Ensuring Medication

Original Language Title: О лекарственном обеспечении

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Read the untranslated law here: http://minjust.gov.tm/ru/mmerkezi/doc_view.php?doc_id=15073

 
Ensuring medication * translated from the official language of Turkmenistan.
 
This law is aimed at improving the legal and organizational basis of State regulation of relations in the field of drug supply.
 
Chapter i. General provisions article 1. The basic concepts used in this law for the purposes of this law, the concepts used are: 1) anatomical therapeutic chemical classification system is an international classification system of medicines designed to synthesize statistical information on medicinal products;
2) pharmacy-medical institution providing medicines manufacturing, storage, disposal (vacation) medicines, medical devices in accordance with the requirements established by the legislation of Turkmenistan;
3) safety of medicinal products, medical products-line medicines, medical products to the requirements of this Act, regulations, guaranteeing in their application, the absence of risk of harm (harm) to human life and health, its heredity.
4) auxiliary substances-substances inorganic or organic origin used in the manufacturing process (manufacturing) of medicines to give them the necessary physico-chemical properties;
5) vosproizvedënnoe drug (generic) is a medicine containing an identical pharmaceutical substance or their combination in drug form, similar to the original product, and is applied after the expiry of titles of protection on the original medicinal product;
6) State pharmacopoeia is a collection of normative documents that establish the requirements for the quality of medicines;
7) counterfeit medicines, medical products-medicines, medical products circulating in compliance with the requirements established by the legislation of Turkmenistan;
8) the State Register of medicines, medical devices-a document containing information on medicinal products, to products for medical purposes, passed the State registration in accordance with the requirements established by this Act;
9) preclinical drug research is biological, microbiological, immunological, toxicological, pharmacological, physical, chemical and other scientific studies in order to obtain scientific methods of evaluation and evidence of pharmacological activity of medicinal products;
10) instructions for use of the drug-medical document containing clinical characteristic of the drug, indications and contraindications for its use and other information concerning its pharmacological properties;
11) quality medicines and medical products-a set of characteristics of medicinal products, medical products, ensuring their conformity to requirements of normative documents;
12) clinical investigation of medicinal products-clinical study of curative, preventive, and pharmacological properties of the drug, its safety, quality and efficacy, conducted in accordance with standards of good practice;
13) drugs-substance or mixture of substances with healing properties medicinal preparations in certain dosage form and strength, ready to use, intended for the prevention, diagnosis, and treatment of diseases;
14) Medicinal raw materials of mineral, plant, animal, synthetic or biotechnological origin, is the source for getting drugs;
15) National Formulary of essential medicines-periodically updated the list of drugs approved for use, as well as guidance on their safe, efficient, effective application that provides standards for the treatment of illness;
16) unsafe medicines, medical products-medicines, medical products, which do not conform to the requirements of normative documents and not suitable for use or expired;
17) Regulations-interstate and State standards (monographs, standards of good practice), other rules and regulations establishing requirements for safety and quality of medicines, medical products;
18) original remedy is a medicine containing the pharmaceutical substance received for the first plant, animal, synthetic or biotechnological origin or a new combination of pharmaceutical substances, safety, quality and effectiveness of which confirmed the results of pre-clinical and clinical trials of the medicinal product;
19) essential (vital) medicines-medicines, to ensure that the priority needs of health for the prevention and treatment of diseases that are most common (predominant) in the structure of morbidity;

20) side effects of the drug-response of the human organism to junk that occurs in connection with use of the drug in the recommended doses;
21) manufacturer (manufacturer) of medicines-Enterprise (pharmacy), carrying out the production (manufacture) of the medicinal product;
22) production (manufacture) drugs-production of medicines in accordance with the requirements for organization of production and quality control of medicines;
23) recipe-medical document in the prescribed form, containing a written request from a doctor (Physician Assistant) to the pharmacy for medicine;
24) the expiration date of the drug, medical products-the period of time during which, while respecting the established storage conditions of the drug, medical products of their producer (manufacturer) guarantees the quality of medicinal products, medical products and after which they shall not be in effect;
25) good practice standards-international rules set by the World Health Organization, which include the rules of good laboratory, clinical, manufacturing, distribution, pharmacy and other types of practices;
26) falsified medicines, medical products-medicines, medical products, accompanied by intentionally incomplete or misleading information about their composition, properties and characteristics of either their manufacturer (manufacturer), the date of manufacture (manufacturing), expiry date;
27) Pharmacopoeial article-normative document approved in the prescribed manner, containing a list of quality indicators and methods of quality control of medicinal products;
28) the pharmaceutical activities-includes development, manufacturing (manufacturing), storage and transportation of drugs and their implementation (vacation);
29) pharmaceutical substance is the main component of the drug, which defines its safety, quality and efficiency;
30) the effectiveness of the drug product characteristics degree of positive effects of the drug on the course or the duration of the illness;
31) medical supplies-medical instruments, apparatus, devices and other medical equipment used for the conduct of preventive, diagnostic and therapeutic measures, including dental, consumable, dressings and sutures, fixing bandages and contact lenses and lenses for vision correction, diagnostic reagents;
32) pharmacological Committee-expert body that is created by the Ministry of health and medical industry of Turkmenistan to address issues related to obtaining permission to conduct clinical trials of medicines and application in clinical practice, medicines, medical products of domestic and foreign manufacture;
33) Pharmacopoeial Committee-expert body that is created by the Ministry of health and medical industry of Turkmenistan for consideration, approval of the normative and technical documentation which establishes requirements for the quality of medicines, medical products;
34) medicines, medical products is a process associated with the procurement, storage, transportation and sale (the release) of medicines, medical products;
35) drugs-a set of organizational, legal, economic and other measures aimed at providing the population with medicines, medical products, approved for use in Turkmenistan;
36) matter of registration of medicinal products, medical products (hereinafter registration)-the set of documents submitted by the applicant to the competent authority for the State registration of medicinal products, medical products;
37) medico-technical activities-activities, including development, production, storage, transportation of medical products and their realization.
 
