REPUBLIC OF LITHUANIA                                     
                                                                                
                               LAW                                              
                                                                                
                                                                                
                  ON PHARMACEUTICAL ACTIVITIES                                  
                                                                                
                                                                                
     This Law  shall regulate  pharmaceutical activities  in  the               
Republic of Lithuania.                                                          
                                                                                
                                                                                
                           Chapter I.                                           
                                                                                
                                                                                
                          Main Concepts                                         
                                                                                
     Article 1.                                                                 
                                                                                
     In this law:                                                               
     "Pharmacy" shall  be the  sphere of scientific and practical               
health  care   which  comprises   the  preparation,   compounder,               
dispensation,  quality   control,  and   custody  of   medicines,               
medicinal substances,  information about  medicine, and  sale  of               
medicines in pharmacies to residents;                                           
     "Pharmaceutical activities" shall be the compounder, quality               
control, dispensation,  custody (with the intention to sell), and               
sale of  medicines and  medicinal  substances  in  pharmacies  to               
residents, as  well as  the dissemination  of  information  about               
medicine;                                                                       
     "Medicinal substances"  shall be substances which effect the               
processes of  human and  animal organisms,  and which, in various               
medicinal forms,  are  used  for  the  treatment  of  humans  and               
animals, and for the diagnosis and prevention of disease;                       
     "Medicines" shall be medicinal substances prepared for use;                
     "Medicine quality"  shall be  the quality  of a  medicine as               
determined by its identity, purity, and composition;                            
     "Pharmacies" shall  be the  companies in  which,  under  the               
permission and  supervision of the State, medicines and medicinal               
goods are  kept, compounded,  controlled, and  sold to residents,               
health-care (and other) institutions, and companies;                            
     "Pharmacopoeia" shall  be the enforced State standards which               
determine the  quality, production, quantity and quality control,               
names, and conditions for keeping medicinal substances;                         
     "State Medicines  Register" shall  be the  sanctioned list of              
medicines and  medicinal substances which are permitted to be used              
for medical and veterinary purposes in the Republic of Lithuania.               
                                                                                
                                                                                
                           Chapter II.                                          
                                                                                
                                                                                
          Guarantees for the Provision of Medicines to                          
             Residents of the Republic of Lithuania                             
                                                                                
     Article 2.                                                                 
                                                                                
     The  State   shall  guarantee   the  provision  of  essential              
medicines and  medicinal products to the residents of the Republic              
of Lithuania.                                                                   
                                                                                
     Article 3.                                                                 
                                                                                
     A list  of essential  medicines and medicinal products shall               
be compiled and approved by the Ministry of Health Care.                        
                                                                                
                                                                                
                          Chapter III.                                          
                                                                                
                                                                                
                 State Registration of Medicines                                
                                                                                
     Article 4.                                                                 
                                                                                
     Medicines and  medicinal substances  used  for  medical  and               
veterinary  purposes   in  the  Republic  of  Lithuania  must  be               
registered in the State Medicines Register.                                     
                                                                                
     Article 5.                                                                 
                                                                                
     Medicines and  medicinal substances  shall be  registered in               
the Republic  of Lithuania according to the procedure established               
by the Ministry of Health Care.                                                 
                                                                                
     Article 6.                                                                 
                                                                                
     Applicants shall  pay an  established fee  to the  State  to               
record medicines  and medicinal substances in the State Medicines               
Register.                                                                       
                                                                                
     Article 7.                                                                 
                                                                                
     State registration  of medicines shall not be necessary if a               
medicine is  compounded in  a pharmacy  from registered medicinal               
substances upon  an individual, official written prescription, or               
an official written order of health institutions.                               
                                                                                
     Article 8.                                                                 
                                                                                
     The Ministry of Health Care:                                               
     1)  may,   in  cases   of  emergency   (natural  calamities,               
catastrophes,  etc.),  permit  the  import  and  distribution  to               
citizens and  to health  and prevention  institutions of  foreign               
medicines which  are not  registered in the Republic of Lithuania               
but which are registered and used in their country of origin; and               
     2) may  permit the  utilization of  medicines and  medicinal               
substances which  are not registered in the Republic of Lithuania               
for scientific and clinical research.                                           
                                                                                
     Article 9.                                                                 
                                                                                
     The Minister  of Health  Care must  suspend and prohibit the               
production, import,  and sale of a medicine if it has been proven               
and established  that this  medicine has  harmful  effects  on  a               
person's health or hereditability.                                              
                                                                                
                                                                                
                           Chapter IV.                                          
                                                                                
                                                                                
          Legal Conditions of Pharmaceutical Activities                         
                                                                                
     Article 10.                                                                
                                                                                
     In the  Republic  of  Lithuania,  companies,  non-production               
organizations,  and   natural  persons   may   only   engage   in               
pharmaceutical activities if they have a permit (license).                      
                                                                                
                                                                                
     Article 11.                                                                
                                                                                
