• Marketing authorisations (registrations)
  • Veterinary products authorised in Estonia (incl. product information)

Assessment fees  

The assessment fees of Marketing Authorisation Applications for veterinary medicines for national and mutual recognition procedure are the following:
 

Type of application	EEK
Complete application, fee per product	15 000
Abridged application, fee per product	15 000
Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder	8 000
Parallel imported or parallel distributed medicinal product, per product and exporting country	10 000
Fee for traditional herbal product	15 000
Fee for homeopathic preparation	15 000

An additional fee of 100 000 EEK will be added to cover the participation of the State Agency of Medicines in the mutual recognition procedure or decentralised procedure as Reference Member State.

The assessment fees for Renewal of Marketing Authorisation Applications for national and mutual recognition procedure are the following:

The assessment fees of Variation Applications for national and mutual recognition procedure are the following:

An additional fee of 8000 EEK will be added to cover the participation of the State Agency of Medicines in the mutual recognition procedure or decentralised procedure as Reference Member State.

Annual fee is 2500 EEK per marketing authorisation which was in force at least 6 months during the previous calendar year.

An invoice will be sent upon receipt of the application. No payment of assessment fee should be made in advance. Please make sure that the whole amount will be credited to our account net of any charges from the issuing or receiving bank.