Article 2. The legislation of Turkmenistan on medication provision 1. The legislation of Turkmenistan on medication provision is based on the Constitution and consists of this law and other normative legal acts of Turkmenistan.
2. If an international treaty to which Turkmenistan stipulates other rules than those stipulated by this law, the rules of the international treaty shall apply.
 
Article 3. The scope of this law 1. This law shall apply to the relations that arise in the field of drug supply.
2. Features of the use on the territory of Turkmenistan of medicines containing narcotic or psychotropic substances, and their precursors, as well as intended for use in veterinary medicine are regulated by other regulatory legal acts of Turkmenistan.
 
Article 4. The main directions of the State policy in the field of drug supply, the main directions of the State policy in the field of drug supply are: 1) the protection of the rights of citizens to health;

2) improved legal and institutional framework of the State regulation of relations in the field of drug supply;
3) creation and implementation of new technologies, as well as the development of highly effective and safe drugs;
4) ensuring the needs of the population of Turkmenistan in a safe, quality and effective drugs;
5) introduction of standards of good practice;
6) rational use of medicines;
7) support and development of international cooperation.
 
Article 5. Financing in the field of drug supply Financing in the field of drug supply is carried out at the expense of the State budget of Turkmenistan, as well as other sources not prohibited by Turkmen law.
 
CHAPTER II. State regulation and control in the sphere of DRUG PROVISION § 1. Authorities exercising State regulation and control in the field of drug supply, their competence, article 6. Authorities exercising State regulation and control in the field of drug supply bodies exercising State regulation and control in the field of drug supply, are the Cabinet of Ministers of Turkmenistan, Ministry of health and medical industry of Turkmenistan, the authorized body in the sphere of drug supply (hereinafter referred to as the authorized body), other government agencies operating in the field of drug supply, local executive bodies and local governments within the limits of their competence.
 
Article 7. Competence of the Cabinet of Ministers of Turkmenistan Cabinet of Ministers of Turkmenistan: 1) defines a uniform State policy in the field of drug supply;
2) publishes the normative legal acts in the field of drug supply;
3) defines the authorized body;
4) argues: a) the State programme for the development of drug supply;
(b)) the provision on the authorized body;
ç) list of diseases, which have the right to purchase medicines, medical products, free of charge or on preferential terms;
(d)), a list of medicines, medical devices, sold (sold) free of charge or on preferential terms;
(e)) the import into and export from Turkmenistan Turkmenistan medicines, medical devices;
ä) procedure for State control in the sphere of drug supply;
5) coordinates the activities of bodies of State power and administration and local self-government bodies in the field of drug supply;
6) exercise other functions referred to his competence, legislation of Turkmenistan.
 
Article 8. The competence of the Ministry of health and medical industry of Turkmenistan, the Ministry of health and medical industry of Turkmenistan: 1) implements a uniform State policy in the field of drug supply;
2) provides an implementation of the State program on development of drug supply;
3) publishes the normative legal acts in the field of drug supply;
4) is responsible for licensing in the field of drug supply;
5) gives permission to conduct clinical trials of medicines;
6) organizes the provision of public medical institutions with medicines, medical products;
7) oversees the provision of safe, high-quality and effective drugs, medical products;
8) develops and submits for approval by the Cabinet of Ministers of Turkmenistan: a) provision for the authorized body;
(b)) the list of diseases, which have the right to purchase medicines, medical products, free of charge or on preferential terms;
ç) list of medicines, medical devices, sold (sold) free of charge or on preferential terms;
(d)) Order entry into Turkmenistan and Turkmenistan export of medicines, medical devices;
e) procedure for State control in the sphere of drug supply;
9) alleges: (a)) the order of State registration of medicines, medical products;
(b) Farmakopejnom) Committee;
ç) Pharmacological Committee;
(d)) position on the Committee on ethics in the field of drug supply in the Ministry of health and medical industry of Turkmenistan;
(e)) position of medical representatives;
ä) procedure to monitor side effects of medicines;
f) list of standard samples of medicinal products manufactured in pharmacies by prescription;
(g)), a list of treatment-and-prophylactic establishments engaged in the conduct of clinical trials on medicinal products;
h) National Formulary of essential drugs;
(I)) rules of the pre-clinical study drugs;
j) rules for the conduct of clinical studies of drugs;
ž) procedure for the implementation of the life and health insurance of persons voluntarily participating in a clinical study of drugs;
k) form a prescription and completing it requirements;
l) implementation rules (release) of the medicinal product;

m) order of destruction (recycling) of substandard medicines, medical products, counterfeit medicines, medical devices, drugs, counterfeit medical products;
n) list of medicines (prescription), sold in pharmacies by prescription;
about) the list of diseases that are most common (predominant) in the structure of morbidity;
ö) model agreement on carrying out of clinical investigations;
p) list of essential (vital) drugs;
10) carries out certification of employees working in the field of drug supply;
11) ensures the development of logistical and informational base in the field of drug supply;
12) temporarily suspends the production (manufacture) medicines, medical devices, their implementation (vacation) in cases of non-conformity requirements for their production (manufacturing), (release);
13) exercise other functions in the field of drug supply, referred to his competence, legislation of Turkmenistan.
 
