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






Frequently asked questions

Gerbiami svetainės lankytojai,
 
Maloniai prašome svetainėje užduoti tik informacinio pobūdžio klausimus.
  
Specifinio pobūdžio klausimais galite kreiptis tiesiai į skyrius kontaktuose nurodytais telefonais.
  
Skundą pateikti galite užpildę skundo dėl Tarnybos veiklos formą.
   
Gyventojams informacija apie vaistinius preparatus teikiama telefonu nemokama linija 8-800 735 68.
   
Esant sveikatos sutrikimams, patariame nedelsiant kreiptis į savo gydytoją. Gydymo klausimais nekonsultuojame.
   
Taip pat Tarnyba neteikia konsultacijų žemiau išvardintais klausimais:

Klausimai

Kompetentinga institucija

Dėl maisto papildų

Valstybinė maisto veterinarijos tarnyba http://vmvt.lt/  (kontrolė)
Vilniaus visuomenės sveikatos centras (http://vilniausvsc.sam.lt/ (notifikavimas, ženklinimas)

Dėl kosmetikos gaminių ir biocidų

Vilniaus visuomenės sveikatos centras
(http://www.vilniausvsc.sam.lt/)

Kompensuojamųjų vaistų kompensavimo ir išdavimo klausimais

Valstybinė ligonių kasa
(http://www.vlk.lt/

Vaistinių preparatų kainodaros klausimais

Sveikatos apsaugos ministerija (http://www.sam.lt/)

Dėl medicinos prietaisų

Valstybinė akreditavimo tarnyba
(http://www.vaspvt.gov.lt/)

Vaistų išvežimo (siuntimo paštu) iš Lietuvos klausimais

Atitinkamos valstybės ambasada

Dėl veterinarinių vaistų registracijos ir kontrolės

Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas http://www.nmvrvi.lt/

Klausimai susiję su NPKID (vaisto identifikacinis numeris)

Sveikatos apsaugos ministerija http://www.sam.lt/)

Daugiau informacijos galite rasti gyventojams skirtoje rubrikoje Dažniausiai užduodami klausimai.
    
Dėkojame už bendradarbiavimą.





Dear Sir/ Madam,
Hope you are doing fine,

Please help confirm Address details for State Medicines Control Agency, at which the registration dossier is submitted.
Also, Please help confirm the number of copies of registration dossier submitted to the agency & what will be the media (via Post/ Courier or by hand) to submit the registration dossier to State Medicines Control Agency, Lithuania.


Thanks & Regards,
Deepak Gupta
2012-06-22
Good afternoon!
We're are going to spend this summer in Lituthania. My mother-in-law will live with my family. She needs the following list of medicines: Vinpocetine, Piracetam, Thrombo ASS, Enap, Concor Cor. Is it allowed to bring this medicines from Russia for 70 days?
Thank you in advance. Please answer in English or in Russian.
2012-05-14
Hello. Hope you could help me with my question. Me and my mother are going to visit your country but we need to have some specific medicine because of my mother's illness. I know that you have some restrictions for some drugs but don't know exactly whether these drugs are prohibited in your country. What shall I do then? Are there any list of prohibited or restricred drugs to find out whether we can to get medicine with us. Hope for your answer.
2011-08-08
Dear Sir or Madam,

I am writing with regard to medicines which are allowed to be taken when crossing the Lithuanian border.
This summer we are going to Lithuania for a month or so. My mother and a little daughter are going with me and I have a question concerning medicines which are allowed to be taken because it is impossible to go for such a long period without any medicine, my mother has to take some of them every day (heart drops and drops from blood pressure).
On your website I found names of elements which are forbidden, but unfortunately I am not in the medicine and do not know all the elements of which this or that medicine consists. I would be very grateful to you for your help and advice.

