НАКАЗ МОЗ УКРАЇНИ 26.08.2005 № 426 (із змінами) Про затвердження Порядку проведення експертизи реєстраційних матеріалів на лікарські засоби, що подаються на державну реєстрацію (перереєстрацію), а також експертизи матеріалів про внесення змін до реєстраційних матеріалів протягом дії реєстраційного посвідчення
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 approved by MoH Order of 26.08.2005 № 426, registered at the Ministry of Justice of Ukraine on September 19, 2005 under N 1069/11349
Annex 1 REGISTRATION FORM for Medicinal Product Submitted for State Registration
Annex 2 REGISTRATION FORM for Homeopathic Medicinal Product Submitted for State Registration
Annex 3 REGISTRATION FORM for Medicinal Product Produced According to the Approved Specification Which is Submitted for State Registration
Annex 4 REGISTRATION FORM for Active Pharmaceutical Ingredient Which is Submitted for State Registration (Re-Registration)
Annex 5 STRUCTURE of Registration Dossier (Format of Common Technical Document – CTD)
Annex 6 General Requirements to the Materials of Registration Dossier (in Format of Common Technical Document)
Annex 7 Specific provisions applicable to homeopathic medicinal products and their registration dossier
Annex 8 Specific provisions applicable to medicinal products produced according to the approved specifications and to their registration dossier
Annex 9 Specific provisions applicable to medicinal products of limited use (orphan products) and to their registration dossier
Annex 10 PARTICULAR MEDICINAL PRODUCTS and special requirements related to their registration dossier
Annex 11 MEDICINAL PRODUCTS of gene and somatic cell therapy and tissue engineered products and specific requirements for their registration dossier
Annex 12 The List of documents required for conducting expert evaluation of registration materials for state registration of API
Annex 13 Criteria for referring the medicinal product for laboratory tests
Annex 14 REGISTRATION FORM for Medicinal Product Submitted for Re-Registration
Annex 15 LIST of documents submitted for re-registration of medicinal product
Annex 16 LIST OF DOCUMENTS submitted for re-registration of medicinal products produced according to the approved specifications
Annex 17 REQUIREMENTS TO DOCUMENTS submitted for expert evaluation at introduction of changes to registration materials during the validity period of the registration certificate
Annex 18 STRUCTURE of instructions for medical use of medicinal product
Annex 19 REQUIREMENTS for Instructions for medical use for medicinal product
Annex 20 STRUCTURE of summary of product characteristics for medicinal product
Annex 21 REQUIREMENTS for summary of product characteristics for medicinal product
Annex 22 REQUIREMENTS for package labelling for medicinal product
Annex 23 LIST of excipients to be obligatory specified on package and information to be stated in instructions for medical use of medicinal product
Annex 24 LETTER
Annex 25 REGISTRATION FORM for changes to registration materials pertinent to medicinal product
Annex 26 CHANGES to instructions for medical use of medicinal product
Annex 27 LIST of documents for expert evaluation of change in applicant (registration certificate holder)
Annex 28 CERTIFICATE OF COMPLIANCE FOR PLASMA MASTER FILE
Annex 29 Preclinical study report
Annex 30 Clinical study report
Annex 31 INFORMATION on completing the preclinical study (PS) report
