics) by updating current regulations some low-risk product categories that are currently defined as drugs under the Food and Drugs Act. Under the CHP Framework, Health Canada is also currently evaluating regulations of sunscreens and will consult on additional revisions to the regulations of sunscreen products.

Good Label and Package Practices Guide – Draft Guidance Document for Industry

The development of Good Label and Package Practices Guide is underway by Health Canada and the Institute for Safe Medication Practices Canada (ISMP Canada) and a draft version is anticipated to be posted for consultation in winter of 2015. The Guide document is a result of Health Canada’s Plain Language Labelling (PLL) Initiative, whereby regulations (Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use)) have been introduced to allow for drug labels and packages to be easier to read and understand by consumers. Although natural health products are not covered by the PLL regulations, the Guide offers best practices for language used in labelling and packaging for natural health products.

The following New natural health products monographs have been published or are expected to be published:

• Multi-Oil Monograph
• Fungal Mushrooms Monograph
• Soybean flour Monograph
• Origanum vulgare Leaf essential oil (oregano essential oil) Monograph
• Ulmus rubra bark (Slippery elm bark) Monograph
• Docusate Sodium Labelling Standard Monograph
• Dextromethorphan – Adult Labelling Standard Monograph

The following existing natural health products monographs have been updated or are expected to be updated:

• the Traditional Chinese Medicine Ingredients
• Disinfectants
• the Multi-Vitamin/Mineral Monograph (MVM) and single ingredient monographs for ingredients found on the MVM
• the Topical Anesthetic/Analgesic/Antipruritic Labelling Standard
• the Antiseptic Skin Cleansers
• Homeopathy

Final Versions of the following Documents will be published:

• The Site License Guidance Document
• Good manufacturing Practices (GMP) Guidance Document
• Quality Assurance Report (QAR) Form

Workshops and Meetings

• Stakeholder associations will be holding ongoing bilateral meetings for the following: 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, La Guilde des herboristes, Traditional Chinese Medicines Community
• The Advisory Council on Traditional Chinese Medicines is expected for July 2015

Updates from Previous Calendar of NNHPD Activities

• The NNHPD continues to evaluate the changes that may be made to broaden the Class II application definition, as per the six month pilot program that commenced in August, 2014. As such, the NNHPD will consult on proposed changes to expand the Class II definition and consequently, update the policy on the Management of Product License Applications.
• Health Canada is evaluating feedback from consultations on a revised approach to site licences, and will provide details on the next steps in winter 2015.
• The NNHPD will be consulting with stakeholders on its new Advisory Body structure in spring 2015.
• The NNHPD is evaluating the Non-prescription Drug Monograph Attestation pilot that commenced in August, 2014 and will provide further information to stakeholders in spring 2015.

dicentra will be sure to provide prompt updates regarding developments on the NHP class review system and other notable changes that pertain to the review of Non-prescription drug applications. dicentra can assist License holders for reviewing their natural health products licenses (NPNs) to update and align with the current NNHPD monographs, and may assist in the regulatory review and preparation of Monograph attestation forms for Non-prescription Drug product applications.