Article 63 and 71




Yüklə 0.74 Mb.
səhifə3/6
tarix14.04.2016
ölçüsü0.74 Mb.
1   2   3   4   5   6
5. Analytic expertise results (conclusion)

 

Section name

Brief comments to the section

Expertise of quality indicators conformity to standard technical documents of the manufacturer to international quality standards, state pharmacopeia of the Republic of Kazakhstan, international pharmacopeias recognized to be valid in the Republic of Kazakhstan

 

Detailed description of progress of medicinal product samples analytical study

 

Conclusions on possibilities of analysis methods reproduction and conformity to requirements of pharmacopeia articles and standard technical documents

 

 

Date

  

Position ________ signature ________ name________

 

Annex 4

to the Procedure of medicinal products expertise
 

 

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

Expertise of normative documents which describe medicinal product quality has been carried out

 

1.

Experts surname, name, patronymic

 

2.

Academic degree, title

 

3.

Application number

 

4.

Date

 

5.

Trade name of the drug

 

6.

International nonproprietary name (INN)

 

7.

The medicinal product is

ҳ original ҳ generic

8.

Specify the name of original medicinal drug for generic

 

9.

Dosage form

 

10.

Dosage

 

11.

Concentration

 

 

12. Package

 

No

Package name

Package kind (primary, secondary)

Size

Volume

Quantity of units in a package

Brief description

1.

 

 

 

 

 

 

2.

 

 

 

 

 

 

...

 

 

 

 

 

 

 

13. 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

 

 

 

 

14. 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 found:

15. The composition of the medicinal product and conclusion on its ingredients’ efficiency and compatibility (specify drug substances and excipients including additives, components of drug covers and others)

 

No

Name

Quantity per dosage form unit

Standard technical document which regulates medicinal product quality and safety control or the State Pharmacopeia of the Republic of Kazakhstan and foreign pharmacopeias recognized to be valid in the Republic of Kazakhstan

1.

Drug substance (s):

 

 

 

 

 

 

2.

Excipients:

 

 

 

 

 

 

3.

Composition of tablet cover or capsule case:

 

 


16. For medicinal plant raw material

 

No

Botanic Latin names of plants which form part of the composition

Normative document which regulates medicinal product quality and safety control or the State Pharmacopeia of the Republic of Kazakhstan and foreign pharmacopeias recognized to be valid in the Republic of Kazakhstan

Wild-growing or domestic

Habitat

1.

 

 

 

 

2.

 

 

 

 

...

 

 

 

 


17. Producers of active substances which form part of the medicinal product

 

No

Name of the substance forming part of the medicinal product

Name of the producer in the Russian and English languages

Country*

Address of the production site in the Russian and English languages

1.

 

 

 

 

2.

 

 

 

 

 

 

 

 

 


18. In case if the 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 of Table List, the fact if the substance is stereoisomer of narcotic drug specified in Table II, in cases when 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)

conclusion on possibility or impossibility to extract controllable substances by an easy method in quantities sufficient for abuse

 

3)

conclusion that some control measures regarding the drug can be dismissed

 

19.

Analysis of origin data, registration in the Republic of Kazakhstan, quality and conclusions on substance application possibility (if GMP certificate is missing)

 

20.

Analysis of quality, quantity data with conclusions on usage permissibility of used excipients, coloring agents, additives

 

21.

Conclusion on production (production formula, production technology description, production process control, production process validation)

 

22.

Finished product characteristics (compliance of parameters stated in the finished products quality certificate or the organization-producer’s passport to the quality control methods described in the standard technical documents, conformity of batches of submitted samples to the batches specified in the certificate)

 

23.

Conclusion on labeling and packaging regarding their sufficiency to preserve the medicinal product quality during storage and transportation (necessity of additional inscriptions), existence of indications for primary and secondary packages. Hygienic conclusion for packaging (for domestic producers)

 

24.

Finished product specification

 

25.

Conclusion on chemical, pharmaceutical and biological (in vitro) equivalence data submitted by the firm for the medicinal product

 

26.

Conclusion of the medicinal product stability, justification of the stated shelf-life, application period after the first unpacking or dissolution

 

27.

Analysis and assessment of the medicinal product application instruction drafts, package and label designs, identity check of storage and transportation conditions specified in the draft of the medicinal product standard technical document for quality and safety control and in the above mentioned drafts

 

28.

Conclusion on the medicinal product storage and transportation conditions and necessity of additional requirements introduction in order to preserve the medicinal product quality

 

29.

Analysis of the medicinal product quality and safety control standard technical document and finished product quality control methods and testing laboratory report assessment

 

30.

Comparison with equivalents registered in the Republic of Kazakhstan. Comparative description of basic quality indicators.

 

31.

Recommendations:

 

1)

not to recommend the medicinal drug for state registration, re-registration (rejection should be grounded)

 

2)

to reexamine the documents after additional materials are submitted upon the expert’s request (with arguments for the necessity to submit additional materials or carry out additional tests)

 

3)

to recommend the medicinal drug for state registration, re-registration (with the medicinal product registration, re-registration time specified, with the necessity to approve standard technical documents for quality and safety control, package and label designs 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

 

Annex 5

to the Procedure of medicinal products expertise

 

 

Form

 

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

Expertise of normative documents, which describe medicinal product safety and efficiency, has been carried out


35.

Expert’s surname, name, patronymic

 

36.

Academic degree, title

 

37.

Application number

 

38.

Date

 

39.

Trade name of the drug

 

40.

International nonproprietary name (INN)

 

41.

The medicinal product is

ҳ original ҳ generic

42.

Specify the name of original medicinal drug for generic

 

43.

Dosage form

 

44.

Dosage

 

45.

Concentration

 

46.

Pharmacotherapeutic group

 

47.

Code according to the Anatomico-therapeutic-chemical classification (ATC-code)

 

48.

Pharmacological effect

 

49.

Dispensing category

ҳ on prescription ҳ without prescription

 

1   2   3   4   5   6


Verilənlər bazası müəlliflik hüququ ilə müdafiə olunur ©azrefs.org 2016
rəhbərliyinə müraciət

    Ana səhifə