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Äåðæàâíîãî ôàðìàêîëîã³÷íîãî öåíòðó ÌÎÇ Óêðà¿íè
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“On MEDICINES”
LAW OF UKRAINE
(Gazette of the Verkhovna Rada [Supreme Council] (GVR) 1996, No 22, art 86)
(Enacted by a resolution of the Verkhovna Rada No 124/96-BP of 04.04.96 (GVR) 1996,
No 22, art 87)
(As amended by Laws No 70/97-BP of 14.02.97, GVR, 1997, No 15, art 115
No 783-XIV (783- 14) of 30.06.99, GVP, 1999, No 34, article 274 - the edition shall come into force simultaneously with enactment of the State Budget Law of Ukraine for 2000)
This Law shall govern the legal relations connected with the development, registration, manufacturing, quality control, and sale of medicinal products, shall specify the rights and obligations of enterprises, institutions, organisations, and citizens, and also the competence of the state executive authorities and officials in this sphere.
Section I.
General Provisions
Article 1. LEGISLATION ON MEDICINES
The legislation on medicinal products shall comprise this Law and other legislation acts adopted in connection with it.
Article 2. DEFINITION OF TERMS
In the legislation on medicinal products terms shall be used in the following meaning:
medicinal products are substances or their mixtures, of natural, synthetic, or biotechnological nature used for prevention of pregnancy, for prophylaxis, diagnosis, and treatment of human diseases, or intended to change the physiological state and functions of the organism.
Medicinal products shall include: active agents (substances); finished medicinal products (medicinal preparations, drugs, medicaments); homoeopathic agents; agents used to detect and eliminate pathogenic organisms or parasites; cosmetic products and medicinal supplements to food products;
finished medicinal products (medicinal preparations, drugs, medicaments) are dosage medicinal products in a form designed for usage;
active agents (substances) are biologically active agents capable to change the state and the functions of the organism or having prophylactic, diagnostic, or therapeutic action and used to manufacture finished medicinal products;
excipients are additional substances necessary to manufacture finished medicinal products;
narcotic medicinal products are those as defined by the legislation;
poisonous medicinal products are those as defined by the Ministry of Health of Ukraine;
drastic medicinal products are those as defined by the Ministry of Health of Ukraine;
radioactive medicinal products are those used in medical practice to produce ionising irradiation due to their properties;
The State Register of the Medicines of Ukraine shall be the regulatory document comprising data on medicinal products permitted for manufacture and use in medicinal practice;
the pharmacopoeial monograph shall be the standard and technical document establishing the requirements for the medicine, its packaging, conditions of storage, shelf-life, and quality control methods;
the technological regulations on manufacturing the medicine (hereinafter referred to as 'technological requirements') shall be the regulatory document specifying technological methods, technical means, norms and standards for the manufacture of the medicine;
The State Pharmacopoeia of Ukraine shall be the legislative document including the general requirements for medicinal products, pharmacopoeial monographs, and also quality control methods for medicinal products;
quality of the medicine shall be the sum of the properties which make the medicine capable to satisfy consumers and to meet the requirements established by the legislation;
shelf-life of medicinal products shall be the period of time within which the medicine shall not lose its quality pursuant to the requirements of the standard and technological documentation.
The meaning of other terms shall be specified by the legislation and by special dictionaries of terms issued by the World Health Organisation.
ARTICLE 3. STATE POLICY IN THE SPHERE OF DEVELOPMENT, MANUFACTURING, QUALITY CONTROL, AND SALE OF MEDICINES
The state policy in the sphere of development, manufacturing, quality control, and sale of medicinal products shall be directed to support scientific research work, development, and introduction of new technologies, and also development of the manufacture of highly effective and safe medicinal products, which meet the demands of the population for medicinal products of proper quality and in assortment by means of utilising relevant national programs, priority financing, rendering of low interest credits, tax remissions etc .
