Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95

Article 1

Subject matter and scope

This Regulation lays down rules concerning:

(a) the fees and charges levied by the European Medicines Agency (the ‘Agency’) for assessment activities relating to obtaining and maintaining a Union authorisation to market medicinal products for human use and veterinary medicinal products, and for other services provided or tasks carried out by the Agency, as provided for in Regulations (EC) No 726/2004 and (EU) 2019/6;

(b) the corresponding remuneration payable by the Agency to the competent authorities of the Member States for the services provided by rapporteurs and, where applicable, co-rapporteurs from competent authorities of the Member States, or by persons performing other roles considered as equivalent for the purposes of this Regulation, as referred to in the Annexes to this Regulation; and

(c) the monitoring of the costs of activities and services provided by the Agency and the monitoring of the costs of the remuneration referred to in point (b).

This Regulation also lays down the following:

(a) the amounts of the fees and charges referred to in paragraph 1, point (a), established on a cost-based evaluation; and

(b) the corresponding amounts of remuneration referred to in paragraph 1, point (b), established on a cost-based evaluation.

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

(1) ‘chargeable unit in relation to medicinal products for human use’ means a unit defined by a unique combination of the following dataset derived from information on all medicinal products authorised in the Union, held by the Agency, and consistent with the obligation of marketing authorisation holders referred to in Article 57(2), points (b) and (c), of Regulation (EC) No 726/2004 to submit such information to the database referred to in Article 57(1), second subparagraph, point (l), of that Regulation: (a) the name of the medicinal product, as defined in Article 1, point (20), of Directive 2001/83/EC; (b) the marketing authorisation holder; (c) the Member State in which the marketing authorisation is valid; (d) the active substance or combination of active substances, except in the case of homeopathic medicinal products or herbal medicinal products, as defined in Article 1, points 5 and 30, respectively, of Directive 2001/83/EC; (e) the pharmaceutical form;

(2) ‘chargeable unit in relation to veterinary medicinal products’ means a unit defined by the unique combination of the following data fields contained in the Union product database established pursuant to Article 55(1) of Regulation (EU) 2019/6: (a) the Permanent Identifier referred to under Data Field ID 3.1 in Annex III to Implementing Regulation (EU) 2021/16; (b) the Product Identifier referred to under Data Field ID 3.2 in Annex III to Implementing Regulation (EU) 2021/16;

(3) ‘medium-sized enterprise’ means a medium-sized enterprise within the meaning of Recommendation 2003/361/EC;

(4) ‘small enterprise’ means a small enterprise within the meaning of Recommendation 2003/361/EC;

(5) ‘microenterprise’ means a microenterprise within the meaning of Recommendation 2003/361/EC;

(6) ‘public health emergency’ means a situation of public health emergency recognised by the Commission in accordance with Article 23(1) of Regulation (EU) 2022/2371 of the European Parliament and of the Council (¹).

Article 3

Types of fees and charges

The Agency may levy the following types of fees or charges:

(a) fees and charges for assessment procedures and services relating to medicinal products for human use, as set out in Annex I;

(b) fees and charges for assessment procedures and services relating to veterinary medicinal products, as set out in Annex II;

(c) annual fees for authorised medicinal products for human use and for authorised veterinary medicinal products, as set out in Annex III;

(d) other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices, as set out in Annex IV.

Article 4

Additional fees and charges

Article 5

Payment of remuneration to competent authorities of the Member States for the provision of services to the Agency

Article 6

Reductions and deferrals of fees and charges

Article 7

Payment of fees and charges

Where the payer receives a request for payment under the first subparagraph, the payer shall make payment by the deadline for payment specified in the request.

Article 8

Working arrangements

Article 9

Due date and measures in case of non-payment

Article 10

Transparency and monitoring

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.

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.

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.

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.

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.

