EMA
- Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)
- Template or form: Template for sections A to E for the scientific part of the application for orphan designation (updated)
Updated PLM Portal eAF timeline now available
- Please find an updated version of the PLM Portal eAF Human Variations Forms timeline. The slide is also available on the PLM Portal Forum.
CMDh
- Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures (March 2023) [Track version]
- Common grounds seen for delaying Day 0 Renewals (March 2023) [Track version]
- Member State agreement upon conditions under which the RMS can start renewal procedures (March 2023) [Track version]
- Request for MRP/RUP / Update assessment report (March 2023)
- Renewals [Track version] (April 2023)