News from Greece – updates at the EOF

08 May News from Greece – updates at the EOF

Posted at 11:58h in News by

CESP update

From 03/04/2017 the submission of electronic documentation, is effective solely through the Common European Submission Portal (Common European Submission Portal, CESP) for human and veterinary medicinal products.

The following procedures should be transmitted through CESP:

  • All submissions for Mutual Recognition/Decentralised Procedures (MRP/DCP)
  • national procedures relating to approvals, variations, renewals, PSURs, ASMFs etc., as well as any other documentation should be submitted using CESP.
  • Responses to deficiencies and any other additional information that can be requested from the EOF within the claims of assessment.

For these submissions, additional CD/DVDs are not required.

For each submission, a corresponding reference number will be automatically assigned and will be sent directly to the applicant.

Full information is available (in Greek) here.

For more information, please contact our Greek EuDRAcon member: https://www.pharosgr.gr/