With the aim of protecting health of the citizens of Ukraine, the State shall ensure the availability of those medicinal products most in need, protect citizens in case of damage to their health after taking prescription-only medicinal products, and also shall establish the privileges and guarantees for special population groups and categories of citizens, providing them with medicinal products in case of illness.
ARTICLE 4. STATE ADMINISTRATION IN THE SPHERE OF DEVELOPMENT, MANUFACTURING, QUALITY CONTROL, AND SALE OF MEDICINES
The Verkhovna Rada of Ukraine shall determine the State policy and shall regulate the development, manufacture, quality control, and sale of medicinal products.
The Cabinet of Ministers of Ukraine through the system of the State executive authorities shall implement the state policy in the sphere of development, manufacture, quality control, and sale of medicinal products, shall provide the elaboration and performance of the relevant State programs and others within the limits of its authority, and shall control implementing the legislation on medicinal products.
Regulation in the sphere of development, manufacture, quality control, and sale of medicinal products within the limits of their competence shall be performed by the Ministry of Health of Ukraine, the State Committee of Ukraine on Medical and Microbiological Industry, and special state bodies authorised by them.
SECTION II
DEVELOPMENT OF MEDICINES
ARTICLE 5. SUBJECTS OF DEVELOPMENT OF MEDICINES
Medicinal products may be developed by enterprises, institutions, organisations, and citizens. The author (and co-author) of the medicinal products shall be the natural person (persons) developing the medicine by inventive, research work. Such person (persons) shall have the right to be rewarded for use of the medicine invented by him (them). Reward may be given in any form not prohibited by the legislation.
The author (and co-authors) may submit an application to Ukraine’s State Committee on the Issues of Intellectual Property to obtain a patent on the medicine. Justification for the decision to issue a patent shall be the positive opinion of the Ministry of Health of Ukraine or of the body authorised by it.
The material and non-material rights connected with the development and manufacturing of the medicine shall be regulated according to the legislation.
ARTICLE 6. PRE-CLINICAL STUDY OF MEDICINES
Pre-clinical study of medicinal products shall provide for chemical, physical, biological, microbiological, pharmacological, toxicological, and other scientific research in order to determine their specific action and safety.
Procedure for conducting pre-clinical study of medicinal products, the requirements for conditions of the conduct of separate researches, and also procedure for conducting expert assessment of materials pertinent to the pre-study of medicinal products shall be specified by the Ministry of Health of Ukraine, taking into account the standard procedures used internationally.
ARTICLE 7. CLINICAL TRIAL OF MEDICINES
Clinical studies of medicinal products shall be performed in order to establish or prove the efficacy and safety of medicinal product. They may be performed at specified health care settings as determined by the Ministry of Health of Ukraine or by the body authorised by it.
Before the start of clinical studies of medicinal products, the enterprises, institutions, organisations, or the citizens shall submit an appropriate application to the Ministry of Health of Ukraine or to the body authorised by it.
This application shall be annexed by materials containing general information on the medicine, the results of its pre-clinical examination, samples of the medicine, and the proposal for the clinical testing program.
The following are required before a decision may be taken on the clinical trial application for clinical testing:
positive opinions on the expert assessment of the pre-clinical data as to the safety and efficacy of the medicine;
data supporting a positive benefit-risk ratio, such that any adverse drug reactions (ADRs) of the medicine shall be considerably lower than the expected positive effect.
The procedure for performing the expert assessment of the clinical data shall be specified by the Ministry of Health of Ukraine or by the body authorised by it.
The applicant for clinical trials shall have the right to receive information concerning the clinical testing of the medicine, to acquaint himself with the results of the clinical experts appraisal, and may request a substitution of specialised health care setting where the clinical trial is performed.
Clinical study of medicinal products shall be performed following obligatory appraisal of the ethical, moral, and legal aspects of the clinical testing program by Ethics Committees that are established and operate under health care settings where the clinical trials are conducted. The Regulations on the Ethics Committee shall be approved by the Ministry of Health of Ukraine or by the body authorised by it.
