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The document ceased to be valid since  August 8, 2015 according to Item 1 of the Order of the Government of the Republic of Kazakhstan of July 27, 2015 No. 592

ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of December 30, 2011 No. 1692

About approval of Rules of marking of medicines, products of medical appointment and medical equipment and modification of the order of the Government of the Republic of Kazakhstan of July 14, 2010 No. 712 "About approval of the technical regulation "Requirements to Safety of Medicines"

(as amended of the Order of the Government of the Republic of Kazakhstan of 21.01.2013 No. 15)

According to article 75 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 enclosed:

1) Rules of marking of medicines;

2) Rules of marking of products of medical appointment and medical equipment.

2. Ceased to be valid according to the Order of the Government of the Republic of Kazakhstan of 21.01.2013 No. 15  

3. This resolution becomes effective after ten calendar days after the first official publication.

 

Prime Minister of the Republic of Kazakhstan

K. Masimov

Approved by the order of the Government of the Republic of Kazakhstan of December 30, 2011 No. 1692

Rules of marking of medicines

1. General provisions

1. These rules of marking of medicines (further - Rules) are developed according to article 75 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 marking of medicines in the Republic of Kazakhstan.

2. Marking of the medicines which are subject to registration in the Republic of Kazakhstan affirms in case of state registration of medicine by state body as the sphere of drug circulation, products of medical appointment and medical equipment (further - state body).

3. Drawing marking with use of stickers is allowed for limited amount of the expensive, seldom applied, orphan medicines. Drawing stickers on packaging is performed by the organization - producer according to these rules.

Information on the organization, the accepting claim (offer) on quality of medicines in the territory of the Republic of Kazakhstan, is specified in the instruction on medical application.

4. In these rules the following concepts are used:

1) medicinal angro-product - the medicine made and realized in large packing, and also used for further production processing for the purpose of production (production) of ready medicines;

2) medicine balk-product - the dosed medicine which passed all stages of engineering procedure except for of final packaging;

3) medicine packaging - means or complex of the means providing protection of medicine against damages and losses, and also protecting the environment from pollution.

Packaging consists of primary (internal) and secondary (external) package:

primary (internal) package is the packaging which is directly adjoining to dosage form;

secondary (external) package is packaging in which medicine in primary package is located;

4) marking - the texts, trademarks, symbol and drawings bearing information for the consumer and applied on labels, counterlabels, kolyeretka, labels, stickers (stickers) medicine packaging;

5) the trade name of medicine - the name under which medicine is registered;

6) the trademark - the designation registered in the Republic of Kazakhstan serving for difference of medicines, products of medical appointment and medical equipment of one producers from uniform products of other producers;

7) number of series - the digital, alphabetic or alphanumeric reference allowing to identify specifically series of medicine and to determine the complete sequence of production and control operations;

8) sticker (sticker) - the additional label on packaging containing information on medicine in the state and Russian languages.

2. Procedure for marking of medicines

5. Marking of medicines is applied with the organization for production of medicines on each packing unit (primary, secondary).

6. Marking and registration of packaging are single for each series of medicine and it is specified in the state and Russian languages.

Authenticity of the text in the state and Russian languages, compliance to the regulating document on medicine and instructions on medical application proves to be true in case of state registration of medicine at stage of specialized examination, the state expert organization in the sphere of drug circulation.

7. Marking of packaging is put with accurate, legible, easily noticeable and indelible letters, well readable font and shall remain during all expiration date of medicine.

8. Marking of secondary package, and in case of its absence - primary package shall include the following information:

1) trade name of medicine;

2) the international unlicensed name in the Russian or English languages (in the presence);

3) name of the manufacturing organization of medicine, address, trademark. The name of the manufacturing organization and its address is allowed to be specified completely or in abbreviated form (the city, the country).

4) the name of the manufacturing organization, being the holder of the license if medicine is made according to the license, its address (the city, the country);

5) dosage form with indication of the weight, amount or quantity of doses in packaging, dosages;

6) active agents and their quantitative structure per unit of dose or, depending on dosage form, per unit of amount or weight.

In unicomponent medicines, on condition of authenticity of the name of medicine and active agent and specifying of its dosage, concentration, activity - the composition of active agents is not specified;

7) list of excipients:

for the medicines intended for parenteral introduction ophthalmologic and for external application, the list of all excipients is specified;

for infusion solutions the high-quality and quantitative composition of all excipients is specified;

for other dosage forms the list of antimicrobic preservatives, dyes, and also sugars and ethanol is specified;

8) method of application and, depending on dosage form, way of introduction (it is allowed not to specify method of application for the tablets and capsules intended for intake);

9) precautionary measures;

10) warning labels;

11) storage conditions, features of storage;

12) leave conditions (according to the recipe or without recipe of the doctor);

13) number of series of medicine;

14) date of production (if it is not entered into number of series);

15) expiration date: "it is suitable to (number, month, year)" or "(number, month, year)"; Writing of expiration date "Is allowed it is suitable to (month, year)" or "(month, year)", at the same time to determine expiration date to 1 number of the specified month.

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