Article 9. Competence of the authorized body Empowered body: 1) implements a uniform State policy in the field of drug supply;
2) implements the State program on development of drug supply;
3) publishes the normative legal acts in the field of drug supply;
4) exercises State control in the field of drug supply;
5) implements State registration of medicines, medical devices;
6) establishes general requirements for the development, production (manufacturing), storage, transportation, advertising, destroy (recycling) of medicines, medical products;
7) develops and submits for approval to the Ministry of health and medical industry of Turkmenistan: a) the procedure for State control in the sphere of drug supply;
(b)) to monitor side effects of medicines;
ç) National Formulary of essential drugs;
(d)) rules of the pre-clinical study drugs;
(e)) the rules for the conduct of the clinical trial of drugs;
ä) the order of State registration of medicines, medical products;
f) destruction (recycling) of substandard medicines, medical products, counterfeit medicines, medical devices, drugs, counterfeit medical products;
8) States: (a)) form for instructions on the use of the medicinal product and the content of its text;
b) packaging design of the medicinal product;
ç) monographs manufacturers located on the territory of Turkmenistan;
9) develops normative documents, as well as taking decision on recognition of the individual standards international pharmacopoeias and Officinal articles on medicines manufactured in foreign countries;
10) gives the certificate on the State registration of medicinal products, medical products (hereinafter referred to as the certificate);
11) establishes the procedure for maintenance of the State Register of medicines, medical devices;
12) gives permission to import to Turkmenistan medicines, medical devices in accordance with the procedure for the import into and export from Turkmenistan Turkmenistan medicines, medical devices;
13) examines the quality of medicines, medical products;
14) is conducting the State Register of medicines, medical devices;
15) monitor the side effects of drugs;
16) participates in the development and implementation of standards for the treatment of diseases;
17) inspects the production (manufacture) of medicines on their conformity to standards of good practices;
18) carries out training and retraining their professionals, including outside Turkmenistan;
19) conducts scientific research in the field of drug supply;
20) informs the public about medicinal products registered in Turkmenistan;
21) takes the decision to suspend the use of the medicinal product, its withdrawal from circulation, destruction (recycling);
22) imposes fines in the manner prescribed by the legislation of Turkmenistan;
23) carries out international cooperation in the field of drug supply, as well as to the introduction of innovative technologies, standards of good practice in the field of drug supply, sends its specialists for enterprises engaged in the production of medicines, medical devices, located on the territory of foreign States;
24) carries out State control of advertising of medicinal products;
25) draws on a contractual basis, scientific institutions and experts to address issues related to drug issues;
26) takes part in conferences, meetings, symposiums and meetings, organizes exhibitions and other events on issues related to drug issues;

27) exercise other functions in the field of drug supply, referred to his competence, legislation of Turkmenistan.
 
Article 10. The competence of other State bodies active in the field of drug supply, the local authorities and local self-government, other State bodies, carrying out activities in the field of drug supply, local executive bodies and local governments within its competence: 1) participate in the implementation of a uniform State policy in the field of drug supply;
2) participate in realization of the State program on development of drug supply;
3) interact with the notified body in carrying out activities in the field of drug supply;
4) take measures to develop State network of pharmacies in public hospitals, primary health care, emergency medical assistance, medical assistance, medical and social assistance, Spa care, palliative medical care;
5) carry out the purchase of medicines, medical devices for public health facilities;
6) exercise other functions in the field of drug supply, referred to their competence, legislation of Turkmenistan.
 
§ 2. State regulation in the field of drug supply Article 11. Licensing of pharmaceutical and medical-technical activities 1. Licensing of pharmaceutical and medical-technical work is carried out in accordance with the legislation of Turkmenistan.
2. A prerequisite for obtaining licenses for carrying out pharmaceutical or medical-technical activities is the attachment to application manufacturer medicines list of dosage forms and (or) species of pharmaceutical substances, products of medical purpose that producer medicines, medical devices intended to produce.
3. In the case of the expansion of the production of medicines due to the creation of new dosage forms and (or) species of pharmaceutical substances, medical products manufacturer of medicines or medical devices must obtain a new license to pharmaceutical or medical-technical activities.
 
Article 12. Standardization and certification in the field of drug supply standardization and certification in the field of drug supply are carried out in the manner prescribed by the legislation of Turkmenistan.
 
Article 13. State registration of medicinal products, medical devices 1. The purpose of State registration of medicines, medical products is to determine their compliance with the requirements established by this law and other normative legal acts of Turkmenistan, as well as preventing the entry into Turkmenistan, production, trafficking drugs, medical products that may pose a risk to human life and health, its heredity.
2. State registration of medicinal products, medical devices (hereinafter registration) is carried out by the notified body.
3. Medicines, medical products may be approved for use in Turkmenistan only after their registration (except for the cases stipulated by the present law), including the following: 1) Medicinal teas and homeopathic medicines, disinfectants, including other measures for the prevention of infectious diseases, medical tools, cosmetics, hygiene products, mineral water, mud and salt used in the treatment-and-prophylactic purposes;
2) original medicines;
3) reproduced drugs (generics);
4) medicines registered previously produced in other dosage forms and new dosage;
5) medicines made on an additional production site;
6) drugs-when changing the owner of the certificate.
4. Not subject to state registration of imported into Turkmenistan medicines, medical items: 1) are their samples (samples of pharmaceutical substances), intended for State registration of not exceeding ten packages;
2) intended for preclinical and clinical research;
3) are exhibition specimens and are not intended to implement or use later;
4) intended for personal use: a) the employees of diplomatic missions and consulates of Turkmenistan abroad, missions of Turkmenistan with the international organizations and diplomatic missions, consular posts of foreign States and international organizations in Turkmenistan;
b) foreign citizens and stateless persons who arrived in Turkmenistan, for the duration of their stay in Turkmenistan;
ç) crew members of all types of vehicles of foreign States who arrived in Turkmenistan, for the duration of their stay in Turkmenistan;