The decision on approval of the program for clinical trials and their performance shall be taken by the Ministry of Health of Ukraine or by the body authorised by it.
Clinical trials of domestic and foreign medicinal products shall be performed in full or in the form of a shortened program, taking into consideration international practice standards. In certain cases, at the discretion of the Ministry of Health of Ukraine or the body authorised by it, clinical testing may not be required.
ARTICLE 8. PROTECTION OF THE RIGHTS OF THE PATIENT (THE VOLUNTEER)
Performance of clinical testing of medicinal products requires written consent of the patient (the volunteer) to participate in the clinical trial, or the written consent of his legally acceptable representative in the case of minors and incapable patients.
The patient (the volunteer) or his legally acceptable representative shall receive the information concerning the nature and possible consequences of the clinical trial, properties of the medicine, its expected efficacy and the level of risk.
The sponsor of the clinical trial shall, prior to its performance, make an Agreement on Insurance of Health and Life of the Patient (the Volunteer), according to the procedure envisaged by the legislation.
The person in charge of the clinical trial shall stop the clinical trial or its separate stages, should there be a trial associated threat to the health and life of the patient (the volunteer), or on demand of the patient (the volunteer) or his legally acceptable representative.
The Ministry of Health of Ukraine or the body authorised by it shall take the decision to stop the clinical testing of the medicine or its separate stages should there be a trial associated threat to the health and life of the patient (the volunteer), and in the case of lack or insufficiency of its efficacy, or if required on ethical grounds.
ARTICLE 9. STATE REGISTRATION OF MEDICINES
Medicinal products shall be allowed for use in Ukraine after their state registration, with the exception of the cases specified by this Law.
The State registration of the medicinal products shall be performed pursuant to the application submitted to the Ministry of Health of Ukraine or to the body authorised by it.
The following data shall be included in the application for the state registration of the medicine: name and address of the manufacturer; name of the medicine and its trade name; name of the active agent (in Latin); synonyms; dosage form; full composition of the medicine; indications and contra-indications; dosage; dispensing conditions; methods of use; term and conditions of storage; information about package; data on the registration status of the medicine in other countries.
Attached to the application shall be submitted: materials pertinent to pre-clinical studies of medicinal product, clinical trials and their expert evaluation; pharmacopoeial monograph or materials about methods of quality control of the medicinal product; draft of technological requirements or information about production technology; samples of the medicine and its packaging; the document confirming payment of the registration fee.
Based on the results of examination of the aforementioned materials, the Ministry of Health of Ukraine or the body authorised by it shall take the decision to approve or reject the application for registration of the medicine within the period of one month.
A decision to approve the state registration of medicine confers approval of the pharmacopoeial monograph or the methods of quality control of the medicine, the reconciliation of the technological requirements or the technology of manufacturing, and the medicine shall be given a registration number which shall be entered the State Register of the Medicinal Products of Ukraine.
The following data shall be specified in the State Register of Medicinal Products of Ukraine: the trade name of the medicine; the manufacturer; the international non-proprietary name; synonyms; chemical name or composition; pharmacological action; pharmacological and therapeutic group; indications; contra-indications; precautionary measures; interactions with other medicinal products; conditions for use and doses; adverse drug reaction; pharmaceutical forms; conditions and term of storage; dispensing conditions.
The applicant shall be given a Certificate for the registered medicine, specifying the period of validity within which the medicine shall be permitted for use in Ukraine.
The medicine may be used in Ukraine within the period of five years from the date of its state registration. At request of the person having submitted the application for state registration the term, within which it is permitted for use in Ukraine, may be reduced in accordance with the registration authority.
Should previously unknown dangerous properties of the medicine be detected, the Ministry of Health of Ukraine or the body authorized by the Ministry may take the decision to prohibit (totally or provisionally) the use of the medicine in Ukraine.
