LAW OF THE REPUBLIC OF TAJIKISTAN

of July 19, 2022 No. 1893

About medicine, medical goods and pharmaceutical activities

Accepted by the Resolution of Majlisi namoyandagon of MORT of May 25, 2022, No. 726

Approved by the Resolution of Majlisi milli of MORT of July 15, 2022, No. 298

This Law governs the public relations in the sphere of public administration of the address, quality control, providing medicines, medical goods and parapharmaceutical means and determines the rights and obligations of subjects of pharmaceutical activities, the principles, powers, process of development, providing information in the field.

Chapter 1. General provisions

Article 1. Basic concepts

In this Law the following basic concepts are used:

1) medicine (medicines) - substances or their combinations coming into contact with human body or animal and getting into their bodies and fabrics applied to prevention, diagnostics (except for substances or their combinations which are not contacting to human body or animal), treatments of disease, rehabilitation, preserving, prevention or termination of pregnancy and received from blood, plasmas of blood, bodies, body tissues of the person or animal, plants, minerals by methods of synthesis or using methods of biological technologies. Also pharmaceutical substances and medicines belong to medicines;

2) original medicine - the medicine different from all earlier registered medicines pharmacological active agent or combination of such substances;

3) the registered medicines - the medicines which passed the control and clinical tests and the normative and technical examinations of authorized state body in health sector and authorized body of the state supervision of pharmaceutical activities entered in the State register of medicines;

4) low-quality medicines - the medicines not suitable for application owing to discrepancy the established standards;

5) generic medicine - the medicine identical to original medicine on composition of active substances, indicators of quality, efficiency and safety and released on the expiration of legal act of the patent;

6) counterfeited medicine - the medicine accompanied with unreliable information about its structure or the producer;

7) the recipe - the document containing the written address of the doctor about medicine leave by drugstores with indication of dose and method of its application;

8) the drugstore - organization where storage is performed, production, acquisition, quality control, trade in medicines and medical goods, and also is provided the relevant information on medicines;

9) the main medicines - the medicines satisfying priority needs of the population for health care;

10) the designated product - product of baby food and small bottles (horns) for feeding, nipples, baby's dummies;

11) medical goods - the products and materials applied in medical practice to diagnostics, treatment and prevention of diseases. Materials (dressing, sutural, account) and medical products (medical equipment, leaving objects) concern to them;

12) pharmaceutical activities - the type of activity including creation, development, production, production, storage, packaging, transportation, state registration, standardization and quality control, marking, trade, advertizing, use of medicines and other actions in the sphere of drug circulation and medical goods;

13) proper pharmaceutical practicians in the sphere of drug circulation - the rules extending to all important stages of drug circulation: proper laboratory practice, proper clinical practice, proper production practice, proper practice of pharmakonadzor, proper pharmaceutical practice, proper distributor practice of medicines;

14) medicinal raw materials - the substance of vegetable, animal, mineral, chemical and other origin subjected to partial processing and the substrata received from its structure by ad hoc methods having medicinal properties and used for creation and production of medicines;

15) the simplified state registration of medicines and medical goods - registration of the medicines and medical goods used during the conducting military operations, emergence of emergency situations, flash of epidemics and in other situations provided by this Law in case of which requirements to the shown documents are mitigated and term of their consideration is reduced;

16) packaging of medicines and medical goods - means or complex of the means providing process of drug circulation by their protection against damages and losses, and also protecting the environment from pollution;

17) safety of medicines - the characteristic of medicines based on the comparative analysis of their efficiency and risk degree;

18) medicines - the medicines applied to prevention, diagnostics, treatment of diseases, rehabilitation, preserving, prevention or termination of pregnancy;

19) parapharmaceutical means - biologically active agents having certain pharmacological action and which are applied in the sphere of prevention of diseases, and also auxiliary therapy of regulation of functional activity of bodies and systems of human body. Parapharmaceutical means include dietary supplements to food, means sanitary and hygienic and cosmetics with medicinal and preventive properties;

20) drug circulation - development, preclinical and clinical trials, examination, state registration and re-registration, standardization and quality control, efficiency, safety, production, production, storage, transportation, import to the territory of the Republic of Tajikistan and export from it, leave, realization, application, advertizing and destruction of medicines;

21) the instruction for use of medicines, medical goods and parapharmaceutical means - the document approved according to the procedure, the determined representative by state body in health sector on which information on procedure and methods of application of medicines, medical goods and parapharmaceutical means contains;

22) pharmakopeyny Article - it is normative - the technical document establishing quality requirements of medicine, to its packaging, conditions and storage durations, methods of the analysis of quality of medicine;

23) the state pharmacopeia - the code of the acts regulating quality of medicines and methods of their determination;

24) production of medicines - engineering procedure of receipt of medicines, their packing, packaging and marking;

25) contract manufacturing of medicines and medical goods - production of medicines and medical goods to order on production capacities of the producer which provides full compliance with requirements of proper production practice and the international standard for medical goods;

26) pharmacological substance - biologically active agent or their mix having certain pharmacological action and being object of clinical trial;

27) authorized state body in health sector - the central executive body of the government realizing state policy in the field of health care and social protection of the population and exercising control and management of process of diagnostics, prevention and treatment in the organizations of health sector irrespective of patterns of ownership and departmental subordination;

28) authorized body of the state supervision of pharmaceutical activities - the body exercising the state control in the sphere of pharmaceutical activities, drug circulation and medical goods, legal drug trafficking, psychotropic substances and precursors applied in medicine, parapharmaceutical means and the designated products;

29) excipient - substance or combination of several substances which do not have pharmacological action, used in case of production of medicines;

30) quality control of medicines - set of actions by means of which compliance of drugs to requirements of the specifications and technical documentation is checked and provided;

31) pharmacological supervision - type of activity which assumes detection, assessment, understanding and prevention of the undesirable phenomena and other problems connected using medicines;

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