(1)

The European Medicines Agency (‘the Agency’) plays a key role in ensuring that only safe, high-quality and efficacious medicinal products are placed on the Union market, thus contributing to the smooth functioning of the internal market and ensuring a high level of protection of human and animal health. It is therefore necessary to ensure sufficient resources are available to the Agency to finance its activities, including resources emanating from fees.

(1)

The European Medicines Agency (‘the Agency’) plays a key role in ensuring that only safe, high-quality and efficacious medicinal products are placed on the Union market, thus contributing to the smooth functioning of the internal market and ensuring a high level of expertise and protection of human and animal health. It is therefore necessary to ensure sufficient resources are available to the Agency to attract and maintain the expertise required to fulfil its tasks and to finance its activities, including resources emanating from fees.

(3)

The fees payable to the Agency should be proportionate to the work carried out in relation to obtaining and maintaining a Union authorisation, and should be based on an evaluation of the Agency’s estimations and forecasts as regards the workload and related costs for that work, as well as on an evaluation of the costs of the services provided to the Agency by the competent authorities of Member States that are responsible for regulating medicinal products, which act as rapporteurs and, where applicable, co-rapporteurs appointed by the scientific committees of the Agency.

(3)

The fees payable to the Agency should be proportionate to the work carried out in relation to obtaining and maintaining a Union authorisation, and should be based on a transparent evaluation of the Agency’s estimations and forecasts as regards the workload and related costs for that work, as well as on an evaluation of the costs of the services provided to the Agency by the competent authorities of Member States that are responsible for regulating medicinal products, which act as rapporteurs and, where applicable, co-rapporteurs appointed by the scientific committees of the Agency. The fees and fee structure should take into account any changes in the Union regulatory framework for medicinal products. Adequate financing should be provided for that critical public infrastructure to boost its expertise and ensure its sustainability through appropriate financing.

(4a)

Following the COVID-19 pandemic and increased initiatives in the field of health at the Union level, the agency is faced with a constantly increasing workload, which entails additional budgetary needs in terms of staff and financial resources. The additional work, which includes following the adoption of Regulation (EU) 2022/123 of the European Parliament and of the Council  (1a) and the creation of the European Health Data Space, should come with an appropriate funding from the Multiannual Financial Framework.

(4b)

Although the majority of its funding comes from private sources, the Agency is a public authority and it is of the utmost importance to safeguard its integrity and independence in order to ensure public trust in the legislative and regulatory framework for pharmaceuticals in the Union. Therefore, sufficient funding should be allocated to the Agency so that it can carry out its obligations and transparency commitments.

(4c)

The fees paid to the Agency should reflect the complex evaluations necessary to obtain and maintain a Union authorisation. It is appropriate to recognise the contributions from Member States’ competent authorities, as well as the expenses incurred by them. It is particularly appropriate to recognise the synergies achieved through multinational assessment teams and support the collaborative efforts of those multinational teams. The Commission and the Agency should therefore monitor the development of multinational assessment teams when determining the changes that are necessary to the structure of remuneration of Member States.

(5)

Fees and charges should cover the cost of statutory services and activities of the Agency that is not already covered by the contributions to its revenue from other sources. All relevant Union legislation governing the Agency’s activities and fees should be taken into account when establishing the fees and charges, including Regulation (EC) No 726/2004, Regulation (EU) 2019/6 of the European Parliament and of the Council (21) , Directive 2001/83/EC, Regulation (EC) No 1901/2006 of the European Parliament and of the Council (22) , Regulation (EC) No 141/2000 of the European Parliament and of the Council (23) , Regulation (EC) No 1394/2007 of the European Parliament and of the Council (24) , Commission Regulation (EC) No 2049/2005 (25) , Commission Regulation (EC) No 1234/2008 (26) , Regulation (EU) 2017/745 of the European Parliament and of the Council (27) , Regulation (EC) No 470/2009 of the European Parliament and of the Council (28) , Commission Regulation (EU) 2018/782 (29) , Commission Implementing Regulation (EU) 2021/1281 (30) and Commission Regulation (EC) No 2141/96 (31) .

