Application forms
Name of the medicinal product
Fees Flow-charts - Flow chart of the national procedure:
Validation (before Day 0) 20 working days + 20 working days of clock-stop | Assessment step I (Day 0-70) SMCA prepares Preliminary Assessment Report and discusses it at Marketing Authorisation Board (herein further referred MAB). Note: SMCA does not provide names of experts involved in assessment of specific applications. | Clock-stop The applicant prepares a response within 90 calendar days. | Assessment step II (Day 71-130) SMCA prepares Final Assessment Report. Clarification of secondary issues with an applicant is possible. MAB issues an opinion in respect to quality, safety and efficacy of the product concerned. | Positive opinion End of the procedure | Negative opinion If the Applicant intends to submit an appeal, he should inform SMCA on that within 5 working days after receiving negative opinion from SMCA by e-mail.
The appeal containing clarifications and arguments against negative opinion of MAB may be submitted within 1 month after receiving this e-mail. However, SMCA cannot accept any additional data with the appeal.
MAB issues a final opinion and, if necessary, SMCA amends assessment report within 60 calendar days. | After procedure SMCA issues Marketing Authorisation, updates national register of medicinal products and publishes product information on website within 30 calendar days. | |
National requirements in DC/MRP - Electronic response documents regarding marketing authorisation, renewal and variations should be sent to State Medicine Control Agency of Lithuania, Žirmūnų str. 139A, Vilnius, Lithuania. A copy may also be send to [email protected] Requirements are available at /index.php?2287345064
- National translations of the final SPC, package leaflet and labelling should be send in Microsoft Word within 5 working days after the end of the procedure to [email protected]. The templates are available here. The translations should be made by the qualified medical professional and reviewed by qualified linguistic professional. Translations of poor quality such as made by Google translator will never be accepted.
- To transfer Marketing Authorisation during the procedure, the original of the transfer agreement signed by both sides should be submitted to [email protected] and a hard copy to State Medicine Control Agency of Lithuania, Žirmūnų str. 139A, Vilnius, Lithuania.
In order to transfer Marketing Authorization during the national step, the following documents must be submitted: - Proof of establishment of the new MAH;
- Power of Attorney;
- Documents showing the capacity of the new MAH to perform all the responsibilities required;
- Transfer agreement (signed by both parties);
- Detailed Description of the Pharmacovigilance System;
- A document identifying the Qualified Person responsible for Pharmacovigilance System.
Name of the medicinal product. More information could be find here .
Zero-day procedure This is a simplified repeat procedure, during which Lithuania would unconditionally recognize the registration of a medicinal product authorised in other European Economic Area (EEA) countries under the mutual recognition or decentralized procedure, when submitting a marketing authorisation dossier identical to the approved one in reference member state (hereinafter – RMS). In other words, the zero-day procedure would apply to those medicinal products whose quality, safety and efficacy have been assessed by experts from the competent authorities of other EEA (at least two individual) countries and an assessment report has been drawn up. It should be noted that potential applicants should always contact the State Medicines Control Agency (hereinafter – SMCA) and provide request before initiating any procedure, where the goal is a short procedure, and SMCA will decide in advance on a case by case basis, if this approach is acceptable. Once the SMCA has confirmed that a zero-day procedure can be initiated, the Applicant should contact the RMS to update an Assessment Report of medicinal product in question, to state the date of submission of application for a zero-day marketing authorization and to initiate a zero-day procedure. Following these steps, the Applicant shall submit an application for a zero-day procedure. An updated dossier should contain all changes and updates to the data and information, and a declaration that the updated dossier is identical to the updated dossier submitted to RMS. Proposed translations of the Summary of Product Characteristics, labelling and (if available) package leaflet into Lithuanian language should be submitted with the dossier as well.
Useful links |
