Letter of attestation
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I’m looking to clarify the requirements around the attestation letter for a submission. Specifically:
Does the attestation letter need to be signed by the manufacturer, or can it be signed by the company responsible for the promotion of the product?
Does the signatory need to be from the Canadian office, or can it be signed by the global team?
Thank you!
-
I’m looking to clarify the requirements around the attestation letter for a submission. Specifically:
Does the attestation letter need to be signed by the manufacturer, or can it be signed by the company responsible for the promotion of the product?
Does the signatory need to be from the Canadian office, or can it be signed by the global team?
Thank you!
Hey @mimi77
This sounds like a file specific question which should be addressed with the review through the eFiles ticket system. If the question is with respect to “attestation letters” in general term, there are many different reasons an attestation letter might be required in a file. The person signing the attestation letter can vary depending on the copy. Most commonly attestation letters are signed by a representative of the manufacturer’s medical or regulatory team. It may be possible for it to be a representative from the global team. There are a number of Q&As which address attestations which may also support your understanding.
