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

• 1. Pre-submission requests by a prospective applicant prior to a potential submission of an application for a marketing authorisation falling within the scope of the centralised procedure
• 3.1. A fee of EUR 8 600 shall apply to each eligibility request submitted with a notification of intention to submit an application for a marketing authorisation falling within the scope of Regulation (EC) No 726/2004 or the scope of the centralised marketing authorisation procedure pursuant to Article 42 of Regulation (EU) 2019/6. The fee shall cover any costs related to pre-submission activities up until the potential submission of the marketing authorisation application. The fee shall apply irrespective of whether or not a marketing authorisation application for the concerned product is subsequently submitted. If an eligibility request with a notification of intention to submit an application for a marketing authorisation has not been submitted, the fee shall apply in addition to the applicable authorisation fee. The remuneration of the competent authority of the Member State, where applicable, shall be EUR 1 600 for the rapporteur and EUR 1 600 for the co-rapporteur.
• 3.2. Where the applicant changes the intended submission date by more than 60 days, an additional fee of EUR 4 200 shall apply. The additional remuneration of the competent authority of the Member State, where applicable, shall be EUR 800 for the rapporteur and EUR 800 for the co-rapporteur.

• 1. Re-examination of an opinion of the Committees referred to in Article 56(1) of Regulation (EC) No 726/2004 and in Article 139(1) of Regulation (EU) 2019/6 The fee for the re-examination of an opinion of any of the committees referred to in Article 56(1) of Regulation (EC) No 726/2004 and in Article 139(1) of Regulation (EU) 2019/6 shall be 30 % of the fee applicable to the initial opinion in accordance with Sections 2, 4, 5 and 6 of Annex I and Sections 3, 4, 6 and 7 of Annex II to this Regulation. The remuneration to the rapporteur and the co-rapporteur shall be calculated based on the same proportion of the respective remuneration.

• 1. Scientific services referred to in Article 4(1) of this Regulation The range for fees for scientific services referred to in Article 4(1) shall be EUR 5 000 to EUR 841 100 . The range for the remuneration shall be EUR 1 300 to EUR 272 200 for the rapporteur and the co-rapporteur. The applicable amounts of the fee and the remuneration within the above ranges shall be determined in accordance with Article 8 of this Regulation.

• 1. Administrative services
• 6.1. Administrative charge A charge of EUR 4 400 shall apply to applications subject to a fee set out in Annex I or II in any of the following situations:
• (a) the application is withdrawn after 24 hours of its submission and prior to completion of the administrative validation;
• (b) the application has been rejected following the conclusion of the administrative validation. The charge laid down in the first subparagraph shall also apply to applications in relation to procedures and services for which the applicable fee is waived in those Annexes. In the cases referred to in the previous subparagraph, the corresponding fee shall not be levied. In addition to the applicable fee or charge set out in Annex I, II or III, a charge of EUR 4 400 shall also apply to applications where a marketing authorisation holder or an applicant claiming, or having claimed, to be entitled to a fee or charge reduction, fails to demonstrate that it is entitled to such a reduction. That charge shall be levied in full also to SMEs, where applicable.
• 6.2. Certificates of medicinal products as referred to in Article 127 of Directive 2001/83/EC and in Article 98 of Regulation (EU) 2019/6
• 6.2.1. A charge of EUR 200 shall apply to each request for a certificate issued by the Agency for a medicinal product, using the standard procedure for issuing the certificate.
• 6.2.2. A charge of EUR 500 shall apply to each request for a certificate issued by the Agency for a medicinal product, using the urgent procedure for issuing the certificate.
• 6.3. Notification of parallel distribution in accordance with Article 57(1), point (o), of Regulation (EC) No 726/2004
• 6.3.1. A charge of EUR 1 400 shall apply to each initial notification for each presentation of a medicinal product, for one Member State of destination having one or more official languages or for several Member States of destination having the same official language. That charge shall cover any subsequent safety update notification relating to the initial notification.
• 6.3.2. A charge of EUR 400 shall apply to each notification of a bulk change. That charge shall cover all initial notifications approved by the date of submission of the notification of bulk changes.
• 6.3.3. A charge of EUR 400 shall apply to each annual update notification. That charge shall cover all the presentations belonging to the same medicinal product for one Member State of destination having one or more official languages, or for several Member States of destination having the same official language. No charge shall apply if there have been no regulatory updates in the past 12 months or if the product was dormant.
• 6.4. Administrative services referred to in Article 4(2) of this Regulation The range for charges for other administrative services referred to in Article 4(2) shall be from EUR 120 to EUR 11 900 . The applicable amounts of the charge within the above range shall be determined in accordance with Article 8 of this Regulation.

