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dossier COM(2023)193 - Procedures van de Unie voor het verlenen van vergunningen en het toezicht met betrekking tot geneesmiddelen voor menselijk ...
document COM(2023)193 EN
datum 26 april 2023
Annex to the Legislative Financial Statement (Annex V to the internal rules), which is uploaded to DECIDE for interservice consultation purposes.

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 
Commitments1.1723.1964.368
Payments1.1723.1964.368


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
Type 102

Average costNoCostNoCostNoCostNoCostTotal NoTotal 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

1.1723.1964.368
Subtotal for specific objective No 11.1723.1964.368
TOTALS1.1723.1964.368
- 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)0.7810.7971.578
Temporary agents (AST grades)0.3910.3990.790
Contract staff
Seconded National Experts

TOTAL1.1721.1962.368


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)1322334040
Temporary agents (AST grades)615192020
Contract staff
Seconded National Experts

TOTAL1937526060


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 2026Year N+3Enter 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) 103

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   104

- 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

XX is the policy area or budget title concerned.

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 staffThe 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 staffThe 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 yearImpact of the proposal/initiative 105
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).


(1) Council 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).
(2) European 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) .
(3) Communication from the Commission, Pharmaceutical Strategy for Europe (COM/2020/761 final), https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe_en .
(4) Mission 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)
(5) Directive 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).
(6) Regulation (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).
(7) Regulation (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).
(8) Regulation (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).
(9) Regulation (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).
(10) Directive 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).
(11) Regulation (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).
(12) 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).
(13) Council 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).
(14) Directive 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).
(15) Regulation (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).
(16) Regulation (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).
(17) Communication from the Commission, Europe's Beating Cancer Plan (COM/2021/44 final).
(18) Regulation (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).
(19) Communication 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).
(20) Communication 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 .
(21) Regulation (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).
(22) Council 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).
(23) European 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 .
(24) Communication from the Commission. The European Green Deal. COM(2019) 640 final.
(25) Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).
(26) Directive 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).
(27) Directive 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).
(28) Strategic Approach to Pharmaceuticals in the Environment,      https://ec.europa.eu/environment/water/water-dangersub/pharmaceuticals.htm .
(29) Communication from the Commission, A European Health Data Space: harnessing the power of health data for people, patients and innovation (COM(2022) 196 final).
(30) Commission staff working document, Impact Assessment, Annex 5: Evaluation. 
(31) Evaluation 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 .
(32) ICH – harmonisation for better health, https://www.ich.org/ .
(33) Commission staff working document, Impact Assessment, Annex 2: Stakeholder Consultation (Synopsis Report).
(34) Commission staff working document, Impact Assessment.
(35) Council Decision of 20 May 1975 setting up a pharmaceutical committee (75/320/EEC).
(36) OJ C , , p. .
(37) OJ C , , p. .
(38) Regulation (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).
(39) Regulation (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).
(40) Regulation (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).
(41) Report 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.
(42) Council 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).
(43) Regulation (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).
(44) Regulation (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).
(45) Directive 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).
(46) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
(47) Regulation (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).
(48) https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf
(49) Directive 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).
(50) Regulation (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).
(51) Directive 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).
(52) Directive 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).
(53) Regulation (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).
(54) Regulation (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).
(55) Regulation (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).
(56) 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).
(57) Regulation (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).
(58) OJ L 123, 12.5.2016, p. 1.
(59) Commission 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).
(60) Commission 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).
(61) Commission 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).
(62) Commission 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).
(63) Commission 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).
(64) [Name of revised Directive 2001/83/EC, date (OJ L XX, XX.XX.XXX, p. X).]
(65) Regulation (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).
(66) Regulation (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).
(67) 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).
(68) 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).
(69) Regulation (EC) No 469/2009 of the European Parliament and of the Council, (OJ L 152, 16.6.2009, p. 1).
(70) Commission 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).
(71) Regulation (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).
(72) Regulation [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].
(73) Regulation [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].
(74) Regulation 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).
(75) Regulation (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).
(76) Commission 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).
(77) Regulation (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).
(78) Interinstitutional 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).
(79) Council 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).
(80) Council 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).
(81) Directive (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).
(82) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41).
(83) Commission 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).
(84) 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).
(85) Directive (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).
(86) Directive (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).
(87) Council 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).
(88) Council 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).
(89) 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 102, 7.4.2004, p. 48).
(90) Directive 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).
(91) Directive 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).
(92) Commission 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).
(93) Commission 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).
(94) Regulation (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).
(95) As referred to in Article 58(2), point (a) or (b), of the Financial Regulation.
(96) Details 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  
(97) Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.
(98) EFTA: European Free Trade Association.
(99) Candidate countries and, where applicable, potential candidates.
(100)    For 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).
(101)    Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.
(102)    Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).
(103)    AC= Contract Staff; AL = Local Staff; END= Seconded National Expert; INT = agency staff; JPD= Junior Professionals in Delegations.
(104)    Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).
(105)    As 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.
Top


