ICDRA

State fees and assessment fees  

01 November 11 print

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 15006, 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:EE403300333416110002
SWIFT code:   FOREEE2X
Bank:Danske Bank A/S Estonia branch
Address:Narva mnt. 11, 15015 Tallinn, ESTONIA

IBAN:EE701700017001577198
SWIFT code:    NDEAEE2X
Bank:Nordea Bank Finland PLC Estonia branch
Address:Liivalaia 45, 10145 Tallinn, ESTONIA

Refund of the state fee


Activity licences for handling of medicinal products

State fee (€)Reference number
Issue or renewal of an acitivity licence
Manufacture of medicinal products (except packaging of herbal substances)319,552900082281
Manufacture of medicinal products - packaging of herbal substances63,912900082281
Wholesale distribution of medicinal products319,552900082281
Retail pharmacy63,912900082281
Hospital pharmacy63,912900082281
Veterinary pharmacy63,912900082281
Change of data on activity licence
Manufacture or wholesale distribution (change of site of activity)191,732900082281
Manufacture - packaging of herbal substances (change of site of activity)19,172900082281
Manufacture or wholesale distribution (change of the competent person or change in the special conditions)63,912900082281
Manufacture - packaging of herbal substances (change of the competent person or change in the special conditions)6,392900082281
Pharmacy (change of site of activity or opening a new subsidiary)31,952900082281
Pharmacy (change of the competent person or change in the special conditions)6,392900082281


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 precursors31,952900082281
Application for an import or export authorisation of narcotic drugs and psychotropic substances6,392900082281
Application for an import or export authorisation of drug precursors6,392900082281


Activity licence for handling cells, tissues and organs

                                                                                                                              State fee (€)Reference number
Issue of an activity licence1597,792900082281
Renewal of an activity licence639,112900082281
Changing data on activity licence319,552900082281


Marketing authorisation applications

State fee (€)Reference number
Issue or renewal of marketing authorisation application (human medicinal product)31,952900082294
Application for variation both type I and II to a marketing authorisation (human medicinal product)15,972900082294
Issue or renewal of marketing authorisation application (veterinary medicinal product)31,952900082294
Application for variation both type I and II to a marketing authorisation (veterinary medicinal product)15,972900082294

"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)383,462900082294
For each additional research centre15,972900082294

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.6390


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 mutual recognition procedure or decentralised procedure as Reference Member State1275


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

Type of applicationPrice (€)
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 State510

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.


State Agency of Medicines - Nooruse 1, 50411 Tartu, Estonia | Tel: +372 7374140 | Fax: +372 7374142 | info@ravimiamet.ee | Location map