A survey conducted by Health Canada in 2005 revealed that 71% of Canadians use natural health products ("NHPs") on a regular basis. These products include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics, and other products like amino acids and essential fatty acids. Since 2004, NHPs are regulated under the Natural Health Products Regulations (the "Regulations") of the Food and Drugs Act (the "Act"). NHPs must receive market authorization from the Natural Health Products Directorate ("NHPD") before they can be sold in Canada.
Currently, there is a backlog of approximately 10,000 licensing applications for NHPs being sold in Canada. The National Association of Pharmacy Regulatory Authorities issued a directive earlier this year advising pharmacists to stop selling NHPs without licences, and the college of pharmacists in a number of provinces followed suit. This led to some pharmacies cancelling orders for unlicenced NHPs.
On August 3, 2010, the National Health Products (Unprocessed Product Licence Applications) Regulations (the "New Regulations") came into force. These New Regulations make it legal to sell unlicenced NHPs on a temporary basis provided that certain conditions are met. Under the New Regulations, the Minister of Health will grant an exemption to a manufacturer of an unlicenced NHP if a product licence application for the NHP has been filed with Health Canada and has been pending for 180 days. For those product licence applications filed with Health Canada before the coming-into-force of the New Regulations, an exemption will be issued within 15 days of the New Regulations coming-into-force or 180 days of the licence application submission, which ever is later.
Unfortunately, the New Regulations do not specify if unlicenced NHPs under exemption can be "advertised". It seems, however, that Health Canada will soon be publishing a guideline allowing such advertising under specific restrictions.
Under the New Regulations, product licence applicants will be notified in writing of the exemption number and the fact that the number will be posted on the Health Canada website (along with the product brand name, and the applicant's name, represented by the company name). Applicants will be given 60 days to consent to the posting of this information and to provide a statement confirming that the product meets specific safety criteria (e.g. the product is not a sterile product for ophthalmic use; the product is not recommended for use in children under 12 years of age, pregnant or breastfeeding women; etc.). Once an exemption number is posted on the Health Canada website, the product licence applicant will be deemed to hold the product licence.
Although exempted from the prohibition to sell without a product licence, these products will be subject to most of the remaining requirements in the Regulations. For example, the on-market safety requirements in the Regulations for licensees to file safety information, to maintain records, and to report adverse reactions, still apply. Moreover, the site licensing and good manufacturing practices requirements in Part 2 and part 3 of the Regulations apply. On the other hand, the requirements to include an NPN or a DIN-HM on the product packaging and labeling do not apply, as such numbers would not have been assigned in respect of these products. Instead, product licence applicants are required to include the assigned exemption number on the label in a reasonable time.
The New Regulations will help the Health Canada Inspectorate remove NHPs without pending licence applications from stores (NHPs without pending licence applications have been the focus of Health Canada's compliance policy along with NHPs that pose an unacceptable health risk). Because of the backlog in applications, inspectors have not been able to differentiate between NHPs that have submitted licence applications and those that have not. Once the backlog is cleared, inspectors will be able to walk into a store and seize products that do not have either a licence number or an exemption number on their labels.
On August 9, 2010, the NHPD released its Management of Product Licence Applications policy document, which sets out new timelines for responding to licensing applications. The NHPD will aim to have applications with pre-cleared information assessed within 60 days. For standard applications that require safety, efficacy, or quality assessments, the NHPD will conduct an initial assessment within 30 days (to ensure the basic paperwork has been filed and verify eligibility), and then a full assessment after 90 days. If the application is not refused, the NHPD may either issue a product licence or an Information Request Notice ("IRN"). The applicant has 30 days to respond to the IRN. If the application is then complete, the NHPD will aim to assess the application within 45 days.
Although the New Regulations are only a temporary solution (they are set to be repealed 30 months after coming into force), and the timelines set out in the NHPD policy document are only targets, together they will hopefully lead to an improvement in the administration and enforcement of the Regulations.