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Document 52023AP0273
P9_TA(2023)0273 – Fees and charges payable to the European Medicines Agency – Amendments adopted by the European Parliament on 12 July 2023 on the proposal for a regulation of the European Parliament and of the Council 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 (COM(2022)0721 – C9-0426/2022 – 2022/0417(COD)) (Ordinary legislative procedure: first reading)
P9_TA(2023)0273 – Fees and charges payable to the European Medicines Agency – Amendments adopted by the European Parliament on 12 July 2023 on the proposal for a regulation of the European Parliament and of the Council 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 (COM(2022)0721 – C9-0426/2022 – 2022/0417(COD)) (Ordinary legislative procedure: first reading)
P9_TA(2023)0273 – Fees and charges payable to the European Medicines Agency – Amendments adopted by the European Parliament on 12 July 2023 on the proposal for a regulation of the European Parliament and of the Council 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 (COM(2022)0721 – C9-0426/2022 – 2022/0417(COD)) (Ordinary legislative procedure: first reading)
OJ C, C/2024/4033, 17.7.2024, ELI: http://data.europa.eu/eli/C/2024/4033/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
Official Journal |
EN C series |
C/2024/4033 |
17.7.2024 |
P9_TA(2023)0273
Fees and charges payable to the European Medicines Agency
Amendments adopted by the European Parliament on 12 July 2023 on the proposal for a regulation of the European Parliament and of the Council 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 (COM(2022)0721 – C9-0426/2022 – 2022/0417(COD)) (1)
(Ordinary legislative procedure: first reading)
(C/2024/4033)
Amendment 1
Proposal for a regulation
Recital 1
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Text proposed by the Commission |
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Amendment 2
Proposal for a regulation
Recital 3
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Amendment 3
Proposal for a regulation
Recital 4 a (new)
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Text proposed by the Commission |
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Amendment 4
Proposal for a regulation
Recital 4 b (new)
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Text proposed by the Commission |
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Amendment 5
Proposal for a regulation
Recital 4 c (new)
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Text proposed by the Commission |
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Amendment 6
Proposal for a regulation
Recital 5
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Amendment 7
Proposal for a regulation
Recital 7
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Amendment 8
Proposal for a regulation
Recital 15
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Text proposed by the Commission |
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Amendment 9
Proposal for a regulation
Recital 17
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Text proposed by the Commission |
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Amendment 10
Proposal for a regulation
Recital 18
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Text proposed by the Commission |
Amendment |
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Amendment 11
Proposal for a regulation
Recital 19
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Text proposed by the Commission |
Amendment |
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Amendment 12
Proposal for a regulation
Recital 26 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 13
Proposal for a regulation
Recital 26 b (new)
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Text proposed by the Commission |
Amendment |
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Amendment 14
Proposal for a regulation
Article 2 – paragraph 1 – point 5 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 15
Proposal for a regulation
Article 2 – paragraph 1 – point 5 b (new)
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Text proposed by the Commission |
Amendment |
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Amendment 16
Proposal for a regulation
Article 2 – paragraph 1 – point 5 c (new)
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Text proposed by the Commission |
Amendment |
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Amendment 17
Proposal for a regulation
Article 2 – paragraph 1 – point 6
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Text proposed by the Commission |
Amendment |
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Amendment 18
Proposal for a regulation
Article 5 – paragraph 2
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Text proposed by the Commission |
Amendment |
2. Unless otherwise provided for in this Regulation, where fee reductions apply, the remuneration to competent authorities of the Member States payable in accordance with this Regulation shall not be reduced. |
2. Unless otherwise provided for in this Regulation, where less than total fee reductions apply, the remuneration to competent authorities of the Member States payable in accordance with this Regulation shall not be reduced. However, unless otherwise provided for in this Regulation, where fee waivers are granted, the remuneration shall be reduced as laid down in Annex V. |
Amendment 19
Proposal for a regulation
Article 6 – paragraph 4
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Text proposed by the Commission |
Amendment |
