Validation of registration dossiers: a new version of the checker

The checker currently used in the FAMHP for technical validation of submitted registration dossiers concerning medicines for human use has been adjusted to take account of restrictions and controls as specified in the "non e-CTD Electronic Submission” (Nees). The automated mails were also adapted.

The new NeeS technical validation rules (v3.0)  become valid for the 1.12.2012: .  Consequently, the agency NeeS  Checker (v3.0) is updated.

For MRP/DCP and the centralized procedure, applicants need to update the Extedo and Lorenz ‘eCTD and NeeS validators’ by 1.12.2012







Last updated on 29/11/2012