• Marketing authorisations (registration)
  • Medicinal products authorised in Estonia (incl. product information)
  • Granting marketing authorisations
• Drug information
• Clinical trials
• European Pharmacopoeia
• Classification of medicinal products
• Pharmacovigilance and Adverse Drug Reactions
• Manufacture, distribution, pharmacy
• Drug statistics
• Travelling with medicines

eSubmissions  

New marketing authorisation applications, renewals and variation have to be submitted only electronically in eCTD (preferred) or NeeS format.

The labelling of the CD or DVD should include the following information:
-Format (eCTD or NeeS)
-Name of the applicant/MAH
-Name of the product and active ingredient
-Procedure No.
-Sequence No.
-Type of the procedure (new application, variation, renewal)

The State Agency checks the submissions in the technical validation according to the requirements published on the EMA website.

eCTD

NeeS

Electronic-only submissions are accepted without accompanying paper copies. However, the following documents in Module 1 have to be submitted additionally on paper with original signatures:
Application form,
Letter of Access,
Power of attorney (if needed)
Letter of consent in case of informed consent applications

The guideline for e-submissions in decentralised and mutual recognition has been published on CMDh website

http://www.hma.eu/277.html