Application forms

 
Common information

Applications
   

in English
  

in Lithuanian
   

Application for granting marketing authorisation
   

Download 

-

Application for renewal 
   

Download 

Application for variation
   

Download 

  -

Application for changing the classification for the supply of a medicinal product  

Download

Download

Application for transfer marketing authorisation   
   

Download

Download

Application for changes to labels and/or patient informatikon leaflets

Download

Download

Application for granting marketing authorisation for parallel import   

 

Download

Application for variation for parallel import
  

 

Download

Application for the common Baltic package procedure
  

Download

 

 

Application for the common Polish and Lithuanian labelling procedure 

Download

 

Application for granting marketing authorisation for homeopathic medicinal product according art.  14 and 16.2 of 2001/83/EC Directive 

Download

 

Request to initiate day zero procedure in Lithuania

Download

 

 

Information about SMCA mail boxes

Information about marketing authorisation:

Atnaujinimo data: 2023-09-06