After expiration of the registration period, within which the medicine is permitted for use in Ukraine its further use shall be possible only on conditions of its re-registration.
A decision on rejection of the state registration of the medicine shall be made when the conclusions about its efficacy and safety are not confirmed.
The Ministry of Health of Ukraine or the body authorized by it shall give the applicant a written motivated opinion on rejection of the state registration of the medicine within 10 days. Decision on rejection may be appealed against through the procedure envisaged by the legislation.
The procedure for the state registration (or re-registration) of the medicine and amounts of fees for the state registration (or re-registration) of the medicine shall be established by the Cabinet of Ministers of Ukraine.
Not subject to state registration are the medicinal products, which are prepared in pharmacies under the prescriptions of doctors and at the request of health care settings from active substances and excipients permitted for use.
Section III
Manufacturing of medicines
ARTICLE 10. TERMS OF MANUFACTURING OF MEDICINES
Manufacturing of medicinal products shall be performed by natural or by legal persons on the grounds of the special permission (licence) issued pursuant to the procedure established by the Cabinet of Ministers of Ukraine or by the body authorized by it.
The grounds for issue of a special permission (licence) to manufacture medicinal products is an availability of appropriate material and technical base, qualified personnel (qualification of separate subject in the case of individual activity), and also of conditions necessary to guarantee the quality control of the medicinal products being manufactured.
General requirements to material and technical base for manufacturing the medicinal products, manufacturing inspection of their quality, and technological regulations are determined by the State Committee of Ukraine on Medical and Microbiological Industry.
ARTICLE 11. GENERAL REQUIREMENTS FOR MANUFACTURING OF MEDICINES
Active ingredients, excipients, and packaging materials permitted for use by the Ministry of Health of Ukraine or by the body authorized by it may be used in the manufacture of medicinal products.
The manufacture of medicinal products shall be performed pursuant to the technological requirements, the pharmacopoeial monographs and other state standards and technical conditions, taking into consideration the international standards on manufacture of the medicinal products.
Should the active or excipient be changed, the manufacturer of the medicine shall apply for registration of the medicine.
ARTICLE 12. LABELING OF MEDICINES
Information included on the label, outer and immediate packaging of the medicine shall contain the following data: name of the medicine; name and address of the manufacturer; registration number; batch number; conditions of use; quantity of the active agent per unit of pharmaceutical form and their number in the package; the shelf-life; storage conditions; precautionary measures.
Additional requirements on labeling and packaging specific to use of particular medicine may be approved at the time of state registration (or re-registration).
Medicinal products intended for clinical study shall carry the text 'For clinical research'.
Each medicine sold shall be accompanied by instructions for use of the medicine comprising information as follows: name of the medicine; general description (chemical name, main physical and chemical properties, composition); pharmacological data; indications for use; contraindications; interactions with other medicinal products; method of use and dosage; adverse effects; precautionary measures; pharmaceutical forms; storage conditions and shelf-life; dispensing conditions.
Section IV.
State quality control of medicines
ARTICLE 13. DEFINITION AND TASKS OF THE STATE QUALITY CONTROL OF MEDICINES
The state quality control of medicinal products shall incorporate the combination of organizational and legal measures designed the subjects of economic activity irrespective of their ownership forms and subordination to follow the legislative requirements to assurance quality of medicinal products.
The State quality control of medicinal products shall be performed by the State executive authorities within the limits of their competence specified by the legislation of Ukraine.
ARTICLE 14. AUTHORITIES OF STATE CONTROL
Authority for the state quality control of medicinal products shall be granted to the State Inspection for Quality Control of Medicines of the Ministry of Health of Ukraine with its directly subordinate State Inspections for the Quality Control of Medicines in the Autonomous Republic of Crimea, regions, and cities of Kyiv and Sevastopol.
