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