State fees and assessment fees

In this page you can find the payment information.

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)):

  1. Stand alone application (based on original data) (§ 2 (3) p 1)

6000 €

  1. Bibliographic application (well-established medicinal use supported by bibliographic literature) (§ 2 (3) p 2)

6000 €

  1. Fixed combination application (new medicinal product made of at least two active substances not previously authorised as a fixed combination medicinal product) (§ 2 (3) p 3)

6000 €

  1. Generic application (§ 2 (2) p 1)

4500 €

  1. Hybrid application (§ 2 (2) p 2)

4500 €

  1. Similar biological medicinal product (§ 2 (2) p 3)

4500 €

  1. Application for traditional herbal medicinal product (§ 2 (1) p 3)

4500 €

  1. Homeopathic medicinal product (§ 2 (1) p 4)

4500 €

  1. Application for parallel import (per source Member State) (§ 2 (1) p 5)

1000 €

  1. Informed consent application (§ 2 (3) p 4)

3000 €

  1. Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder

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)):

  1. Application for marketing authorisation: full dossier

6000 €

  1. Application based on bibliographic data (Regulation (EU) 2019/6 Art 22)

6000 €

  1. Application for combination veterinary medicinal product (Regulation (EU) 2019/6 Art 20)

6000 €

  1. Application for generic veterinary medicinal product (Regulation (EU) 2019/6 Art 18)

4500 €

  1. Application for hybrid veterinary medicinal product (Regulation (EU) 2019/6 Art 19)

4500 €t

  1. Application for homeopathic veterinary medicinal product (Regulation (EU) 2019/6 Art 86)

4500 €

  1. Application for parallel trade (per source Member State) (Regulation (EU) 2019/6 Art 102)

1000 €

  1. Application based on informed consent (Regulation (EU) 2019/6 Art 21)

3000 €

  1. Application for limited markets (Regulation (EU) 2019/6 Art 23)

3000 €

  1. Re-examination of a marketing authorisation for a limited market. (Regulation (EU) 2019/6 Art 24)

3000 €

  1. Application in exceptional circumstances (Regulation (EU) 2019/6 Art 25)

3000 €

  1. Re-examination of a marketing authorisation in exceptional circumstances (Regulation (EU) 2019/6 Art 27)

3000 €

  1. Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder

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):

  1. Marketing authorisation application

1500 €

  1. Subsequent pharmaceutical form or strength containing the same active ingredient, change or addition of the route of administration of the same future marketing authorisation holder

1000 €

  1. Application for subsequent food producing animal

1000 €

Assessment fees for renewal of marketing authorisation.

  1. Renewal of the Marketing Authorisation for national, mutual recognition and decentralised procedure (fee per one medicinal product)

1000 €

  1. Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder

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