ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of February 16, 2021 No. KR DSM-20

About approval of rules of development by the producer of medicines and approvals of the regulating document by the state expert organization for quality of medicines in case of examination of medicines

According to the subitem 2) of Item 5 of article 231 of the Code of the Republic of Kazakhstan "About health of the people and health care system" I ORDER:

1. Approve the enclosed rules of development by producer of medicines and approval of the regulating document by the state expert organization for quality of medicines in case of examination of medicines.

2. Declare invalid the order of the Minister of Health of the Republic of Kazakhstan of November 19, 2009 No. 754 "About approval of Rules of creation, approval and examination of the normative and technical document on control of quality and safety of medicines" (it is registered No. 3, is published 2010 in the Register of state registration of regulatory legal acts at No. 5915, in the Collection of acts of the central executive and other central state bodies of the Republic of Kazakhstan).

2. To provide to committee of medical and pharmaceutical control 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 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 ten calendar days after day of its first official publication.

Approved by the Order of the Minister of Health of the Republic of Kazakhstan of February 16, 2021, No. KR DSM-20

Rules of development by producer of medicines and approval of the regulating document by the state expert organization for quality of medicines in case of examination of medicines

Chapter 1. General provisions

1. These rules of development by producer of medicines and approval of the regulating document by the state expert organization for quality of medicines in case of examination of medicines (further - Rules) are developed according to the subitem 2) of Item 5 of article 231 of the Code of the Republic of Kazakhstan "About health of the people and health care system" (further - the Code) and determine procedure for development by producer of medicines and approval of the regulating document by the state expert organization for quality of medicines in case of examination of medicines.

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

1) the regulating document on quality of medicine (further – the regulating document) – the document establishing requirements to quality control of medicine during the post-registration period based on the carried-out expertize of medicine in case of its registration and containing the specification, the description of analytical techniques and testing of medicine or the reference to such testing, and also the corresponding eligibility criterions for quality indicators;

2) the holder of the registration certificate – the legal entity addressed to whom the registration certificate on medicine is issued;

3) medicine packaging – means or complex of the means providing process of drug circulation by their protection against damages and losses, and also protecting the environment from pollution;

4) standard sample – the identified homogeneous substance or mix of substances, held for use in chemical, physical and biological researches in which his (her) properties are compared to properties of the researched medicine, and having purity degree, sufficient for the corresponding application;

5) the specification of quality - the document containing list of indicators of quality and regulations of their variations, and also references to test methods;

3. Effective period of the regulating document is established according to effective period of the registration certificate.

Chapter 2. Procedure for development and approval of the regulating document on quality of medicines

4. The regulating document is developed by producer of medicine taking into account the modern level of development of science, the equipment and production according to requirements:

1) the State pharmacopeia of the Republic of Kazakhstan (further - GF RK), Pharmacopoeias of the Eurasian Economic Union (further – the Pharmacopoeia of EEU);

2) the leading pharmacopeias of the world recognized acting in the territory of the Republic of Kazakhstan (further – the leading pharmacopeias of the world);

3) the state standards, technical regulations and regulating documents on standardization regulating quality of medicines, techniques of their testing and also packaging, marking and transportation.

5. The regulating document contains the following Sections:

1) the title and last page, drawn up in forms according to appendix 1 to these rules;

2) the composition of medicine including specifying of high-quality and quantitative composition of pharmaceutical substances and excipients with references to the pharmacopoeian Articles or documents regulating their quality.

The amount of active agent is given from calculation:

- for tinctures, liquid extracts, syrups, solutions, fragrant waters, alcohols - in grams or milligrams on 100 milliliters, 100 grams, 1 liter or 1 kilogram;

- for the firm and soft dosed dosage forms (for example, tablets, capsules, suppositories) - in grams (milligrams) per unit of dosage form (for example, one tablet, one capsule, one suppository);

- for drops - in grams (milligrams) on 1 milliliter, 100 milliliters or on packing unit amount;

- for parenteral dosage forms - in grams (milligrams) on 1 milliliter, 1 liter or on packing unit amount.

The composition of excipients is given also for cover of tablets and capsules (separately for the case and lid).

The structure active and excipients of homeopathic medicines is specified in Latin.

The composition of medicine is brought according to part II A of the List of the documents provided for examination by producers of the Republic of Kazakhstan (further - the List) or Section 3.2.P.1 of the module 3 registration files of medicine submitted in format of the General technical document (further - OTD), without specifying of functional purpose of excipients.

3) the specification of quality in form according to appendix 2 to these rules.

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