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The only amendment related to post-market regulation is the Minister’s new (continued) authority to impose terms and conditions for a …

Record Modified: Jul 29, 2021
Record Released: Jul 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic COVID-19 drug amendement Food and Drug Regulations drugs manufacturers submission notice of compliance post-market regulations Minister’s authority

A promising COVID-19 drug may be imported into Canada before it receives a Canadian market authorization.

Record Modified: Jul 29, 2021
Record Released: Jul 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic COVID-19 drug amendement Food and Drug Regulations drugs manufacturers submission notice of compliance pre-positioning of COVID-19 drugs

As a consequence of the review, authorization and oversight of COVID-19 drugs under the Regulations, manufacturers may benefit from …

Record Modified: Jul 29, 2021
Record Released: Jul 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic COVID-19 drug amendement Food and Drug Regulations drugs manufacturers submission notice of compliance intellectual property protections

The Interim Order (IO) expedites the authorization of Class I to IV medical devices used for COVID-19: sets out …

Record Modified: Jul 29, 2021
Record Released: Jul 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic Interim Order expedites authorization class I to IV medical devices safety effectiveness quality filtering facepiece respirators FFRs manufacturers respirators

Information about filtering facepiece respirators and their certification and testing process.

Record Modified: Jul 29, 2021
Record Released: Jul 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic safety performance specifications filtering facepiece respirators FFRs testing process

All Canadian-manufactured respirators must meet the minimum performance testing requirements.

Record Modified: Jul 29, 2021
Record Released: Jul 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic safety performance specifications filtering facepiece respirators FFRs Performance criteria

For an IO submission, Health Canada requires a report on the results of the performance testing requirements that apply to …

Record Modified: Jul 29, 2021
Record Released: Jul 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic safety performance specifications filtering facepiece respirators FFRs interim order submission

Due to the urgent public health needs relating to COVID-19, we can issue a market authorization with conditions.

Record Modified: Jul 29, 2021
Record Released: Jul 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic Moderna COVID-19 vaccine urgent public health needs market authorization authorized with conditions

We are carefully monitoring the post-market (after authorization) safety and effectiveness of authorized COVID-19 vaccines. As part of our …

Record Modified: Jul 29, 2021
Record Released: Jul 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic Moderna COVID-19 vaccine authorized COVID-19 vaccines urgent public health needs market authorization continued monitoring post-market safety effectiveness adverse events following immunization AEFI

Information on the Moderna COVID-19 vaccine, including how it works, how it's given, possible side effects and vaccine safety …

Record Modified: Jul 29, 2021
Record Released: Jul 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: COVID-19 pandemic Moderna COVID-19 vaccine authorized COVID-19 vaccines information on COVID-19 vaccine how it works how it's given possible side effects vaccine safety