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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 12, 2009 No. 695

About Rules of approval of the name of original medicine

According to item 4 of article 70 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", PRIKAZYVAYU:

1. Approve the enclosed Rules of approval of the name of original medicine.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan state registration of this order in the Ministry of Justice of the Republic of Kazakhstan.

3. To department of administrative and legal work of the Ministry of Health of the Republic of Kazakhstan (Bismildin F. B.) provide official publication of this order after its state registration in the Ministry of Justice of the Republic of Kazakhstan.

4. Declare invalid the order of the deputy. The Minister of Health of the Republic of Kazakhstan of February 16, 2007 No. 111 "About Rules of approval of the name of original medicine" (registered in the Register of state registration of regulatory legal acts at No. 4567, published in the Collection of acts of the central executive and other state bodies of the Republic of Kazakhstan, 2007, March).

5. To impose control of execution of this order on the Vice-Minister of Health of the Republic of Kazakhstan E. A. Birtanov.

6. This order becomes effective after ten calendar days after its first official publication.

 

Minister Zh. Doskaliyev

Approved by the order of the Minister of Health of the Republic of Kazakhstan of November 12, 2009 No. 695

Rules of approval of the name of original medicine

1. General provisions

1. These rules determine approval procedure the manufacturing organizations, the organizations developers of the name of original medicine in case of state registration of original medicine (further - Rules).

2. Approval of the name of original medicine is performed after examination of original medicine.

3. The name of original medicine is verbal designation in the form of certain combination of letters (signs) or separate words identifying original medicine with certain structure or pharmacological action.

2. Approval procedure of the name of original medicine

4. The name of original medicine shall identify its structure and (or) action, to be short, easily said and harmonious.

5. For the name of the original medicine which is containing one medicinal substance (monomedicine) and having the international unlicensed name it is allowed to use it as the name. For identification of the manufacturing organization (organization developer) the name of medicine can include their name or abbreviation.

6. The name of the original medicine issued in various dosage forms and having identical indications to application on being its part of the main medicinal substance is allowed. Different names for different dosage forms of the same medicinal substance are allowed only as exception, in case of considerable change of effect of medicine under the influence of dosage form and, respectively, changes of indications on application.

7. The name of the combined medicine may contain combination from the syllables and letters which are its part of medicinal substances.

8. In case of the choice of the name of original medicine it is not allowed:

use of the name capable to mislead the consumer concerning structure and action and encouraging to application according to unproven indications;

content in the name of medicine of information concerning its use, characteristics of medicine, structure, production method, and also the consumer properties representing it as unique, the most effective and safe;

use as the new name of medicine of the designations identical or acknowledged graphical and (or) phonetic similar to names of earlier registered medicines, various or similar on structure and action;

use of the international unlicensed names or graphical and (or) names, phonetic similar to them, for medicine of other chemical composition or action, and also inclusion in names of medicine of words or parts of the words characteristic of names of means of other chemical and (or) pharmacological groups;

inclusion in the name of medicine of its dosage form and dose of substance, except for vegetable raw materials and medicines from medicinal vegetable raw materials;

use of the identical name for the combined medicines differing in structure or ratio of dosages of the pharmaceutical substances entering them;

complete reproduction in the name of medicine of names of diseases and symptoms of diseases, anatomic and physiological terms, proper names, place names, the commonly accepted symbols, words from household lexicon, words graphical, and (or) phonetic similar to obscene expressions;

use as the name of medicine of the designations identical or especially valuable objects of historical and cultural heritage of the people of the Republic of Kazakhstan or objects of the world cultural or natural heritage having graphical and (or) phonetic similarity to official names;

use of the designations reproducing the reduced or full names of the international organizations;

use of the designations representing abbreviated names of the organizations, industries of economy and their abbreviation;

use of the designations contradicting on the content to public concerns, the principles of humanity and morals;

inclusion in the name of medicine of the designations specifying by sight, quality, quantity, property, appointment, value of goods and also on the place and time of their production or sale;

use of the designations reproducing names of the known literary works, sciences, art and their fragments in copyright violation.

9. For approval of the name of original medicine the applicant gives to state body in the sphere of drug circulation, products of medical appointment and medical equipment (further - state body), the request according to appendix to these rules, the explanatory note with reasons for the proposed name, information from the State register of trademarks on availability or lack of registered trade mark similar to the declared designation or the copy of the certificate on the trademark granted by authorized body in the field of intellectual property. Information specified in the request is not subject to disclosure.

10. By consideration of the submitted documents the state body involves specialists of authorized body in the field of health care and its subordinated organizations to rendering the advisory help.

11. The state body no later than thirty calendar days from the date of adoption of the request makes the decision on approval (not approval) of the name of original medicine which is drawn up by the order of the first head of state body, or person replacing it.

12. In approval of the name of original medicine refuses for the following reasons:

documents are introduced with violation of Item 9 of these rules;

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