ORDER 26.08.2005 № 426 (460)

ORDER 26.08.2005 № 426 (Registered at the Ministry of Justice of Ukraine on September 19, 2005 under N 1069/11349) On approval of the Procedure for Conducting Expert Evaluation of Registration 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 Materials during the Validity Period of Registration Certificate
{Amended by MoH Ukraine Orders № 95 of 01.03.2006 № 536 of 11.09.2007 № 543 of 25.09.2008 № 3 of 04.01.2013 № 470 of 07.07.2014 № 566 of 11.08.2014 № 460 of 23.07.2015}

REGISTRATION FORM for Medicinal Product Submitted for State Registration
REGISTRATION FORM for Homeopathic Medicinal Product Submitted for State Registrationt
REGISTRATION FORM for Medicinal Product Produced According to the Approved Specification Which is Submitted for State Registration
REGISTRATION FORM for Active Pharmaceutical Ingredient Which is Submitted for State Registration (Re-Registration)
Structure of Registration Dossier (Format of Common Technical Document – CTD)
General Requirements to the Materials of Registration Dossier (in Format of Common Technical Document)
SPECIFIC PROVISIONS applicable to homeopathic medicinal products and their registration dossier
SPECIFIC PROVISIONS applicable to medicinal products produced according to the approved specifications and to their registration dossier
SPECIFIC PROVISIONS applicable to medicinal products of limited use (orphan products) and to their registration dossier
PARTICULAR MEDICINAL PRODUCTS and special requirements related to their registration dossier specifications
MEDICINAL PRODUCTS of gene and somatic cell therapy and tissue engineered products and specific requirements for their registration dossier
THE LIST OF DOCUMENTS REQUIRED FOR CONDUCTING EXPERT EVALUATION OF REGISTRATION MATERIALS FOR STATE REGISTRATION OF API
Criteria for referring the medicinal product for laboratory tests
REGISTRATION FORM for Medicinal Product Submitted for Re-Registration
LIST of documents submitted for re-registration of medicinal product
LIST OF DOCUMENTS submitted for re-registration of medicinal products produced according to the approved specifications
REQUIREMENTS TO DOCUMENTS submitted for expert evaluation at introduction of changes to registration materials during the validity period of the registration certificate
ESTABLISHING equivalence of generic medicinal products
STRUCTURE of instructions for medical use of medicinal product
REQUIREMENTS for Instructions for medical use for medicinal product
STRUCTURE of summary of product characteristics for medicinal product
REQUIREMENTS for summary of product characteristics for medicinal product
REQUIREMENTS for package labelling for medicinal product
LIST of excipients to be obligatory specified on package and information to be stated in instructions for medical use of medicinal product
Letter (item 3 of section V of the Procedure)
REGISTRATION FORM for changes to registration materials pertinent to medicinal product
CHANGES to instructions for medical use of medicinal product
LIST of documents for expert evaluation of change in applicant (registration certificate holder)