An Update on Vanessa’s Law
May 23, 2018

by: Katie Lee

This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), 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
the Act
In force Associated
Regulations
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

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)

Guidance Document - Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act

Completed requests for disclosure of confidential business information under s. 21.1(3)(c) of the Food and Drugs Act

(see article)

Authorizing powers to order label changes and recalls (s. 21.2, 21.3 of the FDA) Nov 6, 2014 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)
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 Regulationsexpected to be pre-published in 2019

Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products - Guidance for industry

Questions and Answers: Prescription Opioids – Sticker and Handout Requirements for Pharmacists and Practitioners
(see article)

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 will come into force October 23, 2018  (see article) Draft 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

Proposed  Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information)

(see article)

Public Release of Clinical Information – Draft Guidance Document

(see article)

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
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 Regulationsexpected to be pre-published in 2019

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)

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.

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