ORDER of 04.01.2013 №3

26.09.2019 / Оновлено: 22.10.2019 5256

ORDER of 04.01.2013 №3 (Registered at the Ministry of Justice of Ukraine on March 15, 2013 under N 425/2295) On introduction of changes to the MoH Ukraine Order of August 26, 2005 № 426 and declaration as invalid of some MOH Ukraine Orders pertinent to registration of medicinal products

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

Annex 1

Application for State Registration of Medicinal Product

Annex 2

Application for state registration (re-registration) of medicinal product

Annex 3

Application for State Registration (Re-Registration) of API or Active Substance

Annex 4

Application for state re-registration of medicinal product

Annex 5

Structure of registration dossier (format of common technical document – CTD)

Annex 6

The list of documents required for conducting expert evaluation of materials
of registration dossier for state registration of API or active substance

Annex 7

List of documents for conducting expert evaluation of materials for state re-registration of medicinal product

Annex 8

List of documents for conducting expert evaluation of materials for state re-registration of traditional medicinal products and medicinal products produced according to the approved specifications

Annex 9

Structure of Registration Dossier (in format of four parts)

Annex 10

Structure of instructions for medical use of medicinal product/medicinal product (medical immunobiological product)

Annex 11

Materials of registration dossier submitted for expert evaluation of changes made in registration materials during the validity period of the registration certificate

Annex 12

Application for Introduction of Changes to Registration Materials for Medical Product (including medical immunobiological product)

Annex 13

Changes to instructions for medical use of medicinal product/medicinal product (medical immunobiological product)

Annex 14

Structure of summary of product characteristics for medicinal product/medicinal product (medical immunobiological product)

Annex 15

Letter

Annex 16

List of excipients to be obligatory specified on package and information about effect of these substances depending on the route of administration and contents of excipients to be stated in instructions for medical use of medicinal product

The Regulations on the Qualification Commission of the Ministry of Health of Ukraine

ORDER of 04.01.2013 №3

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