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






Authorisation procedures

Application forms 

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 response@vvkt.lt 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 registracija@vvkt.lt. 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 registracija@vvkt.lt 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. 
   
  • The name of the medicinal product should be agreed during validation phase or, as an alternative, during national phase i.e. after Day 90/210. For issues regarding names of the medicinal products please send to pavadinimai@vvkt.lt.

Useful links 

 

 

 

 

 

   

Last Update: 2016-12-09 10:40:55