On 15.04.2015 the Order of the Ministry of the Healthcare of Ukraine N 220 “On cooperation between the Ministry of the Healthcare of Ukraine and the State Expert Center of Ukraine” (hereafter referred to as “the Order N 220”) came into effect.
The Order N 220 sets new rules of the cooperation between the Ministry of the Healthcare of Ukraine and the State Expert Center of Ukraine, for example:
Unlike previous legal acts, the rules set by the Order N 220 establish the clear system of document flow between the Ministry of the Healthcare of Ukraine and the State Expert Center of Ukraine, as well as deadlines for document analyzing and adoption of relevant decisions.
Thus, the Rules concerning elaboration of orders on the state registration set the term for submission of the application on the state registration to the State Expert Center of Ukraine, specify the date of submission of the application, the date of expertise begging, the term for drafting the order on the state registration, the term for submission of the order copy from the Ministry of the Healthcare of Ukraine to the State Expert Center of Ukraine, in addition, the term of the notification about decision made and the submission of documents for signature by the Head of the Department of the pharmaceutical activity and quality of pharmaceutical products of Ministry of the Healthcare of Ukraine (hereafter referred to as “the Department”) was shortened to 3 days, but the term of signature the registration certificate by the Head of the Department was increased for 1 day.
It should be noted, that the new Rules concerning elaboration of orders on the state registration rectify omissions of previous act, in particular: it sets the requirement to submit both the application on the state registration and registration materials as it established by the Order on the state registration (re-registration) of medicinal products, set by the Decree of the Cabinet of the Ministers of Ukraine, dated 26.05.2005 N 376 and the Order of expertise, set by the Order of the Ministry of the Healthcare of Ukraine, dated 26.08.2005 N 426.
Moreover, mentioned document does not have such principal defects as previous act, which provided that if there are some remarks after the expertise of registration materials and receiving of relevant documents from the State Expert Center, the Department submits these remarks to the State Expert Center in the written form or elaborate the refusal on the state registration (re-registration), changing of registration materials.
We emphasize that this provision generated corruption risks and background for illegal abusing. The Department does not have experts on registration issues and cannot have such specialists, because the Department does not have powers to provide expertise of registration materials. Consequently, the exclusion of such provision is an absolute achievement.
The Rules concerning elaboration of decisions on the clinical trials is more progressive than previous act. For example, it entirely describes the full chain of consideration of the application on clinical trial or on the approval of the substantive amendment by the Ministry of the Healthcare of Ukraine and the State Expert Center of Ukraine, sets the system of cooperation between the Ministry of the Healthcare of Ukraine and the State Expert Center of Ukraine at the each stage and sets deadlines for mentioned stages.
Thus, in spite of the fact that the procedure of the state registration and clinical trials is regulated by certain orders, established by the Decrees of the Cabinet of Ministers of Ukraine, the direct cooperation between the Ministry of the Healthcare of Ukraine, represented by the Department, and the State Expert Center of Ukraine within the frame of these procedures is still out of action of these orders. Consequently, due to the absence of the order of cooperation between mentioned authorities and the terms for adoption of relevant decisions the risk of abusing of power existed. In addition, the adoption of Rules allows to make clear the cooperation procedure between the Ministry of the Healthcare of Ukraine, represented by the Department, and the State Expert Center of Ukraine and to minimize the risk of corruption scheme appearance.
It should be reminded that the Order of the Ministry of the Healthcare of Ukraine “On the cooperation between the Department of the development of the pharmacy of the Ministry of the Healthcare of Ukraine and PC “The State Expert Center of the Ministry of the Healthcare of Ukraine”, dated 09.02.2012 N 98, has become inoperative after the adoption of the Order N 220.
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