Guidance for market authorization requirements for COVID-19 drugs: 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 drugs to determine if a drug's brand name could:
- mislead, such as:
- imply it alone is effective but fails to provide evidence to support the claim
- exaggerate the drug's effectiveness
- minimize risk of the drug
- 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 drug. Also see the frequently asked questions on the review of drug brand names for more information.
A product monograph is a factual, scientific document on a drug product. It does not contain promotional material. The monograph describes the properties, claims, indications and conditions of use for the drug. It also contains any other information that may be required for optimal, safe and effective use of the drug.
Health Canada reviews the product monograph (including patient medication information) as part of the drug review process. The monograph is an integral part of a submission.
When developing a product monograph for a drug in an acceptable format and content, refer to the various product monograph guidance documents and notices.
Inner and outer package labels
Sponsors of a COVID-19 drug are to comply with applicable labelling requirements outlined in the Food and Drugs Act and parts A and C of the Regulations. The requirements for drugs are found in the following sections of the Regulations:
- A.01.060.1 to A.01.068
- C.01.001 to C.01.012
- C.03.206 to C.03.209
- C.04.019 and C.04.020
For more information, refer to the:
The plain language labelling requirements for mock-ups of every label to be used in connection with the drug do not apply to drugs filed under the modified requirements for COVID-19 drugs. (See sections C.01.014.1.(2) (m.1), C.08.002.(2) (j.1) and C.08.003(3.1)(a).) However, as a best practice, we recommend that sponsors apply plain language principles in their submissions.
Labelling in both official languages is critical to the safe and effective administration of drugs. Bilingual text should be present within the labelling information (for example, inner and outer labels, package insert) for prescription products and those administered or obtained by a health care professional.
Should sponsors wish to submit mock-up labelling materials, they are encouraged to do so during the review process.
For more information on designing and developing labels and packages that are clear, effective and minimize the risk of errors causing harms, refer to the:
If mock-up labels are not filed during review, sponsors should submit final mock-ups or printed labels when the COVID-19 drug is marketed or launched.
If the product is going to be dispensed in its final packaging, supplementary information on its use (transparency, disclosure of risks) should be provided in the form of a package insert. This insert should be included as part of the drug's packaging materials and submitted for review.
For more information on package inserts, refer to section 5.4.2 of our:
Sponsors considering an abbreviated package insert should see appendix A of our questions and answers document on plain language labelling regulations for prescription drugs for recommendations.
For inquiries about the labelling requirements for proposed COVID-19 drugs, please contact the:
- Therapeutic Products Directorate by email at email@example.com
- Biologic and Radiopharmaceutical Drugs Directorate by email 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 the drug when used to prevent or treat COVID-19.
For more information on RMPs, please consult our:
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 are available
- include timely updates of the list of safety concerns if a safety issue 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
- medication errors
- special populations
- patients with comorbidities
- potential interaction with other therapeutic products
- 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
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