In order to eliminate the conflict of norms regulating procedures related to the expert evaluation of registration dossier materials for medicinal products submitted for re-registration, in terms of determining the timelines for the expert evaluation of registration dossier materials, the State Expert Center of the MoH, guided by the Procedure for State Registration (Re-registration) of Medicinal Products, approved by Resolution of the Cabinet of Ministers of Ukraine of 26.05.2005 No. 376, proposes to introduce the following amendments to the Procedure for Conducting Expert Evaluation of Registration Materials for Medicinal Products Submitted for State Registration (Re-registration), and Expert Evaluation of Materials on Amendments to Registration Materials during the Validity Period of the Registration Certificate, approved by MoH of Ukraine order of August 26, 2005 No. 426 (as amended by MoH of Ukraine order of July 23, 2015 No. 460):
- In the second paragraph of item 11 of section IV, replace the words and figures “3 months” with the words and figures “10 calendar days”.
- In paragraph 2 of section VII, replace the figures and words “90 working days” with the figures and words “80 calendar days”.
- Paragraph two of subparagraph 1.8.2 of paragraph 1.8 of Section 1 of Annex 6 to be worded as follows:
“when registering any medicinal product, except generic medicinal products where the original is registered in Ukraine, and traditional and homeopathic medicinal products registered under a simplified procedure;”.
- In paragraph 5.5 of section 5 of Annex 14, the words and signs “, or a letter of guarantee from the applicant to provide such a document within the period of the specialized expert evaluation” shall be deleted.
