Company code 191351864
Žirmūnų str. 139A, Vilnius, Lithuania
E-mail: vvkt@vvkt.lt,
Phone: +370 5 263 92 64
Fax: +370 5 263 92 65






News title
The Baltic meeting took place in Vilnius
2019-04-19

The meeting of the Baltic States medicines agencies took place on 11th of April 2019 in Vilnius, Lithuania. Representatives of Lithuanian, Latvian and Estonian medicines agencies, both human and veterinary medicines, and Lithuanian Ministry of Health participated in the meeting. During the meeting, information and experience on the ongoing activities of the institutions were shared and relevant topics were discussed.

--->
European Council adopts decision extending the period under "Article 50"
2019-03-28

Following the European Council meeting on 22 March 2019, the date for UK's withdrawal from the EU has been extended beyond 30 March 2019. Under the European Council decision, if the withdrawal agreement between the UKand the EU is approved by the UK House of Commons by 29 March 2019, the extension will be until 22 May 2019. If the withdrawal agreement is not approved by 29 March 2019, the extension will be until 12 April 2019. In that event, the UK will indicate a way forward before 12 April 2019, for consideration by the European Council.

--->
What is being done to prevent possible shortages of medicines due to BREXIT?
2019-03-27

The State Medicines Control Agency is closely monitoring and analyzing the situation in the Register of Medicinal Products of the Republic of Lithuania for the purpose of ensuring that the supply of medicines would not be affected by BREXIT. All the instructions of the European Commission are being implemented, actively cooperation with pharmaceutical manufacturers, registrants and suppliers is being done, the all issues are being resolved and the possibilities of substitutability of medicines are being clarified. The situation is now fully managed and clear.

--->
For Marketing authorisation applicants: Lithuania – RMS in Mutual recognition and / or Decentralised procedures
2019-03-22

Lithuania intends to act as Reference Member State (RMS) in 10 Mutual recognition and/or Decentralised procedures (MRP/DCP) in 2019.

--->
Exemption for batch testing of medicines in UK after 29 March 2019
2019-03-19

Marketing authorisation holders who are unable to transfer their batch testing site from the UK to the EU27 by 29 March may be permitted, for a limited period of time, to rely on quality control testing performed in the UK under certain conditions. For more information, see:

--->
Successfully implemented eu–funded twinning project in the area of medicines, medical devices and pharmaceutical activity
2019-03-12

The closing ceremony organised on 5 March 2019 by the Delegation of the European Union to the Republic of Moldova, the Medicines and Medical Devices Agency of the Republic of Moldova, the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of the Republic of Poland marked the end of implementation of the EU-funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova as regulatory agency in the field of medicines, medical devices and pharmaceutical activity”.

--->
Mission on developing new tasks for the quality control laboratory has been organized
2019-03-07

During the week of 4 – 8 February 2019, an additional mission on the Developing New Tasks for the Quality Control Laboratory within the Activity 5.3 of the EU funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova (MMDA) as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” has been conducted.

--->
Regarding medicinal products for which „sunset clause“ may already be applied
2019-03-04

The State Medicines Control Agency on the ground of market monitoring data has compiled the list of medicinal products authorized in the Republic of Lithuania which more than for three years had not been supplied to the Lithuanian market.

--->
An experts from Moldova were trained in the GGP inspection process in Lithuania
2019-01-23

During 17-21 December 2018, the third mission of the Study visit in respect of the Component 4 of the EU-funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova (MMDA) as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” was organized.

--->
Experts of the medicines and medical devices agency of the republic of moldova were trained in the gmp and gdp inspection process following the eu requirements for conducting and reporting of gmp and gdp inspections
2018-11-22

During 05-09 November 2018, the second mission of the Study visit in respect of the Component 4 of the EU-funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova (MMDA) as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” was organized.

