{"id":789724,"date":"2026-11-10T10:14:45","date_gmt":"2026-11-10T08:14:45","guid":{"rendered":"https:\/\/eba.com.ua\/?p=789724"},"modified":"2026-11-10T10:28:08","modified_gmt":"2026-11-10T08:28:08","slug":"ua-taryfy-na-poslugy-ukrfarmagentstva-mayut-vidpovidaty-zakonu-ta-buty-ekonomichno-obgruntovanymy-eva","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/ua-taryfy-na-poslugy-ukrfarmagentstva-mayut-vidpovidaty-zakonu-ta-buty-ekonomichno-obgruntovanymy-eva\/","title":{"rendered":"[:ua]\u0422\u0430\u0440\u0438\u0444\u0438 \u043d\u0430 \u043f\u043e\u0441\u043b\u0443\u0433\u0438 \u0423\u043a\u0440\u0444\u0430\u0440\u043c\u0430\u0433\u0435\u043d\u0442\u0441\u0442\u0432\u0430 \u043c\u0430\u044e\u0442\u044c \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u0430\u0442\u0438 \u0417\u0430\u043a\u043e\u043d\u0443 \u0442\u0430 \u0431\u0443\u0442\u0438 \u0435\u043a\u043e\u043d\u043e\u043c\u0456\u0447\u043d\u043e \u043e\u0431\u0491\u0440\u0443\u043d\u0442\u043e\u0432\u0430\u043d\u0438\u043c\u0438 – \u0415\u0412\u0410[:en]The tariffs for services provided by the Ukrainian Pharmaceutical Agency must comply with the Law and be economically justified \u2013 EBA[:]"},"content":{"rendered":"

<\/p>\n

Member companies of the European Business Association call for substantial revisions to the draft Resolution of the Cabinet of Ministers of Ukraine on Paid Services Provided by the Ukrainian Pharmaceutical Agency, published by the Ministry of Health<\/a>, and do not support its adoption in the proposed version.<\/p>\n

The business community supports ensuring adequate funding for the new pharmaceutical regulator. However, it points out that the proposed fees are significantly higher than those in reference countries, while the mechanisms for setting them and financing expert assessments need to be revised.<\/strong><\/p>\n

In particular, the proposed fee-setting mechanism needs to be aligned with the provisions of Law of Ukraine No. 2469-IX \u201cOn Medicinal Products\u201d<\/strong>. The Law assigns the authority to set the relevant fees to the Cabinet of Ministers of Ukraine, whereas the draft Resolution provides for the Government to approve only maximum fee amounts, leaving the Ukrainian Pharmaceutical Agency responsible for determining the actual fees.<\/p>\n

Furthermore, the Association emphasises the need to introduce a single fee for each regulatory service<\/strong>, covering all necessary expert assessments without additional payments by applicants. The Ukrainian Pharmaceutical Agency should be responsible for settling payments with the institutions involved, as well as for ensuring the timelines and quality of service delivery.<\/p>\n

The relationship between service fees, annual contributions, charges and budget funding also requires separate regulation. Despite the publication of the draft Resolution on contributions and charges<\/a>, a comprehensive picture of the Ukrainian Pharmaceutical Agency’s funding requires greater transparency. Both draft Resolutions should be considered in conjunction with the Agency’s budget funding. It is important to clearly distinguish which costs will be covered by regular contributions and charges and which will be covered by payments for individual services, in order to avoid charging twice for the same work. Without such a distinction, it is impossible to properly assess the overall financial burden on market participants.<\/p>\n

A key concern is the lack of transparency in the economic justification of the proposed fees.<\/strong> The published materials do not contain sufficiently detailed calculations of the components of service costs, the scope and complexity of the work, or the expenses taken into account. This prevents companies from properly assessing whether the proposed amounts are justified.<\/p>\n

At the same time, a comparison with European reference countries has revealed that the proposed maximum fees in Ukraine significantly exceed the calculated international benchmarks for a number of procedures. The business community believes that both the fee-setting procedure and the amounts themselves need to be revised.<\/p>\n

To assess the proposed maximum fees, the Association analysed publicly available data from the official websites of regulatory authorities and legislative acts in eight reference countries designated by Cabinet of Ministers of Ukraine Resolution No. 439. This list is already used by the state for medicinal product price regulation, and the Association proposes applying a similar approach to determining the cost of regulatory services. The comparison includes Poland, Slovakia, the Czech Republic, Latvia, Hungary, Moldova, Romania and Bulgaria. The methodology applied was the same as that already used by the state for regulating medicinal product prices: of the four lowest figures, the lowest was excluded, and the arithmetic mean of the remaining three was calculated.<\/p>\n

