ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 4, 2022 No. KR DSM-128

About modification and amendments in the order of the Minister of Health of the Republic of Kazakhstan of January 27, 2021 No. KR DSM-10 "About approval of rules of conducting examination of medicines and medical products"

I ORDER:

1. Bring in the order of the Minister of Health of the Republic of Kazakhstan of January 27, 2021 No. KR DSM-10 "About approval of rules of conducting examination of medicines and medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 22144) the following changes and amendments:

in rules of conducting examination of the medicines approved by appendix 1 to the specified order:

2) of Item 35 to state the subitem in the following edition:

"2) to examination of the medicine made according to GMP of the countries of the region of ICH (АйСиЭйч), in the Republic of Kazakhstan according to GMP PK and the General technical document having the registration file in format;";

state Items 39 and 40 in the following edition:

"39. In case of impossibility of laboratory testing of samples of medicines in test laboratory of the state expert organization, including in case of their reference to category of the orphan, narcotic, psychotropic or intended for treatment highspending nozologiya owing to their high cost, impossibility of observance of conditions of transportation of the specified samples on the territory of the Republic of Kazakhstan and (or) their storage, lack of the special equipment and consumable materials in the expert organization, and also if regulating documents on product quality establish the testing connected with big costs of means of the producer, high cost of samples with the samples requiring special conditions of transportation, the specific equipment and supportive applications laboratory researches are carried out in the presence of representatives of the expert organization in laboratory of quality control of the producer or in contractual laboratory, used by the producer.

By results of laboratory researches the Report on results of conducting laboratory research in laboratory of quality control of the producer or in the contractual laboratory used by the producer according to appendix 13 to these rules is constituted.

In case of impossibility of laboratory testing of samples of medicines or in the contractual laboratory used by the producer in connection with emergency situations, origin and elimination of effects of epidemic, pandemic of infectious diseases laboratory researches are carried out to laboratories of quality control of the producer under observation of specialists of the expert organization with use of means of remote interaction, including audio-or video conference, and also based on documentation of the producer (protocols of the analysis of the producer).

40. In case of impossibility of laboratory testing of medicine on separate indicators, the laboratory of the expert organization recognizes results of laboratory researches on the separate indicators specified in the certificate (protocol) of the analysis of the producer, except for biological and immunological medicines.";

add Item 58 with subitem 3-1) of the following content:

"3-1) changes requiring new registration of medicine;";

add with Item 63-1 of the following content:

"63-1. In case of modification, requiring new registration of medicine, the applicant submits the application in form according to appendix 1 to these rules with indication of type of the registration procedure and documents according to appendices 2 or 3 to these rules, and also the data confirming payment by the applicant on the settlement account of the state expert organization of the amount for conducting examination in case of registration.";

the paragraph one of Item 66 to state in the following edition:

"66. Examination of medicine in case of state registration, including modification, requiring new registration, is carried out in time, not exceeding two hundred ten calendar days, including:";

in appendix 1 to the specified Rules:

9, to state line, sequence number in the following edition:

"

9.	Medicine type (it is filled for the corresponding medicine, only one HP type is chosen)
1)	Original medicine
	One-component	Multicomponent
	biological medicine	immunobiological medicine
	new active pharmaceutical substance
2)	The reproduced medicine
	One-component	Multicomponent
	Original medicine:
	name of medicine, dosage, dosage form
	the holder of the registration certificate (the company addressed to which the registration certificate is issued), registration date, number of the registration certificate, the state where original medicine is registered
	Reference medicine for domestic manufacturer who was used in equivalence researches (if those were carried out):
	name of medicine, dosage, dosage form
	the holder of the registration certificate (the company addressed to which the registration certificate is issued), registration date, number of the registration certificate, the state where reference medicine is registered
	give reasons for use of reference medicine in case of its difference from original medicine
	Note. The Section needs to be filled in for each medicine which was used in equivalence researches.
3)	Biosimilar medicine (Биоаналог)
	Original biological medicine:
	name of medicine, dosage, dosage form
	the holder of the registration certificate (the company addressed to which the registration certificate is issued), registration date, number of the registration certificate, the state where original medicine is registered
	Reference biological medicine:
	name of medicine, dosage, dosage form
	the holder of the registration certificate, registration date, number of the registration certificate, the state where reference medicine is registered
	distinctions in comparison with reference biological medicine (if those are available):
4)	Hybrid medicine	distinctions in initial material; distinctions in production process; other indications to application; distinctions in dosage form; other dosage; (quantitative changes of active pharmaceutical substance); other method of introduction; other differences ________________________________________________
	One-component
	Multicomponent
	Original medicine:
	name of medicine, dosage, dosage form
	the holder of the registration certificate, registration date, number of the registration certificate, the state where original medicine is registered
	Distinctions in comparison with original medicine:
5)	The combined medicine	changes of active pharmaceutical substance; other dosage form; other dosage (i) (quantitative changes of active pharmaceutical substance); other method(s) of introduction; other pharmacokinetics (including other bioavailability); other indication to application; other differences __________________________________
	known combination
	new combination
	Original medicine (in case of the known combination)
	name of medicine, dosage, dosage form
	the holder of the registration certificate, registration date, number of the registration certificate, the state where original medicine is registered
6)	Medicine with well studied medical application
	name of medicine, dosage, dosage form
	holder of the registration certificate, registration date, number of the registration certificate.
7)	Radio pharmaceutical medicine
	radio pharmaceutical set
	radionuclide precursor
	radionuclide source (primary and secondary) (in the presence)
	Generator
8)	Homeopathic medicine
	new homeopathic medicine
9)	Vegetable medicine
	binomial scientific name of plant (sort, type, version)	the homeopathic medicine included in pharmacopeias and monographs
	raw materials origin source (laboratory code)
	parts of the making plant
	the name (determination) of substance of plant origin and other names (the synonyms specified in Pharmacopoeias)
10)	Orphan medicine
	Whether the status of orphan medicine in the Republic of Kazakhstan is given to medicine
	No In the course of consideration Yes
	Date
	number of the registration certificate of orphan medicine
	It is refused assignment of the status of orphan medicine
	Date
	Number of the decision
	The application on assignment of the status is withdrawn: date
11)	Transfer the Name, the address of the production site of the transferring party
12)	The active pharmaceutical substance made not in the conditions of GMP or medicinal vegetable raw materials
13)	Prekvalifikation of WHO

";

in appendix 4 to the specified Rules:

state Item 2 in the following edition:

"2. The reproduced medicine

For the reproduced medicines data of pharmaceutical development are represented in comparison with original or reference medicine.