d) individuals participating in international cultural and sports activities and parties with international expeditions;
e) citizens of Turkmenistan in the quantity required for the application for a period not to exceed ten calendar days;
5) intended for medical care in each case patients for health reasons based on the written instructions of the Ministry of health and medical industry of Turkmenistan;
6) designed to provide medical assistance in each case when carrying out the sports, cultural and other activities based on the written instructions of the authorized body;
7) which are humanitarian assistance provided in the order, approved by the Cabinet of Ministers of Turkmenistan.
5. a person who surrenders to the authorized body for the State registration of medicinal products, medical products (hereinafter applicant) shall submit a registration case, which includes a statement of State registration and other necessary documents.
6. State registration includes: 1) in accordance with the established procedure of the registration of the case;
2) examination of the documents contained in the registration of fact necessary to determine availability of quality control methods play a medicinal product submitted by the applicant;
3) the inclusion of medicines, medical devices in the State Register of medicines, medical devices, allowed for the production (manufacture) in Turkmenistan or importation, in Turkmenistan, as well as the issuance of certificates. For each drug, the product for medical purposes since State registration certificate for a period of five years. Form of Certificate approved by the Ministry of health and medical industry of Turkmenistan.
7. For its consideration of the application for the State registration fee, in accordance with the procedure of State registration of medicines, medical products. In the case of a refusal of State registration the amount paid is not refundable collection.
8. the authorized body shall consider the application for State registration and issue a certificate or provide reasoned refusal in State registration within the period not exceeding 180 calendar days from the date of receiving the application.
9. The period of validity of the certificate specified in paragraph 3 of part 6 of this article may be extended if the applicant would request to the competent authority a statement of re-registration of medicinal products, medical products not later than three months before the expiration of the term of validity of the certificate, provided the funds for re-registration of medicinal products, medical products will be credited to the relevant accounts no later than the last day of the expiration of the certificate. While the authorized body is obliged to re-registration of medicinal products, medical products and to issue the relevant document or give the complainant a reasoned refusal of their re-registration.
10. Registered medicines, medical items are entered in the State Register of medicines, medical devices.
11. in the event of the need of making changes and amendments in the case of registration the applicant must within thirty calendar days to apply and relevant documents to the competent authority. Information contained in the documents shall be forwarded to the Pharmacopoeial Committee gives an opinion on the impact of the changes and additions to the safety, quality and efficacy of medicines and medical products.
Changes and additions to the registration thing is based on Pharmacopoeia Committee protocol with optional corresponding entries in the case of registration, is stored in the archive. Changes and additions shall not decrease the safety, quality and efficacy of medicines and medical products.
12. it is not allowed to state registration: 1) various medicines under the same trade name;
2) of one drug, produced by a manufacturer under various trade names and submitted for State registration of two or more drugs;
3) medicines, medical devices, which as a result of the examination of the submitted documents and conducted studies obtained negative conclusion.
13. State registration is carried out by the notified body in accordance with the regulation on State registration of medicines, medical devices, approved by the Ministry of health and medical industry of Turkmenistan.
 
Article 14. A refusal of State registration 1. In case of detection of inconsistency in examination of documents or samples of medicines, medical devices submitted for State registration requirements, the authorized body shall be entitled to make a decision on refusal in State registration.

2. the decision on refusal in State registration can be appealed in the manner prescribed by the legislation of Turkmenistan.
 
Article 15. Cancellation Of Certificate 1. Decision about cancellation of the certificate is accepted by the notified body in the case of: 1) identify side effects of the drug, threaten the health and lives of people, their heredity when applying medication, monitoring its safety;
2) filing the certificate holder or person duly authorized by him, the statement of revocation of the certificate;
3) failure by the owner of the certificate necessary information which may entail amending the certificate within thirty (30) calendar days from the date of occurrence of such changes and additions, as well as in other cases determined by the notified body.
2. the decision on the revocation of a certificate may be appealed in the manner prescribed by the legislation of Turkmenistan.
 
§ 3. State control in the sphere of drug provision, article 16. Implementation of State control in the sphere of drug provision 1. Medicines, medical products produced (made) in Turkmenistan or imported in Turkmenistan shall be subject to State control over their quality on conformity to requirements of normative documents.
2. State control in the field of drug supply includes: 1) monitoring compliance with the legislation of Turkmenistan on medication;
2) undertaking activities aimed at compliance with normative documents;
3) control of dokliniceski and clinical study of drugs;
4) control of the development, production (manufacture), storage, transportation, realization (release), advertising of medicinal products;
5) control over imported to Turkmenistan and Turkmenistan export of medicines, medical devices;
6) Organization and conduct of verification of conformity of medicines, medical devices in circulation on the territory of Turkmenistan, the requirements of normative documents;
7) examination of the quality of medicines;
8) monitoring of side effects of the drug;
9) monitoring destruction (recycling) of medicines, medical products.
3. in order to prevent the entry into Turkmenistan substandard medicines, medical devices, as well as medicines, medical devices, are adulterated or counterfeit, the authorized body shall have the right to decide the direction of their employees by enterprises located on the territory of foreign States, engaged in the production of medicines, medical devices to assess their conditions of production, including at the expense of producers.
4. State quality control of medicinal products is carried out by the notified body, State authorities, local self-government bodies within their competence.
 
Article 17. Law officers of the authorized body in the exercise of State control in the sphere of drug provision 1. Officials of the authorized body in the exercise of State control in the sphere of drug provision have the right: 1) visit in the manner prescribed by the legislation of Turkmenistan, enterprises, institutions and other organizations, regardless of their form of ownership, carrying out the production (manufacture), storage, transportation, realization (leave), the advertising of medicines, in order to monitor compliance with the requirements established by the legislation of Turkmenistan on medication;
2) donated to seize samples of medicines, medical products in sufficient numbers for analysis (tests) their quality in the prescribed manner at the expense of the funds of enterprises, institutions and other organizations that have seized these samples;
3) issue regulations for legal entities engaged in the pharmaceutical or medical-technical activities, to eliminate violations of the requirements established by the regulations, as well as to appoint these persons penalties;
4) request and receive the information needed to make decisions on matters within the competence of the otnesënnym notified body;
5) receive from persons engaged in the pharmaceutical or medical-technical activity, copies of documents necessary for verifying compliance with the requirements established by the regulations;
6) to make a proposal to the Ministry of health and medical industry of Turkmenistan on the suspension of the license for conducting pharmaceutical or medical-technical activity in case of violation of the requirements established by the legislation of Turkmenistan on medication;
7) exercise other rights established by the legislation of Turkmenistan.

