Professional development Vacancies

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE 26.08.2005 No. 426 (as amended) On Approval of the Procedure for Conducting Expert Evaluation of Registration Materials for Medicinal Products Submitted for State Registration (Re-registration), as well as Expert Evaluation of Materials on Amendments to Registration Materials during the Validity of the Registration Certificate

06.05.2021 Updated 17.09.2021 20468 views

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 1069/11349DOCX · 87 KB · 22.10.2026

Annex 1 REGISTRATION FORM for Medicinal Product Submitted for State RegistrationDOCX · 73 KB · 22.10.2026

Annex 2 REGISTRATION FORM for Homeopathic Medicinal Product Submitted for State RegistrationDOCX · 48 KB · 22.10.2026

Annex 3 REGISTRATION FORM for Medicinal Product Produced According to the Approved Specification Which is Submitted for State RegistrationDOCX · 29 KB · 22.10.2026

Annex 4 REGISTRATION FORM for Active Pharmaceutical Ingredient Which is Submitted for State Registration (Re-Registration)DOCX · 30 KB · 22.10.2026

Annex 5 STRUCTURE of Registration Dossier (Format of Common Technical Document – CTD)DOCX · 18 KB · 22.10.2026

Annex 6 General Requirements to the Materials of Registration Dossier (in Format of Common Technical Document)DOCX · 74 KB · 22.10.2026

Annex 7 Specific provisions applicable to homeopathic medicinal products and their registration dossierDOCX · 17 KB · 22.10.2026

Annex 8 Specific provisions applicable to medicinal products produced according to the approved specifications and to their registration dossierDOCX · 16 KB · 22.10.2026

Annex 9 Specific provisions applicable to medicinal products of limited use (orphan products) and to their registration dossierDOCX · 16 KB · 22.10.2026

Annex 10 PARTICULAR MEDICINAL PRODUCTS and special requirements related to their registration dossierDOCX · 33 KB · 22.10.2026

Annex 11 MEDICINAL PRODUCTS of gene and somatic cell therapy and tissue engineered products and specific requirements for their registration dossierDOCX · 34 KB · 22.10.2026

Annex 12 The List of documents required for conducting expert evaluation of registration materials for state registration of APIDOCX · 15 KB · 22.10.2026

Annex 13 Criteria for referring the medicinal product for laboratory testsDOCX · 18 KB · 22.10.2026

Annex 14 REGISTRATION FORM for Medicinal Product Submitted for Re-RegistrationDOCX · 30 KB · 22.10.2026

Annex 15 LIST of documents submitted for re-registration of medicinal productDOCX · 24 KB · 22.10.2026

Annex 16 LIST OF DOCUMENTS submitted for re-registration of medicinal products produced according to the approved specificationsDOCX · 14 KB · 22.10.2026

Annex 17 REQUIREMENTS TO DOCUMENTS submitted for expert evaluation at introduction of changes to registration materials during the validity period of the registration certificateDOCX · 129 KB · 22.10.2026

Annex 18 STRUCTURE of instructions for medical use of medicinal productDOCX · 16 KB · 22.10.2026

Annex 19 REQUIREMENTS for Instructions for medical use for medicinal productDOCX · 19 KB · 22.10.2026

Annex 20 STRUCTURE of summary of product characteristics for medicinal productDOCX · 15 KB · 22.10.2026

Annex 21 REQUIREMENTS for summary of product characteristics for medicinal productDOCX · 19 KB · 22.10.2026

Annex 22 REQUIREMENTS for package labelling for medicinal productDOCX · 21 KB · 22.10.2026

Annex 23 LIST of excipients to be obligatory specified on package and information to be stated in instructions for medical use of medicinal productDOCX · 28 KB · 22.10.2026

Annex 24 LETTERDOCX · 17 KB · 22.10.2026

Annex 25 REGISTRATION FORM for changes to registration materials pertinent to medicinal productDOCX · 84 KB · 22.10.2026

Annex 26 CHANGES to instructions for medical use of medicinal productDOCX · 14 KB · 22.10.2026

Annex 27 LIST of documents for expert evaluation of change in applicant (registration certificate holder)DOCX · 19 KB · 22.10.2026

Annex 28 CERTIFICATE OF COMPLIANCE FOR PLASMA MASTER FILEDOCX · 14 KB · 22.10.2026

Annex 29 Preclinical study reportDOCX · 16 KB · 22.10.2026

Annex 30 Clinical study reportDOCX · 16 KB · 22.10.2026

Annex 31 INFORMATION on completing the preclinical study (PS) reportDOCX · 19 KB · 22.10.2026

Annex 32 INFORMATION on completing the clinical trial (CT) reportDOCX · 17 KB · 22.10.2026