Ministry of Health of Ukraine The State Expert Center
LAW OF UKRAINE "ON MEDICINES" ¹ 124/96-ÂÐ of 04.04.96 (às amended)
Decree of the Cabinet of Ministers of Ukraine of May 26, 2005 ¹ 376On Approval of the Procedure for State Registration (Re-registration) of Medicinal Products and Amounts of Fees for Their State Registration (Re-Registration) (Amended by the Decree of the Cabinet of Ministers ¹ 503 of March 21, 2007, ¹ 1277 of October 31, 2007, ¹ 372 of April 17, 2008)Procedure for State Registration (Re-registration) of Medicinal Products Amounts of Fees for State Registration (Re-Registration) of Medicinal Products
ORDER of the Ministry of Health of Ukraine of 26.08.2005 ¹426 (Registered with the Ministry of Justice of Ukraine on 19 September 2005 under ¹ 1069/11349) On Approval of Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products which are Submitted for State Registration (Re-Registration) and Expert Evaluation of Materials about Introduction of Changes to the Registration Documents during the Validity Period of Registration Certificate Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products, which are Submitted for State Registration (Re-Registration) and Expert Evaluation of Materials about Introduction of Changes to the Registration Documents during the Validity Period of Registration Certificate (As amended by MoH Ukraine Orders as of 01.03.2006 ¹ 95, 11.09.2007 ¹ 536, 25.09.2008 ¹543) Annex 1 to Item 3.2 of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-Registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration Certificate (Annex in wording of MoH Ukraine Orders as of 11.09.2007 ¹536, 25.09.2008 ¹543)APPLICATION FOR CONDUCTING EXPERT EVALUATION OF MATERIALS PERTINENT TO MEDICINAL PRODUCTS SUBMITTED FOR THE STATE REGISTRATION (RE-REGISTRATION) AND FOR EXPERT EVALUATION OF MATERIALS ABOUT INTRODUCTION OF CHANGES TO REGISTRATION DOCUMENTS DURING VALIDITY PERIOD OF REGISTRATION CERTIFICATE Annex 2 to item 6.8 of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-Registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration CertificateStructure of Registration Dossier Annex 3 to Item 6.8 of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration CertifcateStructure of registration dossier (format of common technical document – CTD) Annex 4 to item 6.1of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products which are Submitted for State Registration (Re-registration) and Expert Evaluation of Materials about Introduction of Changes to the Registration Documents during the Validity Period of the Registration CertificateAnalytical, pharmaco-toxicological and clinical standards and protocols related to trials of medicinal products Annex 5 to Item 4.1 of the Procedure for Expert Evaluation of Materials Related to Medicinal Products Submitted for the State Registration (Re-registration) and Expert Evaluation of Materials Related to Changes Introduced to the Registration Materials during the Validity Period of the Registration Certificate (Annex 5 in wording of MoH Ukraine Order as of 01.03.2006 ¹ 95, amended by MoH Ukraine Order as of 11.09.2007 ¹ 536) REQUIREMENTS TO DOCUMENTS SUBMITTED FOR EXPERT EVALUATION OF TYPE I CHANGES MADE IN REGISTRATION MATERIALS DURING THE VALIDITY PERIOD OF THE REGISTRATION CERTIFICATE Annex 6 to Item 4.1 of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration Certificate (Annex 6 in wording of MoH Ukraine Order as of 01.03.2006 ¹ 95)CHANGES REQUIRING NEW REGISTRATION OF MEDICINAL PRODUCT Annex 7 to Item 4.3 of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during the Validity Period of Registration Certificate (in the wording of MoH Ukraine Order as of 11.09.2007 ¹536)APPLICATION for Conducting Expert Evaluation of Materials about Introduction of Changes to Registration Documents for Medical Product Annex 8 to Item 6.1 (j) of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration CertificatePackage leaflet for