2. Decisions taken by the authorized officials of the authority in the exercise of State control in the sphere of drug provision within the limits of their powers, are obligatory for execution by all natural and legal persons engaged in the pharmaceutical or medical-technical activities.
 
Article 18. Monitoring the side effects of drugs 1. All medicines registered in Turkmenistan shall be subject to monitoring of their side effects. Under the monitoring side effects of medicines is understood as a set of activities aimed at the identification, analysis, assessment of side effects of medicines, as well as the adoption of decisions on their side.
2. physicians, medical institutions, regardless of their departmental affiliation, are obliged to submit information to the competent authority all cases identify side effects of medicines.
3. procedure of monitoring the side effects of medicines approved by the Ministry of health and medical industry of Turkmenistan.
 
Article 19. Suspension of the application of medicine to obtain information about the side effects of the drug, about the specifics of its interactions with other drugs that may cause harm (harm) to human life and health, his ancestry, as well as information not relevant medication information vehicle contained in the instructions for use of the drug, the authorized body shall consider the possibility of suspending the application of exemptions from turnover, destruction of a specified drug.
 
CHAPTER III. Development, PRECLINICAL and CLINICAL INVESTIGATION of MEDICINAL PRODUCTS Article 20. Drug development 1. Drug development involves finding new pharmacologically active substances, further study of their pharmacological properties, preclinical and clinical research, the development of technologies for the production of pharmaceutical substances, development of production technology of medicines.
2. All stages of drug development are intellectual property and protected in accordance with the legislation of Turkmenistan.
 
Article 21. Preclinical study of medicinal products 1. Preclinical drug research is conducted using scientific techniques on animals in order to obtain evidence for the safety and quality of the medicinal product.
2. To organize and conduct pre-clinical drug research persons carrying out drug development may involve research and educational institutions with the necessary material and technical base and qualified specialists in this area of research.
3. Preclinical drug research is conducted according to the plan approved by a person engaged in the development of the medicinal product, together with the conduct of the study protocol and the drafting of the report. The report shall contain the results of pre-clinical research and opinion on the possibility of conducting a clinical trial of the medicinal product.
4. Rules for the conduct of pre-clinical studies of medicinal products are defined by standards of good practice.
5. Rules for the conduct of pre-clinical studies of medicines approved by the Ministry of health and medical industry of Turkmenistan.
 
Article 22. Clinical investigation of medicinal products 1. Clinical investigation of medicinal products is carried out using scientific methods to identify or verify the clinical, pharmacological or pharmacodynamic effects of the investigational medicinal product or identify adverse reactions in humans, or to study its absorption, distribution, biotransformation in humans and excretion from the body. In a clinical study of the drug can participate only voluntarily consented to participate in the study.   
2. Clinical investigation of medicinal products is carried out on the basis of a permit issued by the Ministry of health and medical industry of Turkmenistan in accordance with standards of good practice and program (Protocol) for clinical trials of drugs agreed with the Committee on ethics in the field of drug supply in the Ministry of health and medical industry of Turkmenistan (hereinafter referred to as the Ethics Committee).
3. The Ethics Committee is an expert Council and examines the welfare rights, safety and health protection of individuals participating in clinical trials of medicines, assesses the qualifications of persons engaged in the study and the availability of public health institutions to conduct clinical trials of drugs. Statute of the Committee of ethics approved by the Ministry of health and medical industry of Turkmenistan.

4. in order to obtain authorization to conduct a clinical trial person conducting a clinical trial of the medicinal product, or customer clinical study of medicinal product must apply to the Ministry of health and medical industry of Turkmenistan. The statement shall be accompanied by samples of medicinal products and materials that contain information about the results of pre-clinical studies, as well as the draft programme for the observance of a clinical trial of the medicinal product.
5. Clinical trials of drugs are conducted in hospitals, the list of which is approved by the Ministry of health and medical industry of Turkmenistan.
6. A person carrying out a clinical trial of the drug, or the customer may enter into clinical research with medical-prophylactic institution agreement on conducting clinical trials of a certain medication only after receiving permission. This Treaty shall be in writing in accordance with the model treaty about conduct of clinical research.
7. A person carrying out a clinical trial of the drug, or the customer a clinical study must report to the Ministry of health and medical industry of Turkmenistan in all cases to identify side effects of the drug, subject to clinical research, as well as its interaction with other drugs.
8. Financing of a clinical trial of the medicinal product is made at the expense of the person carrying out the development of the medicinal product, or customer of the clinical study of the drug, as well as other sources not prohibited by Turkmen law.
9. Clinical trials of medicines produced in Turkmenistan or imported in Turkmenistan are conducted on a full or reduced programme in accordance with the standards of good practice.
10. Medicines produced in Turkmenistan can be used to conduct clinical trials without State registration.
11. Rules for the conduct of clinical trials of medicines approved by the Ministry of health and medical industry of Turkmenistan.
 
