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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

(as amended of the Order of the Minister of Health of the Republic of Kazakhstan of 24.04.2019 No. KR DSM-48)

According to Item 5 of article 75 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve Rules of creation and execution of the instruction on medical application and general characteristic of medicines and medical products according to appendix to this order.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) official publication of this order in the procedure established by the legislation;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan;

4) within 10 working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of health and social development of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this order.

3. To impose control of execution of this order on the Vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

4. This order becomes effective after ten calendar days after day of its first official publication.

Minister of health and social development of the Republic of Kazakhstan

T. Duysenova

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of May 29, 2015 No. 414

Rules of creation and execution of the instruction on medical application and general characteristic of medicines and medical products

Chapter 1. Procedure for creation and execution of the instruction on medical application and general characteristic of medicines

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:

contraindications;

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);

special preventions;

5) recommendations about application:

dispensing mode;

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;

storage conditions;

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.

2. The instruction of LS is developed based on general characteristic of medicines (further - OHLS) on each dosage form and drawn up in the form of the insert in packaging or its text without reducing is placed on packaging.

3. The text of the Instruction of LS is drawn up in the Kazakh and Russian languages and corresponds to the following:

headings and subtitles are located uniformly and are highlighted in bold type;

drawings and (or) pictograms are provided (if necessary).

4. The text of OHLS contains information on medicine for medical application and No. 88 "About approval of requirements to the instruction on medical application of medicine and general characteristic of medicine for medical application" is developed on each dosage form according to the Decision of Council of the Eurasian economic commission of November 3, 2016.

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