Is it allowed to take the following medicines (unfortunately I do not know all the titles in English):

1. Энап-H, tablets

2. capoten (captopril), tablets

3. ацетилсалициловая кислота (aspirin), tablets

4. bioparox, spray

5. бриллиантовый зеленый раствор (brilliant [ethyl] green)

6. перекись водорода (hydrogen peroxide)

7. nurofen (for children), syrup (ибупрофен)

8. фестал, tablets

9. активированный уголь, tablets

10. аквамарис, spray

11. фуразолидон, tablets

12. тамтум верде (бензидамин), spray

13. парацитамол, tablets

14. фенистил (диметинден), drops

15. эреспал (фенспирид), syrop

I would be grateful if you would answer this letter and advise me on the choice of medicines.

Faithfully yours
Nina S.

2011-06-21
Hi,
i am working in wholesaler company in Poland and we are about to start trading with Lithuanian wholesalers, I am looking on the website for the list of lithuanian wholesalers that can trade with. Please advice if you can provide me such a list or direct me on the right website.
Regards
Wiktor Ros
2011-05-24
Dear Mrs, Dear Mr,
We would like to submit a multicentric clinical trial on several UE countries one of them is Lithuania (One investigator site: Vilnius).
Could you please give us the procedure and all the document required in order to submit the study at SMCA?
Could you also give us the email of the competent Ethic committee in order to contact it?

By anticipation, many thanks.
Best regards,
Sara Leonardo
2011-05-03
Interquim, S.A., a Spanish API manufacturer, is working on the responses raised by the RMS (France) at Day 70 included in a DCP procedure (FR/H/465/01-02/DC) in which Lithuania is a CMS. Please may you kindly inform us the e-mail address in order to send the responses.
Many thanks in advance for your kind collaboration. I am looking forward to hearing from you.

Cristina Peinado
Regulatory Affairs
Interquim, S.A. (Ferrer Grupo)
2010-12-01
Good morning! My name is Simone and I work in the RA Department of an Italian Medical Device company.
We’d like to start selling our CE marked device (an active medical device, belonging to class IIb as per the European Medical Device Directive 93/42) and its disposable circuits (class IIa) in Lithuania.
My question is: is there any notification to be done to your local Ministry of Health before distributing the medical device in Lithuania?
If so, what documentation is to be submitted? Is the documentation to be submitted in Lithuanian language? How long will the registration review process take before approval? Thanks a lot in advance for any info you can give me.
Simone
2010-11-04
Dear Mr.(s),
In a multicentric study conducted in Europe, (Lithuania included) competitive randomization between the participants countries, if addtional patients are to be assigned to Lithuania (insurance addendum provided), will it be considered as "substantial amendment", eventhough the total number of randomized patient maintained the same? Thank you so much for your attention.
2010-09-23
Hi

Is it legal for a person to buy Kamagra (Viagra) "off the shell" in a pharmacy or other places or does it require a receipt from a Doctor or other permit?

Regards...
2009-08-28
Please advise if a clinical trial application must include all investigator signatures or if that for the principle investigator would be sufficient?
Please confirm that you no longer require the EudraCT application form to be submitted in both English and Lithuanian? Many thanks.
2009-07-28
Dear Sirs,

Could you please be so lind to inform me whether at the time of DCP/MRP MAA submission you need the proposed SPC, PL and Labelling in Lithuanian or whether this requirement is only applicable at the national stage of DCP/MRP?

I will be looking forward for your comments.
2009-05-04
Could you please advise on whether you arre undertaking any DCP activities? I look forward to hearing from you.
2009-04-27
Dear sir or madame,

I am interesteted in the fees for application to conduct clinical trials with new investigational medicinal products in Lithuania. I would be delighted to receive a short answert from you.
2009-01-12
If a company wants to withdraw an MA which was authorised via the MRP, is a letter of withdrawal to the Lithuanian authority sufficient or are there any other forms to fill in? Lithuania is a CMS and the drug has never been marketed in Lithuania. Thanks!
2008-09-23
Dear Sir/Madam,

Can you please let me know if it is possible to get a copy of the SPC (summary of product characteristics) for a human medical product licensed in Lithuania.
2008-07-17
Dear Sir or Madam,

We are planning to submit a Clinical Trial Application to your agency for your consideration. I have however been informed that your agency use specific meeting dates. Could you please confirm if this was the case, and if so, could you also tell me the submission dates and deadlines for 2008?
2008-04-29
Dear Sir, Madam,

Could you please send me an overview of fees that have to be paid for Marketing Authorization Applications (national, MRP, DCP), variations etc? I would also like to know what the payment procedure is.