4. On a duly justified proposal from the Executive Director of the Agency, in particular for the protection of public or animal health or for the support of specific types of products or applicants, selected for duly justified reasons, the Management Board of the Agency may grant, following a favourable opinion from the Commission, a total or partial reduction of the applicable amount, in accordance with Article 8. |
4. On a duly justified proposal from the Executive Director of the Agency, in particular for the protection of public or animal health or for the support of specific types of products or types of applicants, selected for duly justified reasons, the Management Board of the Agency may grant, following a favourable opinion from the Commission, a total or partial reduction of the applicable amount, in accordance with Article 8. The Agency shall make information on such reductions publicly available on the Agency’s website, setting out the reasons for the reduction. |
Amendment 20
Proposal for a regulation
Article 6 – paragraph 5
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Text proposed by the Commission |
Amendment |
5. In exceptional circumstances and for imperative reasons of public or animal health, the Executive Director of the Agency may grant, on a case-by-case basis, total or partial reductions for the fees set out in Annexes I, II, III and IV, with the exception of the fees set out in points 6, 15 and 16 of Annex I, points 7 and 10 of Annex II and point 3 of Annex III. Any decision taken pursuant to this Article shall state the reasons on which it is based. |
5. In exceptional circumstances and for duly justified imperative reasons of public or animal health, the Executive Director of the Agency may grant, on a case-by-case basis, total or partial reductions for the fees set out in Annexes I, II, III and IV, with the exception of the fees set out in points 6, 15 and 16 of Annex I, points 7 and 10 of Annex II and point 3 of Annex III. Any decision taken pursuant to this Article shall state the reasons on which it is based. The Agency shall make information on such decisions by the Executive Director, including the reasons for the reduction, publicly available on the Agency’s website. |
Amendment 21
Proposal for a regulation
Article 10 – paragraph 1
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Text proposed by the Commission |
Amendment |
1. The amounts set out in the annexes shall be published on the website of the Agency. |
1. The amounts set out in the annexes shall be published on the website of the Agency and shall be updated to reflect any changes. |
Amendment 22
Proposal for a regulation
Article 10 – paragraph 2
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Text proposed by the Commission |
Amendment |
2. The Agency shall monitor its costs and the Executive Director of the Agency shall provide, as part of the annual activity report delivered to the European Parliament, the Council, the Commission and the Court of Auditors, detailed and substantiated information on the costs to be covered by fees and charges that are within the scope of this Regulation. That information shall include the performance information set out in Annex VI and a cost breakdown related to the previous calendar year and to a forecast for the following calendar year. The Agency shall also publish an overview of that information in its annual report. |
2. The Agency shall monitor its costs and the Executive Director of the Agency shall provide, without delay as part of the annual activity report delivered to the European Parliament, the Council, the Commission and the Court of Auditors, detailed and substantiated information on the costs to be covered by fees and charges that are within the scope of this Regulation. That information shall include the performance information set out in Annex VI and other relevant information, in particular on the practical aspects of carrying out the activities for which the Agency collects fees or charges, and a cost breakdown related to the previous calendar year and to a forecast for the following calendar year. The Agency shall also publish without delay, an overview of that information in its annual report. |
Amendment 23
Proposal for a regulation
Article 10 – paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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2a. All fees received, including those where reductions and waivers have been granted, and fees which are due but not yet received by the Agency shall be published on the Agency’s website and listed in its annual report. |
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The Agency’s annual report shall furthermore list a detailed breakdown of all remunerated amounts paid to national authorities for their work. |
Amendment 24
Proposal for a regulation
Article 10 – paragraph 5
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Text proposed by the Commission |
Amendment |
5. The Commission shall monitor the inflation rate, measured by means of the Harmonised Index of Consumer Prices published by Eurostat pursuant to Regulation (EU) No 2016/792, in relation to the amounts of fees, charges and remuneration set out in the Annexes to this Regulation. The monitoring exercise shall take place no earlier than [OP: please insert date one year after the date of application of this Regulation], and thereafter on an annual basis. Any adjustment, in line with inflation, to fees, charges and remuneration established in accordance with this regulation shall become applicable, at the earliest, on 1 January of the calendar year following the calendar year in which the monitoring exercise took place. |
