Guidance for market authorization requirements for COVID-19 vaccines: Labelling and post-market requirements
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Brand name assessment
The guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 indicates that the plain language labelling requirements for mock-up labels and a brand name assessment package do not apply (C.08.002(2)(j.1) and C.08.002(2)(o)). Although not required, sponsors are invited to provide a brand name assessment should one be available.
Health Canada will assess proposed brand names for COVID-19 vaccines to determine whether a vaccine's brand name could:
- mislead, such as:
- imply it alone is effective but fails to provide evidence to support the claim
- exaggerate the vaccine's effectiveness
- minimize risk
- make a claim of superiority
- be confused with another product authorized for use in Canada (with the aim of preventing medication errors)
Sponsors should refer to the criteria outlined in section 2.2 of our guidance document on the review of drug brand names before proposing a brand name for their vaccine.
Inner and outer product labels
Sponsors of a COVID-19 vaccine are to comply with applicable labelling requirements outlined in the Food and Drugs Act and parts A and C of the Regulations. For vaccines, the requirements are found in A.01.014, A.01.015, C.01.004.1(2), C.01.005 to C.01.011 and C.04.019.
Although the plain language labelling requirements for mock-up labels and a brand name assessment package don't apply to drugs (including vaccines) that are filed under the modified requirements for COVID-19 drugs, we recommend that sponsors consider applying plain language principles in their submissions, as a best practice.
Health Canada believes that labelling in both official languages is critical to the safe and effective administration of vaccines. Bilingual text should be present within the labelling information, where feasible.
For inquiries about the labelling requirements for proposed vaccines, sponsors are asked to contact the Office of Regulatory Affairs, Biologic and Radiopharmaceutical Drugs Directorate (BRDD), at firstname.lastname@example.org. We will consider all concerns, proposals and/or other suggestions for meeting the labelling requirements.
Risk management plan
Companies should submit a risk management plan (RMP) that focuses on the safety risks for a COVID-19 vaccine. For more information on RMPs, please see our guidance document for submitting RMPs and follow-up commitments.
In addition, the Canadian addendum must demonstrate compatibility with Canadian regulatory requirements.
The addendum should contain the following sections:
- include special events of interest, known and potential safety risks and special populations with limited information from (or that were excluded from) clinical trials
- address monitoring strategies in marginalized, remote and indigenous communities where data is available
- include timely updates of the list of safety concerns if a safety signal is observed from post-authorization surveillance
- consider activities in Canada during a pandemic related to collecting, collating, assessing and reporting spontaneous adverse events
- confirm expedited spontaneous reporting of adverse events (spontaneous reporting in Canada is different from other jurisdictions)
- discuss additional measures related to the detection of cases, such as:
- fatal/life-threatening, serious unexpected, special events of interest
- vaccination failure and errors
- special populations
- patients with comorbidities
- potential interaction with other vaccines
- concomitant treatments
- include additional post-market activities as required, such as:
- safety/effectiveness studies
- timely and effective monitoring of the safety profile
- include monthly safety summary reports
- include rapid signal detection and communication of signals leading to a change in the balance of risks and benefits
Risk minimization plan
- include the following information:
- robust labelling with warnings and precautions
- educational materials
- a plan for communicating and sharing safety information internationally in a timely and effective manner
To support the Government of Canada's commitment to transparency and openness, Health Canada will provide the most up-to-date approved Canadian-specific Addendum RMPs for COVID vaccines in their entirety, in conjunction with the core RMPs, to external stakeholders upon request. As part of the authorization process, and before the information becomes available, the sponsor will have the opportunity to make representations about this transparency measure, including with respect to confidential business information and/or confidential information as covered by the vaccine purchase agreements.
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