Module 12 Presentations

PLM eAF - PMS data scope

• In 2022, EMA presented the PLM eAF data elements go-live scope, the 15 so-called “Product Selection Fields” (as shown below) • These are required to (uniquely) select the correct product on the PLM portal prior to completing the Variation Form

• This limited scope structured (IDMP compliant) data elements will increase in the future with increasing structured data integrations in the eAFs to be submitted via PLM portal (incl. for initial MAAs and renewals)

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12