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ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of May 26, 2012 No. 320

About approval of the Technical regulation "About Safety of the Medicines Made in Drugstores"

(as amended of the Order of the Government of the Kyrgyz Republic of 20.01.2015 No. 15)

According to the Law of the Kyrgyz Republic "About bases of technical regulation in the Kyrgyz Republic" the Government of the Kyrgyz Republic decides:

1. Approve the Technical regulation "About Safety of the Medicines Made in Drugstores" according to appendix.

2. To the Ministry of Health of the Kyrgyz Republic to make offers on reduction of regulatory legal acts of the Government of the Kyrgyz Republic in compliance with the Technical regulation specified in Item 1 of this resolution.

3. This resolution becomes effective after six months from the date of official publication. This resolution is effective before entry into force in the territory of the Kyrgyz Republic of the corresponding technical regulation of the Customs union.

Prime Minister

O. Babanov

Appendix

Approved by the Order of the Government of the Kyrgyz Republic of May 26, 2012, No. 320

Technical regulation "About Safety of the Medicines Made in Drugstores"

Chapter 1. General provisions

1. The technical regulation "About Safety of the Medicines Made in Drugstores" (further - the Technical regulation) is applied for the purpose of safety of medicines and protection of life and health of the person, the prevention of the actions misleading consumers concerning safety in case of production of medicines in drugstores.

2. The technical regulation determines mandatory requirements to the medicines produced in drugstores with the production right (further - drugstore), and governs the relations arising in the course of their production.

3. Subjects to regulation of the Technical regulation are:

1) the medicines made in drugstores;

2) processes of production of medicines in drugstores;

3) the rooms and the equipment used for production of medicines in drugstores.

4. Requirements and provisions of the Technical regulation do not extend to finished pharmaceutical products of industrial production, and also the medicines used in veterinary science.

5. The technical regulation establishes:

1) requirements to safety of medicines in the course of production;

2) rules and forms of assessment of conformity of medicines;

3) requirements to packaging and marking of the medicines produced in drugstores.

6. In the Technical regulation the following terms and concepts are applied:

asepsis - conditions and complex of the actions directed to prevention of microbic and other pollution in case of receipt of sterile products at all stages of engineering procedure;

disinfection - process of killing on product either in product, or on surface of pathogenic species of microorganisms (thermal and chemical methods and means);

liquid dosage forms - the medicines received by mixing or dissolution of active ingredients in the solvent and also by extraction of active ingredients from plant material. Liquid dosage forms divide on: medicines for external application; medicines for internal application and medicines for injection application;

indicators - chemicals which in case of titrimetrichesky methods of the analysis allow to find out that to titrable solution the equivalent quantity of titrant is added;

drops eye - the dosage form intended for instillation in eye;

the concentrated solutions (concentrates) - in advance made solutions of medicinal substances of higher concentration, than concentration in which these substances write out in recipes;

marking - selection process of the correct label with all necessary information with the subsequent verification and accession of the label;

material(s) - the general term applied to designation of initial material (active pharmaceutical ingredients and excipients), reagents, solvents, intermediate products, packaging material and labels;

ointments - the soft dosage form intended for drawing on skin, wounds or mucous membranes;

mechanical inclusions - the foreign mobile insoluble substances except gas bubbles which are accidentally present at solutions;

masso-volume concentration - amount of medicinal substance (in grams) in total amount of liquid dosage form (in milliliters); concentration on weight - amount of medicine or individual substance (in grams) in the lump of liquid dosage form (in grams); volume concentration - amount of liquid medicine or individual substance (in milliliters) in total amount of liquid dosage form (in milliliters);

the molyarnost of solution (mol/l) is the amount of dissolved substance expressed in moths containing in one liter of solution. The Molyarnost is calculated as the relation of amount of dissolved substance to solution amount;

normal concentration - the number of grams equivalents of this substance containing in 1 l of solution. Normal concentration is expressed in mol-ekv/l or use reducing "n", "N";

infusions and broths - the liquid dosage forms representing water extraction from medicinal vegetable raw materials and also water solutions of dry or liquid extracts (concentrates);

powders - the firm dosage form for internal and external application which is consisting of one or several crushed substances and having property of flowability;

syrups - the concentrated water solutions of sucrose which may contain medicinal substances, fruit food extracts;

sterilization - process of killing on products or in products and removal from object of microorganisms of all types which are at all stages of development including disputes (thermal and chemical methods and means);

suspensions - the liquid dosage form containing in quality of disperse phase one or several crushed powdery medicinal substances;

suppositories - firm at the room temperature and melting or the dosed dosage forms which are dissolved in case of body temperature;

titrovanny solutions (titrant) - the solutions of precisely known concentration intended for the purposes of the volume analysis;

trituration are the in advance prepared mixes of strong or toxic agents (it is less than 0,05 of) with indifferent substances (dairy sugar in compliance 1:1000 or 1:10);

storage - condition of pharmaceutical products under certain conditions and places until its use;

extracts - the concentrated extraction from medicinal vegetable raw materials;

emulsions - the dosage form, uniform in appearance, consisting of mutually insoluble thinly dispersed liquids, intended for internal, external or parenteral application.

Chapter 2. Safety requirements in case of pharmaceutical production of medicines

7. Production of medicines is performed in the drugstore having the license for production and realization of medicines by rules of production of the liquid medicines containing in appendix 9 to the Technical regulation.

8. Production of medicines in drugstores is performed according to individual recipes of doctors (ex-temporal medicines) and on standard copy-books (official medicines), according to the nomenclature of the intra pharmaceutical procurement approved by authorized state body of the Kyrgyz Republic in the field of health care in the sphere of drug circulation on the basis of the pharmaceutical substances registered in the Kyrgyz Republic.

9. In case of pharmaceutical production of medicines requirements of regulatory legal acts of the Kyrgyz Republic and the pharmacopeias permitted by the Law of the Kyrgyz Republic "About medicines" shall be fulfilled (further - pharmacopeias).

10. General requirements on safety of medicines in case of their production:

1) Respect for sanitary standards and rules; the anti-epidemic mode, and also conditions of aseptic production of the medicines containing in the technical regulation.

2) Observance of rules of obtaining, collection and storage of the water purified waters for injections; timely sanitary processing of the pipeline; control of timely withdrawal of sterile solutions, the water purified, waters for injections for testing for sterility according to the approved regulatory legal acts.

Collections for the water purified, water for injections shall have accurate text: "The water purified", "Water for injections". On the collection of water the label with indication of date of its obtaining, number of the analysis and the signature of checked is attached. In case of simultaneous use of several collections, they shall be numbered.

3) Ensuring serviceability and accuracy of the devices, devices and weight economy, regularity of their checking specified in the List of measuring instruments, the test equipment, laboratory glassware, auxiliary materials, tools, the devices used to analytical works in drugstores (appendix 8 to the Technical regulation).

4) Careful viewing of the recipes arriving in drugstore and requirements of the treatment-and-prophylactic organizations for the purpose of check of correctness of their writing out; compatibility of the substances which are part of medicines; compliance of the registered doses to age of the patient and availability of instructions about methods of application of medicines.

5) Respect for technology of medicines (including homeopathic) according to requirements of regulatory legal acts, methodical instructions.

6) Providing in drugstore of storage conditions of medicines according to their physical and chemical properties and requirements of regulatory legal acts.

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