• 1. Consultation on medical devices
• 7.1. Ancillary substances incorporated in medical devices
• 7.1.1. A fee of EUR 114 700 shall apply to a consultation on one or more ancillary medicinal substances pursuant to Section 5.2 of Annex IX to Regulation (EU) 2017/745, where the medicinal substance from the specified manufacturer has not been evaluated by the Agency or a competent authority designated by the Member States in accordance with Directive 2001/83/EC (‘medicinal products authority’) in connection with a previous marketing authorisation or through a previous consultation by a notified body. One application may include a range of strength or concentrations of the ancillary substance or a range of similar devices from the same medical device manufacturer incorporating the same substance or both. The remuneration shall be EUR 29 400 for the rapporteur and EUR 29 400 for the co-rapporteur.
• 7.1.2. A fee of EUR 57 200 shall apply to a consultation on one or more ancillary medicinal substances pursuant to Section 5.2 of Annex IX to Regulation (EU) 2017/745, where the medicinal substance from the specified manufacturer has been evaluated by a medicinal products authority in connection with a previous marketing authorisation or through a previous consultation by a notified body. One application may include a range of strengths or concentrations of the ancillary substance or a range of similar devices from the same medical device manufacturer incorporating the same substance or both. The remuneration shall be EUR 14 400 for the rapporteur and EUR 14 400 for the co-rapporteur.
• 7.1.3. For the purpose of 7.1.1. and 7.1.2., a fee of EUR 5 000 shall apply to a consultation, pursuant to Section 5.2, point (f), of Annex IX to Regulation (EU) 2017/745, regarding a change with respect to an ancillary medicinal substance incorporated in a device. The remuneration for the rapporteur shall be EUR 1 800 .
• 7.2. Medical devices composed of a substance or a combination of substances that are systemically absorbed to achieve their intended purpose A fee of EUR 86 100 shall apply to a consultation on a medical device or a range of similar devices composed of a substance or a combination of substances that are absorbed by or locally dispersed in the human body, pursuant to Section 5.4 of Annex IX to Regulation (EU) 2017/745. The remuneration shall be EUR 21 900 for the rapporteur and EUR 21 900 for the co-rapporteur.
• 7.3. Companion diagnostic A fee of EUR 56 500 shall apply to a consultation on the suitability of a companion diagnostic in relation to a concerned medicinal product, pursuant to Article 48(3) or (4) of Regulation (EU) 2017/746, and Section 5.2 of Annex IX or Section 3, point (k), of Annex X to that Regulation. The remuneration for the rapporteur shall be EUR 14 800 . A fee of EUR 5 000 shall apply to a consultation on a change affecting the suitability of the companion diagnostic in relation to the medicinal product concerned, pursuant to Section 5.2, point (f), of Annex IX to Regulation (EU) 2017/746. The remuneration for the rapporteur shall be EUR 1 800 .
• 7.4. The fees set out in points 7.1, 7.2 and 7.3 shall be levied to the medical device manufacturer that, according to the application form submitted to the Agency, requested the assessment of conformity of the medical device for which the notified body is consulting the Agency.

