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 |
Refund of the state fee
Activity licences for handling of medical products
State fee (€) | Reference number | |
---|---|---|
Review of applications for activity licence | ||
Manufacture of medicinal products (except packaging of herbal substances) | 1000.00 | 2900082281 |
Manufacture of medicinal products - packaging of herbal substances | 150.00 | 2900082281 |
Wholesale distribution of medicinal products | 1000.00 | 2900082281 |
Retail pharmacy | 150.00 | 2900082281 |
Hospital pharmacy | 150.00 | 2900082281 |
Veterinary pharmacy | 150.00 | 2900082281 |
Brokering of medicinal products | 150.00 | 2900082281 |
Review of applications for amendments of information on the activity licence | ||
Manufacture or wholesale distribution (amendment of site of activity) | 500.00 | 2900082281 |
Manufacture - packaging of herbal substances (amendment of site of activity) | 60.00 | 2900082281 |
Manufacture or wholesale distribution (changing the holder of the activity licence or the competent person or a change in the secondary conditions of the activity licence) | 150.00 | 2900082281 |
Manufacture - packaging of herbal substances (changing of the holder of the activity licence or the competent person or a change in the secondary conditions of the activity licence) | 20.00 | 2900082281 |
Pharmacy (amendment of site of activity or opening a new subsidiary) | 75.00 | 2900082281 |
Pharmacy (changing of the holder of the activity licence or the competent person or a change in the secondary conditions of the activity licence) | 20.00 | 2900082281 |
Amendment of the details of a permanent adress in an activity licence for brokering in medicinal products | 20.00 | 2900082281 |
Review of applications for granting the right of distance sales of medicinal products to a retail pharmacy | 75.00 | 2900082281 |
Handling of narcotic drugs and psyhotropic substances and their precursors
State fee (€) | Reference number | |
---|---|---|
Issue or renewal of an activity licence for handling of drug precursors | 150.00 | 2900082281 |
Application for an import or export authorisation of narcotic drugs and psychotropic substances | 10.00 | 2900082281 |
Application for an import or export authorisation of drug precursors | 10.00 | 2900082281 |
Activity licence for procurement of cells, tissues and organs
State fee (€) | Reference number | |
---|---|---|
Review of applications for activity licence | 665.00 | 2900082281 |
Review of applications for amendments data of activity licence if the facilities of procurement are changed or added and if special conditions of the licence are changed or added | 320.00 | 2900082281 |
Review of applications for amendments data of activity licence if owner of the activity licence is changed, responsible person is changed or the third party performing contract works related with procurement is changed or added and if there are changes in the procurement process due to procurement of infectious materials | 130.00 | 2900082281 |
Activity licence for handling of cells, tissues and organs
State fee (€) | Reference number | |
---|---|---|
Review of applications for activity licence | 1700.00 | 2900082281 |
Review of applications for amendments data of activity licence if the facilities of handling are changed or added and if special conditions of the licence are changed or added | 640.00 | 2900082281 |
Review of applications for amendments data of activity licence if owner of the activity licence is changed, competent person is changed or the third party performing contract works related with handling is changed or added, if changes are to be made in ventilation system or water system of the handling facilities and if there are changes in the handling process and equipment due to handling of infectious materials | 320.00 | 2900082281 |
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 of marketing authorisation application (veterinary medicinal product) | 32.00 | 2900082294 |
Application for variation requiring assessment - VRA (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 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
State fee (€) | Reference number | |
---|---|---|
Clinical trial application (includes one research centre) | 385.00 | 2900082294 |
For each additional research centre | 16.00 | 2900082294 |
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)):
|
6000 € |
|
6000 € |
|
6000 € |
|
4500 € |
|
4500 € |
|
4500 € |
|
4500 € |
|
4500 € |
|
1000 € |
|
3000 € |
|
3000 € |
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)):
|
6000 € |
|
6000 € |
|
6000 € |
|
4500 € |
|
4500 €t |
|
4500 € |
|
1000 € |
|
3000 € |
|
3000 € |
|
3000 € |
|
3000 € |
|
3000 € |
|
3000 € |
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):
|
1500 € |
|
1000 € |
|
1000 € |
Assessment fees for renewal of marketing authorisation.
|
1000 € |
|
500 € |
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
Type of application/procedure |
Price (€) |
Variation Type IA** |
100 |
Variation Type IB* |
150 |
Variation Type II* |
400 |
Variation requiring assessment (VRA) – Veterinary Medicinal Product * |
400 |
Variation not requiring assessment (VNRA) – Veterinary Medicinal Product, annual fee** |
1395 |
Fee to cover the participation of the State Agency of Medicines in the Worksharing procedure as the Reference Member State*** |
1800 |
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 IA variations* |
400 |
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* |
600 |
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 and for variations requiring assessment (VRA)* |
1400 |
* 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
Price (€) |
|
The fee for monitoring safety and quality of a medicinal product per marketing authorisation - Veterinary Medicinal Product |
320 |
The fee for monitoring safety and quality of a medicinal product per marketing authorisation - Human Medicinal Product**** |
160 |
****The fee for monitoring safety and quality of a medicinal product per marketing authorisation 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.
The assessment fees of Clinical Trial Applications
Application type | Price (€) |
---|---|
Clinical trial application | 383 |
Variation to a clinical trial | 63 |
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
Name of the statistcal analysis | Price (€) |
---|---|
Sales of one ATC code divided by preparations | 30 |
Estonian Statistics on Medicines, general report (1 year) | 1533 |
Estonian Statistics on Medicines, general report (½ year) | 862 |
Estonian Statistics on Medicines, general report (¼ year) | 511 |
Estonian Statistics on Medicines, extended general report (1 year) | 1789 |
Estonian Statistics on Medicines, extended general report (½ year) | 1022 |
Estonian Statistics on Medicines, extended general report (¼ year) | 607 |
Estonian Statistics on Medicines, full report (1 year) | 2045 |
Estonian Statistics on Medicines, full report (½ year) | 1182 |
Estonian Statistics on Medicines, full report (¼ year) | 703 |
Other statistical analyses (cost per hour) | 40 |
Payments should be made according to the invoice. No payments should be made in advance.
Last updated: 12.01.2023