The main impact and changes are as follows:

• Upon ‘Finalisation’, the PLM Portal web based human variation eAF will be locked and moved to the ‘Completed’ tab (the form can be opened for further editing if necessary)
• The form will be locked with a digital ‘signature’ called eAF integrity warranty (or eAF integrity stamp)
• Will be launched on 6th March 2025 – after this date the system will include the stamp on all forms that are finalised
• Forms that have not been finalised (i.e. do not contain the integrity stamp) will be rejected by the regulators in the future – date to be confirmed!
• The applicants will still be able to include additional digital signature(s) into the finalised form (exported pdf)
• It will not be possible to include an image of a signature or an ‘adobe signature’ to the form after the stamp is included
• There is no integrity stamp in the ‘legacy’ interactive pdf eAFs

If you have any question please contact plm.valuestream@ema.europa.eu or raise a request in the EMA Service Desk.