Article 63 and 71




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Order of the Minister of Public Health of the Republic of Kazakhstan № 736 of November 18, 2009 on Approval of the Procedure of Expertise of Medicinal Products, Medical Devices, and Equipment

 

On the authority of Article 63 and 71 of the code of the Republic of Kazakhstan of September 18, 2009 “On Public Health and Public Health System”, I ORDER:



1. To approve the enclosed:

1) Procedure of medicinal products expertise according to Annex 1;

2) Procedure of medical devices and equipment expertise according to Annex 2.

2. To appoint the Republican public enterprise "National Expertise Center for Medicinal Products, Medical Devices and Equipment" under the Ministry of Public Health of the Republic of Kazakhstan the governmental expert organization for state registration, re-registration and amending the registration dossier of medicinal products, medical devices and equipment medicinal products, medical devices and equipment in the marketing sphere.

3. The Committee for medical and pharmaceutical activity control under the Ministry of public Health to perform state registration of the present Order with the Ministry of Justice of the Republic of Kazakhstan as established by law.

4. The Department of administrative and legal work (F.B.Bismildin) to arrange official publication of the present Order in the mass media after its state registration as established by law.

5. To impose the duty for control of implementation of the present Order on Y.A. Birtanov, Vice-Minister of Public Health of the Republic of Kazakhstan.

6. The present order becomes effective 10 calendar days after its first official publication.

 

 

Minister

Zh. Doskaliev

 

Annex 1

to the Order of the Minister of Public Health

of the Republic of Kazakhstan No 736

of November 18, 2009



 

 

Medicinal Products Expertise Procedure

 

1. General Provisions

 

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

2. The present Procedure contains the following basic notions:

1) medicinal product expertise is an examination or trial of medicinal products' safety, efficiency and quality by performing of chemical, physical, biological, pre-clinical (non-clinical), clinical studies, their bioequivalence test as well as examination of presented documents for state registration: registration dossier, normative documents on standardization;

2) registration dossier is a set of documents submitted along with the application for state registration, re-registration of a medicinal product and amendments to registration dossier;

3) generated medicinal product (generic) is a medicinal product similar with the original product in terms of the active substances composition and dosage form, coming on the market after expiry of protection document validity for the original drug, or on the ground of a license agreement;

4) Applicant is the developer, producer or their authorized representatives, entitled to submit an application, documents and materials for state registration, re-registration and amendments to medicinal products registration dossier;

3. Medicinal products expertise is performed by the state expert organization specializing in medicinal products, medical devices and equipment not directly involved in the development and production of the medicinal product (hereinafter referred to as expert organization) on the basis of agreement with Applicant.

4. Medicinal products expertise is performed upon transfer of the following items by the governmental body specializing in medicinal products, medical devices and equipment (hereinafter referred to as governmental body):

1) Conclusion from the governmental body on performance of expertise of medicinal product submitted for state registration, re-registration and amendments to registration dossier in the Republic of Kazakhstan;

2) Applications for the state registration, re-registration and amendments to registration dossier of the medicinal product registered (re-registered) in the Republic of Kazakhstan;

3) two identical copies of the registration dossier;

4) medicinal products samples sufficient for three-stage analysis;

5) standard medicinal products and foreign substances samples, consumables, employed during medicinal products study (on extraordinary occasions and on return basis);

6) the document confirming the payment of the expertise fee.

5. The payment for medicinal expertise is effected by the Applicant by transfer to the account to the expert organization.

 

2. Medicinal Products Expertise Procedure

 

6. The expertise of medicinal product upon Type I amendments to the registration dossier, regulated by the Procedure of state registration, re-registration and amendments to the registration dossier of medicinal products, medical devices and equipment which are approved by the Order №735 of the Minister of Public Health of the Republic of Kazakhstan of November 18, 2009 (registered in the State Register of normative legal acts under No5935), (hereinafter referred to as state registration procedure) consists of two stages:



1) primary expertise;

2) analytical and (or) special pharmaceutical expertise and (or) special pharmacological expertise according to the requirements to the amendments.

