DCP with Estonia as RMS

The requests for DCP with Estonia as a RMS should be sent to [email protected].

For request for human medicinal products, please fill in the request form  published on the CMDh web-page. For veterinary medicinal products a filled out request form available on the CMDv website should be provided.

The applicants will be informed whether a time slot has been booked for their submission or not.

SAM should be notified of any changes in agreed submission dates. The changes in active ingredients are decided on a case-by-case basis.

For submission guidance please see e-Submission and CMDh.

Please note that for Human eSubmission starting from 1 December 2025 only eCTDs compliant with EU M1 v3.1.1 and validation criteria v8.2 are accepted. Please see eCTD v3.2 for further details.