Thank you in advance.

Kind regards
Leonie van Liessum

Regulatory Affairs officer at DADA Consultancy B.V., The Netherlands
2008-04-07
Please find below my 2 requests:
1) Do you have an annual fee to pay per authorised product?
2) The marketing authorisation of True Test expires in December 2008, which means that a renewal application has to be submitted in June. Do you require this renewal application before the license is time unlimited and goes into 3 years PSUR cyclus?

Thank you in advance.

Liselotte Kok Rasmussen, Regulatory consultant
Mekos Laboratories, Herredsvejen 3, DK-3400 Hilleroed
2008-03-04
Dear Sir/Madam,

I am looking for the requirements/procedure in Lithuania to import unlicensed products for miltary use only.
The product is a morphine auto-injector to be used exclusively by the Lithuanian military.
Please could you provide me with some advice?

Thank you in advance for your kind assistance.
2008-02-26
Pinewood Healthcare is applying for a MRP. and Lithuania is a Corcened Memeber State (CMS)
Please could you forward me information on the FEEs for Lithuania acting as a CMS.
please can also inform me if these fees are required PRE or POSt MRP.
thanks
Fiona Downey
Regulatory Affairs Officer
2008-02-22
Can you be so kind to inform me about the current SLOT times if an applicant asks Lithuania to act as the RMS in a DCP to register a human generic product.
2008-01-11
Dear Sir/Madam

I am currently looking for information on nalbuphine on the Slovenian market and would appreciate your assistance.

1/ Through a search on the website, it is likely that there is no nalbuphine products currently authorized in Lithuania. Please could you just confirm that information? In case I have missed anything, could you just let me know the name of the product, the date of approval, the marketing authorisation number and if it is a controlled drug or not?

2/ In visiting the MRI index in the Head of Medicines Agencies website, I have found that Lithuania is one of the CMS for a recent MRP (MR number NL/H/0983/001/MR). Please could you let me know if a national licence has just been or would be issued imminently for Nalbuphin Orpha-Devel 10 mg/mL injekcinis tirpalas? And again, if you can confirm please if it is classified as a controlled substance or not.

Your response at your earliest convenience would be very much appreciated.
Thank you very much in advance for your consideration,

Yours sincerely,
Lalao Ramaroson
Regulatory Consultant
GFA Ltd (UK)
2007-12-17
Dear Madam, Dear Sir

I would like to introduce myself; I work for a Belgian Company “B & C Group S.A.” and a part of activities of the company is the storage and the distribution of Investigational Medicinal Products (IMPs).
We were contacted by a customer who wishes to perform a clinical trial in Lithuania. This customer asked the rules for the import of IMPs and wishes to know if it is required to send the products to a warehouse or it is authorized to send directly on the clinical site.

I consulted the website and I found the Decree 484 but I don’t known if this decree is still applicable.
Could you please inform me if this decree is still applicable and if no, could you please send me the new regulation applicable for the import?

On the other hand could you please confirm that for an import: a license is required and that it is authorized to send directly on a clinical site?

Thanks in advance for your help and your collaboration.

Best regards

France De Smedt
QA/RA Officer, Ind. Pharm.
B & C Group S.A.
2007-08-01
Dear Sir, I am investigating a clinical trial where oxaliplatin would be used as the control arm. I undertand that oxaliplatin is not approved in Lithuania ( please confirm). If this is correct are there any rules that I need to consider in importing oxaliplatin into Lithuania and conducting this study.

Kind Regards G Traynor
2007-07-09
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