prescription only medicinal product or medicinal product, used in hospitals and summary of product characteristics Annex 9 to item 6.1 (i) of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products, which are Submitted for State Registration (Re-Registration) and Expert Evaluation of Materials about Introduction of Changes to the Registration Documents during the Validity Period of Registration Certificate (in wording of MoH Ukraine Order as of 11.09.2007 ¹ 536)Requirements to package labelling Annex 10 to Item 6.1 (j) of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration CertificateThe package leaflet for OTC medicinal product Annex 11 to Item 6.3 (v) of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration Certificate (Annex 11 amended by MoH Ukraine Order as of 11.09.2007 ¹ 536)THE REQUIREMENTS TO THE HOMEOPATHIC MEDICINAL PRODUCTS, WHICH REGISTRATION MATERIALS MAY NOT HAVE SCIENTIFIC CLINICAL DATA, AND DATA LEVEL REQUIRED FOR THEIR QUALITY ASSESSMENT Annex 12 to Item 6.3 (c) of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration Certificate (Annex 12 amended by MoH Ukraine Order as of 11.09.2007 ¹ 536)THE REQUIREMENTS, WHICH THE TRADITIONAL HERBAL MEDICINAL PRODUCTS SHALL MEET, AND SPECIFICATIONS OF THE RELATED REGISTRATION MATERIALS Annex 13 to Item 6.3 of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration Certificate (Annex 13 amended by MoH Ukraine Order as of 11.09.2007 ¹ 536)THE LIST OF DOCUMENTS REQUIRED FOR CONDUCTING EXPERT EVALUATION OF MATERIALS PERTINENT TO THE STATE REGISTRATION OF THE ACTIVE SUBSTANCE Annex 14 to Item 3.3 of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration CertificateApplication for state re-registration of medicinal product Annex 15 to Item 6.10 of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during the Validity Period of Registration Certificate (in wording of MoH Ukraine Order as of 11.09.2007 ¹ 536)LIST of documents for conducting expert evaluation of materials for the state re-registration of medicinal product Annex 16 to Item 3.3 of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration CertificateApplication for state registration (re-registration) of active substances Annex 17 to Item 3.3 of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration Certificate (Annex 17 is added to the Procedure añcording to MoH Ukraine Order as of 01.03.2006 ¹ 95, annex 17 amended by MoH Ukraine Order as of 11.09.2007 ¹ 536)APPLICATION FOR CONDUCTING EXPERT EVALUATION OF MATERIALS PERTINENT TO MEDICINAL PRODUCT SUBMITTED FOR STATE REGISTRATION (RE-REGISTRATION) Annex 18 to Item 6.1 of the Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during the Validity Period of Registration Certificate (in wording of MoH Ukraine Order as of 11.09.2007 ¹ 536)LETTER OF GUARANTEE
ORDER MoH Ukraine of 17.03.2010 ¹ 236 On approval of the Procedure for inspecting manufacturing site for medicinal products submitted for state registration Registered with the Ministry of Justice of Ukraine 13 May 2010, ¹ 323/17618 PROCEDURE for inspecting manufacturing site for medicinal products submitted for state registration
ORDER MoH Ukraine of 26.01.2010 ¹ 55 About Approval of Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products of Limited Use which are Submitted for State Registration (Re-registration) Registered with the Ministry of Justice of Ukraine as of 13.02.2010 under ¹ 156/17451 PROCEDURE for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products of Limited Use which are Submitted for Sate Registration (Re-registration)
