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ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of December 6, 2018 No. 564

About approval of the Procedure for the organization of system of pharmakonadzor

For the purpose of implementation of article 16 of the Law of the Kyrgyz Republic "About drug circulation", according to articles 10 and 17 of the constitutional Law of the Kyrgyz Republic "About the Government of the Kyrgyz Republic" the Government of the Kyrgyz Republic decides:

1. Approve the Procedure for the organization of system of pharmakonadzor according to appendix.

2. Determine that requirements to the organization of system of pharmakonadzor are imposed according to the Rules of proper practice of pharmakonadzor of the Eurasian Economic Union approved by the Decision of Council of the Euroasian economic commission of November 3, 2016 No. 87.

3. Bring in the Order of the Government of the Kyrgyz Republic "About approval of the Technical regulation "About Safety of Medicines for Medical Application" of April 6, 2011 No. 137 the following changes:

in the Technical regulation "About Safety of Medicines for Medical Application" approved by the above-named Resolution:

- to recognize Items 391-430 of Chapter 14 invalid;

- to recognize appendices 9-17 to the above-stated Technical regulation invalid.

4. To the Ministry of Health of the Kyrgyz Republic:

- bring the decisions into accord with this Resolution;

- take the adequate measures following from this Resolution.

5. To impose control of execution of this Resolution on department of social development of Government office of the Kyrgyz Republic.

6. This Resolution becomes effective after fifteen days from the date of official publication.

Prime Minister of the Kyrgyz Republic

M. Abylgaziyev

Appendix

to the Order of the Government of the Kyrgyz Republic of December 6, 2018 No. 564

Procedure for the organization of system of pharmakonadzor

Chapter 1. General provisions

1. This Procedure for the organization of system of pharmakonadzor (further - the Procedure) establishes procedures of the organization of system of pharmakonadzor by holders of registration certificates of medicines and the subordinated organization of authorized state body of the Kyrgyz Republic in the field of health care regulating drug circulation and medical products (further - authorized body), for the purpose of development and deployment of measures for ensuring use of medicines in case of exceeding of ratio "advantage risk".

2. The organization and ensuring functioning of system of pharmakonadzor (further - pharmakonadzor) is performed by holders of registration certificates of medicines and authorized body according to the Rules of proper practice of pharmakonadzor of the Eurasian Economic Union approved by the decision of Council of the Euroasian economic commission of November 3, 2016 No. 87 (further - Rules of proper practice of pharmakonadzor), and this Procedure.

3. In this Procedure the following concepts are used:

- the holder of the registration certificate - the legal entity addressed to whom the registration certificate about state registration of medicine is issued;

- medicine - the means representing or containing the substance or combination of substances intended for treatment, prevention of diseases of the person or recovery, correction, or change of physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;

- medicine - medicine in the form of the certain dosage form ready to use;

- the master file of system of pharmakonadzor - the detailed description of the system of pharmakonadzor applied by the holder of the registration certificate concerning data on one or several registered medicines;

- undesirable reaction - the inadvertent adverse reaction of organism connected using the medicinal (researched) drug and assuming availability, at least, of possible interrelation using (researched) drug suspected medicinal;

- the undesirable phenomenon - any adverse change in the state of health of the patient or the subject of clinical trial to which the medicinal (researched) drug, irrespective of cause and effect relationship with its use was appointed. The undesirable phenomenon can represent any adverse and inadvertent change (including variation of laboratory indicator from regulation), symptom or disease which time of origin does not exclude cause and effect relationship using medicine, regardless of availability or lack of interrelation using medicine;

- the wrong use - intended and inadequate use of medicine which does not correspond to the operating general characteristic of medicine or the instruction on medical application;

- unexpected undesirable reaction - undesirable reaction, nature, severity or outcome of which does not correspond to information containing in the operating general characteristic of medicine or in the brochure of the researcher for the unregistered medicine;

- the periodic updated report on safety - the report for representation of assessment of ratio "advantage risk" of medicine the holder of the registration certificate of medicine during certain period of time during post-registration stage;

- the risk management plan - the detailed description of risk management system;

- signal - information arriving from one or several sources which assumes availability of new potential cause and effect relationship or new aspect of the known interrelation between impact of medicine and the undesirable phenomenon or set of the interconnected undesirable phenomena, estimated as sufficient for further actions for verification of signal;

- the signal on which work - signal which was revealed till the accounting period of the periodic updated report on safety is performed and on end date of data collection was in process of assessment;

- risk management system - complex of the actions and actions for pharmakonadzor directed to identification, the characteristic, prevention or risk minimization, connected with medicines including efficiency evaluation of these actions and activities;

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