State Medicines Control Agency of Lithuania - Frequently asked questions

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

INFORMATION

+370 (5) 2124059

Frequently asked questions

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

Question on availability of PALLADONE- - XL 12 mg, 16 mg, 24mg, 32 mg pailginto atpalaidavimo kietos kapsul's
MR Number AT/H70150/001, - 002; - 003 and - 004
Dear Madam/Sir
We have visited the MRI Product Index and found that Lithuania has been acting as CMS for HYDAL UNO RETARD KAPSELN.

Also we tried to retrieve the Summary of Product Characteristics at your Agency website but we were not successul.
Therefore, we would appreciate very much if you would kindly advice us with the following questions:
1) Are the above referred products available on the Lithuanian market?
2) Could you, please, provide us with the Summary of Product Characteristics (one strength is sufficient, if the strengths are on separate SPCs)
Thank you for your kind attention to this matter.
Sincerely
Elvi Metsäranta
Director, Regulatory Affairs
LAB Pharma Ltd
PO Box 980, FIN-20101 Turku, Finland
Visiting address: Biolinja 12, 20750 Turku
Tel: +358 (0)2 333 3662
Mobile: +358 40 7047 808
Fax: +358 (0)2 333 3444
E-mail: elvi.metsaranta@labinc.fi
Web: www.labinc.fi

2007-05-25

Dear Sir or Madam,
I am interested in DCP procedure and the possibility of Lithuanian Agency to act as a RMS. I would like to know how long would it take to start the procedure as I am aware of the fact that there is a pe-procedural step and the calendar that RMS has to follow.
Best regards
Katarzyna Danielewska

2007-04-16

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