(5)

Fees and charges should cover the cost of statutory services and activities of the Agency that is not already covered by the contributions to its revenue from other sources. All relevant Union legislation governing the Agency’s activities and fees should be taken into account when establishing the fees and charges, including Regulation (EC) No 726/2004, Regulation (EU) 2019/6 of the European Parliament and of the Council (21), Directive 2001/83/EC, Regulation (EC) No 1901/2006 of the European Parliament and of the Council (22), Regulation (EC) No 141/2000 of the European Parliament and of the Council (23), Regulation (EC) No 1394/2007 of the European Parliament and of the Council (24), Commission Regulation (EC) No 2049/2005 (25), Commission Regulation (EC) No 1234/2008 (26), Regulation (EU) 2017/745 of the European Parliament and of the Council (27), Regulation (EC) No 470/2009 of the European Parliament and of the Council (28), Regulation (EU) 2022/123,  Commission Regulation (EU) 2018/782 (29), Commission Implementing Regulation (EU) 2021/1281 (30)and Commission Regulation (EC) No 2141/96 (31).

(7)

In line with the Joint Statement of the European Parliament, the Council of the EU and the Commission of 19 July 2012 on decentralised agencies, for bodies for which the revenue is constituted by fees and charges in addition to the Union contribution, fees should be set at a level that avoids a deficit or a significant accumulation of surplus, and should be revised when this is not the case. Therefore, a cost monitoring system should be put in place. The purpose of such monitoring system should be to detect significant changes of costs of the Agency that, taking into account the Union contribution and other non-fee revenue, could require a change in fees, charges or remuneration established under this regulation. That monitoring system should equally be able to detect, based on objective and verifiable information, significant changes of costs of remuneration of services provided to the Agency by the competent authorities of Member States, which act as rapporteurs and, where applicable, co-rapporteurs and by experts contracted by the Agency for the procedures of the expert panels on medical devices. Cost information relating to services remunerated by the Agency should be auditable in accordance with Article 257 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (32) .

(7)

In line with the Joint Statement of the European Parliament, the Council of the EU and the Commission of 19 July 2012 on decentralised agencies, for bodies for which the revenue is constituted by fees and charges in addition to the Union contribution, fees should be set at a level that avoids a deficit or a significant accumulation of surplus, and should be revised when this is not the case. Therefore, a transparent cost monitoring system should be put in place. The purpose of such monitoring system should be to detect significant changes of costs of the Agency that, taking into account the Union contribution and other non-fee revenue, could require a change in fees, charges or remuneration established under this regulation. That monitoring system should equally be able to detect, based on objective and verifiable information, significant changes of costs of remuneration of services provided to the Agency by the competent authorities of Member States, which act as rapporteurs and, where applicable, co-rapporteurs and by experts contracted by the Agency for the procedures of the expert panels on medical devices. Cost information relating to services remunerated by the Agency should be auditable in accordance with Article 257 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (32).

(15)

In line with union policies, it is appropriate to provide for reductions of the fees to support specific sectors and applicants or marketing authorisation holders, such as micro-, small- and medium-sized enterprises (SMEs), or to respond to specific circumstances, such as products responding to recognised public health or animal health priorities or veterinary medicinal products intended for a limited market authorised in accordance with Article 23 of Regulation (EU) 2019/6.

(15)

In line with union policies, it is appropriate to provide for reductions of the fees to support specific sectors and applicants or marketing authorisation holders, such as micro-, small- and medium-sized enterprises (SMEs), non-profit-organisations and the academic sector or to respond to specific circumstances, such as products responding to recognised public health or animal health priorities or veterinary medicinal products intended for a limited market authorised in accordance with Article 23 of Regulation (EU) 2019/6.

(17)

The Management Board of the Agency should be empowered to provide further fee reductions for justified reasons of protection of public and animal health. A favourable opinion from the Commission should be mandatory before granting further fee reductions, in order to ensure alignment with Union law and with overall policies of the Union. In addition, in duly justified exceptional cases, for imperative reasons of public or animal health, it should also be possible for the Executive Director of the Agency to reduce certain types of fees on the basis of a critical examination of the situation specific to each case.

(17)

The Management Board of the Agency should be empowered to provide further fee reductions for duly justified reasons of protection of public and animal health. A favourable opinion from the Commission should be mandatory before granting further fee reductions, in order to ensure alignment with Union law and with overall policies of the Union . For transparency purposes, the Agency should make information on the decisions for further fee reductions publicly available on its website, including on the recipients and the reasons for the decision for further fee reductions . In addition, in duly justified exceptional cases, for imperative reasons of public or animal health, it should also be possible for the Executive Director of the Agency to reduce certain types of fees on the basis of a critical examination of the situation specific to each case. The Agency should ensure that such decisions of the Executive Director are made publicly available on its website and set out the reasons for those decisions.