EUROPEAN COMMISSION

Brussels, 26.4.2023

COM(2023) 193 final


ANNEXES

to the proposal for a

Regulation of the European Parliament and of the Council

laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

{SEC(2023) 390 final} - {SWD(2023) 192 final} - {SWD(2023) 193 final} - {SWD(2023) 194 final}


ANNEX I

MEDICINAL PRODUCTS TO BE AUTHORISED BY THE UNION

1.Medicinal products developed by means of one of the following biotechnological processes:

–recombinant nucleic acid technology;

–controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells.

2.Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007.

3.Medicinal products for human use containing an active substance which on 20 May 2004 was not authorised in the Union, excluding allergen products or herbal medicinal products, which shall in any case not be authorised by the Union. 

4.Medicinal products that are designated as orphan medicinal products pursuant to this Regulation.

5.Medicinal products authorised in accordance with a paediatric use marketing authorisation.

6.Priority antimicrobials as referred to in Article 40.

ANNEX II

LIST OF THE OBLIGATIONS REFERRED TO IN ARTICLE 172

(1)the obligation to submit complete and accurate particulars and documentation in an application for marketing authorisation submitted to the Agency or in response to obligations laid down in this Regulation to the extent that the failure to comply with the obligation concerns a material particular;

(2)the obligation to comply with conditions or restrictions included in the marketing authorisation and concerning the supply or use of the medicinal product for human use, as referred to in Article 12 (4), point (c) and in Article 13(1) fourth subparagraph;

(3)the obligation to comply with conditions or restrictions included in the marketing authorisation with regard to the safe and effective use of the medicinal product for human use as referred to in Article 12(4), points (b), (d), (e), (f) and (g) and in Article 13(1);

(4)the obligation to introduce any necessary variation to the terms of the marketing authorisation to take account of technical and scientific progress and enable the medicinal products for human use to be manufactured and checked by means of generally accepted scientific methods, as provided for in Article 45(1);

(5)the obligation to supply any new information which may entail a variation to the terms of the marketing authorisation, to notify any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product for human use is marketed, or to supply any information that may influence the evaluation of the risks and benefits of the product, as provided for in Article 45(2);

(6)the obligation to keep product information up to date with current scientific knowledge, including the conclusions of the assessment and recommendations made public on the European medicines web-portal, as provided for in Article 45(3);

(7)the obligation to provide, at the request of the Agency, any data demonstrating that the benefit-risk balance remains favourable, as provided for in Article 45(4);

(8)the obligation to place the medicinal product for human use on the market in accordance with the content of the summary of product characteristics and the labelling and package leaflet as contained in the marketing authorisation;

(9)the obligation to comply with the conditions referred to in Article 18(1) and Article 19;

(10)the obligation to notify the Agency of the dates of actual marketing and of the date when the medicinal product for human use ceases to be on the market, and to provide to the Agency data relating to the volume of sales and the volume of prescriptions of the medicinal product for human use, as provided in Article 16(4);

(11)the obligation to operate a comprehensive pharmacovigilance system for the fulfilment of pharmacovigilance tasks, including the operation of a quality system, maintenance of a pharmacovigilance system master file and performance of regular audits, in accordance with Article 99 in conjunction with Article 99 of [revised Directive 2001/83/EC];

(12)the obligation to submit, at the request of the Agency, a copy of the pharmacovigilance system master file, as provided for in Article 45(4);

(13)the obligation to operate a risk management system as provided for in Article 22 and Article 99(2) in conjunction with Article 99(4) of [revised Directive 2001/83/EC];