7. The expertise of medicinal product upon state registration, re-registraion and Type II amendments to the registration dossier regulated by the state registration procedure consists of four stages:

1) primary expertise;

2) analytical expertise;

3) special pharmaceutical expertise;

4) special pharmacological expertise.

8. Each successive stage of medicinal products expertise is based on positive results of the previous one.

9. When performing expertise the expert organization has the right to request Applicant’s explanation or specification for particular provisions in the documents and materials submitted.

10. If the Applicant does not present materials or written grounding of different terms (not more than 60 calendar days) necessary for preparation of these materials within 30 calendar days the expert organization terminates the expertise and informs the governmental body and the Applicant about the decision within 10 calendar days after decision making. 

 

3. Medicinal Products Primary Expertise Procedure

 

11. The primary expertise of medicinal product includes:



1) assessment of completeness and regularity of one set of submitted registration dossier documents. After registration, re-registration it is transferred to the departmental record office;

2) assessment of medicinal products ingredients for presence of banned colouring agents and other excipients, substances derived from human tissues and products of animal origin; and, if such are present in the medicinal products, the document confirming safety of active protein substances used in medicinal products production (prion safety);

3) assessment of analytical part of the registration dossier with regard to conformity of standard technical document on medicinal products safety and quality control;

4) check of medicinal products samples availability, quantity sufficiency and shelf-life for analytical expertise, availability of medicinal substances samples, standard samples of medicinal substances and foreign substances, consumables (in exceptional cases and on return terms) which are necessary for reproduction of medicinal products analytical expertise methods;

5) analysis of the information on pharmacological effect of medicinal product for conformity of the stated basic pharmacological effect to the the Anatomico-therapeutic-chemical classification (hereinafter referred to as ATC-classification);

6) check if the order of drugs dispensing from chemist's shops is specified (on or without prescription) and check of completeness of medicinal products application instruction content;

7) check of conformity of stated amendments specified in the registration dossier (Type I and II amendments) and check of accuracy of specification of the registration dossier sections and pages to be amended;

8) assessment of medicinal products content for existence of narcotic, psychotropic substances and precursors. 

12. In accordance with the results of medicinal products primary expertise expert’s conclusion is prepared in the form according to Annexes 1, 2 to the present Procedure, one copy of which is presented to the Applicant and the other one is transferred to the following stage of the expertise along with the materials.

13. If the expert organization finds out that medicinal products contain coloring agents and accessory substances which form part of the List of coloring agents and accessory substances banned in the Republic of Kazakhstan, they terminate the expertise and present negative expert’s conclusion to the governmental body and the Applicant. 

 

4. Medicinal Products Analytical Expertise Procedure

 

14. Analytical expertise of medicinal product includes:



1) physical, chemical, physicochemical, and biological tests of medical products samples for their conformity to the requirements of standard technical document on medicinal products quality and safety control;

2) assessment of standard technical document on medicinal products quality and safety control with regard to analysis methods reproduction.

15. The testing laboratory prepares the report in accordance with medicinal product analytical expertise in the form according to Annex 3 to the present Procedure.

 

5. Special Pharmaceutical Expertise of Medicinal Product

 

16. Special pharmaceutical expertise of medicinal product includes the assessment of:



1) chemical safety and quality of medical product, influence of amendments to the registration dossier on medicinal products safety, efficiency and quality;

2) the ingredients of the medicinal product and the conclusion on its efficiency, quality of the medicinal and accessory substances;

3) medicinal product production (production formula, production technology, production process control, production process validation);

4) finished product (conformity of parameters specified in the certificate of quality for the finished production to the methods of quality control described in the standard technical document on medicinal products quality and safety control, analysis of the report of the testing laboratory, assessment of reproduction and objectivity of quality control methods, adequacy of the ingredients of the medicinal product and quality control methods);

5) conformity of quality characteristics specified in the standard technical document on medicinal products quality and safety control of the organization-producer to the State Pharmacopoeia of the Republic of Kazakhstan and the international standards of quality;

