Notice: How Health Canada is managing safety updates when a serious health risk is identified under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)

April 22, 2016
Our file number: 16-104599-398

This notice is to inform you of how Health Canada is managing safety updates when a serious health risk is identified under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law). It applies to biologic, pharmaceutical and radiopharmaceutical human drugs pursuant to Division 8 of the Food and Drug Regulations and is only for labelling changes requested by Health Canada.

Background

Throughout the lifecycle of a therapeutic productFootnote 1, new information may raise questions about the product's effect on the health and safety of Canadians. In certain circumstances, the potential harm from the use of the therapeutic product (pursuant to Division 8 of the Food and Drug Regulations) may not be adequately reflected on the approved label. Additionally, brand names that look or sound alike or have similar looking packaging may pose a risk to health due to prescribing and dispensing errors.

In 2014, the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) amended the Food and Drugs Act to include new rules that strengthen the regulation of a therapeutic product by providing Health Canada with the necessary authorities to take quick and appropriate action when a serious health risk is identified. These amendments will ensure new safety information is made available to patients and consumers and provide Canadians confidence that products available on the Canadian market are safe.

Under the new section 21.2 of the Food and Drugs Act, enacted through Vanessa's Law, the Minister may order the authorization holder of a therapeutic product to modify the product's label and/or modify or replace its package if such changes are deemed to be "necessary to prevent injury to health". The general procedure for issuing an Order under this new section is found in the guide entitled "Amendments of 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 safety changes to the label and/or packaging of a product as ordered by the Minister must be filed as a Supplement to a: New Drug Submission (SNDS), an Abbreviated New Drug Submission (SANDS), an Extraordinary New Drug Submission (SEUNDS,) or an Abbreviated Extraordinary New Drug Submission (SAEUNDS) pursuant to the Food and Drug Regulations, sections C.08.003 (1) as there are matters specified in subsection C.08.003 (2) that are significantly different from the information or material contained in the original drug submission.

Prior to 1988, pursuant to C.08.003 of the Food and Drug Regulations, any safety change made to a new drug required the filing of a Supplement to a New Drug Submission (SNDS). In 1995 and 2011 the Food and Drug Regulations were amended to include Abbreviated New Drug Submissions and Extraordinary Use New Drug Submissions, respectively. This included the requirement to file a SANDS or a SEUNDS/SAEUNDS for any safety changes made to a product label. In 1988, the Information Letter No. 739 introduced Notifiable Changes (NCs). The Changes to Marketed New Drugs policy (1994) further defined NCs to reduce the number of SNDSs filed, as a measure for the Department to manage workloads. These policies allowed sponsors to file certain safety changes as NCs.

In 2009, Health Canada released the Post-Notice of Compliance (NOC) Changes Guidance Documents which introduced criteria for the four levels of change based on modern risk management principles. While these guidance documents superseded the previous policies, it maintained the filing of many safety changes as NCs.

With the coming into force of Vanessa's Law, Health Canada is reconsidering its approach in managing post-market safety changes that are considered significantly different than the original submission.

Interim Approach to Health Canada-initiated Drug Safety Updates under Vanessa's Law

Since the coming into force of Vanessa's Law, when Health Canada identifies a label change that is necessary to prevent injury to health, the sponsor will receive an Advisement Letter to request the filing of a S(A)NDS-labelling-only submission. Examples of label changes that may be requested include, but are not limited to: the addition of a new contraindication, a change in an existing contraindication, the addition of a serious Warning or Precaution or the tightening of clinical monitoring requiring a change to the Warnings and Precautions section of the Product Monograph.

Health Canada's request for a label change will be supported by data reviewed by the Department, and a copy of Health Canada's review will be included with each request. A sponsor may respond to a Health Canada request to update the label by filing a S(A)NDS-labelling-only submission, or have the right to submit representations for Health Canada's consideration outside of the submission process. Health Canada will review the representations and decide whether to invoke the label change Order under Section 21.2 of the Food and Drugs Act. In either case, whether the sponsor complies with the initial Advisement Letter or whether Health Canada issues an Order following the review of representations, the sponsor will be requested to implement the label change by filing a S(A)NDS-labelling-only submission.

The current user fees for S(A)NDS-labelling-only will be applied based on the Fees in Respect of Drugs and Medical Devices Regulations and the 60 day performance standard will apply.

For these Health Canada-initiated label changes, sponsors should follow the guidance and information provided in the Advisement Letter rather than the Post-NOC Changes - Safety and Efficacy Guidance Document.

In the interim, safety updates initiated by the sponsor will continue to be accepted as NCs as outlined in the Post-NOC Changes: Safety and Efficacy Guidance Document.

In the long term, it is anticipated that all NCs will be phased out and addressed via the appropriate Supplement. Health Canada will engage stakeholders should further changes be required to the Post-NOC Changes: Safety and Efficacy Guidance Document resulting from Vanessa's Law.

Health Canada is committed to ensuring that Canadians have access to safe, effective and high quality products.

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