On December 23, 2019, the Academy of Managed Care Pharmacy (AMCP) released Version 4.1 of the AMCP Format for Formulary Submissions. This new version of the AMCP Format describes three types of dossiers that manufacturers may choose to develop: Unapproved Product Dossiers, Approved Product Dossiers, and Unapproved Use Dossiers.
While developing Version 4.1 of the AMCP Format, the AMCP Format Executive Committee decided to focus their updated recommendations on Unapproved Product Dossiers and Unapproved Use Dossiers, and made minimal changes to the section on Approved Product Dossiers. Therefore, a piece of good news for manufacturers is that converting an existing Post-Approval Dossier that follows Version 4.0 of the AMCP Format into an Approved Product Dossier that follows Version 4.1 of the AMCP Format is a straightforward process. For these reasons, this article will focus on Unapproved Product Dossiers and Unapproved Use Dossiers.