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