Authorization of Veterinary Medicinal Products
The use of the eAF (electronic application form) is mandatory for all procedures (MRP, DCP, SRP and NP). Further details can be found HERE.
QRD veterinary product information template version 9.1
Electronic documents for veterinary medicinal product marketing authorisation, renewal or variations that require assessment (VRA) should be submitted through the Common European Submission Portal (CESP).
Electronic documents for veterinary medicinal product variations that do not require assessment (VNRA) should be submitted through the Union veterinary medicines database UPD.
Inquiries regarding veterinary medicinal products procedures should be sent via email to: [email protected]
Marketing Authorisation fees are confirmed by the Legal Act of Government of Republic of Lithuania (December 15, 2000, No. 1458). New valid version (available only in Lithuanian) could be found here.
Current fees can be found here.
Method of payment
The Marketing Authorisation fees are payable to the State Tax Inspectorate under the Ministry of Finance of the Republic of Lithuania.
Applicants or MAH’s outside Lithuania should make their payments in Euro.
Beneficiary - State Tax Inspectorate under the Ministry of Finance of the Republic of Lithuania
Address: Vasario 16-osios str. 14, LT- 01514 Vilnius, Lithuania
Reference No.5742 is mandatory to indicate alongside to payment details (VMP name, procedure type (autorisation/renewal/variation) or procedure number.
More detailed information about bank accounts could be found here.
Information about fees refund
Please be kindly informed that, since all fees are paid to the State Tax Inspectorate (STI) under the Ministry of Finance of the Republic of Lithuania, a strict procedure must be followed in order to request a refund.
If you wish to request a refund for overpaid or mistakenly paid fees related to marketing authorization/renewal, variations, or any other changes, you must submit the following documents to the State Tax Inspectorate:
- Form FR0781
(Please note: this form is available only in Lithuanian. All accompanying and explanatory documents must also be in Lithuanian. Therefore, you may need assistance in completing the form.) - A copy of the account statement
(This is the same document that was submitted to the State food and veterinary service(SFVS) along with the application form.) - An original confirmation letter from the SFVS
(This letter must verify that the paid fees were not used and are eligible for a refund.)
To obtain the confirmation letter (which will be issued in Lithuanian), please send an official request letter (this may be in English) to the SFVS, along with a copy of the relevant account statement.
Important: as fees for SFVS services are paid to STI neither SFVS nor STI do not provide any invoices.
The Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (hereinafter – VMP Regulation) applies from 28 January 2022 and repeals Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (hereinafter – Directive).
For smooth transition from the provisions of Directive to implementation of requirements of VMP Regulation European Commission has published a Commission Notice on marketing authorizations for veterinary medicinal products for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6“ (2021/C 274/02).
With this Notice, European Commission aims to assist businesses and national competent authorities in applying the relevant legislation. The purpose of this Notice is to inform stakeholders on how European Commission intends to deal with centrally authorised veterinary medicinal products for which the expiry of the 5-year period of validity of the marketing authorisation falls on or after 28 January 2022. The Notice also addresses certain questions that may arise in relation to nationally authorised products.
The Coordination group for mutual recognition and decentralized procedures for veterinary medicinal products (CMDv) prepared Transitional arrangements for the entry into application of Regulation (EU) 2019/6 for veterinary medicinal products registered under national, mutual recognition and decentralised procedure. Document aims to help both national medicines agencies and marketing authorisation holders to implement the provisions of VMP Regulation.
What actions must Marketing Authorisation Holders take?
Within the Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC , Article 5, point 2. „A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time". MAH must inform the SFVS in advance (3 month prior expiry of marketing authorisation) by email [email protected] whether or not it wishes the authorisation of the veterinary medicinal product to be extended indefinitely. In this case, the MAH does not provide any additional documentation.
If the MAH does not submit inform of the request to issue indefinite marketing authorisation of the registration of the VMP, the registration certificate of the VMP shall be valid until the date currently specified therein.
Marketing authorisation holders can apply for unlimited time of validity of one individual or several or all marketing authorisations at the same time with one single free-form notice. All marketing authorisations for which written notice applies must be listed.
The SFVS informs that by 29 January 2027, the MAH must update the SPC, labelling and package leaflet (product information) of veterinary medicinal products.
The SFVS anticipates that it may receive many applications for such variations at one time, which may make it difficult to assess them. In such a situation, it is planned to propose an exchange at a time acceptable to both parties.
Additional information is available on the blogs of the European Medicines Agency (EMA), Coordination group for mutual recognition and decentralized procedures for veterinary medicinal products (CMDv) and the European Commission (EC):
Last updated: 20-11-2025