A similar approach was applied to the analysis of fees in the field of clinical trials. The calculations took into account the specific features of the procedures established by Regulation (EU) No. 536\/2014, under which the reference countries operate. To ensure comparability, the analysis primarily used fees established for Member States Concerned (MSC), as these most closely correspond to the scope of work performed under national procedures in Ukraine.<\/p>\n

The example of the marketing authorisation of a medicinal product is particularly illustrative. The lowest of the listed fees \u2013 the Moldovan fee of approximately EUR 1,195 \u2013 was excluded from the average. The calculation based on the next three figures \u2013 Hungary (EUR 2,480), Latvia (EUR 2,500) and Bulgaria (EUR 3,835) \u2013 resulted in a benchmark of approximately EUR 2,938<\/strong>. In Ukraine, however, the proposed maximum fee amounts to 235 subsistence minimums for able-bodied persons \u2013 UAH 782,080, or approximately EUR 15,349<\/strong>. Thus, even after excluding the lowest-cost procedure, the Ukrainian ceiling exceeds the calculated benchmark by 5.2 times<\/strong>. It is also higher than each of the eight foreign figures included in the comparison table.<\/p>\n

The differentiation of fees also raises certain questions. In the reference countries, fees for the registration of a generic medicinal product and a product submitted with a full dossier differ, whereas the Ukrainian draft provides for the same maximum fee for both. Clarification is also needed on how fees will be charged for registering a medicinal product in several pharmaceutical forms and strengths: whether the full fee will apply separately to each form and strength, and how shared dossier materials will be taken into account. Without clear rules, applicants cannot estimate the total cost of the procedure in advance. In the opinion of the Association’s member companies, it is necessary to define the unit of fee calculation and provide for differentiation based on the actual scope of expert work, while excluding repeated charges for the assessment of the same materials.<\/p>\n

Even more significant discrepancies have been identified with regard to variations to marketing authorisation dossiers. The proposed maximum fee in Ukraine of 120 subsistence minimums \u2013 UAH 399,360<\/strong> (for all types of variations), or approximately EUR 7,838<\/strong>, exceeds the calculated benchmark for Type IA<\/strong> variations by approximately 31 times<\/strong>, Type IB<\/strong> variations by 19 times<\/strong>, and Type II<\/strong> variations by 7.7 times<\/strong>. It should be noted that these are proposed maximum fee amounts, not final fees that have already been established. Nevertheless, the possibility of setting lower fees in the future does not eliminate the need to provide an economic justification for the proposed maximum amounts.<\/p>\n

These discrepancies demonstrate the need to revise the proposed amounts and publish the relevant cost calculations.<\/strong><\/p>\n

A similar situation is observed with regard to services in the field of clinical trials. The Association’s analysis showed that the proposed maximum fees for the assessment of clinical trial documentation, review of substantial modifications, scientific advice on clinical trials and clinical trial inspections significantly exceed the corresponding benchmarks calculated on the basis of fees in the reference countries.<\/p>\n

In particular, the proposed maximum fee for the assessment of clinical trial documentation is EUR 8,491, compared with a reference benchmark of EUR 2,196\u20135,178; for scientific advice on clinical trials, EUR 5,225 compared with EUR 1,135; and for clinical trial inspections, EUR 3,265 compared with EUR 1,249\u20131,817. For substantial modifications to clinical trial documentation, the proposed maximum fee is EUR 1,632, compared with a reference benchmark of EUR 321\u2013941.<\/p>\n

Overall, depending on the type of procedure, the proposed fees exceed the calculated reference benchmarks by 1.7 to 5.1 times. In the business community’s view, such an approach may negatively affect Ukraine’s attractiveness as a destination for international clinical trials and requires further economic justification.<\/p>\n

In view of these discrepancies, the EBA calls for a revision of the proposed fees for regulatory services, taking into account the fees in reference countries, and for transparent economic justification of their costs.<\/strong> The following aspects also require further refinement:<\/p>\n

\n
\n
    \n
  • the fee-setting mechanism, in accordance with the Law of Ukraine \u201cOn Medicinal Products\u201d;<\/li>\n
  • the procedure for financing expert assessments within the framework of a single service fee;<\/li>\n
  • differentiation of fees depending on the type and complexity of procedures.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n

    The business community believes that establishing economically justified and predictable fees is important not only for the proper functioning of the Ukrainian Pharmaceutical Agency but also for maintaining the affordability of medicinal products. Excessive regulatory costs may affect companies’ decisions regarding the registration and subsequent supply of medicinal products, particularly those with low sales volumes, creating a risk of reducing the range of therapeutic alternatives available to patients.<\/p>\n

    <\/p>","protected":false},"excerpt":{"rendered":"

    Member companies of the European Business Association call for substantial revisions to the draft Resolution of the Cabinet of Ministers of Ukraine on Paid Services Provided by the Ukrainian Pharmaceutical Agency, published by the Ministry of Health, and do not support its adoption in the proposed version. 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