The State Inspection for the Quality Control of Medicines shall be headed by the Chief State Inspector of Ukraine (the Deputy Minister of Health of Ukraine) who shall be appointed to the position and may be dismissed by the President of Ukraine. His Deputies shall be the Deputy Chief State Inspectors of Ukraine for the Quality Control of Medicines.
The Heads of the State Inspections for the Quality Control of Medicines of the Autonomous Republic of Crimea, in regions, and cities of Kyiv and Sevastopol shall be Chief State Inspectors; their Deputies shall correspondingly be Deputy Chief State Inspectors for the Quality Control of Medicines accordingly.
Other specialists of the State Inspections performing the state quality control of medicinal products at the same time shall be the State Inspectors for the Quality Control of Medicines.
The Regulations on the State Inspection for the Quality Control of Medicines shall be approved by the Cabinet of Ministers of Ukraine.
The State control over the manufacturing conditions of the medicinal products shall be performed by the State Committee of Ukraine for Medical and Microbiological Industry and the state bodies authorized by the latter.
ARTICLE 15. COMPETENCE OF THE OFFICIALS OF THE STATE CONTROL AUTHORITIES
The officials of the State control authorities, within the limits of their competence specified by the legislation shall be entitled to:
Check the requirements of the legislation as to the quality of medicinal products at manufacture, during storage, transportation, and sale by the subjects of economic activity;
once permission has been granted, perform freely an examination of any manufacturing, storing, or trading premises of the subjects of economic activity (taking into consideration the established schedule of work);
receive from subjects of economic activity all necessary data on the compliance with standards, technical conditions, the pharmacopoeial monographs and technological requirements, and also measures to ensure the quality of the medicine at the time of manufacturing, transportation, storage, and sale;
select samples of the medicinal products for laboratory testing of their quality. The cost of selected samples and of performing the quality control tests shall be included in the production costs of subjects whom have been taken these samples. The procedure for selection of the medicinal product samples shall be specified by the Cabinet of Ministers of Ukraine;
give binding recommendations to eliminate breaches of the standards and technical conditions, the pharmacopoeial monographs and technological requirements, and also breaches at the time of manufacturing, storing, transportation, and sale of the medicinal products;
transfer the results of sampling, containing the signs of any criminal action, to the authorities of inquiry;
impose a fine on the subjects of economic activity irrespective of their ownership forms in the event of a breach of the standards and technical conditions, the pharmacopoeial monographs and Technological Regulations at the time of manufacturing, storing, transportation, and sale of the medicinal products;
draw up the protocols on administrative offences and impose administrative fines;
apply to the bodies authorized to issue special permission (licence) to perform the manufacturing, wholesale purchase, wholesale and retail sale of medicinal products, for the abolition of licences issued, should the subjects of economic activity breach the terms of the licences, and also should they breach the standards and technical conditions, the pharmacopoeial monographs, and technological requirements;
stop or prohibit the manufacture of medicinal products in the case of the systematic or gross breaching of the requirements of the standards and technical conditions, the pharmacopoeial monographs, and technological requirements;
prohibit the storage, sale, and use of the medicinal products should their quality not meet the established requirements.
The regulatory requirements of the officials providing the state quality control of the medicinal products must be met.
The officials of the state control authorities shall be responsible for disclosure of the information known to them after performance of their duties pursuant to the acting legislation.
ARTICLE 16. LAW PROTECTION OF OFFICIALS OF STATE CONTROL
The officials of State control shall be under the protection of the law. Interference with the activity of the officials of state control authorities which impedes them in the execution of their duties shall constitute an offence pursuant to the acting legislation of Ukraine.
The life and health of the officials shall be subject to the obligatory state insurance against severe injury or disease during performance of their duties. Procedure and terms of insurance shall be established by the Cabinet of Ministers of Ukraine.
