IO No. 2 repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 (IO No. 1) made by the Minister on March 30, 2020 and approved by the Governor in Council (GIC) on April 8, 2020. It extends and modifies certain measures for drugs, medical devices and foods for special dietary purposes introduced in IO No. 1. These measures continue to be necessary to help prevent and alleviate the effects of shortages that are caused or exacerbated, directly or indirectly, by COVID-19.
Some highlights of implications for exceptional importation and sale of drugs, medical devices, and foods for a special dietary purpose under IO No. 2 include, but is not limited to:
- Any importer who is permitted for exceptional importation and sale under IO No. 2 must notify the Minister electronically, in a format that is specified by, or acceptable to, the Minister, at least five business days before importation. These products will still be subject to some of the requirements set out in the Food and Drugs Act and its Regulations, including reporting adverse drug reactions, recall requirements and mandatory problem reporting (medical devices).
- IO No. 2 modifies the definition of a ‘biocide’ that was defined in IO No. 1 so that the term refers only to disinfectants, and not hand sanitizers, which are regulated differently. Many biocides eligible for exceptional import and sale previously will continue to be permitted under the IO No. 2.
- Under IO No. 2, companies wishing to conduct regulated activities related to drug-based hand sanitizers must obtain and have a DEL. Companies who previously conducted such activities without a DEL and who wish to continue conducting licensable activities related to drug-based hand sanitizers will have six months to apply for a DEL. After applying, companies can continue those activities until a determination is made with respect to their applications.
- IO No. 2 no longer permits companies to provide Health Canada with label text in place of a label mock-up as part of an application for a drug identification number (DIN) or a new drug submission on behalf of a drug-based hand sanitizer.
- Under IO No. 2, products that arrive in Canada through exceptional import must have information on the safe conditions of use available in both English and French. Importers wishing to keep their products in the Canadian market will have six months to come into compliance.
For full details on IO No. 2, please refer to the Health Canada webpage. If you have any questions or would like further clarification on how this may impact your company or products, please contact us.