The Ministry of Justice of Ukraine has carried out the state registration of the MoH of Ukraine order approving Amendments to the Procedure for Conducting Expert Evaluation of Registration Materials for Medicinal Products (in particular, regarding the introduction of eCTD).
The Ministry of Health of Ukraine has issued order dated 13.10.2023 No. 1789 “On Approval of 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 of the Registration Certificate” (registered with the Ministry of Justice of Ukraine on 01.11.2023 under No.1897/40953).
This order approves Amendments to the Procedure of 26 August 2005 No. 426 (registered with the Ministry of Justice of Ukraine on 19 September 2005 under No. 1069/11349 (as amended by the order of the Ministry of Health of Ukraine of 23 July 2015 No. 460).
The main novelties of this regulatory legal act concern:
- specifying the necessary time frames for revising the dossier materials for amendments during preliminary expert evaluation;
- improving the procedure for conducting expert evaluation of materials on amendments to the registration dossier materials for a medicinal product;
- settling certain procedural issues of interaction between the Center and the applicant;
- implementation of eCTD in Ukraine in accordance with DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use and Volume 2B Notice to Applicants Medicinal products for human use Presentation and format of the dossier Common Technical Document (CTD), Guideline on the processing of renewals in the centralised procedure EMEA/CHMP/2990/00 Rev.5.
In accordance with the order, the Center must develop and submit to the MoH for approval:
- requirements for the specification and validation criteria of the electronic format of the common technical document (eCTD)
- validation of the eCTD interface's compliance with the specification requirements and validation criteria is ensured.
The order will enter into force on the day of its official publication. This is expected to occur at the end of December 2023.
We will provide additional notice after the official publication of the order.
You can read order No. 1789 and the changes at the link: https://moz.gov.ua/article/ministry-mandates/nakaz-moz-ukraini-vid-13102023–1789-pro-zatverdzhennja-zmin-do-porjadku-provedennja-ekspertizi-reestracijnih-materialiv-na-likarski-zasobi-scho-podajutsja-na-derzhavnu-reestraciju-perereestraciju-a-takozh-ekspertizi-materialiv-pro-vnesennja?preview=1
