On November 29, 2019, a working meeting was held between the management of the State Expert Center of the Ministry of Health of Ukraine (DEC) and member companies of the Association of International Pharmaceutical Manufacturers (AIPM Ukraine).

The meeting was devoted to the discussion of topical issues regarding the interaction of the applicant companies and the SEP, primarily in the areas of examination of registration materials, compliance with the deadlines set by the law, cooperation with other regulatory and supervisory bodies, as well as updating the legal regulation of these areas in accordance with modern world practice.

Thus, the issue of the state of counseling of applicants was discussed, which is connected with the transition of the operation of the CHP to the “service center” model. It is noted that a large number of requests require the involvement of various units of the CHP, in order to provide the most balanced and constructive answer, which requires more time.

In addition, during the meeting, the participants touched upon issues of pharmacovigilance, in particular from the point of view of compliance with the latest practice of EU regulatory regulation.

Particular attention is paid to the gradual introduction of electronic means of communication, interaction and information exchange between the SEP, controlling bodies and applicants. The director of the SEP, Tetyana Dumenko,  reported on the status of the work on the creation of the “electronic cabinet of the applicant” (expected from 01.01.2020), the implementation of “validation blocks (forms)”, prospects for the development of the “electronic dossier” and their storage in the form of an electronic register. At the same time, it was noted that the construction of an electronic system based on the example of the EU requires a significant and systematic update of the legal framework.

A number of practical issues were also discussed during the meeting. We would like to emphasize that the experts of the SEP provided comprehensive and constructive answers to such questions of the applicants, some of them require clarification and will be further elaborated.

At the end of the meeting, the participants exchanged positions on the latest legislative initiatives aimed at changes in the system of protection of intellectual property rights in the pharmaceutical sphere and the possibility of introducing parallel import of medicines. In general, the participants agreed with the positivity of some proposals, in particular the implementation of the “Bolar exclusion”, which, however, require some refinement to ensure the legal application of such provisions by all market participants. Regarding parallel import, Tetyana Dumenko noted that the issues of the powers of the owners of registration certificates that have undergone the registration procedure, the entities that will be responsible for the drugs imported under such a procedure and some others, remain open, and it is also necessary to involve representatives of a number of other state regulators ( the State Accounting Service, the Ministry of Economy, the State Customs Service) to make the most balanced decision.

The Association of Representatives of International Pharmaceutical Manufacturers ( AIPM Ukraine) expresses its gratitude to the Head of the SEP Tetyana Dumenko , the Deputy Director of the SEP for registration Kostyantyn Kuzmenko, the heads of structural divisions and specialists of the SEP for a constructive dialogue on urgent issues, which contributes to further productive joint work on improving the provision of affordable and effective medicines, and hopes for its continuation.