Section V. Importation of medicines into Ukraine and exportation of the medicines from Ukraine
ARTICLE 17. PROCEDURE OF IMPORTATION OF MEDICINES INTO UKRAINE
Medicinal products which have been registered in Ukraine may be imported into Ukraine provided with a certificate of quality issued by the manufacturer.
Control over the importation of medicinal products into the customs territory of Ukraine shall be performed by the State Inspection for the Quality Control of the Medicines.
Medicinal products not registered in Ukraine may be imported in the customs territory of Ukraine for:
pre-clinical studies and clinical trials;
registration of the medicinal products in Ukraine (samples of preparations in dosage forms);
purposes of exhibiting at fairs and conferences, without the right to sale; individual consumption by citizens.
The importation procedure for medicinal products in these cases shall be specified by the Ministry of Health of Ukraine.
In the event of natural disasters, catastrophes, and epidemic diseases, and under the separate permission of the Ministry of Health of Ukraine, the importation of medicinal products not registered in Ukraine shall be allowed, provided that documents confirming the registration and use of such medicinal products in the exporting countries are made available.
ARTICLE 18. EXPORTATION OF MEDICINES FROM UKRAINE
Exportation of medicinal products from Ukraine shall be performed pursuant to the order established by the legislation of Ukraine.
Section VI. Sale of medicines
ARTICLE 19 PROCEDURE OF SALE OF MEDICINES
The wholesale purchase, and wholesale and retail sale of medicinal products in Ukraine shall be conducted by the enterprises, institutions, organizations, and citizens in accordance with the special permission (licence) issued pursuant to the procedure established by the Cabinet of Ministers of Ukraine.
The licence to wholesale purchase, wholesale and retail sale of medicinal products shall specify groups of medicinal products, the purchase and sale of which can be performed by the subject of economic activity if conditions for ensuring storage and quality of medicines are available.
The requirements of Part 1 of this Article shall not be effective with the respect to the activity connected with the wholesale purchase, wholesale and retail sale of the medicinal products which may be sold to the population without medical prescription. Sale of the aforementioned medicinal products shall be performed in accordance with regulations on trade approved by the Cabinet of Ministers of Ukraine.
ARTICLE 20. GENERAL REQUIREMENTS TO SALE OF MEDICINES
Only registered medicinal products may be marketed in Ukraine, with the exception of the cases specified by this Law.
Sale of medicinal products may be performed provided that the certificate of quality issued by the manufacturer is made available.
ARTICLE 21. SALE (DISPENSING) OF MEDICINES TO THE GENERAL PUBLIC
Sale (dispensing) of medicinal products to the public shall be permitted either subject to or without medical prescriptions.
The sale (dispensing) of low quality medicinal products to the public, or those for which shelf-life has expired, or those without certificate of quality issued by the manufacturer, shall be prohibited.
The Rules on Prescribing Medicines and the list of medicinal products, which may be sold without medical prescription shall be approved by the Cabinet of Ministers of Ukraine.
ARTICLE 22. PROVIDING THE POPULATION WITH MEDICINES IN THE CASE OF NATURAL DISASTER, CATASTROPHE, EPIDEMIC DISEASES
To establish and preserve the state reserves of medicinal products to be used in the case of natural disaster, catastrophe, epidemic diseases the Cabinet Ministers of Ukraine or the body authorized by the latter shall establish and determine specialized state institutions and organizations. For this purpose it may make all necessary agreements with the subjects of business activities of any form of property.
The procedure whereby the State reserves of medicinal products are prepared and used, and the amount of these reserves shall be specified by the Cabinet of Ministers of Ukraine.
The Government of the Autonomous Republic of Crimea, the regional state administrations, and the state administrations of the city of Kyiv and the city of Sevastopol shall form their own reserves of the medicinal products for the case of the natural disaster, catastrophe, and epidemic diseases.
