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1. The Agency shall publish on its website the amounts of fees, charges and remuneration set out in the Annexes.

2. The Agency shall monitor its costs and the Executive Director of the Agency shall provide, in a timely manner as part of the annual activity report delivered to the European Parliament, the Council, the Commission and the Court of Auditors, detailed and substantiated information on the costs to be covered by fees and charges that are within the scope of this Regulation. That information shall include the performance information set out in Annex VI and may include other relevant information, such as information related to the practical aspects of carrying out the activities of the Agency, and a cost breakdown related to the previous calendar year and to a forecast for the following calendar year. The Agency shall also publish, in a timely manner, an overview of that information in its annual activity report.

3. In its annual activity report, the Agency shall publish the annual revenue received per type of fee and charge, including where reductions and waivers have been granted, and including fees and charges that are due but have not yet been received by the Agency. The Agency shall also include in its annual activity report a detailed breakdown of all remunerated amounts paid to competent authorities of the Member States for their work.

4. Competent authorities of the Member States responsible for medicinal products or experts contracted for the work of the expert panels on medical devices may provide the Agency with evidence of significant changes in the costs of services provided to the Agency, excluding any effect of inflationary adjustments and any costs for activities that do not constitute a service to the Agency.

Such information may be provided once per calendar year or less frequently, as a complement to the information provided in accordance with Annex VI. Such evidence shall be based on duly justified and specific financial information on the nature and the extent of the financial impact on costs for services to the Agency. To that end, the competent authorities of the Member States or experts contracted for the work of the expert panels on medical devices shall use the common format facilitating comparison and consolidation, established in accordance with Article 8. The competent authorities of the Member States and the experts contracted to the Agency for the procedures of the expert panels on medical devices shall provide such information in the format provided by the Agency, together with any supporting information allowing the correctness of the amounts submitted to be verified. The Agency shall review and aggregate that information and shall use it, in accordance with paragraph 7, as a source for the special report provided for in that paragraph. ◄

5. Article 257 of Regulation (EU, Euratom) 2018/1046 shall apply to the information provided to the Agency in accordance with paragraph 3 of this Article and Annex VI to this Regulation.

6. From 1 January 2025, the Commission shall monitor the inflation rate, measured by means of the Harmonised Index of Consumer Prices published by Eurostat pursuant to Regulation (EU) 2016/792, in relation to the amounts of fees, charges and remuneration set out in the Annexes to this Regulation. Such monitoring shall cover the period since the last inflation adjustment and shall thereafter take place on an annual basis. Any adjustment, in line with inflation, to fees, charges and remuneration established in accordance with this Regulation shall become applicable, at the earliest, on 1 January of the calendar year following the calendar year in which the monitoring exercise took place.

7. At the earliest in January 2026 and at three-year intervals thereafter, the Executive Director of the Agency shall provide the Commission with a special report adopted by the Management Board of the Agency outlining, in an objective, fact-based and sufficiently detailed manner, reasoned recommendations to:

(a) increase or decrease the amount of any fee, charge or remuneration, following a significant change in the respective costs as identified, documented and substantiated in the report;

(b) amend any other element of the Annexes pertaining to the levying of fees and charges by the Agency, including additional fees and charges referred to in Article 4;

(c) adapt the specification of activities for which the Agency collects fees or charges to changing conditions and requirements;

(d) increase, decrease or introduce any fee, charge or remuneration following a change in the statutory tasks of the Agency leading to a significant change in its costs.

8. The special report referred to in paragraph 7 and the recommendations it contains shall be based on the following:

(a) monitoring of the information referred to in paragraphs 2 and 3 and of the cost of the activities necessary for the fulfilment of the statutory tasks of the Agency, aimed at identifying significant changes to the cost base of services and activities of the Agency; and (b) objective and verifiable information, including quantification that directly supports the relevance of the recommended adjustments.

9. The Agency shall make publicly available, in a timely manner, on its website the special report referred to in paragraph 7.

10. The Commission may request any clarification or further substantiation of the special report and its recommendations, if considered necessary. Following such a request, the Executive Director of the Agency shall without undue delay prepare an updated special report which addresses the matters raised in the Commission’s request. That updated special report shall be adopted in accordance with paragraph 7 and submitted forthwith to the Commission.

11. The time interval for the first special report as well as the reporting time interval referred to in paragraph 7 may be shortened in any of the following situations:

(a) a public health emergency;

(b) a change in the statutory tasks of the Agency;

(c) there is evidence of significant changes in the costs or the cost-revenue balance of the Agency;

(d) there is evidence of significant changes in the costs for cost-based remuneration to competent authorities of the Member States.