The State Enterprise “State Expert Center of the Ministry of Health of Ukraine” (hereinafter – the Center) asks you to pay attention to the situation that has arisen with the editorial approval by applicants of draft documents, in particular, the instructions for medical use of a medicinal product and the summary of product characteristics (if available), quality control methods (QCMs), the text of the labeling of the primary and secondary (if available) packaging of the finished medicinal product, amendments to the QCMs and/or the instructions for medical use of a medicinal product and the summary of product characteristics (if available), before the lists of medicinal products proposed for state registration (re-registration) or for amendments to registration materials (hereinafter – the Lists) are drawn up.
Thus, in the second quarter of 2019, employees of the Department for Coordination of Expert Materials prepared and provided for editorial approval draft documents for more than 2 840 medicinal products, in 90% of which the Applicant made corrections. At the same time, corrections were made repeatedly in a significant number of documents, which required additional work by the Center that is not provided for by any regulatory legal act.
This situation has led to a significant workload for Center employees and, as a consequence, to delays in preparing draft documents for editorial approval by Applicants and to delays in the timelines for including medicinal products in the Lists.
It should be noted that the date of completion of the expert evaluation of the registration dossier materials, in accordance with paragraph 4 of Section VII of 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 order of 26.08.2005 No. 426 (as amended by MoH order of 23.07.2015 No. 460) (hereinafter – the Procedure), is considered to be the date on which the head of the Center signs the conclusions of the registration experts based on the results of the expert evaluation conducted, and discrepancies in the documents approved at registration are technical errors.
At the same time, it should be noted that during the editorial agreement by Applicants of draft documents, before the Lists are compiled, edits may be made only to draft registration certificates and/or inserts thereto, since all other edits fall under technical errors. Details on technical errors are set out in subparagraph 2.4. of paragraph 2 of Section VI of the Procedure.
