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.
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.
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.
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.