This chart has been updated since its original publication.
This is a special update on Vanessa’s Law, the Protecting Canadians from Unsafe Drugs Act which was approved on November 6, 2014, amending the Food and Drugs Act (“FDA”) and granting new powers to the Minister of Health directed at post-marketing oversight over therapeutic products (drugs, medical devices and drug-device combinations).
There have been many developments since 2014, including passage of certain associated regulations (see our articles in this issue on New regulations governing powers to require assessments, tests and studies and notification of foreign incidents and New regulations governing post-market oversight over opioids) and release of Health Canada Guidance. We have prepared a summary chart of the current status of the coming into force of key provisions under the Act, associated Regulations, and related Health Canada Guidance. That chart includes links to previously published articles, and our current articles on the new regulations. We will continue to report updates as further regulations and guidance arise.
Amendments to | In force | Associated | Associated Health Canada Guidance |
Authorizing disclosure of confidential business information without notifying or consent of the person to whose business the information relates if the product may present a serious risk of injury to human health (s. 21.1 of the FDA) | Nov 6, 2014 | Completed requests for disclosure of confidential business information under s. 21.1(3)(c) of the Food and Drugs Act | |
Authorizing powers to order label changes and recalls (s. 21.2, 21.3 of the FDA) | Nov 6, 2014 | ||
Authorizing creation of regulations to impose terms and conditions on therapeutic product authorizations (s. 30(1.2)(b) of the FDA) | Nov 6, 2014 | Regulations Amending the Food and Drug Regulations (Opioids) – April 23, 2018 (see article) Notice of Intent – Medical Device Regulations – expected to be pre-published in 2019 | Questions and Answers: Prescription Opioids – Sticker and Handout Requirements for Pharmacists and Practitioners |
Authorizing creation of regulations requiring reporting of foreign risks (s. 30(1.2)(d) of the FDA) | Nov 6, 2014 | 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) – relevant provisions came into force October 23, 2018 (see article) | Guidance Document for Notifying Health Canada of Foreign Risk*** |
Authorizing creation of regulations designating when confidential business information ceases to be confidential and disclosing such information (s. 30(1.2)(d.1)-(d.2) of the FDA) | Nov 6, 2014 | Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information)## - March 4, 2019 | |
Imposing elevated penalties for contravening the Act or Regulations (s. 31 of the FDA) | Nov 6, 2014 | ||
Imposing requirements on health care institutions to report serious adverse reactions or medical device incidents and authorizing creation of regulations governing health care institution reporting (s. 21.8, 30(1.2)(h-j), 30(1.3) of the FDA) | June 20, 2017 | Regulations Amending the Food and Drugs Regulations (Importation of Drugs for an Urgent Public Health Need) – June 20, 2017 Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting — Hospitals) – Part I of the Gazette, June 16, 2018* Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals) – Part I of the Gazette, June 16, 2018* | |
Authorizing ordering of assessments, tests and studies and regulations regarding same (s. 21.31, 21.32, 30(1.2)(f.1-f.3) of the FDA) | April 20, 2018 | 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) – April 23, 2018 (see article) Notice of Intent – Medical Device Regulations – expected to be pre-published in 2019 Proposed Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices) — Part I of the Gazette, June 15, 2019### | Format and content for post-market drug benefit-risk assessment in Canada - Guidance document# |
**Updated on July 27, 2018.
***Updated on December 18, 2018
#Updated on February 25, 2019
##Updated on March 27, 2019
###Updated on June 26, 2019
*Updated on July 29, 2018.
If you have any questions or would like further information, please contact a member of our Pharmaceutical and Life Sciences group
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.