1. Order of Ministry of Health of Ukraine № 426 dated August 26, 2005 "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".

1.1. Annex 1 to Item 3.2 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.
1.2. Annex 2 to Item 6.5 Structure of Registration Dossier
1.3. Annex 3 to Item 6.5 Structure of Registration Dossier (format of common technical document - CTD)
1.4. Annex 4 to Item 3.10 Analytical, pharmaco-toxicological and clinical standards and protocols related to trials of medicinal products.
1.5. Annex 5 to Item 4.1 List of type I variations/conditions to be fulfilled
1.6. Annex 6 to Item 4.1 Changes resulting in an extension of application
1.7. Annex 7 to Item 4.3 Application for Conducting Expert Evaluation of Materials about Introduction of Changes to Registration Documents for Medical Product
1.8. Annex 8 to Item 6.1 (j) Package leaflet for prescription only medicinal product or medicinal product, used in hospitals and summary of product characteristics
1.9. Annex 9 to the Item 6.1 (j) Requirements for package labelling
1.10. Annex 10 to Item 6.1 (j) The package leaflet for OTC medicinal product
1.11. Annex 11 to Item 6.3 (v) The requirements to the homeopathic medicinal products, which registration materials may not have scientific clinical data, and data level required for their quality assessment.
1.12. Annex 12 to Item 6.3 (c) The requirements, which the traditional herbal medicinal products shall meet, and specifications of the related registration materials
1.13. Annex 13 to Item 6.3 The list of documents required for conducting expert evaluation of materials pertinent to the state registration of the active substance
1.14. Annex 14 to Item 3.2 Application for State Re-registration of Medicinal Product
1.15. Annex 15 to Item 6.3 The list of documents for conducting expert evaluation of materials for the state re-registration of the medicinal product
1.16. Annex 16 to Item 3.2 Application for conducting expert evaluation of materials pertinent to the state registration of the active substances

2. Decree of Cabinet of Ministers of Ukraine № 376 dated May 26, 2005 "On Approval of the Procedure for State Registration (Re-registration) of Medicinal Products and Amounts of Fees for Their State Registration (Re-Registration)"