REPUBLIC OF LITHUANIA

REPUBLIC OF LITHUANIA 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