Legislation

Verkhovna Rada of Ukraine

Government Pornal

State Expert Centre

Registration of Finished 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

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

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

 

 

 

 
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