LAW OF THE AZERBAIJAN REPUBLIC

of December 22, 2006 No. 208-IIIQ

About medicines

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 - the medicinal substances which are consisting from natural (plant, animal origin, mineral, etc.), synthetic and biotechnological origin, having biological and pharmacological activity, substances or their mix, including the immunobiological medicines used for diagnosis, prevention and treatment of diseases, prevention, continuation and termination of pregnancy, rehabilitation of patients for change of condition and physiological functions of human body;

1.0.2. medicinal substances - substances, including medicinal substances, natural (plant, 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 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;

1.0.5-1. the state register of medicines (further - the state register) - the information system consisting of data on the medicines, medicinal substances and medical means which underwent state registration in the Azerbaijan Republic according to this Law;

1.0.6. the treatment of medicines - carrying out scientific research with medicinal and medical means, and also on medicinal substances respectively, their certification, production, production, packaging, storage, transportation, import and export, state registration, quality control, efficiency and safety, sale, application, implementation фармакоконтроля concerning medicines, withdrawal of medicines, destruction of medicines and medicinal substances after the term of their validity and receipt to worthlessness, and also implementation of other transactions in connection with them;

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

1.0.8. state registration of medicine - the system of measures providing introduction of medicines and medicinal substances based on results of examination of medicines and medicinal substances, including the simplified examination of medicines, and also medical means with higher, high and (or) average risk degree established by body (structure) determined by relevant organ of the executive authority in the state register and issue of permission to their industrial production to the Azerbaijan Republic (taking into account article 6.14 of this Law), import and application;

1.0.9. pharmacopoeian Article - the technical regulatory legal act establishing quality requirements, to packaging, conditions and storage duration of medicines and medicinal substances, the reactants used in case of their production and the analysis and also to methods of control of their quality;

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 - the individual entrepreneur or legal persons performing taking into account the cases established by this Law, 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 technical regulatory legal acts operating in the Azerbaijan Republic;

1.0.13. the certificate of medical means - the document confirming compliance of medical means to requirements of the corresponding technical regulatory legal acts;

1.0.14. quality of medical means - compliance of medical means of the corresponding technical regulatory legal acts and to the documents issued by the producer based on these requirements;

1.0.15. safety of medicines - the characteristic of medicines based on comparative analysis of efficiency and assessment of probability of possible harm to health;

1.0.16. efficiency of medicines - exponent of positive impact of medicines on the course of treatment of disease;

1.0.17. additional impact - unexpected negative reaction of human body when using medicine in specified and instructions for application of dose of medicinal substance;

1.0.18. equivalent medicines and medicinal substances - medicines and medicinal substances with identical active ingredient (substances), pharmaceutical form and single amount (dose) of raw substance;

1.0.19. analog medicines and medicinal substances - medicines and medicinal substances which have identical active ingredient (substances), pharmaceutical form, but differ by single amount (dose) of raw substance and (or) quantity of units in packaging;

1.0.20. biologically active food products - intended for enrichment of diet, consisting of one or several feedstuffs and other biologically active agents having nutritious and physiological action which daily dose of acceptance is determined and dosed (capsules, tablets, ampoules, drops and other similar forms) food products;

1.0.21. фармакоконтроль - activities in the direction of identification, assessment and prevention of side effects of the medicines and other undesirable effects arising when using medicines;

1.0.22. the certificate on state registration of medicine - the official document issued to the applicant by the permitting body, confirming entering of medicinal and medical means, and also medicinal substances into the state register;

1.0.23. the owner of the certificate on state registration of medicine - the inventor of medicinal and medical means, and also medicinal substances having the certificate of state registration of medicine and bearing responsibility for quality, efficiency and safety of medicinal and medical means, and also medicinal substances, the body (structure) determined by relevant organ of the executive authority, producer or the wholesale pharmaceutical company;

1.0.24. the medicine and medicinal substances which is under special control - the medicine and medicinal substances requiring special control over application from the point of view of harmful effects on health of the person;

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