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Marketing authorisation of medicinal products

25.04.2017
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An application for a marketing authorisation for a human or veterinary a medicinal product may be filed under the mutual recognition, decentralised, centralised or the national procedure.

The requirements of quality, safety and efficacy are based upon the Medicinal Products Act of 2005 and respective regulations by the Minister of Social Affairs.

The submission of the applications for a marketing authorisation but as well as variation and renewal applications is very easy in Estonia, there is no need for paper copies, all applications can be submitted electronically and there are no country-specific requirements for supplementary documentation.

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: http://esubmission.ema.europa.eu/eaf/index.html” and CMDh 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.

State fees
Refund of the state fee
Assessment fees


Templates for product information

Templates for MRP/DCP and national procedures (Estonian)

Human medicines - The template indicates updates (tracked) of last two versions.
Veterinary medicines

QRD templates for centrally authorised products

Human medicines
Veterinary medicines

 

Related links

Authorised products
Authorised veterinary products
The meetings of the marketing authorisation committees in 2017