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Procedure of medicinal products expertise

 

 

Form

 

Conclusion for Primary Expertise of Medicinal Product Documents and Materials

Submitted to State Registration, Re-registration in the Republic of Kazakhstan
 

Expertise of documents and materials submitted for state registration, re-registration of medicinal products in the Republic of Kazakhstan has been carried out


1.

Experts surname, name, patronymic

 

2.

Experts position

 

3.

Phone, fax, E-mail

 

 

Information on medicinal product

 

1.

Application date and number

 

2.

Trade name of the drug

 

3.

International nonproprietary name

 

4.

Dosage form

 

5.

Dosage

 

6.

Concentration

 

 

7. Package


No

Package name

Package kind (immediate, secondary)

Volume

Quantity of units in a package

1.

 

 

 

 

2.

 

 

 

 

...

 

 

 

 

 

8. Information on the producer


No

Organization type or production section

Organization name

Country

Legal address

1.

Applicant

 

 

 

2.

Producer

 

 

 

3.

Packer

 

 

 

4.

Marketing authorization holder

 

 

 


9. Dispensing procedure

 

10.

Another medicinal product with different composition of active substances was earlier registered under the trade name in the Republic of Kazakhstan

NO YES (mark the item that applies)


Assessment of the registration dossier completeness, sufficiency and execution correctness of submitted documents

 

11.

The dossier is classified by sections, all pages are numbered, record statement is made

NO YES (mark the item that applies)

12.

A set of documents complies to the approved list

NO YES (mark the item that applies)

13.

Existence of coloured package designs and their verification with the applicant’s stamp (for medicinal drugs), compliance of the medicinal product package to the requirements of the legislation of the Republic of Kazakhstan

NO YES (mark the item that applies)


Medicinal product composition expertise

 

14.

Existence of banned coloring agents and other excipients in the medicinal product

NO YES (mark if any)

15.

Existence of substances made of human and animal blood, organs and tissues in the medicinal product. Existence of prion safety certificate

NO YES (mark the item that applies)

 

Expertise of the analytical part of the registration dossier

 

16.

Analysis of standard technical documents for compliance of the document structure with regulatory legal acts of the Republic of Kazakhstan

 

17.

Existence of medicinal product samples in a final package, sufficient for three-stage analysis:

 

18.

Conformity of the product samples batch to the batch specified in the certificate

 

19.

Remaining shelf-life of products samples

 

20.

Existence of substance samples

 

21.

Existence of standards for foreign substance detection

 

22.

Existence of reference-standards

 

23.

Testing laboratory recommendation for expertise, with equipment taken into account

 


Expertise of information about the pharmacological effect of the medicinal product

 

24.

Conformity of the medicinal product application instruction structure and execution to the legislation requirements of the Republic of Kazakhstan

 

 

Expert’s conclusion

 

Expertise conclusion*:

Conclusion date                          Expert’s signature

_______________

Surname, name, patronymic and signature of the expert organization head

________________________

Surname, name, patronymic and signature of the department head

________________________
The results of the primary expertise are acknowledged:

Applicant’s name and signature _______________________________

 

Date______________

 

* Note:

1) positive expertise conclusion text:

«Materials and documents of the registration dossier for the medicinal product submitted for state registration, re-registration in the Republic of Kazakhstan, meet the requirements and are subject to further expertise.»;

2) negative expertise conclusion text:

«The primary expertise of the registration dossier submitted for state registration, re-registration in the Republic of Kazakhstan has shown that the registration dossier does not meet the requirements according to the following parameters:

____________________________________________________________________________________________________________________

____________________________________________________________________________________________________________________

____________________________________________________________________________________________________________________

You are requested to submit missing documents and materials within the period, not exceeding thirty calendar days. The expert works are terminated and will be resumed after the missing documents, materials, corrections are submitted and positive expert’s conclusion are received. In case the missing materials are not submitted, the expert works will not be performed»;

3) the expert conclusion is executed in two copies, one copy for the applicant.

 

Annex 2



to the Procedure of medicinal products expertise

 

 

Form

 

Primary expertise conclusion for amendments to the medicinal product registration dossier

 

I,

_________________________________________________________________________________________

(surname, name, patronymic, expert’s position, phone, fax, Е-mail)

have carried out expertise of the application documents and materials for the medicinal product submitted for amendments to the registration dossier. The stated amendments are as follows:

type I, type II (mark the item that applies)

the medicinal product ______________________________________________________________

(trade name, dosage form, dosage, concentration and admission space, quantity of doses in a package, organization-producer, producer’s country) marketing authorization number

________________________________________________

Assessment of completeness, sufficiency and execution correctness of the submitted documents

________________________________________________________________________________________

_________________________________________________________________________________________

Correctness of sections, pages of the registration dossier

________________________________________________________________________________________

Expertise conclusion:___________________________________________________________________

_________________________________________________________________________________________

Date __________ Expert’s signature

_________________________________________________________________________________________

Primary expertise comments are resolved completely ____________ date, year _______________

_________________________________________________________________________________________

Expert’s surname, name, patronymic and signature

_________________________________________________________________________________________

Applicant’s surname, name, patronymic and signature

_________________________________________________________________________________________

Expert organization head’s surname, name, patronymic and signature

_________________________________________________________________________________________

Department head’s surname, name, patronymic and signature

_________________________________________________________________________________________

The results of the primary expertise are acknowledged:

Applicant’s surname, name, patronymic and signature _______________ Date

_________________________________________________________________________________________

Note:

  1. positive expertise conclusion text:

«Documents and materials of the medicinal product submitted for amendments to the registration dossier of the medicinal product meet the requirements and are subject to further expertise»;

2) negative expertise conclusion text:

«The primary expertise of the documents and materials submitted for amendments to the registration dossier of the medicinal product has shown non-compliance to the requirements according to the following parameters:

_______________________________________________________________________________________

_______________________________________________________________________________________

You are requested to submit missing documents and materials.

The expert works are stopped and will resume after the missing documents, materials, corrections are presented and positive expert’s conclusion are received»;

3) the expert conclusion is executed in two copies, one copy for the applicant.

 

Annex 3

to the Procedure of medicinal products expertise

 

Form

 

REPORT

on Analytical Expertise of the Medicinal Product during State Registration
 

1. Information on accredited testing laboratory

 

Name, legal status

 

Accreditation certificate (number, date)

 

Postal code, address

 

Phone number

 

Fax

 

Е-mail

 

 

2. Information on the medicinal product

 

Application number

 

Application date

 

Trade name

 

Dosage form

 

Dosage, concentration

 

International nonproprietary name (INN)

 

 

Package

 

No

Package name

Package kind (primary, secondary)

Size

Volume

Quantity of units

in a package

Brief description

1.

 

 

 

 

 

 

2.

 

 

 

 

 

 

..

 

 

 

 

 

 

 

Producer, country

 

Applicant

 


Information on samples submitted for expertise


No

Batch

Date of manufacture

Quantity of samples

Expiry date

Shelf-life

1.

 

 

 

 

 

2.

 

 

 

 

 

Date of receipt for analysis

 

Date of work completion

 

Date of receipt for the Pharmocopeia commission

 

Date of return for further development

 

Date of report receipt by the Pharmacopeia commission

 


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