                                                                                
     Pharmaceutical activity permits (licenses) may only be issued              
to natural  persons who  have had  higher or specialized secondary              
pharmaceutical  education,   and  whose  qualifications  meet  the              
requirements approved by the Ministry of Health Care.                           
                                                                                
     Article 12.                                                                
                                                                                
     Persons  who   have  had  higher  or  specialized  secondary               
pharmaceutical education,  and who have permits (licenses), shall               
have the  right, under  bilateral agreements  with pharmacies, to               
sell medicine to residents at local medical centres.                            
                                                                                
     Article 13.                                                                
                                                                                
     The  compounder   of  medicine   upon   individual   written               
prescriptions shall only be permitted in pharmacies.                            
                                                                                
     Article 14.                                                                
                                                                                
     Medicines, medicinal  substances, and  substances of natural               
origin which  are used  for pharmaceutical  purposes may  only be               
sold to residents in pharmacies, in accordance with the procedure               
established by  the regulations  of  the  establishment  and  the               
activities of  the pharmacy.  These regulations shall be approved               
by the Minister of Health Care.                                                 
                                                                                
     Article 15.                                                                
                                                                                
     State bodies  who are  authorized by  the Government  of the               
Republic of  Lithuania shall  regulate the price of medicines and               
medicinal substances,  as well as the cost of medicine production               
in pharmacies;  these  rates  shall  be  uniform  throughout  the               
Republic.                                                                       
                                                                                
     Article 16.                                                                
                                                                                
     Only  auxiliary   substances  which  are  specified  in  the               
Pharmacopoeia  and  other  standard  documents  approved  by  the               
Minister of  Health  Care  may  be  used  in  the  compounder  of               
medicines.                                                                      
                                                                                
     Article 17.                                                                
                                                                                
     Information concerning  the use  of medicines  and medicinal               
substances  for   medical  treatment   may  only   be   furnished               
(disseminated) by  companies, non-production  organizations,  and               
natural  persons  who  have  the  right  to  engage  in  medical,               
pharmaceutical, and  veterinary activities.  The advertisement of               
medicines shall  only be  permitted in  special publications  and               
other special informational media.                                              
                                                                                
     Article 18.                                                                
                                                                                
     Pharmaceutical activities  which violate  the requirements of              
this law  or legislative acts which are connected with it shall be              
considered illegal.                                                             
     Companies, non-production organizations, and natural persons               
who carry  out illegal  pharmaceutical activities  shall be  held               
responsible in  accordance with  the  laws  of  the  Republic  of               
Lithuania.                                                                      
                                                                                
                                                                                
                           Chapter V.                                           
                                                                                
                                                                                
         State Supervision of Pharmaceutical Activities                         
                                                                                
     Article 19.                                                                
                                                                                
     The Ministry of Health Care shall supervise pharmaceutical                 
activities in the Republic of Lithuania.                                        
                                                                                
     Article 20.                                                                
                                                                                
     In the  Republic of Lithuania, quality control of medicines,               
medicinal substances,  and substances  of natural origin shall be               
carried out  according to  the requirements of the Pharmacopoeia,               
requirements of  bilateral agreements  of which  the Republic  of               
Lithuania is  a party,  or requirements  for quality  and quality               
control of  medicines as  established by  international  organiza               
tions of which the Republic of Lithuania is a member.                           
                                                                                
                                                                                
                           Chapter VI.                                          
                                                                                
                                                                                
        Pharmaceutical Activities in Veterinary Medicine                        
                                                                                
     Article 21.                                                                
                                                                                
     Medicines which  are only  used in  veterinary medicine  and               
veterinary goods  shall be  registered, and  lists  of  essential               
veterinary medicines shall be compiled and approved, according to               
the procedure  established by  the Ministry of Agriculture of the               
Republic of Lithuania.                                                          
                                                                                
     Article 22.                                                                
                                                                                
     In the  Republic of  Lithuania, the  Ministry of Agriculture               
shall have  the right  to issue and revoke permits (licenses) for               
companies, non-production  organizations, and  natural persons to               
engage in pharmaceutical activities in veterinary medicine.                     
     In  specific   cases   (epizootics,   catastrophes,   etc.),               
veterinary medicines  which are not registered in the Republic of               
Lithuania may  be imported  in the  procedure established  by the               
Ministry of Agriculture.                                                        
                                                                                
     Article 23.                                                                
                                                                                
     Persons engaged in pharmaceutical activities and employed in               
veterinary pharmacies  must have  higher or specialized secondary               
pharmaceutical or veterinary education.                                         
                                                                                
     Article 24.                                                                
                                                                                
     Pharmaceutical activities concerning the production, quality               
control, dispensation,  custody, and  sale of  medicines used for               
veterinary  purposes  shall  be  regulated  by  the  Ministry  of               
Agriculture.                                                                    
                                                                                
                                                                                
Vytautas Landsbergis                                                            
                                                                                
President                                                                       
Supreme Council                                                                 
Republic of Lithuania                                                           
                                                                                
                                                                                
Vilnius, 31 January, 1991                                                       
No. I-1025