Annexes to COM(2023)193 - Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency - Main contents
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| dossier | COM(2023)193 - Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing ... |
|---|---|
| document | COM(2023)193  |
| date | April 26, 2023 |
EUR million (to three decimal places)
| Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | Enter as many years as necessary to show the duration of the impact (see point 1.6) | TOTAL | |||||
| DG: SANTE | ||||||||||
| Human resources | ||||||||||
| Other administrative expenditure | ||||||||||
| TOTAL DG <…….> | Appropriations |
| TOTAL appropriations under HEADING 7 of the multiannual financial framework | (Total commitments = Total payments) |
EUR million (to three decimal places)
| Year 2024 | Year 2025 | Year 2026 | Year 2027 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | TOTAL | ||||
| TOTAL appropriations under HEADINGS 1 to 7 of the multiannual financial framework | Commitments | 1.172 | 3.196 | 4.368 | |||||
| Payments | 1.172 | 3.196 | 4.368 |
3.2.2. Estimated output funded with operational appropriations
Commitment appropriations in EUR million (to three decimal places)
| Indicate objectives and outputs | Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | TOTAL | ||||||||||||||
| OUTPUTS | |||||||||||||||||||
| Type0 | Average cost | No | Cost | No | Cost | No | Cost | No | Cost | Total No | Total cost | ||||||||
| Specific objective 1. Promote innovation, in particular for unmet medical needs, including for rare disease patients and children. | |||||||||||||||||||
| Support to “not-for-profit” entities | 1.172 | 3.196 | 4.368 | ||||||||||||||||
| Subtotal for specific objective No 1 | 1.172 | 3.196 | 4.368 | ||||||||||||||||
| TOTALS | 1.172 | 3.196 | 4.368 | ||||||||||||||||
| - Output | |||||||||||||||||||
3.2.3. Estimated impact on EMA’s human resources
- The proposal/initiative does not require the use of appropriations of an administrative nature
- The proposal/initiative requires the use of appropriations of an administrative nature, as explained below:
EUR million (to three decimal places)
| Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | TOTAL |
| Temporary agents (AD Grades) | 0.781 | 0.797 | 1.578 | ||
| Temporary agents (AST grades) | 0.391 | 0.399 | 0.790 | ||
| Contract staff | |||||
| Seconded National Experts |
| TOTAL | 1.172 | 1.196 | 2.368 |
Staff requirements (FTE): Total posts Union funded and funded from fees
| Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | TOTAL |
| Temporary agents (AD Grades) | 13 | 22 | 33 | 40 | 40 |
| Temporary agents (AST grades) | 6 | 15 | 19 | 20 | 20 |
| Contract staff | |||||
| Seconded National Experts |
| TOTAL | 19 | 37 | 52 | 60 | 60 |
The appropriations required for human resources and other expenditure of an administrative nature will be met by appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
3.2.3.1. Estimated requirements of human resources
- The proposal/initiative does not require the use of human resources.
- The proposal/initiative requires the use of human resources, as explained below:
Estimate to be expressed in full time equivalent units
| Year 2024 | Year 2025 | Year 2026 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | |||||
| Establishment plan posts (officials and temporary staff) | |||||||||
| 20 01 02 01 (Headquarters and Commission’s Representation Offices) | |||||||||
| 20 01 02 03 (Delegations) | |||||||||
| 01 01 01 01 (Indirect research) | |||||||||
| 01 01 01 11 (Direct research) | |||||||||
| Other budget lines (specify) | |||||||||
| External staff (in Full Time Equivalent unit: FTE)0 | |||||||||
| 20 02 01 (AC, END, INT from the ‘global envelope’) | |||||||||
| 20 02 03 (AC, AL, END, INT and JPD in the delegations) | |||||||||
| XX 01 xx yy zz 0 | - at Headquarters | ||||||||
| - in Delegations | |||||||||
| 01 01 01 02 (AC, END, INT - Indirect research) | |||||||||
| 01 01 01 12 (AC, END, INT - Direct research) | |||||||||
| Other budget lines (specify) | |||||||||
| TOTAL |
The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
Description of tasks to be carried out from the FTE, funded by Union contribution:
| Officials and temporary staff | The requested FTE (4 AD and 2 AST) are necessary to set up the Academia Office at EMA that will be managing the procedures. The tasks of the office will be similar to the tasks of the SME office and will include procedural and administrative assistance to “not-for-profit” entities, including direct assistance and briefing meetings on regulatory strategy, providing fee waivers and reductions to eligible entities, provide free-of-charge translations of the product information in all EU languages for initial EU marketing authorisations, provide training and education to “not-for-profit” entities, etc |
| External staff |
3.2.4. Description of tasks to be carried out from the FTE, funded by EMA fees:
| Officials and temporary staff | The requested staff (54 FTE) will be: - managing (AD profiles) and providing support (AST profiles) to operational expert groups in the area of the Environmental Risk Assessment (ERA); - with a scientific and regulatory profile to work in the shortages management and security of supply; - Good Manufacturing Practice and Good Clinical Practice inspectors (AD) necessary to establish an EU inspectorate resourced by EMA staff that would provide help to the inspections done by Member States (lacking resources), and deal with emergency situations which require dedicated and dependable intervention (e.g., similar to inspections required during the pandemic); - Legal officers (AD profiles), needed in the field of orphan designations that are already today a litigious topic and so it is assumed the proposed changes in the decision making on orphan designation would generate an increased in workload for even more legal queries and litigations; - defining business requirements for the data register, following up on the implementation and perform the related scientific activities when the register is live;, develop trainings on ERA, etc.; - providing administrative support to the operational expert groups; - working in the area of inspection planning; - general assistants, assistants, supporting on procedural aspects or working on document creation. |
| External staff |
3.2.5. Compatibility with the current multiannual financial framework
The proposal/initiative:
- can be fully financed through redeployment within the relevant heading of the Multiannual Financial Framework (MFF).