ANNEX V

Fee and charge reductions and deferrals

• 1. Fee and charge reductions granted to SMEs
• 1.1. The following total or partial reductions to the fees and charges laid down in this Regulation shall be granted to SMEs:
• 1.1.1. for a small or medium-sized enterprise, a reduction of 40 % of the applicable amount shall apply to the following fees and charges:
• (a) extension of a marketing authorisation for medicinal products for human use pursuant to Section 4 of Annex I;
• (b) major type-II variations for medicinal products for human use pursuant to Section 5 of Annex I, excluding point 5.4 of that section;
• (c) referral procedures for medicinal products for human use pursuant to points 6.4 to 6.7 of Annex I;
• (d) request for scientific advice by the Committee on Herbal Medicinal Products related to traditional herbal medicinal products pursuant to Section 7 of Annex I;
• (e) certification of compliance with Union legislation for plasma master files pursuant to Section 8 of Annex I;
• (f) certification of compliance with Union legislation regarding vaccine antigen master files (VAMF) pursuant to Section 9 of Annex I;
• (g) assessment of periodic safety update reports for medicinal products for human use pursuant to Section 14 of Annex I;
• (h) assessment of post-authorisation safety studies for medicinal products for human use pursuant to Section 15 of Annex I;
• (i) variations to the terms of a marketing authorisation requiring assessment pursuant to Section 6 of Annex II, excluding point 6.5 of that section;
• (j) referral procedures for veterinary medicinal products pursuant to points 7.4 to 7.5 of Annex II;
• (k) certification of compliance with Union legislation for VAMF pursuant to Section 8 of Annex II;
• (l) certification of compliance with Union legislation vPTMF pursuant to Section 9 of Annex II;
• (m) assessment of post-marketing surveillance studies for veterinary medicinal products pursuant to Section 10 of Annex II;
• (n) annual fee for medicinal products for human use or for veterinary medicinal products pursuant to Section 1 or 2, respectively, of Annex III;
• (o) annual pharmacovigilance fee for medicinal products for human use or veterinary medicinal products pursuant to Annex III;
• (p) transfer of a marketing authorisation to another SME, both for medicinal products for human use and veterinary medicinal products pursuant to Section 2 of Annex IV;
• 1.1.2. for a small or medium-sized enterprise, a fee reduction of 90 % of the applicable amount shall apply to a consultation on medical devices pursuant to Section 7 of Annex IV, where the medical device manufacturer has been assigned the small and medium-sized enterprise status by the Agency;
• 1.1.3. for a micro enterprise, a reduction of 100 % shall apply to the fees and charges set out in points 1.1.1. and 1.1.2.
• 1.2. The reductions set out in point 1.1 shall apply in addition to fee reductions and incentives provided for in Regulation (EC) No 2049/2005 or in the Union pharmaceutical legislation.
• 1.3. The reductions set out in point 1.1 shall not be granted to SMEs acting as applicant or marketing authorisation holder for the relevant medicinal product by virtue of a contractual arrangement with a non-SME legal entity. Such contractual arrangements shall be declared to the Agency ahead of any service listed under point 1.1.

• 1. Fee reductions applied to entities not engaged in an economic activity
• 2.1. The fees set out in Section 1 of Annex I, and Section 1 of Annex II, shall be waived where the scientific advice provided by the Agency in accordance with Article 57(1), second subparagraph, point (n), of Regulation (EC) No 726/2004 is provided to entities not engaged in an economic activity.

• 1. Applications relating to core dossier medicinal products to be used in a human pandemic situation
• 3.1. The payment of the fee for an application for a marketing authorisation of a medicinal product to be used in a human pandemic situation shall be deferred until the pandemic situation is duly recognised, either by the World Health Organization or by the Commission in accordance with Article 23(1) of Regulation (EU) 2022/2371. Such deferral shall not exceed five years.
• 3.2. In addition to the deferral provided for in point 3.1, for regulatory activities within the framework of the submission of a core dossier for a pandemic vaccine and the follow-up submission of a pandemic variation, a fee and charge reduction of 100 % shall apply in the following cases:
• (a) pre-submission activities pursuant to Section 3 of Annex IV;
• (b) scientific advice pursuant to Section 1 of Annex I;
• (c) extension of marketing authorisation pursuant to Section 4 of Annex I;
• (d) major type-II variation pursuant to Section 5 of Annex I;
• (e) annual fee pursuant to Section 1 of Annex III. Those reductions shall apply until the human pandemic situation is duly recognised.
• 3.3. Where reductions apply pursuant to point 3.2, no remuneration shall be paid to competent authorities of the Member States for the annual fees referred to in point 3.2(e).