(14)the obligation to record and report suspected adverse reactions for medicinal products for human use, in accordance with Article 106 (1) in conjunction with Article 105 of [revised Directive 2001/83/EC];

(15)the obligation to submit periodic safety update reports, in accordance with Article 106(2) in conjunction with of [revised Directive 2001/83/EC];

(16)the obligation to conduct post-marketing studies, including post-authorisation safety studies and post-authorisation efficacy studies, and to submit them for review, as provided for in Article 20;

(17)the obligation to ensure that public announcements relating to information on pharmacovigilance concerns are presented objectively and are not misleading and to notify them to the Agency, as provided for in Articles 104 of [revised Directive 2001/83/EC];

(18)the obligation to comply with the time limits for initiating or completing measures specified in the Agency’s decision on deferral following the initial marketing authorisation of the medicinal product for human use concerned and in accordance with the definitive opinion referred to in Article 81(2);

(19)the obligation to submit to the Agency an updated version of the paediatric investigation plan in accordance with the agreed timing as provided for in Article 74(2) and Article 74(3);

(20)the obligation to place the medicinal product for human use on the market within two years of the date on which the paediatric indication is authorised, as provided for in Article 59 of [revised Directive 2001/83/EC];

(21)the obligation to notify the Agency the intention to discontinue the placing on the market of the product no less than six months before the discontinuation as provided for in Article 60 of [revised Directive 2001/83/EC];

(22)the obligation to transfer the marketing authorisation or to allow a third party to use documentation contained in the file of the medicinal product, as provided for in Article 60 of [revised Directive 2001/83/EC];

(23)the obligation to notify the Agency of the intention to discontinue the conduct of an agreed paediatric investigation plan and provide the reasons for such discontinuation no less than six months before the discontinuation as provided in Article 88;

(24)the obligation to submit paediatric studies to the Agency or to the Member States, including the obligation to enter information on third country clinical trials into the European database, as provided for in Articles 91;

(25)the obligation to submit to the Agency a paediatric investigation plan with a request for agreement or an application for a waiver from it, not later than upon completion of the human pharmaco-kinetic studies in adults, except in duly justified cases, as provided for in Article 76(1).

ANNEX III

PROCEDURE AND CRITERIA GOVERNING INSPECTIONS CARRIED OUT BY THE AGENCY

Reasoned request by the competent authority

The supervisory authority may submit after consultation with the Agency, a reasoned request to the Agency to carry out an inspection or to participate with its inspectors to an inspection carried out of a site located in a third country. The reasoned request should specify:

–The precise identification of the site, the scope of the inspections and if relevant the concerned products;

–The timeline for this inspection to be completed;

–The reasons for requesting the support of the Agency, by reference to the criteria set out in this Annex.

The Agency may refuse an inspection request after consideration of the request, the scope and availability of internal inspection capacity.

Assessment by the Agency

The Agency decides whether it accepts to carry out such inspection or to participate with its inspectors in such inspection, based on the following criteria:

–The site is located in a non-EU/EEA country;

–The inspection is in the interest of the Union, when one or more of the following situations apply to ensure faster or continuous access to medicines of patients:

–to prevent, mitigate or address shortages of medicinal products or their active substances or other supply issues;

–to prevent, mitigate or address a possible threat to public health, a public health emergency or a major event which requires immediate action;

–to address a suspicion of non-compliance of the manufacturing site;

–to enable the process of granting of the marketing authorisation for centrally authorised products/emergency use authorisation and for their active substance master files;

–to improve the oversight of medicines production worldwide;

–to address serious challenges of an unexpected and temporary nature with inspections capacities at national level;

–other relevant situations.

The compilation of Union procedures on inspections and exchange of information referred to in Article 3(1) of Directive 2017/1572 might be updated to cover rules applicable to situations where the Agency may be requested to carry out an inspection or to participate in a joint inspection.

In the context of inspections referred under Article 78 of Regulation (EU) 536/2014, the above criteria apply mutatis mutandis.

