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The document ceased to be valid since  December 15, 2016 according to article 31 of the Law of the Republic of Armenia of May 17, 2016 No. ZR-86

LAW OF THE REPUBLIC OF ARMENIA

of November 26, 1998 No. ZR-259

About drugs

(as amended on 24-11-2015)

Accepted by National Assembly of the Republic of Armenia on October 27, 1998

This Law regulates the address of drugs in the Republic of Armenia including them production, production, dosage, packaging, registration, quality control and other actions for the purpose of obtaining or destruction of drugs. Regulates also acquisition, storage, warehousing, distribution, leave, sale, export, import of drugs, information on them, advertizing, determines competence of state bodies of the Republic of Armenia of these spheres.

Article 1. The basic concepts used in the Law

In this Law the following basic concepts are used:

a) medicine - the dosed means having biological activity received on the basis of one or several medicinal and excipients having standard structure, the invariable name, necessary medicinal dose, form and registration. It intends for treatment, diagnostics, prevention of diseases of the person and animal, anesthesia, prevention of pregnancy, influences functions of organism.

As drugs are considered also:

antiseptics (antiseptics) - the means destroying or killing causative agents of infectious or parasitic diseases, and also their carriers

disinfectants - the substances having antibacterial activity, used for disinfection of objects of medical appointment

immunobiological medicines - the medicines of bacterial, animal, vegetable and other biotechnology origin used for the purpose of prevention, diagnostics and treatment of diseases

homeopathic remedies - the drugs produced and used in the corresponding doses under the laws of homeopathy and included in special department of the state register of drugs;

b) medicinal substance - the substance of natural, synthetic, biotechnology origin having biological activity, used for production and production of drugs;

c) dosage form - form of release of tablets, pills, capsules, drops, ampoules, liquids for the injection, etc. in certain structure established for use the form, steady aggregate state (firm, viscous, liquid, gaseous) having the complex characteristic of physical and chemical properties;

d) compounding - structure and form of medicine in which the main and other medicinal substances, excipients, fillers and other components are listed in the sequence of rendering target impact of medicine and in quantities, necessary for production of medicine;

e) the recipe - the authenticated document containing doctor's instructions to the druggist with indication of structure, dosage of medicine, its production, registration and leave, and to the patient - medicine method of application, and other necessary information.

Types of recipes following:

- on drugs,

- on psychotropic drugs,

- ordinary.

Forms of recipes are established by the Government of the Republic of Armenia;

e) pharmaceutical goods - drugs, goods of medical appointment, objects of care of the patient, sanitation and hygiene;

g) goods of medical appointment - the objects, products, tools, the equipment, devices used for the purpose of prevention, diagnostics and treatment of diseases, prevention of pregnancy;

h) drugs - the drugs leading to drug addiction, their list, procedure for import which export, production, obtaining, storage, accounting, leave, sale, use and destruction it is established by the legislation of the Republic of Armenia;

i) The national form of drugs - the collection containing the description of pharmacological and therapeutic properties of the main drugs permitted for medical application in the Republic of Armenia;

j) pharmaceutical activities - the activities performed in the field of production, transportation, storage, leave, consultation, distribution, realization, export, import and destruction of pharmaceutical products;

k) medicinal dose - the quantity of medicine established for one-time, daily, course, method of treatment;

l) The state register of drugs - the document including data on the drugs registered in the Republic of Armenia;

m) the list of the main drugs - the document including drugs which generally provide public health care and at any time shall be in the Republic of Armenia in enough and the corresponding dosage forms. The list of the main drugs approves the state body authorized by the Government of the Republic of Armenia (further - the body authorized by the Government);

o) pharmacopeia - the collection of the standards normalizing quality of medicines;

o) controlled drugs - the drugs leading to drug addiction and psychotropic drugs which list affirms the Government of the Republic of Armenia;

p) the drugstore - the company or division of the company which produces drugs exercises intra pharmaceutical quality control of drugs, their dosage, packaging, storage, destruction, and also performs trade in drugs, goods of medical appointment and other joint products, gives the corresponding consultation and information.

In the presence of the corresponding license the drugstore can produce drugs;

c) the pharmaceutical booth - the company or division of the company which produces drugs exercises intra pharmaceutical quality control, dosage, packaging, storage of drugs, and also performs trade in drugs, goods of medical appointment and other joint products, gives the corresponding consultation and information;

r) the pharmacologist - person with the higher pharmaceutical education;

s) the druggist - person with secondary pharmaceutical education.

Article 2. Occupation pharmaceutical activities

Pharmaceutical activities have the right to be engaged the persons who got the higher and secondary vocational education and having the license.

Responsibility for illegal occupation pharmaceutical activities is established by the law.

Bear responsibility for the violation or improper execution of professional obligations of person which are engaged in pharmaceutical activities according to the procedure, established by this Law.

Article 3. Licensing of pharmaceutical activities

1. Grants the license for pharmaceutical activities and the body authorized by the Government deprives licenses.

In the Republic of Armenia the license for pharmaceutical activities is granted for:

- productions of drugs,

- processings of officinal herbs,

- pharmaceutical activities,

- import and export of drugs,

- trade in drugs.

2. The procedure for realization of veterinary medicines is established by the Government of the Republic of Armenia.

Article 4. Providing population with drugs

The population is provided with drugstore drugs.

Drugstores can open and function only in the presence of the corresponding license.

Drugstores have the right to acquire and sell drugs which are registered in the Republic of Armenia.

The body authorized by the Government claims and publishes the list of the drugs released without recipe and psychotropic drugs. Drugstores according to the main list shall have the minimum range of drugs.

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