New Guidance from Health Canada- Vanessa’s Law

Vanessa's Law

This week Health Canada published two draft guidance documents regarding regulations falling under Vanessa’s Law. Also known as Protecting Canadians from Unsafe Drugs Act, Vanessa’s law amends the Food & Drugs Act through rules strengthening the regulation of therapeutic products, improving the reporting of adverse reactions by healthcare institutions. Vanessa’s Law is also intended to improve the ability of Health Canada to collect post-market safety information and take appropriate action on serious health risks.

Draft Guidance for Notifying Health Canada of Foreign Risk

The proposed amendment to the Food & Drug Regulations would require the holder of an authorization to provide the Minister with information regarding any serious injury to health of which the holder becomes aware, and is relevant to the safety of the drug, within 48 hours of receiving it, or becoming aware of it. This includes information regarding:

  • risks related to a manufacturing issue
  • risks related to a new contraindication or warning
  • changes to the labelling communicated to or requested by certain regulatory authorities
  • recalls conducted within certain foreign regulatory jurisdictions
  • reassessments of market authorizations, which resulted in a change to risk mitigation measures for a drug or the addition of enhanced vigilance requirements
  • the suspension or revocation of manufacturing authorizations (e.g. site licences)
  • the suspension or revocation of market authorizations (e.g. Notice of Compliance (NOC), permission to sell)

The proposed notification requirements will apply to prescription drugs and drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner. The majority of Over the Counter Drugs (OTCs) are exempt from the proposed requirement, with the exception of drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner. This provision captures “ethical OTCs” that are available for emergency use, as well as consumer health products listed in Schedule II of the National Drug Schedules.

Further details on this draft guidance are available here.

Additional Sections – Amendments to the Food and Drugs Act: Guide to New Authorities

This draft document provides guidance on the requirement to reassess and require tests and studies under the powers of Vanessa’s Law. The draft guidance outlines the process for issuing orders and the threshold required to leverage these powers. These provisions apply to all OTCs and orders can be issued when new information received post-market.

The Minister may issue an Order if there are reasonable grounds to believe that:

  • In the case of a Drug Identification Number (DIN) or NOC holder there are significant uncertainties related to the benefits or harms of the drug
  • In the case of an Establishment Licence (EL) holder, the manner in which the holder conducts an activity has introduced significant uncertainties relating to the benefits or harms associated with the drug
  • The authorization holder is currently unable to provide information sufficient to manage those uncertainties
  • The applicable requirements as well as any terms and conditions that have been imposed on the authorization do not allow for sufficient information to be obtained to manage those uncertainties

Further details on this draft guidance are available here.

If you have any questions, please feel free to contact Focal Point Research.  We are industry leading Over the Counter Drug Regulatory Consultants that you can trust to help guide your company in the right direction.