(18)

In order to provide flexibility, in particular to adapt to developments in science, the Management Board of the Agency should be enabled to specify working arrangements to facilitate the application of this Regulation, on a duly justified proposal from the Executive Director. In particular, the Management Board should be able to establish due dates and deadlines for payment, payment methods, timetables, detailed classifications, lists of additional fee reductions, and detailed amounts within the limits of an established range. A favourable opinion from the Commission should be mandatory before the proposal is put to the Management Board for adoption, in order to ensure alignment with Union law and with overall policies of the Union.

(18)

In order to provide flexibility, in particular to adapt to developments in science and to address unforeseen circumstances and medical needs , the Management Board of the Agency should be enabled to specify working arrangements to facilitate the application of this Regulation, on a duly justified proposal from the Executive Director. In particular, the Management Board should be able to establish due dates and deadlines for payment, payment methods, timetables, detailed classifications, lists of additional fee reductions, and detailed amounts within the limits of an established range. A favourable opinion from the Commission should be mandatory before the proposal is put to the Management Board for adoption, in order to ensure alignment with Union law and with overall policies of the Union.

(19)

For their assessments, rapporteurs and co-rapporteurs and the other roles considered as equivalent for the purposes of this regulation in scientific advice and inspections rely on the scientific evaluations and resources of the competent authorities of Member States, while it is the responsibility of the Agency to coordinate the existing scientific resources put at its disposal by the Member States, in accordance with Article 55 of Regulation (EC) No 726/2004. In light of that, and to ensure appropriate resources for the scientific assessments relating to the procedures carried out at Union level, the Agency should remunerate the scientific assessment services provided by the rapporteurs and co-rapporteurs appointed by the Member States as members of the scientific committees of the Agency, or, where relevant, provided by rapporteurs and co-rapporteurs in the coordination group referred to in Article 27 of Directive 2001/83/EC. The amount of remuneration for the services provided by those rapporteurs and co-rapporteurs should be based on estimations of the workload involved and should be taken into account in setting the level of the fees charged by the Agency.

(19)

For their assessments, rapporteurs and co-rapporteurs and the other roles considered as equivalent for the purposes of this regulation in scientific advice and inspections rely on the scientific evaluations and resources of the competent authorities of Member States, while it is the responsibility of the Agency to coordinate the existing scientific resources put at its disposal by the Member States, in accordance with Article 55 of Regulation (EC) No 726/2004. In light of that, and to ensure appropriate resources for the scientific assessments relating to the procedures carried out at Union level, the Agency should remunerate the scientific assessment services provided by the rapporteurs and co-rapporteurs appointed by the Member States as members of the scientific committees of the Agency, or, where relevant, provided by rapporteurs and co-rapporteurs in the coordination group referred to in Article 27 of Directive 2001/83/EC. The amount of remuneration for the services provided by those rapporteurs and co-rapporteurs should be based on estimations of the workload involved and should be taken into account in setting the level of the fees charged by the Agency. Based on a specific public interest benefitting both the Union and the Member States, where the Agency grants a total waiver of fees, the remuneration of rapporteurs and co-rapporteurs should be reduced by 50% or 100%, as specified in Annex V.

(26a)

Member States should ensure that adequate financial resources are available to provide the national competent authorities with staff and other resources necessary to carry out the relevant activities associated with the fees and charges levied in accordance with this Regulation. Any revision of the fees and charges pursuant to Article 11 should also be taken into account.

(26b)

The calculation of the amounts of the fees, charges and remuneration take into account the inflation rate measured by means of the Harmonised Index of Consumer Prices published by Eurostat pursuant to Regulation (EU) No 2016/792 until the date of adoption of the proposal for this Regulation. The inflation rate was high when the proposal for this Regulation was submitted, remains high as measured in 2023, and, according to the forecast of the European Central Bank, is projected to remain high in 2024. The relevant amounts should be updated to ensure that the fees, charges and remuneration payable are adjusted for such inflation before the date of application of this Regulation. The Commission should therefore adopt a delegated act to amend the relevant Annexes to this Regulation on the basis of the inflation rate published four months before the date of application of this Regulation.