5. The Commission shall monitor the inflation rate, measured by means of the Harmonised Index of Consumer Prices published by Eurostat pursuant to Regulation (EU) No 2016/792, in relation to the amounts of fees, charges and remuneration set out in the Annexes to this Regulation. The monitoring exercise shall take place no earlier than [OP: please insert date one year after the date of application of this Regulation], and thereafter on an annual basis. On the basis of this exercise, the Commission shall draw up a report and submit it to the European Parliament and to the Council. Any adjustment, in line with inflation and following the annual activity report referred to in Article 10(2), to fees, charges and remuneration established in accordance with this regulation shall become applicable, at the earliest, on 1 January of the calendar year following the calendar year in which the monitoring exercise took place. |
Amendment 25
Proposal for a regulation
Article 10 – paragraph 6 – introductory part
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Text proposed by the Commission |
Amendment |
6. At the earliest on [OP: please insert date 3 years after the date of application] and at three-year intervals thereafter, the Executive Director of the Agency may , where considered relevant in view of Article 11(2), and after consultation of the Management Board of the Agency, provide the Commission with a special report outlining, in an objective, fact-based and sufficiently detailed manner, justified recommendations: |
6. At the earliest on [OP: please insert date 3 years after the date of application] and at three-year intervals thereafter, the Executive Director of the Agency shall , where considered relevant in view of Article 11(2), and after consultation of the Management Board of the Agency, provide the Commission with a special report . The Agency shall publish the special report without delay and shall set out in an objective , justified , fact-based and sufficiently detailed manner, the following recommendations: |
Amendment 26
Proposal for a regulation
Article 10 – paragraph 6 – point a a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 27
Proposal for a regulation
Article 10 – paragraph 6 – subparagraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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The special report shall be submitted to the European Parliament and to the Council for information. |
Amendment 28
Proposal for a regulation
Article 10 – paragraph 6 a (new)
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Text proposed by the Commission |
Amendment |
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6a. With a view to supporting the Agency reach its conclusions in an efficient and effective manner, during the preparation of a report, the Agency shall organise consultations with stakeholders in order to receive input on the structure and level of fees, charges and remuneration, including the reasons for any change thereto. |
Amendment 29
Proposal for a regulation
Article 10 – paragraph 6 b (new)
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Text proposed by the Commission |
Amendment |
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6b. The special report shall be made publicly available without delay on the Agency’s website. The special report shall include information on the stakeholders consulted in the preparation of that report. |
Amendment 30
Proposal for a regulation
Article 10 – paragraph 8
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Text proposed by the Commission |
Amendment |
8. The Commission may request any clarification or further substantiation of the report and its recommendations, if considered necessary. Following such a request, the Agency shall without undue delay provide the Commission with an updated version of the report which addresses any comments made and questions raised by the Commission . |
8. The Commission , the European Parliament or the Council may request any clarification or further substantiation of the report and its recommendations, if considered necessary. Following such a request, the Agency shall without undue delay provide the Commission , the European Parliament and the Council with an updated version of the report which addresses any comments made and questions raised by the respective institution . |
Amendment 31
Proposal for a regulation
Article 10 – paragraph 9 – introductory part
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Text proposed by the Commission |
Amendment |
9. The reporting time interval referred to in paragraph 6 may be shortened in any of the following situations: |
9. The time interval for the first special report as well as the reporting time interval referred to in paragraph 6 may be shortened in any of the following situations: |
Amendment 32
Proposal for a regulation
Article 11 – paragraph -1 (new)
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Text proposed by the Commission |
Amendment |
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-1. By ... [four months before the date of application of this Regulation], the Commission shall adopt, notwithstanding Article 10(5), a delegated act in accordance with Article 13, to amend Annexes I, II, III and IV, in order to adjust the amounts set out therein to the inflation rate published four months before ... [the date of application of this Regulation]. |
Amendment 33
Proposal for a regulation
Article 11 – paragraph 1 – point c
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Text proposed by the Commission |
Amendment |
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deleted |
Amendment 34
Proposal for a regulation
Article 11 – paragraph 1 – point e
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Text proposed by the Commission |
Amendment |
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deleted |
Amendment 35
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 a (new)
