ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of December 23, 2011 No. 1595

About approval of Storage precautions and transportations of medicines, products of medical appointment and medical equipment in the conditions providing preserving their safety, efficiency and quality

According to article 78 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" the Government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed Storage precautions and transportations of medicines, products of medical appointment and medical equipment in the conditions providing preserving their safety, efficiency and quality.

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

Approved by the order of the Government of the Republic of Kazakhstan of December 23, 2011 No. 1595

Storage precautions and transportations of medicines, products of medical appointment and medical equipment in the conditions providing preserving their safety, efficiency and quality

1. General provisions

1. These rules of storage and transportation of medicines, products of medical appointment and medical equipment in the conditions providing preserving their safety, efficiency and quality (further - Rules) are developed according to article 78 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" and determine procedure for storage and transportation of various groups of medicines, products of medical appointment and medical equipment in the territory of the Republic of Kazakhstan.

2. Storage and transportation of medicines, products of medical appointment and medical equipment is performed in conditions:

1) providing preserving safety, efficiency and quality throughout all term of their validity in accordance with the terms of established by manufacturer which is specified in the normative and technical document on control of quality and safety, on packaging, in the instruction on medical application for medicines and products of medical appointment; operational documents for medical equipment, on packaging (container), the label, kolyeretka, the counterlabel, label, sticker (sticker);

2) preventing contamination, cross contamination and regrading.

3. Storage of medicines, products of medical appointment and medical equipment is performed in rooms of storage of objects in the sphere of drug circulation, products of medical appointment and medical equipment (drugstore, pharmaceutical Item mobile pharmaceutical unit for the remote rural zones, pharmaceutical warehouse, warehouse of temporary storage of medicines, products of medical appointment and medical equipment, shop of optics, shop of medical equipment and products of medical appointment, warehouse of medical equipment and products of medical appointment, the organization for production of medicines, products of medical appointment and medical equipment).

4. The basic concepts used in these rules:

1) angro-product - the status of products characterizing its production and realization in large packing and assuming its further processing for the purpose of production of ready dosage forms, products of medical appointment;

2) medicinal substance - substance or mix of substances, regardless of the origin nature, having certain pharmacological activity, intended for production and production of medicines;

3) medicine expiration date - date after which expiration, medicine is not subject to application;

4) medicine packaging - means or complex of the means providing process of drug circulation by their protection against damages and losses, and also protecting the environment from pollution;

5) consumer packaging - the packaging which is arriving to the consumer with medicines, products of medical appointment, medical equipment and not performing function of shipping package.

Consumer packaging includes primary and secondary package: primary (internal) package - reservoir or other form of packaging which materials directly contact to medicine, products of medical appointment, medical equipment;

secondary package (external) - container or other form of packaging in which medicine, products of medical appointment, medical equipment in primary package is located;

6) group container - the packaging uniting certain amount of medicines, products of medical appointment, medical equipment in consumer packaging;

7) transport container - the container forming independent transport unit;

8) shipping package - the packaging intended for storage, identification or transportation of goods;

9) original packing - consumer packaging with indication of the plant of the producer;

10) the normative and technical document on control of quality and safety of medicine (further - the regulating document) - the document establishing the complex of regulations of quality of medicine, the techniques of its determination ensuring equal security and efficiency of medicine irrespective of series, and also permanency and uniformity of its production approved according to Rules of state registration, re-registration and modification of the registration file of medicine, products of medical appointment and medical equipment;

11) rooms of storage - specially allocated and equipped production rooms intended for storage of medicines, products of medical appointment and medical equipment;

12) storage of medicines, products of medical appointment and medical equipment - process of placement (warehousing) of products with providing storage conditions in the conditions providing preserving their safety, efficiency and quality;

13) storage in the dark place - storage of medicines, products of medical appointment in the place protected from light;

14) storage in the dry place - storage of medicines, products of medical appointment, medical equipment in rooms with relative humidity of air no more than 65 percent;

15) storage in the cool place - storage of medicines, products of medical appointment, medical equipment at temperature from +8 to + 15C;

16) storage at the room temperature - storage of medicines, products of medical appointment, medical equipment at temperature from +15 to + 25C;

17) thermal container - container (box or bag) for transfer of the medicines, products of medical appointment requiring protection against impact of the increased temperature with the heat-insulating properties and skintight cover where optimum temperature condition (from + 2C to + 8C) is provided by means of the refrigerated refrigerating elements placed in his cavity;

18) refrigerating element (further - hladoelement) - plastic or squared metal reservoir with airtight stopper for filling with water which is refrigerated before use and serves for maintenance of temperature in container ranging from + 2C to + 8C;

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info