ANNEX IV

AVAILABILITY


Part I

Information to be provided in case of a suspension or cessation of marketing of a medicinal product or withdrawal of the marketing authorisation of a medicinal product

For the purpose of the notification in accordance with Article 116(1), points (a), (b) and (c), the marketing authorisation holder shall notify the following minimum set of information:

(1)Product details:

(a)Product name;

(b)Active substance(s) and active substance supplier(s);

(c)Finished product manufacturer;

(d)Anatomical Therapeutic Chemical (ATC)code;

(e)Therapeutic indication(s);

(f)Pharmaceutical form;

(g)Strength(s);

(h)Route(s) of administration;

(i)Affected pack size(s);

(j)Alternative, pharmaceutical form, strength, route of administration or pack size, not affected by the suspension, cessation or withdrawal;

(k)Details of authorisation: procedure type (national (including Member State(s) involved)/ centralised marketing authorisation) and reference;

(l)Member States in which the product is placed on the market.


(2)Details of action (suspension, cessation or withdrawal):

(a)Category of action (suspension, cessation or withdrawal);

(b)Available stock up to start date of action;

(c)Start date of action, per Member State;

(d)Reason for action and information on alternative medicinal product(s), where relevant;

(e)Impacted EU/ EEA countries;

(f)Reference to pending regulatory action, Rapid Alert (quality/ safety) or Quality Defect Report related to the action, if relevant;

(g)Other competent authorities notified;

(h)Any actions completed or planned based on a request of the competent authorities of the Member State concerned.


(3)Contact details

(a)Marketing authorisation holder name and address;

(b)Name and contact details of person notifying.


Part II 

Risk assessment of impact of suspension, cessation or withdrawal

For the purpose of the request made by the competent authority concerned in accordance with Article 118(2), the marketing authorisation holder shall notify at least the following information:

(1)Risk assessment of impact of suspension, cessation or withdrawal, including:

(a)Potential alternative medicinal products;

(b)Estimated market share per Member State in previous 12 months;

(c)Quantities delivered per month per Member State in previous 12 months;

(d)Manufacturing capacity globally per manufacturing site;

(e)Forecast of supply per month and per Member State until suspension, cessation or withdrawal occurs;

(f)Forecast of demand per month and per Member State in next 6 months;

(g)Impact on the supply of other medicinal products from the same marketing authorisation holder;

(h)Potential impact on the consumption of or demand for other medicinal products.

(2)Any risk-mitigating measures taken by the marketing authorisation holder to address the shortage.

Part III

Information to be provided in case of a temporary disruption of supply (to monitor potential or actual shortage)

For the purpose of the notification in accordance with Article 116(1), point (d) the marketing authorisation holder shall notify the following information:

(1)Product details

(a)Product name;

(b)Active substance(s) and active substance manufacturer(s);

(c)Finished product manufacturer;

(d)Therapeutic indication(s);

(e)ATC code;

(f)Pharmaceutical form;

(g)Strength(s);

(h)Route(s) of administration;

(i)Affected pack size;

(j)Alternative, pharmaceutical form, strength, route of administration or pack size, not affected by the supply disruption;

(k)Details of authorisation: procedure type (national (including Member State(s) involved)/ centralised marketing authorisation) and reference;

(l)Member States in which the product is placed on the market.


(2)Details of supply disruption

(a)Shortage status (actual, potential);

(b)Available stock per month

(c)Expected start date of shortage by Member State;

(d)Expected end date of shortage by Member State;

(e)Reason for shortage;

(f)Impacted EU/ EEA countries and where available other impacted countries;

(g)Reference to pending regulatory action, Rapid Alert (quality/ safety) or Quality Defect Report related to the action, if relevant;

(h)Other competent authorities notified;

(i)Any actions completed or planned based on a request of competent authorities of Member State concerned.

(3)Contact details

(a)Marketing authorisation holder name and address;

(b)Name and contact details of person notifying.


Part IV

The Shortage Mitigation Plan

For the purpose of the request made by the competent authority concerned in accordance with Article 118(2), the marketing authorisation holder shall notify at least the following information:

1.Shortage mitigation plan, detailing the risk assessment of impact of shortage, including, where available:

(a)Potential alternative medicinal products;

(b)Estimated market share by Member State in previous 12 months;

(c)Quantities delivered per month per Member State, in previous 12 months;

(d)Manufacturing capacity globally per manufacturing site;

(e)Forecast of supply per month and per Member State for the duration of the shortage,

(f)Forecast of demand per month and per Member State for the duration of the shortage;

(g)Impact on the supply of other medicinal products from the same marketing authorisation holder;

(h)Potential impact on the consumption of or demand for other medicinal products;

(i)Any risk-mitigating measures taken or planned by the marketing authorisation holder to address the shortage.