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Text proposed by the Commission |
Amendment |
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By way of derogation from the first subparagraph, the Commission may take into account other factors that could have a substantive impact on the Agency’s budget, including but not limited to its workload and potential risks related to fluctuations in its fee revenues. The level of fees shall be set at a level which ensures that the revenue derived from them, when combined with other sources of revenue of the Agency, is sufficient to cover the costs of the services delivered in accordance with the key performance indicators and transparency principles set out in Annex VI. |
Amendment 36
Proposal for a regulation
Article 13 – paragraph 4
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Text proposed by the Commission |
Amendment |
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. |
4. Before adopting a delegated act, the Commission shall take into account any opinions delivered by experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. |
Amendment 37
Proposal for a regulation
Article 17 – paragraph 2 a (new)
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Text proposed by the Commission |
Amendment |
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The delegated act referred to in Article 11(-1) shall apply from ... [OP: please insert date of first day of the month following expiration of 6 months after entry into force]. |
Amendment 38
Proposal for a regulation
Annex I – point 1 – point 1.1 – paragraph 1 – introductory part
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Text proposed by the Commission |
Amendment |
A fee of EUR 55 200 shall apply to any of the following requests: |
A fee of EUR 94 000 shall apply to any of the following requests: |
Amendment 39
Proposal for a regulation
Annex I – point 1 – point 1.1 – paragraph 2
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Text proposed by the Commission |
Amendment |
The remuneration shall be EUR 10 400 for each of the two scientific advice co-ordinators. |
The remuneration shall be EUR 23 500 for each of the two scientific advice co-ordinators. |
Amendment 40
Proposal for a regulation
Annex I – point 1 – point 1.2 – paragraph 1 – introductory part
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Text proposed by the Commission |
Amendment |
A fee of EUR 44 700 shall apply to any of the following requests: |
A fee of EUR 70 600 shall apply to any of the following requests: |
Amendment 41
Proposal for a regulation
Annex I – point 1 – point 1.2 – paragraph 2
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Text proposed by the Commission |
Amendment |
The remuneration shall be EUR 6 500 for each of the two scientific advice co-ordinators. |
The remuneration shall be EUR 17 650 for each of the two scientific advice co-ordinators. |
Amendment 42
Proposal for a regulation
Annex I – point 1 – point 1.3 – paragraph 1 – introductory part
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Text proposed by the Commission |
Amendment |
A fee of EUR 37 200 shall apply to any of the following requests: |
A fee of EUR 46 900 shall apply to any of the following requests: |
Amendment 43
Proposal for a regulation
Annex I – point 1 – point 1.3 – paragraph 2
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Text proposed by the Commission |
Amendment |
The remuneration shall be EUR 5 300 for each of the two scientific advice co-ordinators. |
The remuneration shall be EUR 11 730 for each of the two scientific advice co-ordinators. |
Amendment 44
Proposal for a regulation
Annex I – point 6 – point 6.1
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Text proposed by the Commission |
Amendment |
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Amendment 45
Proposal for a regulation
Annex I – point 6 – point 6.2
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Text proposed by the Commission |
Amendment |
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Amendment 46
Proposal for a regulation
Annex I – point 6 – point 6.3
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Text proposed by the Commission |
Amendment |
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Amendment 47
Proposal for a regulation
Annex I – point 10 – point 10.1
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Text proposed by the Commission |
Amendment |
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Amendment 48
Proposal for a regulation
Annex I – point 10 – point 10.2
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Text proposed by the Commission |
Amendment |
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Amendment 49
Proposal for a regulation
Annex I – point 11 – point 11.1
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Text proposed by the Commission |
Amendment |
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Amendment 50
Proposal for a regulation
Annex I – point 11 – point 11.2
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Text proposed by the Commission |
Amendment |
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Amendment 51
Proposal for a regulation
Annex I – point 11 – point 11.3
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Text proposed by the Commission |
Amendment |
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Amendment 52
Proposal for a regulation
Annex I – point 11 – point 11.4
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Text proposed by the Commission |
Amendment |
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Amendment 53
Proposal for a regulation
Annex I – point 12 – paragraph 2
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Text proposed by the Commission |