For the proof of equivalence of generic with original (reference) medicine in the Module 5 of the OTD format or part IV of the List of the documents provided for examination by producers of the Republic of Kazakhstan (further – the List) in the registration file of generic results of researches according to the Rules of carrying out researches of bioequivalence of medicines within the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 85 are reported.";

5) of Item 5 to state the subitem in the following edition:

"5) complete description and packet of data on production process, since development of vectors of expression and banks of cages, culture (fermentation) of cages, collection, cleaning, reactions of modification, filling of containers for ready dosage form;";

6) of Item 7 to state the subitem in the following edition:

"6) periodically updated report on safety of medicine over the last 5 years from the moment of registration in the country of the producer before filing of application by foreign producers.

In the absence of experience of application in the country of the producer in 5 years from the moment of registration, periodically updated report on safety of medicine for the actual time of presence in the market according to requirements of proper practice of pharmakonadzor (GVP) is provided.";

state Item 12 in the following edition:

"12. Orphan medicines

In case of examination of orphan medicines the positive conclusion about safety is issued under the obligation of the applicant on the following terms:

1) accomplishment in certain terms of certain research program which results will be the basis for revaluation of ratio "advantage risk";

2) use of medicine under strict observation of the doctor;

3) the immediate notification of state body on any undesirable reactions which arose in case of use of orphan medicine, and the taken measures according to the rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products approved by the order of the Minister of Health of the Republic of Kazakhstan of December 23, 2020 No. KR DSM-320/2020 "About approval of rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 21896).

The expert organization approves the research program obligatory to carrying out after receipt of registration developed and provided by the applicant for examination according to the subitem 1) of this Item.

During accomplishment of the set conditions the expert organization provides in state body information obtained from the applicant about carrying out certain research program for annual reassessment of ratio "advantage risk" for the registered orphan medicine. The instruction on medical application and other medical information about the orphan medicine registered thus contains instructions about insufficiency of data.";

state Item 17 in the following edition:

"17. The accelerated medicine examination

When conducting the accelerated examination requirements to safety, quality and efficiency of medicines do not decrease.

1) the Accelerated examination of medicines is performed according to the decision of authorized body and carried out in cases:

purposes of medicines for prevention, treatment, diagnosis of rare diseases;

prevention of emergency situations, origin and elimination of effects of epidemic, pandemic of infectious diseases (the medicines of etiopatogenetichesky therapy applied in emergency situations in response to health hazards of the population (pandemic) and included in clinical protocols of treatment;

threats of risk of items out of stock of medicine in the market of the Republic of Kazakhstan in connection with geopolitical situation, military operations in the world;

purposes of medicine, the foreign producer, for transfer of technologies on the production site in the territory of the Republic of Kazakhstan.

2) Examination of the medicines participating in the procedure of joint prekvalifikation of WHO is performed according to appendix 8 Series of Technical reports of WHO, No. 996, 2016. "The procedure of joint registration between group on provisional estimate of the World Health Organization (WHO) and national authorities of regulation for assessment and the accelerated national registration of the pharmaceutical products and vaccines which passed preliminary qualification of WHO".

This appendix extends also to the medicines which are at stage of expert works before entry into force of these rules.";

in appendix 9 to the specified Rules:

26, to state line, sequence number in the following edition:

"

26	The fixed combinations of nonsteroid anti-inflammatory medicines with atropinopodobny medicines (spazmolitika)

";

27, to exclude line, sequence number;

in appendix 10 to the specified Rules:

7, to state line, sequence number in the following edition:

"

7.	Medicine is	Original medicine The reproduced medicine Hybrid medicine Biological medicine Immunobiological medicine Biosimilar medicine (Biosimilyar) The combined medicine Medicine with well studied medical application Radio pharmaceutical medicine or precursor Homeopathic medicine Vegetable medicine Orphan medicine The active pharmaceutical substance made not in the conditions of GMP Medicinal natural raw materials (not pharmacopoeian)
		Prekvalifikation of WHO
		Transfer

";

in appendix 11 to the specified Rules:

7, to state line, sequence number in the following edition:

"

7.

Medicine

Original medicine The reproduced medicine Hybrid medicine Biological medicine Immunobiological medicine Biosimilar medicine (Biosimilyar) The combined medicine Medicine with well studied medical application Radio pharmaceutical medicine or precursor Homeopathic medicine Vegetable medicine Orphan medicine The active pharmaceutical substance made not in the conditions of GMP Medicinal natural raw materials (not pharmacopoeian)

";

appendix 18 to the specified Rules to be reworded as follows according to appendix to this order;

in rules of conducting examination of the medical products approved by appendix 2 to the specified order:

state Item 32 in the following edition:

"32. In case of impossibility of laboratory testing of medical product on separate indicators, the expert organization recognizes results of laboratory researches on the separate indicators specified in the certificate (protocol) of the analysis of the producer.";

add with Item 32-1 of the following content:

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