Article 11

Revision

The Commission is empowered to adopt delegated acts in accordance with Article 13 to amend the Annexes where justified in view of any of the following:

(a) a special report received by the Commission in accordance with Article 10(7);

(b) the findings from the monitoring of the inflation rate referred to in Article 10(6); or

(c) the budgetary reporting of the Agency.

The Commission may take into account any factors that could have a substantive impact on the Agency’s costs, including but not limited to the workload associated with its activities, and potential risks related to fluctuations in its fee revenue. The fees and charges shall be set at a level which ensures that the Agency has sufficient revenue to cover the costs of the services delivered.

Article 12

Estimate of the Agency’s budget

The Agency shall, when producing an estimate of revenue and expenditure for the following financial year in accordance with Article 67(6) of Regulation (EC) No 726/2004, include detailed information on income from each type of fee and charge and on the corresponding remuneration. In accordance with the typology of fees and charges set out in Article 3 of this Regulation, that information shall distinguish between the following:

(a) medicinal products for human use and consultations on medical devices;

(b) veterinary medicinal products;

(c) annual fees, by type;

(d) other fees and charges, by type.

The Agency may provide a breakdown by type of procedure in an annex to the single programming document produced in accordance with Article 32(1) of Delegated Regulation (EU) 2019/715.

Article 13

Exercise of the delegation

Article 14

Amendment to Regulation (EU) 2017/745

In Article 106 of Regulation (EU) 2017/745, paragraph 14 is replaced by the following:

The fees related to the advice provided by expert panels are payable to EMA pursuant to Article 30, point (f), of Regulation (EU) 2022/123 of the European Parliament and of the Council (^*1).

The fees related to the advice provided by expert laboratories are payable to the Commission.

Article 15

Amendment to Regulation (EU) 2022/123

Article 30 , point (f), of Regulation (EU) 2022/123 is replaced by the following:

‘(f) levy fees in accordance with Article 106(14) of Regulation (EU) 2017/745 and ensure that remuneration and expenses are provided to experts in accordance with implementing acts adopted by the Commission pursuant to Article 106(1) of Regulation (EU) 2017/745;’.

Article 16

Repeal

Regulation (EU) No 658/2014 of the European Parliament and of the Council (²) and Council Regulation (EC) No 297/95 (³) are repealed with effect from 1 January 2025.

References to Regulation (EC) No 297/95 shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VII to this Regulation.

Article 17

Transitional provisions

This Regulation shall not apply to annual fees, procedures or services for which the amount became due pursuant to Regulation (EC) No 297/95 or Regulation (EU) No 658/2014 before 1 January 2025.

Article 18

Entry into force and date of application

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 January 2025.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

Fees, charges and remuneration for assessment procedures and services relating to medicinal products for human use

1.1. A fee of EUR 98 400 shall apply to each of the following requests: (a) a request regarding quality, non-clinical and clinical development; (b) a request regarding quality and clinical development; (c) a request regarding non-clinical and clinical development; (d) a request regarding qualification of novel methodologies. The remuneration for each of the two scientific advice coordinators shall be EUR 24 600 . 1.2. A fee of EUR 73 900 shall apply to each of the following requests: (a) a request regarding clinical development; (b) a request regarding quality and non-clinical development; (c) a request regarding quality development and bioequivalence studies for generic medicinal products as defined in Article 10(2), point (b), of Directive 2001/83/EC. The remuneration for each of the two scientific advice coordinators shall be EUR 18 500 . 1.3. A fee of EUR 51 900 shall apply to each of the following requests: (a) a request regarding quality development; (b) a request regarding non-clinical development; (c) a request regarding bioequivalence studies for generic medicinal products as defined in Article 10(2), point (b), of Directive 2001/83/EC. The remuneration for each of the two scientific advice coordinators shall be EUR 12 300 .

