of September 10, 2020 No. KR DSM-101/2020
About approval of Rules of creation and execution of the instruction on medical application of medicines and medical products and general characteristic of medicine
According to item 4 of article 242 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" PRIKAZYVAYU:
1) the order of the Minister of health and social development of the Republic of Kazakhstan of May 29, 2015 No. 414 "About approval of Rules of creation and execution of the instruction on medical application and general characteristic of medicines and medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 11495, it is published on July 14, 2015 in information system of law of Ad_let);
2) the order of the Minister of Health of the Republic of Kazakhstan of April 24, 2019 No. KR DSM-48 "About introduction of amendments to the order of the Minister of health and social development of the Republic of Kazakhstan of May 29, 2015 No. 414 "About approval of Rules of creation and execution of the instruction on medical application of medicines and products of medical appointment" (it is registered in the Register of state registration of regulatory legal acts at No. 18584, it is published on April 30, 2019 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan in electronic form).
3. To provide to committee of quality control and safety of goods and services of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;
3) within ten working days after state registration of this order submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.
4. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.
Minister of Health of the Republic of Kazakhstan
Approved by the Order of the Minister of Health of the Republic of Kazakhstan of September 10, 2020, No. KR DSM-101/2020
1. The instruction on medical application of medicine (leaf insert) (further - the Instruction of LS) is constituted with use of the terms, accurate and clear for the patient, reflecting medical and scientific data on medicine and contains the following information:
1) identification data of medicine:
the name of medicine which the dosage and dosage form follows. If medicine contains only one active (operating) agent, then its international non-proprietary name (in case of absence - the commonly accepted name) needs to be specified in brackets directly behind the trade name of this medicine (it differs from the trade name); for medicines, the containing several their active (operating) agents, it is necessary to specify in the form of the list under the name;
2) the pharmakoterapevtichesky group or the description of activity which are easily understood by the patient;
3) indications to application contain list of diseases and syndromes in case of which medicine is recommended for medical application; application conditions in certain groups (children, pregnant women and the nursing women, elderly, persons with certain pathological conditions);
4) the list of the data necessary prior to use of medicine:
necessary precautionary measures in case of application;
interaction types with medicines and the interaction types capable to influence effect of medicine (with alcohol, tobacco, food); data on possible influence on capability to steer vehicles or to work with mechanisms (when applicable);
5) recommendations about application:
method and way of introduction (if necessary);
application frequency with indication of acceptance time (if necessary);
the treatment duration (depending on properties of medicine if it needs to be limited);
measures which need to be accepted in case of overdose (symptoms, urgent procedures);
measures necessary in case of the omission of one or several doses of medicine (if necessary);
specifying on availability of risk of symptoms of cancellation (if necessary);
recommendations about the request for consultation to the health worker for explanation of method of application of medicine;
6) the description of undesirable reactions which are shown in case of standard use of medicine and measure which should be accepted in this case (if necessary);
7) the standard text recommending to patients to address in case of the expected medicinal reactions the health worker, the pharmaceutical worker or directly in the information database on undesirable reactions (actions) to medicines, including messages on inefficiency of medicines, and specifying various ways of such message (the electronic message, the mailing and (or) another);
8) additional data:
complete high-quality (pharmaceutical substances and excipients) and quantitative composition of pharmaceutical substances with use of their commonly accepted names for each form of release of medicine;
description of appearance, smell, taste;
9) expiry date of the validity, with indication of prohibition of use of medicine after expiration date;
warning of certain visible signs of quality degradation (if necessary);
10) data on producer of medicine:
the complete and reduced (in the presence) name, the legal, (actual) address and contact information (phone, the fax, e-mail) of the producer;
the complete and reduced (in the presence) name, the legal, (actual) address and contact information (phone, the fax, e-mail) of the holder of the registration certificate (further - DRU) (in appropriate cases name of the representative appointed by DRU for the purpose of representation of its interests).
the name and contact information (phone, the fax, e-mail) of the organization, the accepting claim (offer) on medicine from consumers in the territory of the Republic of Kazakhstan;
11) date of the last update of the Instruction of LS.
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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