Information for applicants
The use of the eAF (electronic application form) is mandatory from 1st January 2016 for all applications (MRP, DCP and national procedure applications for marketing authorisation, renewal and variations). Further details can be found on: http://esubmission.ema.europa.eu/eaf/index.html.
QRD veterinary product-information template version 8.2
Electronic documentation can be submitted in the following ways:
o Via CESP (http://cesp.hma.eu/)
o to the e-mail address: vaistu.registracija@vmvt.lt
o Eudralink (https://eudralink.ema.europa.eu)
Please use only one delivery option.
Fees
State Fees payable for marketing authorisation of veterinary medicinal products were initially adopted by the Government of the Republic of Lithuania on 15 December 2000 (Decision No. 1458). Latest amendments were last adopted on 15 December 2014 (Decision No. 1442) and amended fees came into effect on 1 January 2015.
The SFVS informs, that the “Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council” and “Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations (EMA/CMDv/7381/2021)”will be applied from January 28th, 2022. In the current regulation the variations are classified as Type IA, Type IB and Type II, but this classification will no longer apply. In order to implement the provisions of the above-mentioned documents, the SFVS informs that the fees for variations do not change (see table below). Therefore, before submitting your application, you should check carefully in advance whether you are indicating the correct type of variation in your application (as described in Regulation (EU) 2021/17 or the EMA guidelines (EMA / CMDv / 7381/2021)).
Current marketing authorisation fees can be found here.
Payment details
Fees are payable to any of the following accounts of the State Tax Inspectorate under the Ministry of Finance of the Republic of Lithuania:
|
Bank |
Account No. (IBAN) |
Bank code |
SWIFT |
|
AB "Citadele" bankas |
LT78 7290 0000 0013 0151 |
72900 |
INDULT2X |
|
Luminor Bank AB |
LT74 4010 0510 0132 4763 |
40100 |
AGBLLT2X |
|
AB SEB bankas |
LT05 7044 0600 0788 7175 |
70440 |
CBVILT2X |
|
AB Šiaulių bankas |
LT32 7180 0000 0014 1038 |
71800 |
CBSBLT26 |
|
Danske Bank A/S Lietuvos filialas |
LT74 7400 0000 0872 3870 |
74000 |
SMPOLT22 |
|
AB "Swedbank" |
LT24 7300 0101 1239 4300 |
73000 |
HABALT22 |
|
UAB Medicinos bankas |
LT42 7230 0000 0012 0025 |
72300 |
MDBALT22 |
Beneficiary: State Tax Inspectorate under the Ministry of Finance of the Republic of Lithuania
Beneficiary‘s address: Vasario 16-osios g. 14, 01514 Vilnius, Lithuania
Reference number: 5742 is mandatory to indicate alongside to payment details (product name, procedure type: authorisation/mutual recognition/renewal/variation).