The AMCP/Dymaxium partnership is the basis for the AMCP eDossier System, which is powered by Dymaxium Healthcare Innovations, Ltd. AMCP and Dymaxium are working together to launch this new system and ensure that it meets the needs of stakeholders. In general, AMCP will be responsible for educational efforts and will provide guidance related to the System and its related processes. Dymaxium will be responsible for all technical, operational, administrative, R&D, and support aspects related to the System.
Yes, the manufacturer always retains full control
over who has access to their product eDossiers. Requests for access to a product eDossier MUST originate from a health care decision maker (HCDM) in order to adhere to unsolicited request requirements. Once a request is received, the manufacturer is in control of authorizing access. Manufacturers may update access permissions as they deem appropriate.
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A HCDM must
provide a documented unsolicited request (using the System’s eRequest Tool) for any product eDossier that he/she wishes to access. A product manufacturer will review the request and determine if access to the requested product eDossier is authorized (assuming the product eDossier is available on the System). Decision makers are pre-screened by the AMCP eDossier System to verify that they are working with a health care organization and are directly involved in the formulary and/or benefit design decision making process. Manufacturers, however, follow their own internal processes to determine who will be authorized to access a specific product eDossier that is available on the System, after it is requested by a HCDM.
Yes. Together, executives from AMCP, FMCP, and Dymaxium have communicated with the FDA and incorporated feedback into the System processes. The same policies and procedures that
the FDA has in place which regulate the use of hard copy dossiers prepared using the AMCP Format for Formulary Submissions
pertain to eDossiers made available through the AMCP eDossier System. The System has been structured to be in strict compliance with all FDA governing provisions, including those regarding the distribution of information based on an unsolicited request
The manufacturer has sole responsibility for dossier content. Neither AMCP nor Dymaxium create, endorse, or review dossier content.
Yes. The AMCP eDossier System is secure. The security is comparable to that used in other industries (e.g., banking) that require protection of applications and data. Specific information related to the security of the System can be provided upon request.
HCDMs who are directly involved in making formulary and/or benefit design decisions are invited to register on the System. Each registration is individually evaluated. An employer-provided email address must