ORDER 26.08.2005 № 426 (460)

26.09.2019 / Оновлено: 27.10.2020 19964

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}

Annex 1

REGISTRATION FORM for Medicinal Product Submitted for State Registration

Annex 2

REGISTRATION FORM for Homeopathic Medicinal Product Submitted for State Registrationt

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 specifications

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