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.

State 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.

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 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.

Refund of the state fee

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.

Assessment 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 documentation concerning the marketing authorisations for human and veterinary medicinal products should be submitted electronically only.

State Agency of Medicines encourages the applicants to use CESP (Common European Submission Portal) for submission of marketing authorisation documentation.

We accept all types of submissions for marketing authorisations for human and veterinary medicinal products via CESP: national and MRP/DCP new applications, renewals, variations, response documents, PSURs for veterinary medicinal products, ASMFs etc.

There is no size limit for CESP submissions.

If the applicant cannot use CESP the following ways of submissions are accepted:

  • Via email (if < 10 MB) or Eudralink (if < 200 MB per one file) to the e-mail address

[email protected]: applications, responses and additional documentation for marketing authorisation, renewal and variations via national and MRP/DC procedure.

[email protected]: translations of final product information for MRP/DC procedures (initial, renewal, variations)

  • On CD/DVD to postal address: 1 Nooruse Str, 50411 Tartu, Estonia

Only one way of submission must be used. Sending double submissions leads to confusion and will delay processing of the application.

Centralised Procedure applications must not be submitted to the State Agency of Medicines. Further guidance can be found here.


PSUR submission

Submitting PSURs for veterinary medicinal products

PSURs for veterinary medicinal products should be submitted via CESP or to the e-mail address [email protected]. For submissions larger than 10MB please use CESP (preferred) or send 1 CD/DVD to postal address: 1 Nooruse Str, 50411 Tartu, Estonia.

Submitting PSURs for human medicinal products

All PSURs for human medicinal products must be submitted electronically via eSubmission Gateway / Web Client to the PSUR Repository. Information regarding PSUR Repository is available on the EMA eSubmission website.

Referral submissions for human medicinal products

The use of the Common Repository for human Referral submissions is mandatory for all NCAs since 1st of December 2017. Additional copies should not be submitted directly to the NCAs on CD/DVD or via CESP as this might lead to validation issues and cause delays. Information regarding Common Repository is available on EMA eSubmission website.


Requirements for eSubmission

State fees: The state fee has to be paid prior to the submission of the application and the proof of payment should be enclosed.

Samples: The applicant is not required to submit the sample of the medicinal product with the MA application. One sample has to be presented when the medicinal product is actually launched.

Assessment fees: An invoice on the assessment fee will be sent within 10 days after acceptance of the application for processing. The applicant shall pay the fee within 40 days after presentation of the invoice.

Activity licences for handling of medicinal 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 psychotropic 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 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."


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 decentrilised procedure

Type of application Price (€)
Complete application, fee per one human medicinal product 1275
Complete application, fee per one veterinary medicinal product 958
Abridged application, fee per product 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 Renewal of Marketing Authorisation Applications for national, mutual recognition and decentrilised 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 procedure or renewal procedure in the mutual recognition 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

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.


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 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.
 


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 and 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: 09.01.2023