RESOLUTION OF THE CABINET OF MINISTERS OF THE KYRGYZ REPUBLIC

of December 2, 2024 No. 720

About approval of Rules of proper pharmaceutical practice

According to part 3 of article 14 of the Law of the Kyrgyz Republic "About drug circulation", articles 13, of the 17th constitutional Law of the Kyrgyz Republic "About the Cabinet of Ministers of the Kyrgyz Republic" the Cabinet of Ministers of the Kyrgyz Republic decides:

1. Approve Rules of proper pharmaceutical practice according to appendix.

2. Declare invalid appendix 5 to the Technical regulation "About Safety of Medicines for Medical Application" approved by 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.

3. Determine that the realization of this resolution is enabled:

1) for the state organizations of health care within the approved budget of the Ministry of Health of the Kyrgyz Republic for the corresponding years;

2) for the pharmaceutical organizations with private pattern of ownership and the state companies at the expense of own means.

4. This resolution becomes effective after ten days from the date of official publication.

Appendix

to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic of December 2, 2024 No. 720

Rules of proper pharmaceutical practice

Chapter 1. General provisions

1. Rules of proper pharmaceutical practice (further - Rules) regulate the main requirements imposed to work of the pharmaceutical organizations and are directed to strengthening of health, rational use of high-quality, safe medicines and drugs by the population for the purpose of achievement of the maximum therapeutic advantage with the minimum manifestations of adverse effects.

2. The pharmaceutical organizations shall conform to licensed requirements.

3. The pharmaceutical organizations in the work shall be guided by sanitary and epidemiologic regulations, industrial safety rules and safe engineering, the fire-proof rules and other requirements established by regulatory legal acts of the Kyrgyz Republic.

4. Retail sale of medicines and drugs shall be performed according to requirements of these rules.

5. The organization of work on retail sale of medicines and drugs shall guarantee and provide their proper quality and service quality of the population.

6. Acquisition, storage, realization and destruction of the drugs, psychotropic substances and precursors which are subject to control in the Kyrgyz Republic is performed according to the legislation of the Kyrgyz Republic in the field of the address of drugs, psychotropic substances and precursors.

Chapter 2. Basic principles and requirements

7. Rules represent complex of the requirements directed on:

1) leave of medicines and drugs of proper quality;

2) provision of reliable information;

3) promotion of rational prescription of medicines and drugs and their correct use;

4) establishment of partner, confidential relations with workers of health care (doctors) concerning pharmacotherapy;

5) proper provision of pharmaceutical services.

8. The main requirements of proper pharmaceutical practice are:

1) assistance to rational appointment and proper use of medicines and drugs;

2) orientation of each element of pharmaceutical service on the individual;

3) observance of professional ethics and confidentiality;

4) rendering high-quality pharmaceutical services;

5) availability of the qualified personnel owning fundamentals of pharmacology, pharmacotherapy and deontology;

6) availability of the corresponding equipment, the rooms and other necessary conditions providing proper promotion of high-quality medicines and drugs to the consumer including storage, accounting and realization;

7) availability of the respective room, the equipment and special literature for rendering the advisory and information help to the population and conducting diagnostic testing;

8) the interaction of the pharmaceutical and medical organization implying mutual trust and confidentiality in all questions relating to the Section of pharmacotherapy, strengthening of health, prevention of diseases of the population and pharmacological supervision;

9) availability of educational programs for systematic increase in level of knowledge of personnel;

10) availability of the necessary documentation determined by these rules;

11) providing actions for purchasing system of medicines and drugs, goods of pharmaceutical assortment, to detection and prevention of distribution of counterfeited pharmaceutical products.

9. The head of the pharmaceutical organization designates person, the responsible person for monitoring of side effects of medicines and drugs.

10. In the pharmaceutical organization maps messages of the established form for their filling with druggists or patients in case of identification of side effects of medicines and drugs shall be provided. The map message is filled in in paper form or by means of the operating electronic systems of authorized body in the field of drug circulation.

11. The fact of filling of the map message shall be fixed in the magazine of registration of the revealed side effects of medicines and drugs by person responsible for monitoring of side effects of medicines and drugs.

12. The maps messages completed in paper form shall be transferred to authorized body in the field of drug circulation.

Chapter 3. Ensuring rational use of prescription drugs and drugs

13. Ensuring rational use of prescription medicines and drugs - the activities connected with realization to the population of prescription medicines and drugs, their storage, appointment and use.

14. Activities of personnel of the pharmaceutical organization for providing and rational use of prescription medicines and drugs include:

1) availability of enough qualified personnel;

2) observance of manufacturing techniques and quality assurance of medicines and drugs (when applicable);

3) implementation of leave of prescription medicines and drugs according to prescription forms of the established sample, including check of correctness of registration and completeness of data in the recipe;

4) observance of rules of writing out of recipes, manufacturing techniques of dosage forms, check of compliance to age of the patient, the regulation of one-time leave, compatibility of the written-out prescription medicines and drugs stated in the recipe of doses;

5) possibility of acquisition by the patient of the written-out prescription medicine or drug in the corresponding terms and for reasonable price;

6) ensuring proper leave of prescription medicines and drugs with the corresponding marking and packaging;

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