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What should be included in a pre submission meeting with Health Canada?

What should be included in a pre submission meeting with Health Canada?

A pre-submission meeting with Health Canada to discuss the safety and efficacy evidence required to support market authorization and the data requirements to bridge the proposed product to the reference product.

How does Health Canada promote predictability of evidence?

To promote predictability of evidence expectations and consistency in Health Canada’s regulatory decision making, the Health Products and Food Branch (HPFB) is publishing criteria for assembling a Submission Relying on Third-Party Data (SRTD) and clarifying the evidence requirements for the proposed commercial products. Skip to main content

How to collect and submit evidence for Guinness World Records?

For a mass participation record we require Stewards to supervise groups of 50 or fewer participants, in order to disqualify any attendees who do not successfully take part in the record attempt. Please give your Stewards these templates to fill out. You need to upload all Steward Statements as part of your evidence.

What should be included in a Drug Submission?

a new drug submission (or supplement) that contains complete study reports of clinical safety and efficacy [that is (i.e.) clinical data] generated by the drug sponsor or for the drug sponsor. Literature

When is the submission of evidence rule effective?

These modifications to our regulations will better describe your duty to submit all evidence that relates to your disability claim and enable us to have more complete case records on which to make more accurate disability determinations and decisions. This rule is effective April 20, 2015.

When is it acceptable to inform us about evidence without submitting it?

In addition, it is only acceptable for a representative to inform us about evidence without submitting it if the representative shows that, despite good faith efforts, he or she could not obtain the evidence.

When do representatives need to submit written evidence?

Therefore, we expect representatives to submit or inform us about written evidence as soon as they obtain or become aware of it.

What happens if you don’t submit evidence in dispute?

Failing to do so may cause significant delays in dispute processing, including forfeiting your right to reclaim disputed funds. Clicking Submit evidence begins the response process and provides additional information about the type of dispute and what steps you should take.