Part V

The shortage prevention plan

The Shortage Prevention Plan referred to in Article 117 shall contain the following minimum set of information:

(1)Product details:

(a)Product name;

(b)Active substance(s) and active substance manufacturer(s);

(c)Finished product manufacturer;

(d)ATC code;

(e)Therapeutic indication(s);

(f)Pharmaceutical form;

(g)Strength(s);

(h)Route(s) of administration;

(i)Pack size(s);

(j)Details of authorisation: procedure type (national (including Member State(s) involved)/ centralised marketing authorisation) and reference;

(k)Member States in which the product is placed on the market.

(2)Shortage prevention measures and supply chain risk assessment:

(a)Alternative marketed medicinal products;

(b)Supply chain map, with risk identification and analysis with particular attention to supply chain vulnerabilities;

(c)Shortage management measures, to include:

(i)a risk control strategy in place, to include information on strategies to minimise risks of shortages and how these are implemented;

(ii)a process for the detection and notification of supply disruptions and

(iii)a record of root causes of resolved shortages and mitigation measures taken for those shortages.

(d)Process for check of effectiveness, review and update of the shortage prevention plan.

(3)Contact details

(a)Marketing authorisation holder name and address;

(b)Name and details of contact person.


ANNEX V

CORRELATION TABLE

Regulation (EC) No 726/2004Directive 2001/83/ECRegulation (EC) No 141/2000Regulation (EC) No 1901/2006This Regulation
Art. 1Art. 1
Art. 2Art. 2Art. 2Art. 2
Art. 3(1)Art. 3(1)
Art. 3(2), point (b)Art. 3(2), introductory sentence and point (a)
Art. 3(2), point (b)
Art. 4(2)Art. 3(4)
Art. 3(3), introductory sentence, points (a) and (b)Art. 4
Art. 2, 4th subparagraphArt. 5(1)
Art. 5(2-7)
Art. 6(1)Art. 6(1)
Art. 6(2)
Art. 6(1), 2nd subparagraphArt. 6(3)
Art. 6(4) and (5)
Art. 6(3)Art. 6(6)
Art. 14(9)Art. 6(7)
Art. 14(9), 1st subparagraph, 2nd sentenceArt. 6(7), 1st subparagraph
Art. 14(9), 2nd subparagraphArt. 6(7), 2nd subparagraph
Art. 7
Art. 8
Art. 9
Art. 7Art. 10, paragraph 1, points (a) and (b)
Art. 10, paragraph 2
Art. 8(1)Art. 11(1)
Art. 8(2), 1st and 2nd subparagraphArt. 11(2), 1st and 2nd subparagraph
