Marketing authorisation of medicinal products

The marketing authorisation applications should be submitted in accordance with the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6).

Regulation (EU) 2019/6

eSubmissons

Procedural guidance on decentralised, mutual recognition and subsequent recognition procedures is provided by CMDv.

Application forms and information on fees

The use of the eAF (electronic application form) will be mandatory from 1st January 2016 for all applications (human and veterinary MRP, DCP and national procedure applications for marketing authorisation, renewal and variations). Further details can be found on: eSubmission: VET eSub (europa.eu) and CMDv website.

Fees

There are two types of fees for the marketing authorisation applications in Estonia.

The state fee has to be paid prior the submission of the application. For the assessment fees, the invoice will be issued upon receipt of the valid application. No payment of assessment fee should be made in advance.

You can find all State and Assessment fees here.

Last updated: 04.05.2022