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.

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.

IBAN: EE932200221023778606
SWIFT code: HABAEE2X
Bank: Swedbank
Address: Liivalaia 8, 15040 Tallinn, ESTONIA
IBAN: EE891010220034796011
SWIFT code: EEUHEE2X
Bank: SEB
Address: Tornimäe 2, 15010 Tallinn, ESTONIA
IBAN: EE701700017001577198
SWIFT code: NDEAEE2X
Bank: Luminor Bank
Address: Liivalaia 45, 10145 Tallinn, ESTONIA


Marketing authorisation applications

State fee (€) Reference number
Issue or renewal of marketing authorisation application (human medicinal product) 32.00 2900082294
Application for variation both type I and II to a marketing authorisation (human medicinal product) 16.00 2900082294
Issue or renewal of marketing authorisation application (veterinary medicinal product) 32.00 2900082294
Application for variation both type I and II to a marketing authorisation (veterinary medicinal product) 16.00 2900082294

"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 worksharing applications and type IA notifications for several marketing authorisations one single application form is to be submitted for all marketing authorisations of the same holder concerned. In addition this is also acceptable for grouped Type IB and II variations. The state fee has to be paid for submitting the application, irrespective of how many variations are listed on the application form.

A person who has paid a state fee has the right to request the refund of the state fee from the State Agency of Medicines if the paid amount exceeds the prescribed amount, if the state fee was paid for an act the performance of which was not requested, if the state fee was paid by the person who is exempt from payment of the state fee, the person withdraws the application before the application is reviewed or the application for performing the act is not reviewed. A claim for refund of a state fee expires two years as of the end of the year of payment of the state fee.

The application for refund are required with original signature or digital signature and shall consist following data:

1. Name and surname of the applicant and personal identification code or name of the legal person and registration code;
2. Bank details and the account from which the state fee has been paid;
3. Date of the payment;
4. Bank details and the account where the state fee has been paid to;
5. Name of the performance of which the request the refund of the state fee is applied, the amount of the requested state fee and the legal ground for refund;
6. Bank details and the account where state fee should be refunded (bank, account no, name of the owner of the account, personal identification code or registration code, also SWIFT and IBAN if applicable).
 

State Agency of Medicines verifies the data of submitted application and makes the decision during 30 days after receiving correct application for refund.

The assessment fees of Marketing Authorisation Applications for medicines for national, mutual recognition and decentrilised procedure

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.

Type of application Price (€)
Complete application, fee per one human medicinal product:
Stand alone application
Bibliographic application
Fixed dose combination  application
Informed consent application
1275
Complete application, fee per one veterinary medicinal product
Stand alone application
Bibliographic application
Fixed dose combination  application
Informed consent application
958
Abridged application, fee per product
Generic application
Hybrid application
958
Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder 511
Licence for parallel import, per product and exporting country 639
Fee for traditional herbal medicinal product 958
Fee for homeopathic preparation 958
Additional fee to cover the participation of the State Agency of Medicines in the mutual recognition procedure or decentralised procedure as Reference Member State. 14000


The assessment fees for repeat use and renewal of Marketing Authorisation Applications for national, mutual recognition and decentralised procedure

Type of application Price (€)
Fee per one medicinal product 639
Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder 383
Fee for traditional herbal medicinal product 383
Fee for homeopathic preparation 383
Additional fee to cover the participation of the State Agency of Medicines in the repeat use mutual recognition procedure as Reference Member State 3000
Additional fee to cover the participation of the State Agency of Medicines in  the renewal of mutual recognition procedure or decentralised procedure as Reference Member State 3000


The assessment fees of Variation Applications for national, mutual recognition and decentrilised procedure*

Type of application Price (€)
Variation Type IB 100
Variation Type II 383
Additional fee to cover the participation of the State Agency of Medicines in the mutual recognition procedure or decentralised procedure as Reference Member State for type IB variations 500
Additional fee to cover the participation of the State Agency of Medicines in the mutual recognition procedure or decentralised procedure as Reference Member State for type II variations 1000

* 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.


Fee for Monitoring the Safety and Quality of Medicinal Products

Price (€)
The fee for monitoring safety and quality of a medicinal product per marketing authorization 160
The fee for monitoring safety and quality of a medicinal product per marketing authorization if the State Agency of Medicines is acting as Reference Member State in the mutual recognition procedure or decentralised procedure or is the assessor of the PSUR for the active substance 320

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.

Last updated: 02.02.2022