• 1. Applications submitted under Article 30 of Regulation (EC) No 1901/2006 A 50 % fee reduction shall apply to paediatric use marketing authorisation applications submitted under Article 30 of Regulation (EC) No 1901/2006 for the following services:
• (a) initial marketing authorisation application pursuant to Section 2 of Annex I to this Regulation;
• (b) pre-authorisation inspection pursuant to Section 1 of Annex IV to this Regulation;
• (c) extension of a marketing authorisation pursuant to Section 4 of Annex I to this Regulation, in the first year from granting of the marketing authorisation;
• (d) major type-II variation pursuant to Section 5 of Annex I to this Regulation, in the first year from granting of a marketing authorisation;
• (e) annual fee pursuant to Section 1 of Annex III to this Regulation, in the first year from granting of a marketing authorisation;
• (f) post-authorisation inspection pursuant to Section 1 of Annex IV to this Regulation, in the first year from granting of a marketing authorisation.

• 1. Immunological veterinary medicinal products A fee and charge reduction of 50 % shall apply to immunological veterinary medicinal products for the following activities:
• (a) scientific advice pursuant to Section 1 of Annex II;
• (b) request for classification of a veterinary medicinal product as intended for a limited market as defined in Article 4, point (29), of Regulation (EU) 2019/6 and for consideration for eligibility for authorisation according to Article 23 of that Regulation, pursuant to Section 2 of Annex II to this Regulation;
• (c) authorisation to market veterinary medicinal products falling within the scope of the centralised marketing authorisation procedure pursuant to Article 42 of Regulation (EU) 2019/6, pursuant to Section 4 of Annex II to this Regulation;
• (d) variations to the terms of a marketing authorisation requiring assessment in accordance with Articles 64, 65 and 66 of Regulation (EU) 2019/6, pursuant to Section 6 of Annex II to this Regulation; in the specific case of point 6.5 of Annex II to this Regulation, the reduction shall apply to the variations subject to a fee and shall not apply to the variations subject to a charge;
• (e) certification of compliance with Union legislation for VAMF pursuant to Section 8 of Annex II;
• (f) certification of compliance with Union legislation for vPTMF pursuant to Section 9 of Annex II;
• (g) assessment of post-marketing surveillance studies pursuant to Section 10 of Annex II;
• (h) annual fee pursuant to Section 2 of Annex III;
• (i) pre-submission requests pursuant to Section 3 of Annex IV.

• 1. Veterinary medicinal products for limited markets
• 6.1. A fee reduction of 50 % shall apply to veterinary medicinal products classified as intended for a limited market as defined in Article 4, point (29), of Regulation (EU) 2019/6 and considered eligible for authorisation or authorised pursuant to Article 23 of that Regulation, for the following activities:
• (a) scientific advice pursuant to section 1 of Annex II to this Regulation;
• (b) establishment, modification or extension of an MRL pursuant to Section 3 of Annex II to this Regulation;
• (c) authorisation to market veterinary medicinal products falling within the scope of the centralised marketing authorisation procedure pursuant to Article 42 of Regulation (EU) 2019/6, pursuant to Article 23 of that Regulation and pursuant to point 4.1 or 4.2 of Annex II to this Regulation;
• (d) variations to the terms of a marketing authorisation requiring assessment in accordance with Articles 64, 65 and 66 of Regulation (EU) 2019/6, pursuant to Section 6 of Annex II to this Regulation; in the specific case of point 6.5 of Annex II, the reduction shall apply to the variations subject to a fee and shall not apply to the variations subject to a charge;
• (e) certification of compliance with Union legislation for VAMF pursuant to Section 8 of Annex II to this Regulation;
• (f) certification of compliance with Union legislation for vPTMF pursuant to Section 9 of Annex II to this Regulation;
• (g) assessment of post-marketing surveillance studies pursuant to Section 10 of Annex II to this Regulation;
• (h) annual fee pursuant to Section 2 of Annex III to this Regulation;
• (i) pre-submission requests pursuant Section 3 to Annex IV to this Regulation.
• 6.2. A reduction of 100 % shall apply to the fee for extension of MRL set out in Section 3 of Annex II, when such extension does not require assessment of data.

