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50. Package

 

No

Package name

Package kind (immediate, secondary)

Size

Volume

Quantity of units in a package

1.

 

 

 

 

 

2.

 

 

 

 

 

...

 

 

 

 

 

 

51. Information on the producer

 

No

Organization type or production section

Organization name

Country

Legal address

1.

Applicant

 

 

 

2.

Producer

 

 

 

3.

Packer

 

 

 

4.

Production section

 

 

 

5.

Marketing authorization holder

 

 

 

 

52. Detailed description of pharmacovigilance system and risk management

 

No

Pharmacovigilance structure

 

1.

Global pharmacovigilance

 

2.

Person in charge for global pharmacovigilance

 

3.

Local pharmacovigilance

 

4.

Person in charge for local pharmacovigilance in the RoK

 

5.

Risk management plan for medicinal product application

 

 

53. Registration in the producer’s country and other countries

 

No

Country name

Marketing authorization number (marketing license)

Date of issue

Validity

1.

 

 

 

 

2.

 

 

 

 


As a result of the expertise the following has been established


54.

In case if substance liable to control according to the Act of the RoK “On narcotic drugs, psychotropic substances, precursors and counteraction measures against their illegal traffic and abuse” forms part of the medicinal product:

1)

Conclusion on belonging to controllable substances (based on study of international nonproprietary name, trade name, chemical name, structural formula on belonging to controllable substances with indication of position in the List Table, the fact if the substance is stereoisomer of narcotic drug specified in Table II, in cases the existence of such stereoisomer is possible within the framework of the given chemical notation (if such are not definitely excluded), is salt of all narcotic drugs specified in Table II, including isomers of salts, as provided above, in all cases when existence of such salts is possible; is salt of psychotropic substances specified in Tables II and III, if existence of such salts is possible.

 

2)

science-based qualification of abuse risk degree: high risk of abuse or abuse risk is missing or is not significant; specification of maximum permissible content of narcotic drugs, psychotropic substances and precursors in medicinal products;

 

3)

conclusion that some control measures regarding the drug can be dismissed

 

55.

Analysis of accuracy of the qualitative and quantitative composition of active substances and excipients specified in the medicinal application instruction, comparing with the composition stated in the application, the analytical normative documents and package model;

 

56.

Assessment of pharmacological compatibility of components; in case of registration of re-produced medicinal product one should compare with the composition of the original drug;

 

57.

Analysis of pre-clinical study documents: toxicity (acute, chronical, LD50, LD100), carcinogenicity, embryotoxicity, teratogenicity, topical-product-induced irritation effect, immune system influence, specific pharmacological (biological) activity.

 

58.

Analysis of clinical study documents (clinical study phases, post-marketing researches, protocols and reports, Ethic commission conclusions and other). In this regard it is necessary to specify where the study was carried out, date, sponsor, quantity of persons under test, sex, age, inclusion/exclusion criteria, study purpose, study design, randomization, study duration, drug dosage regimen, adverse effects monitoring in the process of clinical studies, conformity of the report to the protocol, conclusion on the “benefit-risk” ratio

 

59.

Bioequivalence data analysis (protocols and reports, Ethic commission conclusions and other). In this regard it necessary to describe where the study was carried out, date, sponsor, quantity of persons under test, sex, age, inclusion/exclusion criteria, study purpose, study design, randomization, test-drug, reference-drug, drug dosage form, drug dosage regimen, introduction way, adverse effects monitoring, conformity of the report to the protocol, bioanalytical study methods, internal standard, individual chromatograms, pharmacokinetic curves, statistic data of pharmacokinetic parameters (in tabular form), conclusion on bioequivalence. Conformity of bioequivalence studies to the requirements of the Republic of Kazakhstan

 

60.

Assessment of the medicinal product safety and efficiency according to results of clinical studies regarding stated age groups of patients, justification of therapeutic indications choice, counterindications, precautions when using the drug, adverse effects profile.

 

61.

Assessment of origin source (blood, human and animal organs and tissues) and specific activity for immunobiological drugs

 

62.

Assessment of nutrient medium used for virus and bacteria generation and epidemiologic efficiency for vaccines;

 

63.

The medicinal application instruction expertise is carried out in comparison with the brief description of the medicinal drug. Conclusion is made on conformity or non-conformity of therapeutic indications, adverse effects, counterindications, special recommendations, drug interactions, overdose specified in the medicinal product application instruction to the brief description of the medicinal drug

 

64.

Assessment of conformity of code assignment of the Anatomico-therapeutic-chemical classification (ATC), conformity of the pharmacotheraupetic group to the ATC classification, pharmacological effect, therapeutic indications. In case if the ATC code and the pharmacotherapeutic group are not correctly stated, it is required to indicate ones recommended by the expert.

 

65.

Check the adequacy of stated doses and dosage regimen according to the pharmacokinetic parameters (half- life, degree of binding to blood plasma proteins, effect on hepatic enzyme activity, retention time of bacteriostatic/bacterial concentration in case of antibacterial drugs). It is required to pay special attention to doses recommended to children, elder people, patients with kidney and liver malfunctions

 

66.

Check the conformity of the shelf-life stated in the application, in the brief description of the medicinal drug, the medicinal application instruction, package designs to the shelf-life specified in the normative document.

 

67.

Compliance of the submitted medicinal application instruction to the current legislation of the Republic of Kazakhstan

 

68.

Accuracy and authenticity of medicinal application instruction text translated into the national and Russian languages

 

69.

Analysis of occurring complications, adverse effects (profile of expected adverse effects, overdose symptoms and overdose elimination measures).

 

70.