ARTICLE 23. UTILIZATION AND DESTRUCTION OF MEDICINES
Medicinal products of low quality, including those for which the shelf-life has expired, shall be utilized and destroyed.
The destruction of medicinal products shall be performed according to the Rules approved by the Ministry of Health of Ukraine and other requirements of the legislation.
Section VII. Final provisions
ARTICLE 24. FINANCIAL PROVISION
Development, pre-clinical examination, clinical trial, manufacturing, and quality control of the medicinal products shall be financed through the State Budget of Ukraine, budget of the Autonomous Republic of Crimea and local budgets, non-budget funds, assets of the enterprises, institutions, organizations, and citizens, and also from any other sources not prohibited by the legislation.
The expenses incurred financing scientific work on development of new medicinal products shall be related to the cost of the products pursuant to the procedure established by the Cabinet of Ministers of Ukraine.
(Part 3 of the Article 24 becomes void based on the Law No 783-XIV (783-14) of 30.06.99 - the wording is enacted simultaneously with enactment of the State Budget Law of Ukraine for 2000) From the total amount of funds received from the payment of fees for State registration of the medicine, 60% shall be directed to development of the state system of registration of the medicinal products, 30% shall be directed to development of the system of the State Inspection for Quality Control of Medicines. In addition, 10% of the money collected in fines imposed on the subjects of economic activity for breach of the requirements of the legislation to ensure the quality of the medicinal products shall be directed to the development of the system of the State Inspection for Quality Control of Medicines.
ARTICLE 25. MATERIAL AND TECHNICAL PROVISION
The State shall organize material and technical provisions for the development, manufacturing, quality control, and sale of medicinal products in the amount required to provide the population with the guaranteed level of health care.
Norms for minimum provision of the population with medicinal products, the sale of which is provided by state health care settings are determined by the Cabinet of Ministers of Ukraine.
ARTICLE 26. PROVISION OF INFORMATION
The State shall establish proper conditions for the provision of information in the sphere of development, manufacturing, quality control, and sale of medicinal products in Ukraine.
The Ministry of Health of Ukraine shall ensure that information is provided on those medicinal products registered or excluded from the State Register of the Medicinal Products of Ukraine.
The advertising of medicinal product is made in accordance with the “On Advertising” Ukrainian Law (270/96-BP). (Part 3 of the article 26 in the edition of the Law No 70/97-BP of 14.02.97).
(Part 4 of the article 26 is excluded on the basis of the Law No 70/97-BP of 14.02.97) Information which may be specified in the advertisement of medicinal products being sold to the general public on a medical prescription shall be coordinated with the Ministry of Health of Ukraine or with the body authorized by the latter.
(Part 5 of the article 26 is excluded on the basis of the Law No 70/97-BP of 14.02.97). Financial benefit obtained from the advertising of medicinal products in breach of the requirements of this Article shall be payable to the State Budget of Ukraine.
(Part 6 of the article 26 is excluded on the basis of the Law No 70/97-BP of 14.02.97) A restricted information on medicinal products for health care providers is not permitted except cases established by the acting legislation.
ARTICLE 27. RESPONSIBILITY FOR BREACHING THE LEGISLATION ON MEDICINES
Persons found guilty of breaching the legislation on medicines shall receive disciplinary administrative, civil, or criminal action pursuant to the legislation.
ARTICLE 28. INTERNATIONAL COLLABORATION
Ukraine shall participate in international collaboration in the sphere of development, quality control, and sale of medicinal products. For this purpose international scientific programs shall be developed and implemented, the exchange of information; progressive methods and technologies for development and manufacturing of medicinal products, their exportation and importation, professional and scientific communication of health care providers, etc. shall be provided.
The State shall develop and support all forms of international collaboration in the sphere of development, manufacturing, quality control and sale of the medicinal products, which is not in contradiction to the legislation of Ukraine.
L KUCHMA
President of Ukraine, 4 April 1996.
No 123/96-ÂÐ