Marketing authorization fees

Marketing Authorisation fees are confirmed by the Legal Act of Government of Republic of Lithuania (December 15, 2000, No. 1458). New  valid version ((in force since 16 07 2021, available only in Lithuanian) could be found here  

Marketing Authorisation fees in EUR (adapted version of the Resolution) could be found here.
The Marketing Authorisation fees are payable to the State Tax Inspectorate under the Ministry of Finance of the Republic of Lithuania

The fees indicated do not include any payment for bank transactions, therefore applicants or MAH’s are to cover all expenses related to banking transactions.

Method of payment:

Applicants or MAH’s outside Lithuania should make their payments in Euro.

Beneficiary‘s address:  Vasario 16-osios  str. 14, LT- 01514 Vilnius, Lithuania
Beneficiary  - State Tax Inspectorate under the Ministry of Finance of the Republic of Lithuania
More detailed information about bank accounts could be found here. 

Reference No. 5749 (mandatory to note in the field for notes if there is no special field)

Note: as fees for  State Medicines Control Agency’s (SMCA) services are paid to  State Tax Inspectorate (STI) neither SMCA nor STI do not provide any invoices. 

Proof of payment should be provided with the application form submitting to State Medicines Control Agency of Lithuania together with explanation for which application the fee is paid.

Explanation form.

Cheques are not accepted.

Information about fees refund could be find here: 

Note: When the application for grouping of variations (IA+  IB + II) of medicinal product (several strengths/pharmaceutical forms of the same medicinal product) is being submitted, the applicant pays one state fee for the main variation (either for IA, or for IB, or for II).