(5a)

‘Academia’ or ‘academic sector’ means public or private higher education establishments awarding academic degrees, public or private non-profit research organisations whose primary mission is to pursue research, and international European interest organisations;

(5b)

‘Non-profit organisation’ or ‘non-profit legal entity’ means a legal entity which by its legal form is non-profit-making or which has a legal or statutory obligation not to distribute profits to its shareholders or individual members;

(5c)

‘International European interest organisation’ means an international organisation, the majority of whose members are Member States or associated countries, and whose principal objective is to promote scientific and technological cooperation in the Union;

(6)

‘public health emergency’ means a situation of public health emergency recognised by the Commission in accordance with Article 12(1) of Decision No 1082/2013/EU of the European Parliament and of the Council (40).

(6)

‘public health emergency’ means a situation of public health emergency recognised by the Commission in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council (40).

(aa)

to adapt any fee, charge or remuneration, or introduce a new fee, charge or remuneration following a change in the statutory tasks of the Agency resulting in a significant change in the respective costs;

(c)

a change in the statutory tasks of the Agency leading to a significant change in its costs;

(e)

other relevant information, in particular on practical aspects for the execution of activities for which the Agency collects fees or charges.

6.1.

A fee of EUR 136 700 shall apply to the assessment carried out in the context of a procedure initiated under Article 5(3) of Regulation (EC) No 726/2004. Such fee shall be waived in full. The remuneration shall be EUR 12 400 for the rapporteur and EUR 12 400 for the co-rapporteur.

6.1.

A fee of EUR 136 700 shall apply to the assessment carried out in the context of a procedure initiated under Article 5(3) of Regulation (EC) No 726/2004. Such fee shall be waived in full. The remuneration shall be EUR 6 200 for the rapporteur and EUR 6 200 for the co-rapporteur.

6.2.

A fee of EUR 262 400 shall apply to the assessment carried out in the context of a procedure initiated under Article 13 of Regulation (EC) No 1234/2008. Such fee shall be waived in full. The remuneration shall be EUR 15 300 for the rapporteur and EUR 15 300 for the co-rapporteur.

6.2.

A fee of EUR 262 400 shall apply to the assessment carried out in the context of a procedure initiated under Article 13 of Regulation (EC) No 1234/2008. Such fee shall be waived in full. The remuneration shall be EUR 7 650 for the rapporteur and EUR 7 650 for the co-rapporteur.

6.3.

A fee of EUR 83 000 shall apply to the assessment carried out in the context of a procedure initiated under Article 29(4) of Directive 2001/83/EC. Such fee shall be waived in full. The remuneration shall be EUR 2 800 for the rapporteur and EUR 2 800 for the co-rapporteur.

6.3.

A fee of EUR 83 000 shall apply to the assessment carried out in the context of a procedure initiated under Article 29(4) of Directive 2001/83/EC. Such fee shall be waived in full. The remuneration shall be EUR 1 400 for the rapporteur and EUR 1 400 for the co-rapporteur.

10.1.

A fee of EUR 143 200 shall apply to an application for evaluating and certifying the quality and non-clinical data pursuant to Article 18 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council (43) . Such fee shall be waived in full. The remuneration shall be EUR 47 400 for the rapporteur.

10.1.

A fee of EUR 143 200 shall apply to an application for evaluating and certifying the quality and non-clinical data pursuant to Article 18 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council (43). Such fee shall be waived in full. The remuneration shall be EUR 23 700 for the rapporteur.

10.2.

A fee of EUR 95 200 shall apply to an application for evaluating and certifying only the quality data pursuant to Article 18 of Regulation (EC) No 1394/2007. Such fee shall be waived in full. The remuneration shall be EUR 31 500 for the rapporteur.

10.2.

A fee of EUR 95 200 shall apply to an application for evaluating and certifying only the quality data pursuant to Article 18 of Regulation (EC) No 1394/2007. Such fee shall be waived in full. The remuneration shall be EUR 15 750 for the rapporteur.

11.1.

A fee of EUR 31 700 shall apply to an application for agreement of a paediatric investigation plan requested pursuant to Article 15 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 6 700 for the rapporteur.

