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Registration of Finished Products, of API

LAW OF UKRAINE “ON MEDICINES” № 124/96-ВР of 04.04.96 (аs amended)

Decree of the Cabinet of Ministers of Ukraine of May 26, 2005 № 376
On 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 № 503 of March 21, 2007, № 1277 of October 31, 2007, № 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 №426 (Registered with the Ministry of Justice of Ukraine on 19 September 2005 under № 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 № 95, 11.09.2007 № 536, 25.09.2008 №543)

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 №536, 25.09.2008 №543)
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 Certificate
Structure 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 Certifcate
Structure 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 Certificate
Analytical, 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 № 95, amended by MoH Ukraine Order as of 11.09.2007 № 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 № 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 №536)
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 Certificate
Package 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  № 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 Certificate
The 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 № 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 № 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 № 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 Certificate
Application 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 № 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 Certificate
Application 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 aсcording to MoH Ukraine Order as of 01.03.2006
№ 95, annex 17 amended by MoH Ukraine Order as of 11.09.2007 № 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 № 536)
LETTER OF GUARANTEE

ORDER MoH Ukraine of 23.09.2009 № 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 № 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 Trials
LIST 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 Trials
COVER LETTER
To the application for getting conclusion of the State Pharmacological Center MoH Ukraine about clinical trial of medicinal product
To 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 Trials
APPLICATION FORM
REQUEST 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
TEMPLATE
APPLICATION 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 Trials
NOTIFICATION 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 Trials
LIST 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 LETTER
To the application for getting conclusion of the State Pharmacological Center MoH Ukraine regarding significant amendments to materials pertinent to clinical trial
To 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 Trials
APPLICATION 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 Trials
NOTIFICATION 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 Trials
REQUIREMENTS 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 Trials
REQUIREMENTS 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 №190 (Registered with the Ministry of Justice of Ukraine under №949/14216 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 № 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 Use

Annex 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 №500 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 № 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