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  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. Series submissions for brands under one PSP umbrella
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Series submissions for brands under one PSP umbrella

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • A Offline
    A Offline
    amyl
    wrote on last edited by
    #1

    Hi there,

    If a group of brands are under one PSP umbrella and are developing enrolment forms that will be identical, except for the products mentioned, logos, indications, and dosage for the particular products, will we be able to submit these as a series submission? I have seen series submissions for pieces within one brand with multiple indications, but wanted to confirm if this is still possible for a similar piece for different brands as described above, as long as they are >60% identical.

    Thank you in advance for your guidance!

    Jennifer CarrollJ 1 Reply Last reply
    0
    • A amyl

      Hi there,

      If a group of brands are under one PSP umbrella and are developing enrolment forms that will be identical, except for the products mentioned, logos, indications, and dosage for the particular products, will we be able to submit these as a series submission? I have seen series submissions for pieces within one brand with multiple indications, but wanted to confirm if this is still possible for a similar piece for different brands as described above, as long as they are >60% identical.

      Thank you in advance for your guidance!

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Hi @amyl

      We missed this question and sincerely apologize for the delay in responding!

      Yes, they may be submitted as a series. Series files are usually submitted together on the same day. Please see our submission guidance document for series submissions.

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