Health Canada has proposed regulations that will permit the continued sale of certain natural health products for which product license applications have been filed and are still pending. The proposed regulations have the potential to provide a temporary solution for the estimated 10,000 unprocessed product license applications.
Background
In January 2010, the National Association of Pharmacy Regulatory Authorities (NAPRA) issued a position statement advising pharmacists not to sell marketed health products without a Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM). It was reported that the NAPRA position statement was adopted by some provincial Colleges of Pharmacists including the Ontario College of Pharmacists which indicated its intention to prohibit Ontario pharmacies from selling health products, including natural health products that were not approved for safety and efficacy by Health Canada.
Many in the natural health community felt that the actions of the pharmacists was not reasonable since, in many cases, the completion of the licensing process was outside of their control.
Overview
The proposed regulations would make the sale of products, for which an application was pending, legal through the issuance of a Ministerial exemption. The exemption, granted by the Minister in the form of an exemption number, would stay in effect until the application(s) was withdrawn, processed and a decision to issue or refuse a licence was made, or until the proposed regulations were repealed. The proposed regulations would also assert key safety oversight measures such as adverse reaction reporting, site licensing, and the authority to suspend or stop sales if a safety issue is identified.
Although exempted from the prohibition to sell without a product licence, these products would be subject to most of the remaining requirements in the Natural Health Products Regulation under the Food and Drugs Act (NHPR).
For example, the Minister would have the authority under sections 17–21 of the NHPR to direct an applicant to stop sales of product and to suspend or cancel a deemed licence to prevent injury to health. In addition, the Minister would have the authority under the proposed regulations to suspend a deemed licence if he has reasonable grounds to believe the person has contravened the proposed regulations or if it is later confirmed to be a product that does not meet certain described safety criteria.
The requirements (sections 93 and 94) to include an NPN or a DIN-HM on the product packaging and labelling would not apply, as such numbers would not have been assigned in respect of these products. Instead, product licence applicants would be required to include the assigned exemption number on the label in a reasonable time, and when applicable, in accordance with the requirement for product numbers in these sections. In addition, the numbers must be shown on the label in accordance with sections 88 and 89 of the NHPR, to ensure that exemption number is clearly and prominently displayed, and readily discernible to consumers and retailers. It would be prohibited for an exemption number to be displayed on a label unless the exemption number is posted on the Health Canada Web site.
Site licence information (information regarding importation, distribution, manufacturing, packaging, labelling or storing) would be required before commencing sale of the product. However, if the product is already being sold when it is issued an exemption number, this information would be required as requested by Health Canada, or if the product is an NHP that has been assigned a DIN, within 30 days. For the purpose of compliance and enforcement activities, the applicant would be required to inform Health Canada of the licensed sites.
Final Comments
Health Canada is considering comments on the proposed Regulations until June 7, 2010. We would be pleased to assist in assessing the impact of the proposed regulations or in assisting stakeholders to prepare comments on the proposed regulation or submission to Health Canada.
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