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:

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 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:

Safety specifications

Pharmacovigilance plan

Risk minimization plan

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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