Amendment |
A fee of EUR 16 800 shall apply to an application for the designation of an orphan medicinal product pursuant to Regulation (EC) No 141/2000. Such fee shall be waived in full. The remuneration shall be EUR 1 500 for the rapporteur. |
A fee of EUR 16 800 shall apply to an application for the designation of an orphan medicinal product pursuant to Regulation (EC) No 141/2000. Such fee shall be waived in full. The remuneration shall be EUR 750 for the rapporteur. |
Amendment 54
Proposal for a regulation
Annex II – point 7 – point 7.1
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Text proposed by the Commission |
Amendment |
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Amendment 55
Proposal for a regulation
Annex II – point 7 – point 7.2
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Text proposed by the Commission |
Amendment |
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Amendment 56
Proposal for a regulation
Annex II – point 7 – point 7.3
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Text proposed by the Commission |
Amendment |
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Amendment 57
Proposal for a regulation
Annex V – point 1 a (new)
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Text proposed by the Commission |
Amendment |
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For the purposes of paragraph 2, point (c), control may, in particular, take either of the following forms: |
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Upon receipt of a scientific advice request, the Agency shall check the applicant’s declaration of eligibility and the acceptability of the declaration based on defined template as well as the supporting documents. |
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The Agency shall reserve its right to conduct an ex-post check and to request evidence confirming that the criteria for the fee exemption are fulfilled at any time before the adoption of the final advice letter. |
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Amendment 58
Proposal for a regulation
Annex V – point 8 – paragraph 2 – introductory part
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Text proposed by the Commission |
Amendment |
A fee reduction of 20 % shall apply to the annual pharmacovigilance fee set out in section 3 of Annex III for the following medicinal products: |
A fee reduction of 30% shall apply to the annual pharmacovigilance fee set out in section 3 of Annex III for the following medicinal products: |
Amendment 59
Proposal for a regulation
Annex VI – paragraph 1 – introductory part
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Text proposed by the Commission |
Amendment |
The following information shall relate to each calendar year: |
The following information shall relate to each calendar year and shall be made publicly available on the Agency’s website : |
Amendment 60
Proposal for a regulation
Annex VI – paragraph 1 – point 4 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 61
Proposal for a regulation
Annex VI – paragraph 1 – point 6
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Text proposed by the Commission |
Amendment |
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Amendment 62
Proposal for a regulation
Annex VI – paragraph 1 – point 6 a (new)
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Text proposed by the Commission |
Amendment |
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Amendment 63
Proposal for a regulation
Annex VI – paragraph 1 – point 6 b (new)
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Text proposed by the Commission |
Amendment |
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(1) The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A9-0224/2023).
(1a) 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).
(21) 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).
(21) 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).
(22) 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).
(22) 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).
(23) 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).
(23) 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).
(24) 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).
(24) 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).
(25) 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).
(25) 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).
(26) 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).
(26) 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).
(27) 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).
(27) 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).
(28) 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. 11).
(28) 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. 11).
(29) Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (OJ L 132, 30.5.2018, p. 5).
(29) Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (OJ L 132, 30.5.2018, p. 5).
(30) Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products (OJ L 279, 3.8.2021, p. 15).
(30) Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products (OJ L 279, 3.8.2021, p. 15).
(31) 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).
(31) 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).
(32) 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).
(32) 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).
(40) Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1) .
(40) 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) .
(43) 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).
(43) 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).
ELI: http://data.europa.eu/eli/C/2024/4033/oj
ISSN 1977-091X (electronic edition)