Article 23. Conditions of clinical trials of medicinal products 1. Clinical research of drugs, involving a natural person shall be conducted in the presence of his or her written consent to participate in clinical trials of drugs.
2. physical person participating in a clinical trial of the medicinal product, shall have the right to refuse to participate in it at any stage of the study.
3. physical person participating in a clinical study of the drug, should be insured by the employer of clinical studies of the drug. Insurance of individuals participating in clinical trials of medicines are developed and approved by the Ministry of health and medical industry of Turkmenistan.
4. Clinical trial of the medicinal product may be interrupted if the vote found danger for the life and health of persons participating in the study.
5. Decision on the termination of a clinical trial drug program manager can accept the study.
6. it is not allowed to participate in the clinical trial of the medicinal product: 1) pregnant women, unless the drug to clinical research, is intended for the treatment of this category of persons, or the purpose of a clinical trial is to optimize the dosing regime or the use of the drug for pregnant women, as well as if necessary the results can only be obtained when the clinical trial of the drug on pregnant woman and if completely removed the risk of harm (harm) the life and health of the pregnant woman and the fetus;
2) a minor, except if the drug to clinical research, is intended for the treatment of childhood diseases or the purpose of a clinical trial is to optimize the dosing regime or the use of the drug to a minor;
3) children-orphans, usynovlënnogo children, children left without parental care;
4) troops, including soldiers serving under the undertaking and soldiers serving on the appeal;
5) persons detained on suspicion of committing a crime, inmate in custody serving sentences in places of deprivation of liberty or under administrative arrest;
6) persons, recognized in the manner prescribed by incapable, as well as persons with a mental disorder (illness), forcibly hospitalized and forced treatment in a psychiatric institution.
 
CHAPTER IV. Requirements To Production (MANUFACTURING), Trafficking And Elimination (Recycling) Of MEDICINES, Medical Products
 

Article 24. Requirements to production (manufacturing) of medicines, medical devices 1. Production (manufacture) of medicines, medical devices is carried out by legal entities on the basis of licences issued in accordance with the legislation of Turkmenistan.
2. legal entities in the production (manufacture) of the medicinal product are required to comply with the standards of good practice, as well as other requirements established by the legislation of Turkmenistan.
3. production of medicines prescribed are carried out in accordance with standard propisâmi medicines manufactured in pharmacies by prescription, the list of which is approved by the Ministry of health and medical industry of Turkmenistan.
 
Article 25. Requirements for packaging, labeling and packaging of medicinal products 1. Persons carrying out the packing, packaging and labeling of medications, are obliged to comply with the requirements of regulatory documents to their packaging, packing, marking, as well as the materials used for packaging and labeling of medications.
2. On the packaging of the medicinal product shall be indicated the trade name of the medicinal product, the name of the active ingredient using international nepatentovannogo names (INNS), the manufacturer of the medicinal product and its legal address, date of production, shelf life of the medicinal product, its pharmaceutical form, dose of active ingredient.
3. each product shall be accompanied by instructions for use of the drug in the State language, Russian and/or English and other languages with the following information: 1) name of the medicinal product;
2) General description of the medicinal product (chemical name, basic physico-chemical properties, composition);
3) information on the pharmacological properties of the drug;
4) indications and contraindications;
5) interaction of this medication with other drugs;
6) uses and dosage of the medicinal product;
7) side effects of the drug;
8) precautions in use of the medicinal product;
9) release forms of the drug;
10) storage conditions of the drug;
11) drug terms ("no prescription" or "prescription");
12) other information on the clinical characteristics of the medicinal product.
Form instructions for use of the drug, the contents of her text, as well as the packaging design of the medicinal product shall be approved by the authorized body.
4. Marking of packages of the drug, medical products are manufactured in the State language, Russian and/or English and other languages, and must contain the following information: 1) name of the medicinal product;
2) address of the manufacturer of the medicinal product;
3) lot number (series) of the medicinal product;
4) released medication (for immunobiological drugs);
5) shelf life of the medicinal product;
6) uses of the medicinal product;
7) dosage or concentration, volume, the activity in the activity units or the number of doses of the drug;
8) conditions of storage of the medicinal product;
9) precautions when applying the medication.
 
Article 26. Requirements for the import into and export from Turkmenistan Turkmenistan medicines, medical devices 1. Import and export from Turkmenistan Turkmenistan medicines, medical products by individuals is not permitted, except as provided by paragraph 2 of this article.
2. individuals have the right to import to Turkmenistan and Turkmenistan to export medicines, medical products in the following situations, if they: 1) are intended for personal use: and) employees of diplomatic missions and consulates of Turkmenistan abroad, missions of Turkmenistan with the international organizations and diplomatic missions, consular posts of foreign States and international organizations in Turkmenistan;
b) foreign citizens and stateless persons who arrived in Turkmenistan, for the duration of their stay in Turkmenistan;
ç) crew members of all types of vehicles of foreign States who arrived in Turkmenistan, for the duration of their stay in Turkmenistan;
d) individuals participating in international cultural and sports activities and parties with international expeditions;
e) citizens of Turkmenistan in the quantity required for the application for a period not to exceed ten calendar days;
2) designed: (a)) for the treatment of the occupants of a vehicle arriving in Turkmenistan or serving of Turkmenistan;
(b)) to conduct pre-clinical and clinical studies;
ç) for exhibiting at trade shows, fairs, conferences without the right implementation;
(d)) to use as samples of medicines, medical devices (samples of pharmaceutical substances) intended for State registration of not exceeding ten packages;

