When does the pre-NOC period begin
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Hi PAAB team!
Looking for some clarification on when the pre-NOC period is considered to have started.
Does the pre-NOC period begin 1 year before expected NOC? 5 years? As soon as the manufacturer is reasonably sure they have a therapy that will eventually be approved for use on the Canadian market?
For context, I am looking to understand at what point a piece that only discusses disease state information (no mention of pharmacotherapy) can be submitted for exemption vs. when it must be submitted for full PAAB review as a pre-NOC editorial piece.
Thank you!
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Hi @maryssa,
Pre-NOC is considered when a drug product has not yet been approved for use in Canada. For unbranded disease information material without mention of any drug treatment/pharmacotherapy or pre-NOC editorial material, they may be submitted for full review or opinion at any time. Please see our Pre-NOC Corporate/Editorial communications for additional information and cautions regarding pre-NOC communications. While the unbranded disease information without mention of any drug treatment may meet criteria for exemption, we suggest submitting for an opinion as the PAAB reviews help to ensure the company and materials are not inadvertently in violation of C.08.002 of the Food and Drug Regulations.