Art. 11(2), 3rd subparagraph
Art. 9(1)Art. 12(1)
Art. 9(2), 1st subparagraphArt. 12(2), 1st subparagraph
Art. 62(1), 5th subparagraph, 2nd sentenceArt. 12(2), 2nd subparagraph
Art. 9(2), 2nd subparagraphArt. 12(2), 3rd subparagraph
Art. 9(3)Art. 12(3)
Art. 9(4)Art. 12(4)
Art. 14(10)Art. 12(5)
Art. 10(1)Art. 13(1)
Art. 10Art. 13(2-4)
Art. 11Art. 14
Art. 12Art. 15
Art. 13Art. 16
Art. 14(1)Art. 17(1)
Art. 14(2)Art. 17(2)
Art. 14(8)Art. 18
Art. 14-a(1)Art. 19(1)
Art. 14-a(3) to (9)Art. 19(2) to (8)
Art. 10aArt. 20
Art. 10bArt. 21
Art. 14aArt. 22
Art. 15Art. 23
Art. 14b(1)Art. 24(1), 1st subparagraph
Art. 24(1), 2nd subparagraph
Art. 14b(2) and (3)Art. 24(2) and (3)
Art. 24(4)
Art. 82(1)Art. 25(1), 1st and 2nd subparagraph
Art. 25(1), 3rd subparagraph
Art. 82(2) and (3)Art. 25(2) and (3)
Art. 83(1)Art. 26(1)
Art. 26(1), 2nd sentence
Art. 83(2-3)Art. 26(2) and (3)
Art. 83(4), 1st subparagraphArt. 26(4), 1st subparagraph
Art. 26(4), 2nd to 4th subparagraph
Art. 83(5) to (9)Art. 26(5) to (9)
Art. 26(10)
Art. 5(3), 1st and 2nd sentenceArt. 27, 1st subparagraph 
Art. 27, 2nd subparagraph
Art. 81Art. 28
Art. 14(11)Art. 29
Art. 30
Art. 31
Art. 32
Art. 33
Art. 34
Art. 35
Art. 36
Art. 37
Art. 38
Art. 39
Art. 40
Art. 41
Art. 42
Art. 43
Art. 44
Art. 16(1), (2) and (3)Art. 45(1), (2) and (3)
Art. 16(3a), 1st subparagraphArt. 45(4), 1st subparagraph, 1st and 2nd sentence
Art. 45(4), 1st subparagraph, 3rd sentence
Art. 16(3a), 2nd subparagraphArt. 45(4), 2nd subparagraph
Art. 46
Art. 47(1)
Art. 16a(1)Art. 47(2)
Art. 16a(2)Art. 47(3), 1st and 2nd sentence
Art. 47(3), 3rd sentence
Art. 47(4), point (a)
Art. 16(3)Art. 47(4), points (b) and (c)
Art. 47(4), points (d) and (e)
Art. 48
Art. 16bArt. 49
Art. 18Art. 50
Art. 19(1), 1st subparagraphArt. 51(1), 1st subparagraph
Art. 51(1), 2nd subparagraph
Art. 19(1), 2nd subparagraphArt. 51(1), 3rd subparagraph
Art. 19(2) and (3)Art. 51(2) and (3)
Art. 52
Art. 53
Art. 54
Art. 20Art. 55
Art. 20aArt. 56
Art. 127aArticle 57
Art. 58
Art. 59
Art. 60
Art. 61
Art. 62
Article 3(1), (a) 1st subparagraph and (b)Art. 63(1)
Art. 63(2)
Article 3(2)Art. 63(3)
Article 5(1)Art. 64(1)
Article 5(2)Art. 64(2), 1st subparagraph
Art. 64(2), 2nd subparagraph
Article 5(3)