6) stability of medicinal product, relevance of the stated expiration date, period of application after first unpacking or dissolution;

7) information on medicinal product chemical, pharmaceutical equivalence;

8) labeling and packaging with regard to preservation of medicinal product quality during the product storage and transportation;

9) text of the instruction on medicinal product application, package and label designs with regard to conformity of information on conditions of storage, transportation, shelf-life, and application after first unpacking or dissolution and availability of necessary warning notes;

10) the medicinal product composition, to check its belonging to narcotic, psychotropic substances and precursors, if there is an easy method of extraction of substance liable to control in quantities sufficient for abuse with the purpose of exclusion some control measures.

17. According to the results of the medicinal product special pharmaceutical expertise the expert prepares expert’s conclusion in the form according to Annex 4 to the present Procedures.

The expert conclusion is considered during the Pharmacopoeial committee session.

 

 

6. Special Pharmacological Expertise of Medicinal Products

 

18. Special pharmacological expertise includes:



1) analysis of qualitative and qualitative composition of active and excipients declared in the instruction on medical application as compared with the composition stated in the application, analytical normative document and package model;

2) assessment of pharmacological compatibility of components; in case of generic registration, comparison with the original product composition;

3) scientific evaluation of abuse risk level: high risk of abuse, no risk of abuse or low risk of abuse; identification of maximum permissible content of narcotic, psychotropic substances and precursors in medicinal products;

4) analysis of documentation on pre-clinical studies – evaluation of toxicity level study results, influence on reproductive function, embryotoxity, teratogenecity, mutagenicity, carcinogenicity, pharmacodynamics, adequate choice of objects and methods of study, methods of application and dosage;

5) analysis of documentation of clinical studies - evaluation of the protocol and report on clinical studies, general research plan, people under test and their quantity, method of grouping of people under test, dosage, treatment methods, blind test levels and methods, control methods;

6) assessment of medicinal product safety and efficiency in accordance with results of clinical studies based on the analysis of complications observed, adverse reactions, remedial measures, medicinal product dose, concentration, and their connection with medicinal product safety and efficiency;

7) analysis of the information on bioequivalence (in case of state registration, re-registration of generic except for the dosage forms when bioequivalence study is impossible) - assessment of a correct choice of medicinal product for comparison, relevance of the type of the research and general research plan: study objects, experiment conditions, methods of medical product concentration determination, diagrams construction, parameters determination, grounding of conclusions concerning bioequivalence;

8) check of conformity of the medical application instruction text to the brief characteristics of the medicinal product and up-to-date reference information;

9) assessment of correct assignment of the Anatomic-therapeutic-chemical classification code in accordance with pharmacological properties and therapeutic indications;

10) check of adequacy of the stated doses according to the pharmacokinetic parameters – analysis of recommended doses, dosage regimen with pharmacokinetical properties (half-life period, intensity of binding with blood plasma proteins, influence on liver ferment activity, bacteriostatic (bactericidal) concentration hold time in case of antimicrobials), special attention to the doses recommended to children, elder people, patients with liver, kidney malfunctions;

11) analysis of the stated shelf-life accuracy– comparison of self-life stated in: the application, medicinal product brief characteristics, medical application instruction, and package design, and conformity to the shelf-life specified in the normative document;

12) order of drugs dispensing from chemist's shops (on or without prescription) with pharmacological effect taken into account, adverse reactions profile, risks of overdose, dependence and abuse;

13) assessment of description of pharmacological safety control system and risks management system which allow the holder of the marketing authorization to perform adequate monitoring of adverse reactions of medicinal products detected in the Republic of Kazakhstan and other countries;

14) assessment of medicinal product safety and efficiency based on the occasionally updated safety reports – analysis of safety profile, introduction of new adverse reactions, counterindications into the medicinal product brief characteristics and medical application instruction or rejection of the product re-registration, amendments to the registration status of the product in other countries, updated data on measures taken by the regulatory body or the producer for reasons of safety, changes in the product safety information, sales volume, number of patients who took the medicinal product within reference period, examination of the description of particular cases and adverse reactions list and summary tables, particular cases of adverse reaction appearance, submitted by the registration action holder, character and number of serious adverse reactions and adverse reactions not registered by the company before;