--->
The seventh steering committee meeting has been organized
2018-11-06

The seventh meeting of the Steering Committee of the EU-funded Twinning Project "Strengthening the Medicines and Medical Devices Agency of the Republic of Moldova as a regulatory agency in the field of medicines, medical devices and pharmaceutical activity" was held on the 11 of October 2018.

--->
New Marketing Authorisation Application Form version mandatory from 15th of October, 2018
2018-10-11

Please be kindly informed that from 15-10-2018 new Marketing Authorisation Application Form (eAF) version v1.23 (Revision 13) will become mandatory. This new version will fully replace the version 1.22.0.1 after transitional period, on 15 October 2018. The version of the form should not be changed during an ongoing procedure. Please find the new eAF here: http://esubmission.ema.europa.eu/eaf/index.html or /Common-information.

--->
Marketing authorization fees
2018-09-26

Please be informed that same marketing authorization fees (renewal, variations) has been changed since 25 th of September, 2018. You can find all information about fees here.

--->
The sixth steering committee meeting has been organized
2018-09-06

The sixth meeting of the Steering Committee of the EU-funded Twinning Project "Strengthening the Medicines and Medical Devices Agency of the Republic of Moldova as a regulatory agency in the field of medicines, medical devices and pharmaceutical activity" was held on the 19 of July 2018.

--->
Lithuania intends to take RMS role from UK in 70 MRP/DCP
2018-07-04

The United Kingdom (UK) submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (EU). This means that The United Kingdom will then become a 'third country' from 30 March 2019. According to Directive 2001/83/EC the reference member state (RMS) can be only EU state. This means that RMS role in Mutual recognition and decentralised procedures (MRP/DCP) should be switched to other EU state.

--->
The Baltic meeting took place in Estonia
2018-05-24

The meeting of drug regulatory agencies of human and veterinary medicinal products of Baltic States took place on 10th of May 2018 in Tartu, Estonia. The aim of the meeting was to exchange information, to find new areas where we could promote Baltic strength based on our long cooperation and to harmonize the positions for different procedures in the area of regulation of medicinal products. Heads of Estonian, Latvian and Lithuanian agencies together with 40 specialists participated in the meeting. The organisations participating were Estonian State Agency of Medicines, Latvian State Agency of Medicines, Latvian Food and Veterinary Service, Lithuanian State Medicines Control Agency, Lithuanian National Food and Veterinary Risk Assessment Institute and Lithuanian State Food and Veterinary Service.

--->
Delegation from Poland paid an official visit to the Agency
2018-05-21

Representatives from Poland: Dr. Zbigniew J.  Król, the Vice Minister of the Ministry of Health, Dr. Roman Topór-Mądry,  the President of the Agency for Health Technology Assessment and Tariff System,  Dominik Dziurda, the Director of the Healthcare Services Department at the Agency for Health Technology Assessment and Tariff System, and Katarzyna Kędzior, the analyst from of the Healthcare Services Department at the Agency for Health Technology Assessment and Tariff System paid an official visit to Lithuanian State Medicines Control Agency (SMCA) on May 17.

--->
The additional risk minimisation measure for medicinal products
2018-05-18

During the Baltic Meeting held on 10th May 2018 in Tartu (Estonia) there was a discussion of Subgroup of common visual reminder (boxed warning and pictogram) to warn patient about teratogenic or foetotoxic effect on Baltic Package. The use, location and layout of the pictogram, also boxed warning issues were agreed.

--->
The fifth steering committee meeting has been organized
2018-05-11

On 19th April 2018, the fifth Steering Committee meeting of the EU-funded Twinning Project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” was held to evaluate the results of the activities implemented within the project, as well as to set the main targets for the next quarter.

--->
Experts of the Medicines and Medical Devices Agency of the Republic of Moldova were trained in the gvp and gmp inspection process following the EU requirements for conducting and reporting of GVP and GMP inspections
2018-05-03

During 23-27April 2018, the third mission of the Study visit in respect of the Component 2 of the EU-funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova (MMDA) as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” was organized. 

--->
 1 2 Next ->