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State fees and assessment fees

08.02.2019
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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 medicinal products

 State fee (€)Reference number
Review of applications for activity licence  
Manufacture of medicinal products (except packaging of herbal substances)1000.002900082281
Manufacture of medicinal products - packaging of herbal substances150.002900082281
Wholesale distribution of medicinal products1000.002900082281
Retail pharmacy150.002900082281
Hospital pharmacy150.002900082281
Veterinary pharmacy150.002900082281
Brokering of medicinal products150.002900082281
Review of applications for amendments of information on the activity licence  
Manufacture or wholesale distribution (amendment of site of activity)500.002900082281
Manufacture - packaging of herbal substances (amendment of site of activity)60.002900082281
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)150.002900082281
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)20.002900082281
Pharmacy (amendment of site of activity or opening a new subsidiary)75.002900082281
Pharmacy (changing of the holder of the activity licence or the competent person or a change in the secondary conditions of the activity licence)20.002900082281
Amendment of the details of a permanent adress in an activity licence for brokering in medicinal products20.002900082281
Review of applications for granting the right of distance sales of medicinal products to a retail pharmacy75.002900082281

 


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 precursors150.002900082281
Application for an import or export authorisation of narcotic drugs and psychotropic substances10.002900082281
Application for an import or export authorisation of drug precursors10.002900082281

 

Activity licence for procurement of cells, tissues and organs

 State fee (€)Reference number
Review of applications for activity licence665.002900082281
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 added320.002900082281
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 materials130.002900082281

 


Activity licence for handling of cells, tissues and organs

                                                                                                                              State fee (€)Reference number
Review of applications for activity licence1700.002900082281
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 added640.002900082281
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 materials320.002900082281

 


Marketing authorisation applications

 State fee (€)Reference number
Issue or renewal of marketing authorisation application (human medicinal product)32.002900082294
Application for variation both type I and II to a marketing authorisation (human medicinal product)16.002900082294
Issue or renewal of marketing authorisation application (veterinary medicinal product)32.002900082294
Application for variation both type I and II to a marketing authorisation (veterinary medicinal product)16.002900082294

 "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)385.002900082294
For each additional research centre16.002900082294

 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 applicationPrice (€)
Complete application, fee per one human medicinal product1275
Complete application, fee per one veterinary medicinal product958
Abridged application, fee per product958
Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder511
Licence for parallel import, per product and exporting country639
Fee for traditional herbal medicinal product958
Fee for homeopathic preparation958
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 applicationPrice (€)
Fee per one medicinal product639
Subsequent pharmaceutical form or strength containing the same active ingredient of the same future marketing authorisation holder383
Fee for traditional herbal medicinal product383
Fee for homeopathic preparation383
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 State3000

 


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

Type of applicationPrice (€)
Variation Type IB100
Variation Type II383
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 variations500
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 variations1000

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 authorization160
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 substance320

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 application383
Variation to a clinical trial63

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 analysisPrice (€)
Sales of one ATC code divided by preparations30
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.