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I.O'S ORDER. MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of December 24, 2020 No. KR DSM-326/2020

About approval of rules of forming of the Kazakhstan national medicinal form, and also rules of development of medicinal forms of the organizations of health care

(as amended on 31-12-2021)

According to the subitem 47) article 7 of the Code of the Republic of Kazakhstan "About health of the people and health care system" PRIKAZYVAYU:

1. Approve:

1) rules of forming of the Kazakhstan national medicinal form according to appendix 1 to this order;

2) rules of development of medicinal forms of the organizations of health care according to appendix 2 to this order.

2. Recognize invalid:

1) order of the deputy. The Minister of Health of the Republic of Kazakhstan of June 14, 2019 No. KR DSM-94 "About approval of Rules of implementation of activities of form system" (it is registered in the Register of state registration of regulatory legal acts for No. 18856, it is published on June 21, 2019 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan in electronic form);

2) the order of the Minister of health and social development of the Republic of Kazakhstan of May 22, 2015 No. 369 "About approval of Rules of forming of the Kazakhstan national medicinal form, list of medicines and medical products for free and (or) preferential out-patient ensuring separate categories of citizens with certain diseases (conditions), and also developments of medicinal forms of the organizations of health care" (it is registered in the Register of state registration of regulatory legal acts for No. 11429, it is published in the Information system of law of Ad_let on July 03, 2015; "The Kazakhstan truth" of June 25, 2016 No. 121 (28247); "Egemen Kazakstan" on June 25, 2016 No. 121 (28849)).

3. To provide to department of medicinal policy of the Ministry of Health of the Republic of Kazakhstan in the procedure for the Republic of Kazakhstan established by the legislation:

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 in the Ministry of Justice of the Republic of Kazakhstan 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.

5. This order becomes effective after the expiration of ten calendar days after day of its first official publication

Deputy. Minister of Health of the Republic of Kazakhstan

M. Shoranov

Appendix 1

to the Order of the First vice-Minister of Health of the Republic of Kazakhstan of December 24, 2020 No. KR DSM-326/2020

Rules of forming of the Kazakhstan national medicinal form

Chapter 1. General provisions

1. These rules of forming of the Kazakhstan national medicinal form (further - Rules) are developed according to the subitem 47) of article 7 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" (further - the Code) and determine procedure for forming of the Kazakhstan national medicinal form.

2. In these rules the following main terms and determinations are used:

1) the State register of medicines and medical products - the electronic information resource containing data about the medicines and medical products registered and allowed for medical application in the Republic of Kazakhstan;

2) medicine - the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;

3) medicine - medicine in the form of dosage form;

4) the international non-proprietary name of medicine (further - MNN) - the name of medicine recommended by the World Health Organization;

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

6) the clinical protocol - scientifically proved recommendations about prevention, diagnostics, treatment, medical rehabilitation and palliative medical care in case of certain disease or the patient's condition;

7) the Kazakhstan national medicinal form (further - KNF) - the list of medicines with the proved clinical safety and efficiency, and also orphan (rare) medicines which is obligatory basis for development of medicinal forms of the medical organizations and forming of lists of purchase of medicines within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance.

Chapter 2. Procedure for forming of the Kazakhstan national medicinal form

3. The procedure for forming of the Kazakhstan national medicinal form includes the following:

1) filing of application of the producer or his official representative in the Republic of Kazakhstan (further - the applicant) in the subordinated organization of authorized body which competence questions of conducting the examination providing assessment of data on clinical safety and efficiency of medicine, the confirmed clinical trials and also in meta-analyses and (or) systematic reviews enter (further - the Center);

2) conducting professional examination by the Center;

3) preparation of the conclusion by the Center by results of professional examination for the Form commission of authorized body in the field of health care (further - the Form commission);

4) consideration and acceptance the decision the Form commission based on the conclusion by results of professional examination;

5) forming by the KNF authorized body.

4. The applicant submits to the Center the application in form, according to appendix 1 to these rules.

The statement is constituted on Kazakh or Russian, is signed by the authorized person of the applicant.

Are enclosed to the application:

1) the file constituted according to the requirements provided in appendix 2 to these rules;

2) materials (Articles, the summary, from scientific and medical publications), the confirmatory data containing in the file in original language in the form of complete texts in translation on Kazakh or Russian.

The materials specified in this Item are represented on paper and electronic carriers in duplicate.

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