3) for medical care in each case patients for health reasons based on the written instructions of the Ministry of health and medical industry of Turkmenistan;
4) for medical care in each case when carrying out the sports, cultural and other activities based on the written instructions of the authorized body.
3. Customs duties in the cases referred to in paragraph 2 of this article shall not be charged.
4. legal entities, regardless of their form of ownership, have the right to import and export from Turkmenistan Turkmenistan medicines, medical products, including raw materials, pharmaceutical substances, excipients used in the production (manufacture) of medicines on the basis of a permit issued by the notified body for a period of one year.
5. For issuing import permits in Turkmenistan medicines, medical devices fee in accordance with the procedure for the import into and export from Turkmenistan Turkmenistan medicines, medical products. When this permit is issued after the specified collection to the appropriate accounts. In case the specified permission collection paid amount is not refundable.
6. Customs clearance of imported into Turkmenistan medicines, medical devices is carried out in accordance with the legislation of Turkmenistan, unless otherwise stipulated by this law.
7. For medicines, medical devices, on the packaging which is missing the date of manufacture (manufacturing) and installed only shelf life, information on the date of their production (manufacturing) must be confirmed in writing by the manufacturer (manufacturer) in the accompanying documents.
8. obligations of producers (manufacturers) medicines, medical devices, associated with compliance of normative documents requirements for medicines, products of medical purpose, imported in Turkmenistan, as well as guarantees of compliance with these requirements were a sine qua non for contracts for the supply of medicines, medical devices if these medicines, medical products are imported in Turkmenistan on the basis of the relevant treaties.
9. legal entities, regardless of their form of ownership, exercising the purchase of medicines, medical devices from the manufacturer (seller) or that organise their follow-up (distributors), is entitled to under the contract, defining the rights and obligations of the parties, conditions of delivery, transportation, ensuring the quality of medicines, medical devices and other conditions, to exercise their import into and export from Turkmenistan Turkmenistan, implementation, return, destruction (recycling) in accordance with the requirements of established by the legislation of Turkmenistan and the standards of good practice.
10. it is not allowed entry into Turkmenistan medicines, medical devices: 1) If before the expiry of their validity less than sixty percent of the time from the expiration date, and on medicines, the expiration date which is not more than six months, less than thirty percent of the time from the expiration date;
2) do not have certificates of conformity, as well as documents confirming their origin;
3) without appropriate markings in accordance with requirements of normative documents;
4) have not been registered in accordance with the established procedure, except as provided by paragraph 4 of article 13 of this Act;
5) are substandard or fake or counterfeit.
 
Article 27. Requirements for storage and transportation of drugs, medical devices 1. Storage and transportation of medicines, medical devices are carried out by producers (manufacturers) medicines, medical products, wholesale trade organizations, as well as pharmacies, have license to pharmaceutical or medical-technical activities.
2. Requirements for the storage and transportation of drugs, medical devices are installed by an authorized body.
 
Article 28. Implementation requirements (release) drugs 1. Realization (vacation) medicines, medical products is carried out on the basis of the relevant licenses issued in the manner prescribed by the legislation of Turkmenistan.


2. Implementation (vacation) medicines, medical devices must be carried out by individuals with secondary or higher pharmaceutical education.

3. it is not allowed to (leave) substandard medicines, and drugs are adulterated or counterfeit.

4. it is not allowed to (leave) of medicines in pharmacies without a prescription, sold (prescription drugs) as a "drug, prescription dispensed. List of medicines (prescription), sold in pharmacies by prescription, approved by the Ministry of health and medical industry of Turkmenistan.
5. based on the results of the implementation of the (holiday) drugs in the prescribed manner shall be prepared monthly, quarterly and annual reports, in accordance with their anatomical therapeutic chemical classification.
6. Rules for implementing (leave) drugs are developed and approved by the Ministry of health and medical industry of Turkmenistan.
 
Article 29. Destruction requirements (recycling) of medicines, medical devices 1. Unsafe medicines, medical products, as well as medicines, medical products are adulterated or counterfeit, subject to seizure and destruction of (recyclable) one of the following grounds: (a)) owner (seller) medicines, medical devices;
(b)) decision of an authorized body;
ç) judgment.
2. as a result of destruction (recycling) of substandard medicines, medical devices, as well as medicines, medical devices, are adulterated or counterfeit, the owner (the seller) listed medicines, medical devices must submit to the competent authority or court document confirming their destruction (recycling).
3. costs associated with the destruction of the (recycling) of substandard medicines, medical devices, as well as medicines, medical devices, are adulterated or counterfeit will be reimbursed by the owner (the seller) listed drugs, medical products.
4. destruction of (waste) withdrawn from circulation of substandard drugs, medical devices, as well as medicines, medical devices, are adulterated or counterfeit, shall be as approved by the Ministry of health and medical industry of Turkmenistan.
 
CHAPTER V. RIGHTS AND OBLIGATIONS OF PERSONS ENGAGED IN THE PHARMACEUTICAL OR MEDICAL-TECHNICAL ACTIVITIES. The DESIGNATION of MEDICINAL PRODUCTS Article 30. The rights of legal persons engaged in the pharmaceutical or medical-technical activities



 

Legal persons engaged in the pharmaceutical or medical-technical activities, have the right to: 1) production (manufacture), import to Turkmenistan (export from Turkmenistan), implementation (vacation) medicines, medical devices in the order established by this law;
2) implementation of licensing of pharmaceutical or medical-technical activities;
3) obtaining the required information from the relevant government bodies on the procedure for licensing of pharmaceutical or medical-technical activities, the order of the State registration of medicines, medical devices;
4) upgrading the qualifications of their employees, their certification;
5) appeal in accordance with the established procedure actions (inactivity) of State bodies and their officials;
6) exercise other rights stipulated by the legislation of Turkmenistan.
 


Article 31. Responsibilities of legal entities engaged in the pharmaceutical or medical-technical activities



 

Legal persons engaged in the pharmaceutical or medical-technical activities shall: 1) to the pharmaceutical or medical-technical activities, in accordance with the relevant license;
2) comply with the requirements of normative documents in the field of drug supply, as well as regulations and the conclusion of the relevant State bodies involved in quality control of medicines, medical products;
3) implement (vacation) medicines, medical devices in the presence of the certificate of conformity;
4) comply with the requirements of the production (manufacture) and quality control of medicines, medical products;
5) comply with the terms and conditions of storage of medicines, medical devices;
6) to inform citizens about medicines, products of medical purpose, implemented (prescription) prescription.


 



Article 32. Appointment of medicines



 

1. appointment of medicines produced by a physician (Medical Assistant), directly carrying out the treatment of the patient.
2. appointment of medicines when providing first aid and emergency medical assistance is made by a doctor (nurse) visiting emergency and emergency medical assistance.



3. appointment of medicines intended for the treatment of diseases, the most common (prevailing) in the structure of morbidity of the population shall be carried out in accordance with clinical standards (protocols), approved by the Ministry of health and medical industry of Turkmenistan, as well as a list of essential (vital) medicines and National layout key essential medicines. Under clinical standards (protocols) refers to practical advice, including information about the optimal strategy for efficient and safe technologies in the treatment of patients.

