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LAW OF THE AZERBAIJAN REPUBLIC

of December 22, 2006 No. 208-IIIQ

About medicines

(as amended on 03-12-2021)

This Law determines legal and organizational basis of the address with medicinal and medical means in the Azerbaijan Republic, governs the relations arising in this sphere.

Chapter I. General provisions

Article 1. Basic concepts

1.0. In this Law the following concepts are used:

1.0.1. medicines - medicinal substances natural (vegetable, animal origin, mineral, etc.), synthetic and biotechnological origin, having biological and pharmacological activity, or their mix, including the immunobiological medicines used for diagnostics, prevention and treatment of diseases, prevention of pregnancy, rehabilitation of patients for change of condition and physiological functions of human body.

Medical means (medical devices, products, objects and materials, tools, the equipment, medical reactants and optical accessories) used for the purpose of diagnostics of prevention and treatment of diseases for the purposes of this Law are equated to medicines;

1.0.2. medicinal substances (medicinal substances) of substance natural (vegetable, animal origin, mineral, etc.), synthetic and biotechnological origin, having biological activity, capable to change condition and physiological functions of human body, and used in production of medicines;

1.0.3. effective substance - the main medicinal substance (medicinal substance) used in production of medicines;

1.0.4. original medicines - the medicines which arrived in the address with the patented own names;

1.0.5. analogs (geneticists) of original medicines - the medicines made by other producers in the same structure, doses and form after the expiration of time of exclusive patent laws for original medicines;

1.0.6. the treatment of medicines - implementation of scientific research, production, production, packaging, storage, transportation, import and export, state registration, implementation pharmakokontrolya, certification, quality control, efficiency and safety, sale, application, response, destruction of medicines (their substances) after expiration date and in cases of worthlessness and other transactions connected with medicines;

1.0.7. pharmaceutical activities - the activities connected with production, production, wholesale and retail sale of medicines;

1.0.8. state registration of medicines - the system of actions providing issue of permission to production of medicines by industrial method, import and application in the Azerbaijan Republic based on results of examination of medicines for the purpose of use in medical practice and acceptance on accounting in accordance with the established procedure;

1.0.9. pharmakopeyny Article - the document determining quality requirements, to packaging, conditions and storage durations and also to quality control of medicines;

1.0.10. the pharmaceutical company of wholesale - the legal entity performing wholesale of medicines taking into account requirements of this Law;

1.0.11. the pharmaceutical organization - physical and legal persons performing retail sale of medicines (including preparation of medicines on the basis of individual orders) taking into account requirements of this Law;

1.0.12. producer of medicines - the legal entity making medicines by industrial method taking into account this Law and requirements of the corresponding standards existing in the Azerbaijan Republic;

1.0.13. the certificate of medicines - the document confirming compliance of medicines to requirements of the corresponding state standards;

1.0.14. quality of medicines - compliance of medicines to requirements of state standards;

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