ORDER MoH Ukraine of 14.12.2009 ¹ 944 About Approval of Procedure for Conducting Pre-clinical Studies of Medicinal Products and Expert Evaluation of Materials Pertinent to Pre-clinical Studies of Medicinal Products Registered with the Ministry of Justice of Ukraine as of 19.01.2010 under ¹ 53/17348 PROCEDURE FOR CONDUCTING PRE-CLINICAL STUDIES OF MEDICINAL PRODUCTS AND EXPERT EVALUATION OF MATERIALS PERTINENT TO PRE-CLINICAL STUDIES OF MEDICINAL PRODUCTS) Annex 1 to the procedure for conducting pre-clinical study of medicinal products and expert evaluation of materials pertinent to pre-clinical study of medicinal products STRUCTURE OF REPORT ABOUT PRE-CLINICAL STUDY OF MEDICINAL PRODUCT Annex 2 to the procedure for conducting pre-clinical study of medicinal products and expert evaluation of materials pertinent to pre-clinical study of medicinal products STURCTURE OF PROTOCOL (PLAN) OF PRE-CLINICAL STUDY OF MEDICINAL PRODUCT Annex 3 to the procedure for conducting pre-clinical study of medicinal products and expert evaluation of materials pertinent to pre-clinical study of medicinal products AMENDMENT TO PROTOCOL (PLAN) OF PRE-CLINICAL STUDYAnnex 4 to the procedure for conducting pre-clinical study of medicinal products and expert evaluation of materials pertinent to pre-clinical study of medicinal products DEVIATION FROM PROTOCOL (PLAN) OF PRE-CLINICAL STUDYAnnex 5 to the procedure for conducting pre-clinical study of medicinal products and expert evaluation of materials pertinent to pre-clinical study of medicinal products TEMPLATE CORRECTION/ADDITION TO THE REPORT OF PRE-CLINICAL STUDYORDER MoH Ukraine of 23.09.2009 ¹ 690 About Approval of Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committees Registered at the Ministry of Justice of Ukraine on 29.10.2009 under ¹ 1010/17026 PROCEDURE FOR CONDUCTING CLINICAL TRIALS OF MEDICINAL PRODUCTS AND EXPERT EVALUATION OF MATERIALS PERTINENT TO CLINICAL TRIALS Annex 1 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical TrialsLIST OF MAIN DOCUMENTS PERTINENT TO CLINICAL TRIAL THAT ARE TO BE STORED AT HEALTH CARE SETTING (HCS)/CLINICAL TRIAL SITE AND SPONSOR Annex 2 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical TrialsCOVER LETTERTo the application for getting conclusion of the State Pharmacological Center MoH Ukraine about clinical trial of medicinal productTo the application for getting approval of the Central Ethics Committee MoH Ukraine pertinent to the clinical trial of medicinal product Annex 3 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical TrialsAPPLICATION FORMREQUEST FOR GETTING CONCLUSION OF THE STATE PHARMACOLOGICAL CENTER MOH UKRAINE/APPROVAL OF THE CENTRAL ETHICS COMMITTEE PERTINENT TO CONDUCTING CLINICAL TRIAL OF MEDICINAL PRODUCT Annex 4 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials COMPLETE DOSSIER OF INVESTIGATIONAL MEDICINAL PRODUCT Annex 5 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials TEMPLATEAPPLICATION OF PRINCIPAL INVESTIGATOR Annex 6 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials INFORMATION ABOUT SPECIALIZED HEALTH CARE SETTING (HEREINAFTER - HCS) AND CLINICAL TRIAL SITE Annex 7 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical TrialsNOTIFICATION ABOUT THE START OF CLINICAL TRIAL IN UKRAINE Annex 8 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical TrialsLIST OF ASPECTS OF CLINICAL TRIAL WHICH MAY BE AMENDED SIGNIFICANTLY BY SPONSOR Annex 9 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials COVER LETTERTo the application for getting conclusion of the State Pharmacological Center MoH Ukraine regarding significant amendments to materials pertinent to clinical trialTo the application for approval of the Central Ethics Committee MoH Ukraine regarding significant amendments to materials pertinent to clinical trial Annex 10 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical TrialsAPPLICATION FORM REQUEST FOR CONCLUSION OF THE STATE PHARMACOLOGICAL CENTER MOH UKRAINE AND FOR APPROVAL OF THE CENTRAL ETHICS COMMITTEE MOH UKRAINE PERTINENT TO SIGNIFICANT AMENDMENT TO CLINICAL TRIAL DOCUMENTS Annex 11 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical TrialsNOTIFICATION ABOUT COMPLETION OF CLINICAL TRIAL Annex 12 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials PERIODICAL REPORT ON STATUS OF CLINICAL TRIAL IN UKRAINE Annex 13 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials FORMAT OF FINAL CLINICAL TRIAL REPORT Annex 14 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical TrialsREQUIREMENTS TO NOTIFICATION ABOUT SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTION Annex 15 to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical TrialsREQUIREMENTS TO PERIODICAL SAFETY UPDATE REPORT ABOUT INVESTIGATIONAL MEDICINAL PRODUCT MODEL REGULATIONS OF THE ETHICS COMMITTEES