11.1.

A fee of EUR 31 700 shall apply to an application for agreement of a paediatric investigation plan requested pursuant to Article 15 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 3 350 for the rapporteur.

11.2.

A fee of EUR 17 600 shall apply to an application for a modification of an agreed paediatric investigation plan pursuant to Article 22 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 6 400 for the rapporteur.

11.2.

A fee of EUR 17 600 shall apply to an application for a modification of an agreed paediatric investigation plan pursuant to Article 22 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 3 200 for the rapporteur.

11.3.

A fee of EUR 12 000 shall apply to an application for a product-specific waiver pursuant to Article 13 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 1 800 for the rapporteur.

11.3.

A fee of EUR 12 000 shall apply to an application for a product-specific waiver pursuant to Article 13 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 900 for the rapporteur.

11.4.

A fee of EUR 8 000 shall apply to a request for compliance check with the paediatric investigation plan pursuant to Article 23 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 1 000 for the rapporteur.

11.4.

A fee of EUR 8 000 shall apply to a request for compliance check with the paediatric investigation plan pursuant to Article 23 of Regulation (EC) No 1901/2006. Such fee shall be waived in full. The remuneration shall be EUR 500 for the rapporteur.

7.1.

A fee of EUR 152 700 shall apply to an assessment carried out in the context of a procedure initiated under Article 54(8) of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 21 100 for the rapporteur and EUR 9 600 for the co-rapporteur.

7.1.

A fee of EUR 152 700 shall apply to an assessment carried out in the context of a procedure initiated under Article 54(8) of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 10 550 for the rapporteur and EUR 4 800 for the co-rapporteur.

7.2.

A fee of EUR 209 300 shall apply to the assessment carried out in the context of a procedure initiated under Article 70(11) of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 29 200 for the rapporteur and EUR 12 900 for the co-rapporteur.

7.2.

A fee of EUR 209 300 shall apply to the assessment carried out in the context of a procedure initiated under Article 70(11) of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 14 600 for the rapporteur and EUR 6 450 for the co-rapporteur.

7.3.

A fee of EUR 147 200 shall apply to the assessment carried out pursuant to Article 141(1), points (c) and (e), of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 17 500 for the rapporteur and EUR 7 700 for the co-rapporteur.

7.3.

A fee of EUR 147 200 shall apply to the assessment carried out pursuant to Article 141(1), points (c) and (e), of Regulation (EU) 2019/6. Such fee shall be waived in full. The remuneration shall be EUR 8 750 for the rapporteur and EUR 3 850 for the co-rapporteur.

1a.

Fee reductions granted to academia and the non-profit research sector

1.

2.

(a)

the Legal Entity Form (LEF) and the “founding document” (or any other suitable document provided during the application process);

(b)

evidence of the place of establishment, which may be the founding document or any other suitable document proving that the entity’s seat is located in the Union, Iceland, Liechtenstein or Norway;

(c)

proof that the applicant is not under direct or indirect control of any PPO.

(i)

the direct or indirect holding of more than 50 % of the nominal value of the issued share capital in the applicant, or of a majority of the voting rights of the shareholders or associates of that applicant, or

(ii)

the direct or indirect holding, in fact or in law, of decision-making powers in the applicant.

3.

(4a)

number of fee reductions granted as per executive decisions set out in Article 6;

(6)

number of working hours spent by the rapporteur and the co-rapporteurs and experts contracted for the procedures of the expert panels on medical devices per procedures on the basis of the information provided to the Agency by the national competent authorities concerned. The procedures to be included shall be decided by the Management Board based on a proposal by the Agency.

(6)

number of working hours spent by the rapporteur and the co-rapporteurs , including hours spent by experts and others employed by the competent authorities of the Member States to assist them, and experts contracted for the procedures of the expert panels on medical devices per procedures on the basis of the information provided to the Agency by the national competent authorities concerned. The procedures to be included shall be decided by the Management Board based on a proposal by the Agency.

(6a)

any performance indicators relevant to scientific service fees or charges for administrative services levied in accordance with Article 4(1) and (2) of this Regulation;

(6b)

any additional relevant key performance indicators that impact the evolving workload of the Agency and national competent authorities in the Member States in the Union pharmaceutical regulatory framework, including procedures for the authorisation and supervision of medicinal products.