4. appointment of the drugs reflected in medical patient documents.
5. drugs (over-the-counter drugs), sold in pharmacies by prescription, to be carried out (leave) based on prescription. Prescription issued by a doctor (nurse), working in a health care, medico-social or sanatorium-resort Center, scientific-clinical center, regardless of their form of ownership. The shape of the prescription, as well as requirements for completing it are approved by the Ministry of health and medical industry of Turkmenistan.
6. control over the destination of the drugs and their rational use is carried out by the Ministry of health and medical industry of Turkmenistan.


 



CHAPTER VI. DISSEMINATION OF INFORMATION



 ABOUT MEDICINES



 



Article 33. Information on medicinal products 1. Source of official information on medicinal products registered in Turkmenistan, is the instruction for use of the drug.
2. information on medicines sold (prescription) the prescription may contain only in specialized publications intended for medical and pharmaceutical workers, and (or) instructions for use of the drug.
3. information on medicinal products sold without a prescription, is placed in the media as well as in specialized publications and (or) instructions for use of the drug.
4. information on the medicines included in the list of essential (vital) medical products, is entered into a national formulary of essential medicines (pereizdavaemyj), published by the Ministry of health and medical industry of Turkmenistan.


 



Article 34. Maintenance and publication of the State Pharmacopoeia



 

Maintenance and publication of the State Pharmacopoeia shall be made in accordance with the procedure set out by the legislation of Turkmenistan.
 
Article 35. Requirements for advertising of medicines, medical devices 1. Advertising medicines should promote the pharmaceutical market is safe, of high quality and effective drugs, promoting their rational use.
2. the Advertising of a medicinal product intended for use, should be presented in an accessible form and contain the following information: 1) information about its registration in Turkmenistan;
2) name and address of the manufacturer or distributor (manufacturer);
3) trade name;
4) name of the active ingredient using international nepatentovannogo name (Inn);
5) indications for use, basic precautions, contraindications and special precautions for pregnant women, nursing mothers, children and the elderly;
6) dosage and order reception;
7) side effects and the main unwanted reactions;
8) information, providing assistance in making management decisions on the use of medicines, prescription drugs without a prescription;
9) information on its interaction with other drugs.
3. The advertising of medicinal products, regardless of its form, must meet the clinical pharmacological data on medicinal products obtained in clinical trials of drugs.
4. the content of the advertising of the drug, sold without the prescription must match the content of the instructions for use of the drug. The content of the advertising of a medicinal product must be agreed with the competent authority.
5. advertising of a medicinal product must not present remedy as unique, the most secure, efficient and effective, exclusive on the absence of side effects and should not be misleading regarding the composition, origin, the novelty of the medicinal product.
6. advertising of a medicinal product must not compare the drug with other drugs in order to enhance the advertising effect.
7. the advertising of medicinal products, medical products, and registration with the State (prescription drugs) without prescription.

8. dissemination of the medical establishment advertising information on medicinal products, products of medical purpose medical representatives (distributors) of medicines, medical products is allowed only with the permission of the Ministry of health and medical industry of Turkmenistan. Under the medical representative is a person authorized by the manufacturer (Distributor) of medicines, medical products. The provision on medical representatives is being developed by the notified body and is approved by the Ministry of health and medical industry of Turkmenistan.  
9. In order to prevent uncontrolled self-treatment is prohibited: 1) advertise antimicrobials regardless of the stated manufacturer (manufacturer) of the conditions of their release ("prescription" or "over-the-counter");
2) place in pharmacies, as well as on the stands and other advertising media sample packages of drugs, as well as promotional information on medicinal products sold (prescription) prescription drugs;
3) used in the advertising of medicines, medical products image of medical worker, as well as to rely on the opinions of famous people, professionals, cured patients and their relatives.
10. Requirements for the advertising of medicines, medical devices are installed by an authorized body.
 
CHAPTER VII. FINAL PROVISIONS Article 36. The citizens ' right to reparation (harm) caused to their lives and health 1. Citizens have the right to reparation (harm) caused to their lives and health, in the case of: 1) violations of the producer (manufacturer) of medicines, medical devices technology for their production (manufacturing);
2) identify inaccurate information contained in the instructions for use of the medicinal product;
3) delivery and implementation (leave) substandard medicines, medical devices, as well as medicines, medical devices, are adulterated or counterfeit;
4) (vacation) medicines that are not usable due to violations of the rules of their production (manufacturing);
5) inappropriate prescribing;
6) advertising substandard medicines, medical devices, as well as medicines, medical devices, are adulterated or counterfeit.
2. Compensation (injury), caused to life or health of citizens as a result of the use of medicines, medical devices or commit illegal actions (inactivity) of the producer (manufacturer) medicines, medical products, is carried out in accordance with the legislation of Turkmenistan.
 
Article 37. Liability for violation of this law persons guilty of violating this law bear responsibility in the manner prescribed by the legislation of Turkmenistan.
 
Article 38. Settlement of disputes disputes arising in the area of drug provision, shall be settled in the manner prescribed by the legislation of Turkmenistan.
 
Article 39. The entry into force of this law 1. This law shall enter into force on the day of its official publication.
2. the void: the law of Turkmenistan on July 5, 2002 "on pharmaceutical activity and medication provision" (statements of the Mejlis of Turkmenistan, 2002, no. 2, p. 19);
part XXXVI, Turkmenistan law dated April 18, 2009 year amending, supplementing and repealing certain acts of Turkmenistan "(records of the Mejlis of Turkmenistan, 2009 г., no. 2, p. 33).
3. the Cabinet of Ministers of Turkmenistan within six months to prepare and make, in accordance with established procedure, amendments and additions to legislation arising from this Act.
 
 
     Turkmen President Gurbanguly Berdimuhamedov mountains. Ashgabat January 12, 2016 year no. 319-V.