It is filled in only when applying for state registration of the medicinal drug. Assessment of the medicinal products safety and efficiency on the basis of data of occasionally updated reports on safety – analysis of safety profile, introduction of new adverse effects, counterindications into the brief description of the medicinal drug and the medicinal application instruction or rejection to re-register the drug, changes in the registration status of the drug in other countries, updated data on measures taken by the regulatory body or the producer for safety reasons, changes of the drug safety information, sales volume, quantity of patients who took the drug during the period under review, study of particular cases description and a list of adverse effects and summary tables, particular cases of adverse effects appearance detected by the marketing authorization holder, character and quantity of serious adverse effects and formerly not registered by the company. General assessment of safety on the basis of data of occasionally updated reports on safety and conclusion on preservation or change of the safety profile, introduction of new adverse effects, counterindications into the medicinal application instruction or rejection to re-register the drug.

 

71.

Assessment of the medicinal product safety and efficiency according to the “benefit-risk” ratio– counterindications, warnings and precautions when using the drug. It is required to pay special attention to children, pregnant and nursing women, elder people, patients with kidney and hepatic malfunction

 

72.

Recommendations

 

1)

to recommend the medicinal drug for state registration, re-registration (with the time of the medicinal product registration, re-registration specified and the necessity to approve medicinal application instruction, package design) with approved therapeutic indications, counterindications, special recommendations and drug interactions described

 

2)

to reexamine documents after additional materials are presented upon the expert’s request (with arguments specified for the necessity to submit additional materials which confirm medicinal drug safety and efficiency or to carry out additional pre-clinical or clinical tests)

 

3)

not to recommend the medicinal drug for state registration, re-registraion (with rejection arguments specified)

 


Date of receipt of the documents by the expert

Date of completion of the documents expertise

All the data in the expert’s conclusion is accurate and meets the current requirements which is confirmed by my own signature.

 

Surname, name, patronymic

Signature

Date

SUB6

Annex 6

to the Procedure of medicinal products expertise

 

 

Form
Conclusion on Safety, Efficiency and Quality of the Medicinal Product Submitted for State Registration, Re-registration in the Republic of Kazakhstan
 

1. The expert organization informs of expertise results on safety, efficiency and quality of the medicinal product for state registration, re-registration in the Republic of Kazakhstan:


No

Trade name of the medicinal product (with dosage form, dosage, concentration and admission space, quantity of doses in a package specified – for the medicinal drug)

Organization-producer, producers country

License contract (before patent expiry)

Secured by the protection document in the Republic of Kazakhstan (yes, no)

1

2

3

31

4


Continuation of the table


Primary expertise conclusion (positive or negative)

Testing laboratory conclusion: date and number of protocol, report (positive or negative)

Pharmacopeia center conclusion (state registration, re-registration (state registration, re-registration with the time period specified are recommended or rejection to state registration, re-registration is recommended)

Pharmacopeia center conclusion (state registration, re-registration (state registration, re-registration with the time period specified are recommended or rejection to state registration, re-registration is recommended)

5

6

7

8

Date __________

_______________ ________________ _______________________

 

 

Position signature Surname, name, patronymic of the person in charge
Stamp here

 

Note:

1. Column 8 is not filled in the conclusion on medicinal substance safety, efficiency and quality.

2. In case if it is recommended to reject the medicinal product to state registration, re-registration, rejection arguments shall be presented along with the Conclusion on safety, efficiency and quality.

 

Annex 2


to the Order of the Minister of Public Health

of the Republic of Kazakhstan No 736



of November 18, 2009

 

 

Medical Devices and Medical Equipment Expertise Procedure

 

1. General Provisions

 

1. The present Procedure defines organization and performance of medical devices and equipment expertise for the state registration, re-registration and amendments to registration dossier for the period of marketing authorization validity (hereinafter referred to as medical devices and equipment expertise).

2. The present Procedure contains the following basic notions:

1) state expert organization in the distribution chain of medical devices and equipment is the organization appointed by authorized agency in the sphere of public health in order to perform the expertise of medicinal products, medical devices and equipment, not directly involved in development and production of medical devices and equipment (hereinafter referred to as expert organization);

2) applicant is the developer, producer (manufacturer), individual entrepreneur or their authorized representative, entitled to submit an application, documents and materials for state registration, re-registration and amendments to the medical devices and equipment registration dossier;

3) accessories of medical devices and equipment is a product and (or) a device used as a component of medical devices and equipment, designed to be used according to medical devices and equipment functional purpose;

4) normative (standard) document is a set of rules defining requirements to medical devices and equipment quality, safety, production and application conditions, testing methods, transportation and storage of medical devices and equipment;

5) medical devices and equipment samples are medical devices and equipment submitted by the applicant for expertise during state registration, re-registration and amendments to the medical devices and equipment registration dossier;

6) consumables to medical devices and equipment are devices and materials consumed for application of medical devices and equipment ensuring manipulations according to the function of medical devices and equipment;

7) registration dossier is a set of documents and materials of an established scheme submitted by the applicant for state registration, re-registration, amendments to the medical devices and equipment registration dossier;

8) expertise is a study or a test of medical devices and equipment and their safety, efficiency and quality by means of chemical, physical, biological, pre-clinical (non-clinical), clinical studies as well as study of documents of the registration dossier, normative documents on standardization of medical devices and equipment submitted for registration.

3. The expert organization carries out medical devices and equipment expertise for registration, re-registration and amendments to the registration dossier.

If necessary according to decision of the relevant public health body specialized public health organizations will be involved.

4. An expertise is performed after receiving the following materials from the governmental body specialized
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