The increase of appropriations for EMA budget line 06.100302 in years 2026 and 2027 by 4.4 million EUR, will be done via internal redeployment within heading 2b, i.e. by an equal reduction of the EU4Health budget line 06.0601 for this period.
- requires use of the unallocated margin under the relevant heading of the MFF and/or use of the special instruments as defined in the MFF Regulation.
Explain what is required, specifying the headings and budget lines concerned, the corresponding amounts, and the instruments proposed to be used.
- requires a revision of the MFF.
Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts.
3.2.6. Third-party contributions
The proposal/initiative:
- does not provide for co-financing by third parties
- provides for the co-financing by third parties estimated below:
Appropriations in EUR million (to three decimal places)
| Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | Enter as many years as necessary to show the duration of the impact (see point 1.6) | Total | |||
| Specify the co-financing body | ||||||||
| TOTAL appropriations co-financed |
3.3. Estimated impact on revenue
- The proposal/initiative has no financial impact on revenue.
- The proposal/initiative has the following financial impact:
- on own resources
- on other revenue
- please indicate, if the revenue is assigned to expenditure lines ◻
EUR million (to three decimal places)
| Budget revenue line: | Appropriations available for the current financial year | Impact of the proposal/initiative0 | ||||||
| Year 2024 | Year 2025 | Year 2026 | Year 2027 and subsequent years | Enter as many years as necessary to show the duration of the impact (see point 1.6) | ||||
| Article …………. |
For assigned revenue, specify the budget expenditure line(s) affected.
Other remarks (e.g. method/formula used for calculating the impact on revenue or any other information).
1Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States (OJ C 269, 23.07.2016, p. 31). Council conclusions on access to medicines and medical devices for a stronger and resilient EU, 2021/C 269 I/02 (OJ C 269I, 7.7.2021, p. 3).
2European Parliament resolution of 2 March 2017 on EU options for improving access to medicine (2016/2057(INI), European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (2020/2071(INI).
3Communication from the Commission, Pharmaceutical Strategy for Europe (COM/2020/761 final), https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe_en.
4Mission letter of the President of the European Commission to Stella Kyriakides,
Commissioner for Health and Food Safety, mission-letter-stella-kyriakides_en.pdf (europa.eu)
5Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
6Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
7Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
8Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).
9Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
10Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (OJ L 109, 30.4.2009, p. 10).
11Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
12Regulation (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).
13Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products, and Regulation (EU) No 658/2014 of the European Parliament and of the Council on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (OJ L 35, 15.2.1995, p. 1).
14Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, and Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells(OJ L 033, 8.2.2003, p. 30).
15Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1) and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
16Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1).
17Communication from the Commission, Europe's Beating Cancer Plan (COM/2021/44 final).
18Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1).
19Communication from the Commission, Making the most of the EU’s innovative potential. An intellectual property action plan to support the EU’s recovery and resilience (COM/2020/760 final).
20Communication from the Commission, A European One Health Action Plan against Antimicrobial Resistance (AMR), https://ec.europa.eu/health/system/files/2020-01/amr_2017_action-plan_0.pdf.
21Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, p. 1).
22Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8).
23European Health Union - Protecting the health of Europeans and collectively responding to cross-border health crises,
https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-way-life/european-health-union_en.
