Scientific-regulatory advice

Scientific-regulatory advice

Pursuant to Article 8 (15¹) of the Law on Farmacy of the Republic of Lithuania, the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (hereinafter – Agency) provides scientific and regulatory advice to legal entities, engaged in development, experimental and (or) scientific research and experimental development of medicinal products, as well as to the marketing authorization holder or their representatives.

Scientific-regulatory advice from the Agency is not legally binding and provided in order to assist during the development of a medicinal product, its authorization and post-authorization period, quality assurance of a medicinal product in pre-clinical and clinical research stages, and to help ensure the required standards and compliance with relevant guidelines in the relevant field for the assessment of health technologies, including medicinal products, their starting materials and, if necessary, intermediates products in the stages of laboratory research.

Scientific-regulatory advice is based on the information provided by the applicant, the requirements of valid legal acts and contemporary scientific knowledge. During scientific-regulatory advice the benefit-risk ratio of the medicinal product is not evaluated. The procedure for providing scientific-regulatory advice is determined by the Head of the Agency.

A state fee is payable for the application to receive scientific-regulatory advice, the evaluation of the submitted documents and information and the issuance of scientific-regulatory advice documents in accordance with the Resolution of the Government of the Republic of Lithuania 15 December 2000 No. 1458 "On the approval of the list of specific amounts of the state fee and the rules for payment and refund of the state fee". The following fees have been established for the assessment of the documents and information submitted together with the application for scientific-regulatory advice and the issuance of scientific-regulatory advice documents: https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr

Where to pay?

State fees are payable to the State Tax Inspectorate under the Ministry of Finance of the Republic of Lithuania.

Beneficiary State Tax Inspectorate under the Ministry of Finance of the Republic of Lithuania(Legal entity code - 188659752, address: Vasario 16-osios str. 14, 01107 Vilnius, Lithuania).  

Reference No. 5750 (mandatory to note in the field for notes if there is no special field).

Application procedure

Application procedure established by the Order of the Head of the Agency dated on 2 April 2024 No.(1.72E)1A-412 “Regarding approval of the description of the procedure for providing scientific-regulatory advice provided by the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania"

Download the Order

Application form

Downloadthe Application form for scientific-regulatory advice

https://vvkt.lrv.lt/en/marketing-authorisation/advice-to-applicants-and-pre-submission-meetings/