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LAW OF TURKMENISTAN

of January 12, 2016 No. 319-V

About provision of medicines

(as amended on 24-07-2022)

This Law is directed to enhancement of legal and organizational basis of state regulation of the relations arising in the sphere of provision of medicines.

Chapter I. General provisions

Article 1. The basic concepts used in this Law

For the purposes of this Law, the used basic concepts mean the following:

1) anatomo - therapeutic and chemical classification - the international classification system of medicines intended for generalization of statistical information on medicines;

2) drugstore - the medical institution performing production of medicines, storage, realization (leave) of medicines, products of medical appointment according to the requirements established by the legislation of Turkmenistan;

3) safety of medicine, product of medical appointment - compliance of medicine, product of medical appointment to the requirements of this Law, regulating documents guaranteeing in case of their application lack of risk of damnification (harm) of life and to health of the person, his heredity;

4) excipients - the substances of inorganic or organic origin used in production process (production) of medicines for giving of necessary physical and chemical properties to them;

5) the reproduced medicine (generic) - the medicine containing identical pharmaceutical substance or their combination in the dosage form similar to original medicine, and applied after expiration of security documents on original medicine;

6) the State pharmacopeia - the collection of the regulating documents establishing quality requirements of medicines;

7) counterfeit medicines, products of medical appointment - medicines, the products of medical appointment which are in circulation with violation of the requirements established by the legislation of Turkmenistan;

8) The state register of medicines, products of medical appointment - the document containing information on medicines, on the products of medical appointment which underwent state registration according to the requirements established by this Law;

9) preclinical research of medicine - the biological, microbiological, immunological, toxicological, pharmacological, physical, chemical and other scientific research conducted for the purpose of obtaining by scientific methods of estimates and proofs of pharmacological activity of medicine;

10) the instruction for use of medicine - the medical document containing the clinical characteristic of medicine, the indication and contraindication on its application and other data on its pharmacological properties;

11) quality of medicine, product of medical appointment - set of characteristics of medicine, the product of medical appointment providing their compliance to requirements of regulating documents;

12) clinical trial of medicine - the clinical trial of medicinal, preventive, pharmacological properties of medicine, its safety, quality and efficiency which is carried out according to standards of proper practice;

13) medicines - the substances or mix of substances having medicinal properties, the medicines in certain dosage form and dose, ready to application, intended for prevention, diagnostics, treatment of diseases;

14) medicinal raw materials - the materials of mineral, vegetable, animal, synthetic or biotechnological origin which are source for receipt of medicines;

15) the National form of the main medicines - periodically updated list of the medicines allowed for use and also the management on their safe, effective, rational application providing standards of treatment of diseases;

16) substandard medicines, products of medical appointment - medicines, the products of medical appointment which are not conforming to requirements of regulating documents and not suitable for application or expired;

17) regulating documents - interstate and state standards (pharmakopeyny Articles, standards of proper practice), other regulations and rules establishing requirements to safety and quality of medicines, products of medical appointment;

18) original medicine - the medicine containing for the first time the received pharmaceutical substance of vegetable, animal, synthetic or biotechnological origin or new combination of pharmaceutical substances which safety, quality and efficiency are confirmed with results of preclinical and clinical trials of medicine;

19) the main (vital) medicines - the medicines providing priority requirements of health care for the purpose of prevention and treatment of the diseases which are the most widespread (prevailing) in structure of population morbidity;

20) side effect of medicine - the undesirable reaction of human body arising in connection with use of medicine in recommended doses;

21) the producer (manufacturer) of medicines - the company (drugstore) performing production (production) of medicines;

22) production (production) of medicines - the serial release of medicines performed according to requirements to production organization and quality control of medicines;

23) the recipe - the medical document of the established form comprising the written address of the doctor (paramedic) to drugstore about medicine leave;

24) expiration date of medicine, product of medical appointment - period of time during which in case of observance of the established storage conditions of medicine, products of medical appointment their producer (manufacturer) guarantees quality of medicine, product of medical appointment and after which they are not subject to application;

25) standards of proper practice - the international rules established by the World Health Organization, including rules proper laboratory, clinical, production, distributor, pharmaceutical and other types the practician;

26) counterfeited medicines, products of medical appointment - medicines, the products of medical appointment which are intentionally accompanied with incomplete or unreliable information about their structure, properties and characteristics or about their producer (manufacturer), date of production (production), expiration date;

27) pharmakopeyny Article - the regulating document approved in accordance with the established procedure, comprising the list of indicators of quality and methods of quality control of medicine;

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