24Communication from the Commission. The European Green Deal. COM(2019) 640 final.
25Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).
26Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334 17.12.2010, p. 17).
27Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1) and Directive 2013/39/EU of the European Parliament and of the Council of 12 August 2013 amending Directives 2000/60/EC and 2008/105/EC as regards priority substances in the field of water policy Text with EEA relevance (OJ L 226, 24.8.2013, p. 1).
28Strategic Approach to Pharmaceuticals in the Environment,
https://ec.europa.eu/environment/water/water-dangersub/pharmaceuticals.htm.
29Communication from the Commission, A European Health Data Space: harnessing the power of health data for people, patients and innovation (COM(2022) 196 final).
1Commission staff working document, Impact Assessment, Annex 5: Evaluation.
2Evaluation of the medicines for rare diseases and children legislation,
https://health.ec.europa.eu/medicinal-products/medicines-children/evaluation-medicines-rare-diseases-and-children-legislation_en.
3ICH – harmonisation for better health, https://www.ich.org/.
4Commission staff working document, Impact Assessment, Annex 2: Stakeholder Consultation (Synopsis Report).
5Commission staff working document, Impact Assessment.
1Council Decision of 20 May 1975 setting up a pharmaceutical committee (75/320/EEC).
2OJ C , , p. .
3OJ C , , p. .
4Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
5Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).
6Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 1).
7Report from the Commission to the European Parliament and the Council on the experience acquired with the procedures for authorising and supervising medicinal products for human use, in accordance with the requirements set out in the EU legislation on medicinal products for human use, COM(2021)497 final.
8Council Regulation (EEC) No 1647/2003 of 18 June 2003 amending Regulation (EEC) No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of Medicinal Products (OJ L 245, 29.9.2003, p. 19).
9Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, p. 1).
10Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
11Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
12Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
13Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
14https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf
15Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
16Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
17Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
18Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (OJ L 125, 21.5.2009, p. 75).
19Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
20Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
21Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
22Regulation (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).
23Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
24OJ L 123, 12.5.2016, p. 1.
25Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, p. 10).
26Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93 (OJ L 286, 8.11.1996, p. 6).
27Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (OJ L 329, 16.12.2005, p. 4).
28Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 92, 30.3.2006, p. 6).
29Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, p. 7).
1[Name of revised Directive 2001/83/EC, date (OJ L XX, XX.XX.XXX, p. X).]
2Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1).
1Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ L 154, 16.6.2017, p. 1).
2Regulation (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).
3Regulation (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).
1Regulation (EC) No 469/2009 of the European Parliament and of the Council, (OJ L 152, 16.6.2009, p. 1).
1Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ L 238, 16.9.2017, p. 44).
1Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
1Regulation [XXX] of the European Parliament and of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) 2017/745 of the European Parliament and of the Council and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 of the European Parliament and of the Council [OJ L X, XX.XX.XXXX, p. X].
1Regulation [XXX] of the European Parliament and of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) 2017/745 of the European Parliament and of the Council and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 of the European Parliament and of the Council [OJ L X, XX.XX.XXXX, p. X].
1Regulation No 31 (EEC), 11 (EAEC) by the Council of the European Economic Community and by the Council of the European Atomic Energy Community, laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Economic Community and the European Atomic Energy Community (OJ 45, 14.6.1962, p. 1385).
2Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
3Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (OJ L 122, 10.5.2019, p. 1).
4Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).
5Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-fraud Office (OLAF) (OJ L 136, 31.5.1999, p. 15).
6Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).
7Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1).
8Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union's financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29).
9Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41).
10Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53).
11Council 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).
12Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ L 305, 26.11.2019, p. 17).
13Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).
1Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom (OJ L 180, 9.7.1997, p. 22).
2Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation (OJ L 159, 29.6.1996, p. 1).
3Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
4Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 033, 8.2.2003, p. 30).
5Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14).
1Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (OJ L 65, 8.3.2013, p. 17).
2Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts 'similar medicinal product' and 'clinical superiority' (OJ L 103, 28.4.2000, p. 5).
0Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).
0As referred to in Article 58(2), point (a) or (b), of the Financial Regulation.
0Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx
0Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.
0EFTA: European Free Trade Association.
0Candidate countries and, where applicable, potential candidates.
0For 2026 the total amount covers the costs for 6 TAs. For 2027 the total amount covers the costs for 6 TAs (1.196 million EUR) and the costs for the incentives to “not-for-profit” entities (2 million EUR).
0Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
0Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).
0AC= Contract Staff; AL = Local Staff; END= Seconded National Expert; INT = agency staff; JPD= Junior Professionals in Delegations.
0Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).
0As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 20 % for collection costs.
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