On April 20, 2018, the sections of Vanessa's Law that grant powers to the Minister to require assessments, tests and studies, and to create appropriate regulations came into force. The accompanying Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) came into force on April 23, 2018 other than the provision relating to foreign risk reporting requirements which will come into force on October 23, 2018.
The amendments to the Regulations, among other matters:
- Establish a framework to require assessments, tests and studies (see also consequent revisions to Health Canada's Amendments to the Food and Drugs Act: Guide to New Authorities (power to require and disclose information, power to order a label change and power to order a recall));
- Support post-market safety through imposing notification requirements for foreign incidents which must be reported within 72 hours (see also Draft Guidance Document for Notifying Health Canada of Foreign Risk, with the final Guidance expected soon); and
- Eliminate the requirement for filing clinical case reports in a filed submission or supplement, unless requested by the Minister, in order to alleviate administrative burden.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.