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LAW OF THE REPUBLIC OF ARMENIA

of June 13, 2016 No. ZR-86

About medicines

(as amended on 05-06-2020)

Accepted by National Assembly of the Republic of Armenia on May 17, 2016

Chapter 1. General provisions

Article 1. Subject of regulation of the law

1. This Law governs the relations connected with drug circulation, medicinal substances, medicinal vegetable raw materials, the researched pharmaceutical products for the purpose of providing the population with safe, effective, high-quality, available medicines and reliable information about them, and also establishes powers of competent state bodies of the Republic of Armenia and subjects of drug circulation in this sphere.

2. The relations connected with drug circulation of the medicinal substances, medicinal vegetable raw materials, the researched pharmaceutical products containing drugs or psychotropic substances are regulated by this Law if the Law "About Drugs and Psychotropic Substances" does not provide other.

Article 2. Legal regulation of drug circulation, medicinal substances, medicinal vegetable raw materials, the researched pharmaceutical products

1. Drug circulation, medicinal substances, medicinal vegetable raw materials, the researched pharmaceutical products is regulated by this Law, other laws and legal acts.

2. If the international treaties ratified by the Republic of Armenia establish other regulations, than it is provided by this Law, then regulations of international treaties are applied.

Article 3 the Basic concepts used in the Law

1. In this Law the following basic concepts are used:

1) medicine – the means of human and (or) animal and (or) vegetable and (or) chemical and (or) biotechnological origin having medicinal and (or) immunological and (or) metabolic activity in the corresponding dose and dosage form, in necessary packaging and with marking which is provided for application for the purpose of treatment of prevention of diseases at people and animals and (or) for change, recovery, regulation of physiological functions of organism or is entered into human body or animal for diagnosis of disease,

2) immunobiological medicines – vaccines or serums or toxins or globulins or allergens or medicines containing allergenic materials,

3) radioactive medicines – the medicine containing one or several radionuclides

4) medicinal vegetable medicine - the medicine containing in quality of active element one or several types mostly of vegetable medicinal raw materials or the medicine received as a result of processing of medicinal vegetable raw materials

5) homeopathic medicine - the medicine made according to the homeopathic production processes described in the pharmacopeias included in the list approved in the procedure established by this Law

6) dosage form – the release form allocated with the complex characteristic of physical, chemical and pharmacological qualities, providing diagnostic or preventive or medical effect convenient for application,

7) dosage – the approved content active (active) element (elements) medicinal (medicinal) substance (substances), expressed in the unit of measure established for each dosage form

8) medicinal substances – substances human (human blood, product from blood, other substances of human origin) and (or) animal (microorganism, intact animal, parts of bodies, allocations of animals, the toxins, extracts, products received from blood, other substances of animal origin and (or) vegetable (microorganisms, plants, parts of plants, vegetable allocations, extracts, other substances of phytogenesis) and (or) chemical (the elements, natural chemicals, chemical goods received as a result of chemical transformation or synthesis, other substance of chemical origin), used for production or production of drugs, allocated with pharmacological or immunological or metabolic activity,

9) medicinal vegetable raw materials – the raw, dried-up or fresh plants, whole, either their parts or which are cut off, separate parts of plants or seaweed or mushrooms or lichens used for production or production of medicines

10) excipients – any element which is not active element or packaging material for medicine

11) the researched pharmaceutical products – active element or placebo (the product which is not containing active elements) in certain dosage used during the clinical experiment as an example or comparative sample, and also the registered medicine, ways of application or production of which differ from registrirovanny drugs (dosage form or packaging), or this indication for application is not registered or is researched for the purpose of receipt of additional data on the registered dosage form,

12) new (original) medicine – medicine with the new, for the first time created active elements (element),

13) the reproduced medicine – equivalent to original medicine on impact medicine, with the same active elements (element), made in the same medicinal dosage, in the same dosage form which bioequivalence is proved to the original in the procedure established by the legislation of the Republic of Armenia,

14) bioanalogues – the reproduced medicines of biotechnological and biological origin,

15) counterfeited medicine – products which it is intentional and (or) deception are provided by false information about its authenticity (including, packaging, marking, the name, structure, quantity of separate components) and (or) origin (including, the producer, the country of origin, country of source, the certificate holder about registration) and (or) these distribution channels (including, the protocols accompanying documents),

16) controlled medicines and medicines - the medicines and medicines which are subject to personalized and quantitative accounting in health care system of the Republic of Armenia which list establishes state body, the representative for health care,

17) the main medicines – the medicines necessary for ensuring first-priority needs of the population of the Republic of Armenia for health sector specified by the general name

18) production – activities for serial production which include either acquisition of initial materials or technological production processes, or quality control or packaging or repacking or marking or release of series and the accompanying control,

19) producer of medicines – the legal entity or the individual entrepreneur who obtained the license on production of medicines

20) drug circulation - development or preclinical researches or standardization or production or production or processing of medicinal vegetable raw materials or quality control or registration or import or export or transportation, storage or realization or distribution or application or observation of efficiency, safety and side effects or distribution of information or advertizing or destruction of medicines,

21) subjects of drug circulation - the legal entities or individual entrepreneurs performing one of stages of drug circulation

22) medicinal policy - component of the policy performed in health sector which purpose is providing the population with safe, effective, high-quality, available medicines, and also ensuring their rational application

23) safety – lack of possible unacceptable risk of harming health,

24) efficiency – the characteristic of extent of manifestation of the expected positive impact of medicine,

25) quality – compliance to requirements of the pharmacopeias included in the list approved in the procedure established by this Law, and (or) to the quality determinations (specifications) established in the procedure provided by this Law

26) proper laboratory practice – the system of quality assurance relating to organizational processes and conditions of planning, implementation, observation, fixation, archiving of not clinical trials about health and safety of the environment

27) proper clinical practice - requirements to designing, management, carrying out, observation, checks of clinical testing, registration, the analysis, the report of data which guarantee reliability and accuracy of the yielded and registered results, and also ensuring protection of the rights, safety of examinees and confidentiality of data,

28) proper production practice – element of system of quality assurance to which it is guaranteed that products are steadily made and controlled according to quality determinations (specifications), relevant requirements of the provided appointment and registration,

29) proper practice of distribution - the element of system of quality assurance which by means of the corresponding control of the actions performed in the course of distribution guarantees stable product quality and also is means for prevention of penetration into distribution channels counterfeit, unregistered, illegally imported, stolen, low-quality, containing not declared elements and (or) incorrectly marked products,

30) activities for proper cultivation and collection of herbs - element of system of quality assurance to which quality of medicinal vegetable raw materials for invariable production of herbal remedy is guaranteed,

31) proper activities for storage - element of system of quality assurance to which in storage time by means of corresponding control stable product quality is guaranteed,

32) expiration date – the period determined as a result of stability researches during which, in case of storage in the conditions corresponding to the pharmacopeias included in the list approved in the procedure established by this Law and (or) to quality determinations (specifications), indicators of quality remain invariable or change in the approved terms,

33) pharmacopeia – the collection of pharmakopeyny Articles, methods of the analysis, quality control of medicines and or components and other requirements of standards. The list of the pharmacopeias operating in the Republic of Armenia approves the Government of the Republic of Armenia,

34) pharmakopeyny Article – measure description of quality and methods of quality control of medicine and their components,

35) preclinical researches of medicine - physical, chemical, biological, bacteriological, pharmaceutical, pharmacological, toxicological and other researches of active element in vitro for the purpose of estimation of safety and efficiency of active pharmacological agent, without participation of the person,

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