15) assessment of source of origin (blood, human and animal organs, tissues) and specific activity for immunobiological product;

16) assessment of nutrient medium used for generation of viruses and bacteria and epidemiological efficiency for vaccines;

17) assessment of the stated amendments to the registration dossier;

18) recommendation to state registration/re-registration or amendments to the registration dossier during the marketing authorization validity or grounding of the necessity of the additional documents submission; or additional pre-clinical or clinical studies; or relevant recommendation on state registration/re-registration or amendments to the registration dossier rejection.

19. According to the results of medicinal products special pharmacological expertise the expert prepares conclusion in the form according to Annex 5 to the present Procedure.

The expert’s conclusion is examined during the pharmacological committee session.

 

 

7. Conclusion on Medicinal Product Safety, Efficiency and Quality

 

20. Based on the results of medicinal products primary, analytical and special pharmaceutical and pharmacological expertise the expert organization draws up medicinal product safety, efficiency and quality conclusion in the form according to Annex 6 to the present Procedure.



21. Conclusion on medicinal product safety, efficiency and quality is submitted to the governmental body for taking decision concerning medicinal product state registration, re-registration and amendments to the registration dossier or rejection. 

 

8. Medicinal Products Expertise Timing

 

22. Medicinal products expertise for Type I amendments to the registration dossier not requiring new registration is performed within the following periods:



1) primary expertise – not more than ten calendar days;

2) analytical expertise – not more than twenty-five calendar days;

3) special pharmaceutical expertise – not more than twenty calendar days;

4) special pharmacological expertise – not more than twenty calendar days;

5) execution of medicinal products safety, efficiency and quality conclusion and drafts of medicinal products expertise final documents – not more than fifteen calendar days;

23. Medicinal products expertise as well as expertise of Type II amendments to the registration dossier requiring new registration is performed within the period of not more than nine calendar months; re-registration expertise is carried out within the period of not more than four months; expertise of Type I amendments to the registration dossier is carried out within the period of not more than three calendar months.

24. Medicinal products expertise during state registration and Type II amendments requiring new registration is performed within the following periods:

1) primary expertise – not more than twenty calendar days;

2) analytical expertise – not more than fifty calendar days (for complicated method of analysis including medicinal immuno-biological product – not more than seventy calendar days);

3) special pharmaceutical expertise – not more than ninety calendar days;

4) special pharmacological expertise – not more than ninety calendar days;

5) execution of medicinal products safety, efficiency and quality conclusion and drafts of medicinal products expertise final documents – not more than twenty calendar days;

25. Medicinal products expertise for state re-registration is performed within the following periods:

1) primary expertise – not more than ten calendar days;

2) analytical expertise – not more than fourty calendar days (for complicated method of analysis including medical immunobiological product – not more than fifty calendar days);

3) special pharmaceutical expertise (including the expertise of standard technical document on medicinal product safety and quality control) – not more than twenty-five calendar days;

4) special pharmacological expertise – not more than twenty-five calendar days;

5) execution of medicinal products safety, efficiency and quality conclusion and drafts of medicinal products expertise final documents – not more than twenty calendar days;

26. Expedited procedure of state registration, re-registration includes all the stages of medicinal products expertise within the following periods:

1) primary expertise – not more than twenty calendar days;

2) analytical expertise up to forty calendar days (in complicated cases – up to fifty days);

3) special pharmaceutical expertise – not more than fifty calendar days;

4) special pharmacological expertise – not more than fifty calendar days;

5) execution of medicinal products safety, efficiency and quality conclusion and drafts of medicinal products expertise final documents – not more than twenty calendar days;

27. Medical products expertise performance periods do not include the period for addition of missing documents to the registration dossier, submission by the Applicant of documents reasonably requested by the expert commission, as well as the period of clinical and (or) bioequivalence studies

 

Annex 1

to the
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