State fees and assessment fees

Payment information

The state fee has to be paid prior to the submission of the application and the proof of payment should be enclosed. Please note that the bank charges should be paid by the applicant.

The state fee has to be paid to the Ministry of Finance (Rahandusministeerium)
Address: Suur-Ameerika 1, Tallinn 10122, ESTONIA
Reference number: please choose the correct reference number from the table below.

Refund of the state fee

Activity licences for handling of medical products

Handling of narcotic drugs and psyhotropic substances and their precursors

Activity licence for procurement of cells, tissues and organs

Activity licence for handling of cells, tissues and organs

Marketing authorisation applications

Please note that the proof of payment should include at least the following data:

•  the name of the product, pharmaceutical form and strength;
•  the number and type of applications;
•  reference number according to the type of application."

The state fee has to be paid for each application. For initial MA application and for renewal application, the single form should be submitted for each strength and pharmaceutical form.

In case of variation applications where grouping is accepted, one single application form will be submitted. The state fee has to be paid for submitting the application, irrespective of how many variations are listed on the application form.

No state fee is imposed for a variation not requiring assessment (VNRA) of the Veterinary Medicinal Product.

Clinical trial applications

 Please note that the proof of payment should also include the EudraCT reference number.

Other fees

The assessment fees of Marketing Authorisation Applications for medicines for national, mutual recognition and decentralised procedures

An invoice will be sent upon receipt of the application. No payment of assessment fee should be made in advance. Please note that the bank charges should be paid by the applicant.

Medicinal products for human use: assessment fees for marketing authorisation applications of national and decentralised procedures where Estonia is participating as the reference Member State (RMS). Where an applicant for a marketing authorisation requests that Estonia participate in the decentralised marketing authorisation procedure or marketing authorisation procedure of mutual recognition as a reference country, the amount of 14 000 euros is added to the assessment fee (according to the  Medicinal Products Act § 67(2)):

Veterinary medicinal products: assessment fees for marketing authorisation applications of national and decentralised procedures where Estonia is participating as the reference Member State (RMS). Where an applicant for a marketing authorisation requests that Estonia participate in the decentralised marketing authorisation procedure or marketing authorisation procedure of mutual recognition as a reference country, the amount of 14 000 euros is added to the assessment fee (according to the Medicinal Products Act § 67(2)):

Medicinal products for human use or veterinary medicinal products: assessment fees for marketing authorisation applications of decentralised procedures and mutual (and subsequent) recognition procedures where Estonia is participating as the Member State concerned (CMS):

Assessment fees for renewal of marketing authorisation.

In the event of a repeated marketing authorisation procedure of mutual recognition and, upon renewal of a marketing authorisation in the event of decentralised marketing authorisation procedure or marketing authorisation procedure of mutual recognition in which Estonia participates as a reference country, the amount of 3000 euros is added to the assessment fee (according to the Medicinal Products Act § 67).

The assessment fees of Variation Applications for national, mutual recognition and decentralised procedures

* The assessment fee for variations is charged for every separate variation. All strengths and/or pharmaceutical forms of a certain product are considered the same marketing authorisation in the context of variation applications.

** VNRA annual fee is charged for every separate marketing authorisation valid last year.

*** The assessment fee for Worksharing is charged for every separate application/procedure.

Fee for monitoring the safety and quality of medicinal products

An invoice will be sent to the marketing authorisation holder by 1 February of the calendar year following the year for which the fee is calculated.

No payment of the fee should be made in advance. Please note that the bank charges should be paid by the applicant.

The assessment fees of Clinical Trial Applications

An invoice will be sent upon receipt of the application. No payment of assessment fee should be made in advance. Please note that the bank charges should be paid by the applicant.

Drug statistics analyses fees

 Payments should be made according to the invoice. No payments should be made in advance.