ORDER of the Ministry of Health of Ukraine of 17.04.2007 ¹190 (Registered with the Ministry of Justice of Ukraine under ¹949/14216 on 17 August, 2007) On approval of the Procedure for conducting additional studies of medicinal products during expert evaluation of registration materials
ORDER of the Ministry of Health of Ukraine of 27.12.2006 ¹ 898 About Approval of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical UseAnnex 1 to item 5.1 of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — REPORT FORM ON ADVERSE REACTION OR LACK OF EFFICACY OF MEDICINAL PRODUCT AT MEDICAL USE (to be filled by physician) Annex 2 to Item 5.2 of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — REQUIREMENTS TO COMPLETION OF REPORT FORM ON ADVERSE REACTION OR LACK OF EFFICACY OF MEDICINAL PRODUCT AT MEDICAL USE (to be completed by doctor) Annex 3 to item 6.1 of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — REPORT ON ADVERSE REACTIONS AT MEDICAL USE OF MEDICINAL PRODUCTS AT HEALTH CARE SETTINGS during 20_ Annex 4 to Item 6.2 of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — REQUIREMENTS FOR DRAWING UP A REPORT ON ADVERSE REACTIONS AT MEDICAL USE OF MEDICINAL PRODUCTS IN HEALTH CARE SETTINGS Annex 5 to sub-item 7.1.1. of item 7.1. of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — CASE REPORT ON ADVERSE REACTION OR LACK OF EFFICACY OF MEDICIANL PRODUCT AT MEDICAL USE (to be filled by manufacturer/ applicant (or his representative) Annex 6 to sub-item 7.1.1 of Item 7.1 of the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — REQUIREMENTS FOR DRAWING UP A CASE REPORT ON ADVERSE REACTION OR LACK OF EFFICACY OF MEDICINAL PRODUCTS AT MEDICAL USE (to be completed by manufacturer/applicant (or his representative) Annex 7 to item 7.2. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — STRUCTURE OF PERIODIC SAFETY UPDATED REPORT OF MEDICINAL PRODUCT PERMITTED FOR MEDICLA USE Annex 8 to item 7.5. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — FORM FOR SUBMITTING BY MANUFACTURER/APPLICANT (OR HIS REPRESENTATIVE) OF SUMMARY DATA ABOUT SAFETY OF MEDICINAL PRODUCT IN UKRAINE DURING THE VALIDITY PERIOD OF THE MOST RECENT REGISTRATION CERTIFICATE Annex 9 to sub-item 8.3.1. of item 8.3. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — STRUCTURE OF THE PROTOCOL OF SAFETY STUDY OF MEDICIANL PRODUCT PERMITTED FOR MEDICAL USE Annex 10 to sub-item 8.3.3. of item 8.3. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — NOTIFICATION ABOUT STARTING SAFETY STUDY OF MEDICINAL PRODUCT PERMITTED FOR MEDICAL USE Annex 11 to sub-item 8.3.6. of item 8.3. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — NOTIFICATION ABOUT THE END OR SUSPENSION OF SAFETY STUDY OF MEDICIANL PRODUCT PERMITTED FOR MEDICAL USE Annex 12 to sub-item 8.3.8. of item 8.3. of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use — STRUCTURE OF REPORT ON SAFETY STUDY OF MEDICIANL PRODUCT PERMITTED FOR MEDICAL USE
ORDER of the Ministry of Health of Ukraine of 20.07.2006 ¹500 On Approval of Lists of terms for pharmaceutical dosage forms and packages for medicinal products
Annex approved by the Order of Director, Public Enterprise "State Pharmacological Center" MoH Ukraine ¹ 32 of April 24, 2008 COST OF WORK for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-Registration) and for Expert Evaluation of Materials about Introduction of Changes to Registration Documents during Validity Period of Registration Certificate
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