Art. 64(3)
Article 5(4) and 5(5)Art. 64(4)
Art. 64(5)
Article 5(11)Art. 65
Art. 66
Article 5(9)Art. 67
Art. 6(1)Art. 68(1), introductory sentence, point (a)
Art. 68(1), points (b) and (c)
Article 9(1)Article 68(2)
Art. 7Art. 69
Art. 70
Art. 8(1)Art. 71(1)
Art. 71(2) to (3) and (5) and (6)
Art. 8(5)Art. 71(7)
Art. 8(3)Art. 71(4)
Article 72
Article 7(2)Article 73
Art. 15(2)Art. 74(1)
Art. 74(2), (3) and (4)
Art. 11Art. 75(1) and (2)
Art. 75(3)
Art. 16Art. 76(1), (2) and (3)
Art. 76(4)
Art. 17(1) and (2)Art. 77(1)
Art. 77(2) to (6)
Art. 12 13 14(2) and 14 (3)Art. 78
Art. 14(1)Art. 79
Art. 19Art. 80
Art. 20(1)Art. 81(1) and (2)
Art. 81 (3)
Art. 20(2)Art. 81(4)
Art. 82
Art. 82(3)
Art. 83
Art. 22, 1st sentenceArt. 84(1), 1st sentence
Art. 84(1), 2nd sentence
Art. 84(2) and (3)
Art. 10Art. 85(1)
Art. 85(2)
Art. 23(1)Art. 86
Art. 25Art. 87
Art. 88
Art. 26Art. 89
Art. 28Art. 90
Art. 46Art. 91
Art. 30Art. 92
Art. 38(1)Art. 93
Art. 41Art. 94
Art. 44Art. 95
Art. 39(1) and Art. 40(1)Art. 96
Art. 47(1)Art. 97(1)
Art. 47(3)Art. 97(2)
Art. 48Art. 97(3)
Art. 50(1)Art. 98, introductory sentence
Art. 98, points (a) to (h)
Art. 21Art. 99
Art. 22Art. 100
Art. 24Art. 101
Art. 25Art. 102
Art. 25aArt. 103
Art. 26Art. 104
Art. 27Art. 105
Art. 28Art. 106
Art. 28aArt. 107
Art. 28bArt. 108
Art. 28cArt. 109
Art. 28dArt. 110
Art. 28eArt. 111
Art. 28fArt. 112
Art. 113
Art. 114
Art. 115
Art. 116
Art. 117
Art. 118
Art. 119
Art. 120
Art. 121
Art. 122
Art. 123
Art. 124
Art. 125
Art. 126
Art. 127
Art. 128
Art. 129
Art. 130
Art. 131
Art. 132
Art. 133
Art. 134
Art. 55Art. 135
Art. 71Art. 136
Art. 64(2)Art. 136(3)
Art. 71aArt. 137
Art. 57Art. 138
Art. 59Art. 139
Art. 58Art. 140
Art. 141(1) and (2)
Art. 77Art. 141(3)
Art. 56Art. 142
Art. 65Art. 143
Art. 66Art. 144
Art. 64Art. 145
Art. 146(1)
Art. 63(1)Art. 146(2)
Art. 61Art. 146(3) to (6)
Art. 78(2), 1st sentenceArt. 146(8), 1st subparagraph, 1st sentence
Art. 146(7)
Art. 146(8), 1st subparagraph, 2nd and 3rd sentence
Art. 78(2), 2nd sentenceArt. 146(8), 2nd subparagraph
Art. 146(9)
Art. 63(2)Art. 147
Art. 5(2)Art. 148(1)
Art. 61(5)Art. 148(2)
Art. 148(3)
Art. 61(2)148(4)
Art. 61(1), 2nd and 3rd subparagraphArt. 148(5)
Art. 148(6) and (7)
Art. 61 (8)Art. 148 (8)
Art. 61a(6)Art. 149(1)
Art. 61a(1-4)Art. 149(2) to (5)
Art. 56(2), 1st subparagraphArt. 150(1), 1st subparagraph
Art. 150(1), 2nd and 3rd subparagraph
Art. 150(2) to (5)
Art. 56(2), 2nd subparagraphArt. 150(6)
Art. 62(5)Art. 151(1)
Art. 62(2), 1st subparagraphArt. 151(2)
Art. 151(3), 1st subparagraph
Art. 62(4), 2nd subparagraphArt. 151(3), 2nd subparagraph
Art. 62(2), 2nd subparagraphArt. 151(4)
Art. 151(5), (6) and (7)
Art. 62(1), 1st subparagraphArt. 152(1), 1st subparagraph
Art. 152(1), 2nd subparagraph
Art. 62(1), 2nd, 3rd and 4th subparagraphArt. 152(1), 3rd to 5th subparagraph
Art. 62(3)Art. 152(2)
Art. 67(1-4)Art. 152(1) and (3-4)
Art. 60Art. 153
Art. 67(5)Art. 153(5), 1st subparagraph, 1st sentence
Art. 154
Art. 67(6-12)Art. 154(6) to (12)
Art. 68Art. 155
Art. 69Art. 156(1) and (2)
Art. 156(3) to (6)
Art. 72Art. 157
Art. 73Art. 158
Art. 74Art. 159
Art. 160, 1st and 2nd subparagraph
Art. 75, 2nd subparagraphArt. 160, 3rd subparagraph
Art. 161
Art. 162
Art. 78(1)Art. 163
Art. 164
Art. 80Art. 165, 1st and 2nd subparagraph
Art. 165, 3rd subparagraph
Art. 166
Art. 167
Art. 168
Art. 169
Art. 170
Art. 84Art. 171
Art. 84aArt. 172
Art. 87Art. 173
Art. 87a, 2nd subparagraphArt. 174(1)
Art. 87aArt. 174(2)
Art. 87bArt. 175
Art. 176
Art. 177
Art. 178
Art. 179
Art. 180, 1st and 2nd subparagraph
Art. 90Art. 181
ANNEX I (1) to (4)ANNEX I (1) to (4)
ANNEX I (5) and (6)
ANNEX IIANNEX II
ANNEX III
ANNEX IV
ANNEX V


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