2.1. A fee of EUR 865 200 shall apply to an application for a marketing authorisation for a medicinal product pursuant to Article 8(3) of Directive 2001/83/EC where the applicant claims a new active substance. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 272 200 for the rapporteur, EUR 237 100 for the co-rapporteur and EUR 25 500 for the Pharmacovigilance Risk Assessment Committee (PRAC) rapporteur. 2.2. A fee of EUR 690 700 shall apply to an application for a marketing authorisation for a medicinal product pursuant to Article 8(3) of Directive 2001/83/EC where the applicant claims a known active substance. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 191 600 for the rapporteur, EUR 179 500 for the co-rapporteur and EUR 18 600 for the PRAC rapporteur. 2.3. A fee of EUR 571 100 shall apply to an application for a fixed combination medicinal product pursuant to Article 10b of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 177 200 for the rapporteur, EUR 104 000 for the co-rapporteur and EUR 14 100 for the PRAC rapporteur. 2.4. A fee of EUR 732 400 shall apply to an application for a biological medicinal product which is similar to a reference biological product pursuant to Article 10(4) of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 296 200 for the rapporteur, EUR 190 000 for the co-rapporteur and EUR 24 300 for the PRAC rapporteur. 2.5. A fee of EUR 780 900 shall apply to an application for a marketing authorisation for a medicinal product pursuant to Article 10a of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 201 200 for the rapporteur, EUR 187 100 for the co-rapporteur and EUR 19 400 for the PRAC rapporteur. 2.6. A fee of EUR 177 900 shall apply to an application for a marketing authorisation for a generic medicinal product pursuant to Article 10(1) of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 78 300 for the rapporteur and EUR 3 900 for the PRAC rapporteur. 2.7. A fee of EUR 172 800 shall apply to an application based on informed consent for a marketing authorisation for a medicinal product pursuant to Article 10c of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 50 400 for the rapporteur and EUR 2 500 for the PRAC rapporteur. 2.8. A fee of EUR 426 100 shall apply to an application for a marketing authorisation for a medicinal product pursuant to Article 10(3) of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in that application. The remuneration shall be EUR 111 600 for the rapporteur, EUR 111 600 for the co-rapporteur and EUR 11 200 for the PRAC rapporteur. 2.9. A fee of EUR 33 300 shall apply to the second and to each subsequent application for a marketing authorisation submitted pursuant to Article 10(1), (3) or (4) of Directive 2001/83/EC on patent grounds where indications or dosage forms of the reference medicinal product are still covered by patent law. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in the same application. The remuneration shall be EUR 8 500 for the rapporteur and EUR 1 300 for the co-rapporteur.

3.1. The amounts of the fees and the amounts of the corresponding remuneration laid down in Section 2 shall apply to any of the following: (a) an opinion on a medicinal product for compassionate use pursuant to Article 83 of Regulation (EC) No 726/2004; (b) an assessment on an on-going basis of data packages of particulars and documents submitted to the Agency by a prospective applicant prior to a formal submission of an application for a marketing authorisation falling within the scope of Regulation (EC) No 726/2004. 3.2. The amounts applicable pursuant to points 3.1(a) and 3.1(b) shall cover all strengths, all pharmaceutical forms and all presentations submitted in the same application. 3.3. An additional fee and additional remuneration shall apply to the assessment set out in point 3.1(b). The amount of that additional fee and the amounts of the corresponding additional remuneration shall be equal to 15 per cent of the respective amounts for an application for a marketing authorisation for a medicinal product falling within the scope of Regulation (EC) No 726/2004 that are laid down in point 2. 3.4. In the event of multiple submissions of data packages submitted by the same prospective applicant for the same product, the fees applicable pursuant to point 3.1(b) and point 3.3 shall only be levied once, namely when the first data package is submitted. 3.5. The amounts applicable pursuant to points 3.1(a) and 3.1(b) shall be deducted from the respective fee and remuneration payable to competent authorities of the Member States for an application for a marketing authorisation for the same product, where such application is submitted by the same applicant.