• 1. Veterinary vaccines against certain major epizootic diseases
• 7.1. A reduction of 100 % shall apply to the annual fee for vaccines against infection with bluetongue virus (serotypes 1-24), highly pathogenic avian influenza, foot and mouth disease and classical swine fever, where the vaccine is authorised under normal circumstances and the product has not been marketed within the Union at any time during the totality of the period covered by the fee.
• 7.2. Where a reduction applies pursuant to point 7.1, no remuneration shall be paid to competent authorities of the Member States for the annual fees referred to in point 7.1.

• 1. Annual fee for veterinary medicinal products A fee reduction of 25 % shall apply to the annual fee for veterinary medicinal products set out in Section 2 of Annex III, with the exclusion of those products already listed in Sections 5, 6 and 7 of this Annex.

• 1. Annual pharmacovigilance fee for generic, homeopathic and herbal medicinal products and for medicinal products authorised under provisions relating to well-established medicinal use A fee reduction of 25 % shall apply to the annual pharmacovigilance fee set out in Section 3 of Annex III for the following medicinal products:
• (a) medicinal products for human use as referred to in Article 10(1) and Article 10a of Directive 2001/83/EC;
• (b) homeopathic medicinal products for human use;
• (c) herbal medicinal products for human use;
• (d) veterinary medicinal products as referred to in Articles 18 and 22 of Regulation (EU) 2019/6;
• (e) homeopathic veterinary medicinal products;
• (f) homeopathic veterinary medicinal products registered in accordance with Article 87 of Regulation (EU) 2019/6.

ANNEX VI

Performance information

The following information relating to each calendar year shall be made publicly available on the Agency’s website:

• (1) the overall cost and breakdown of Agency staff and non-staff costs relating to the fees and charges referred to in Article 3;

• (2) number of Agency staff involved and the overall costs for obtaining and maintaining a Union authorisation to market medicinal products for human use and veterinary medicinal products and for other services of the Agency;

• (3) number of procedures for obtaining and maintaining a Union authorisation to market medicinal products for human use and veterinary medicinal products and for other services of the Agency;

• (4) number and amount of fee reductions or waivers granted per type of fee reduction or waiver under Union legislation and number of applicants or holders concerned;

• (5) attribution of rapporteurs, co-rapporteurs or persons performing other roles considered as equivalent for the purposes of this Regulation as referred to in the Annexes to this Regulation, per Member State and per type of procedure;

• (6) number of working hours spent by the rapporteur, the co-rapporteurs or persons performing other roles considered as equivalent for the purposes of this Regulation as referred to in the Annexes to this Regulation, including hours spent by experts and others employed by the competent authorities of the Member States to assist them, and number of working hours spent by experts contracted for the work of the expert panels on medical devices. Information shall be provided per type of procedure on the basis of the information provided to the Agency by the competent authorities of the Member States concerned. The types of procedure to be included shall be decided by the Management Board based on a proposal by the Agency;

• (7) 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;

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

ANNEX VII

Correlation table

[^E0001]: Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26).

[^E0002]: Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).’.

[^E0003]: Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (OJ L 189, 27.6.2014, p. 112).

[^E0004]: Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 35, 15.2.1995, p. 1).