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From · report parliamentary committee draft · 2023-10-20 ENVI-PR-753550 on 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
To · Plenary report · 2024-03-21 A-9-2024-0141 on 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
+1012 added · −290 removed · 115 modified paragraphs

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of ...,25 October 2023,

– having regard to the opinionafter ofconsulting the Committee of the Regions of ...,Regions,

– having regard to Rule 59 of its Rules of Procedure,

– having regard to the letters from the Committee on Budgets and the Committee on Agriculture and Rural Development,

– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A90000/2023),(A9-0141/2024),

1. Adopts its position at first reading hereinafter set out;

Proposal for a regulation

Recital 9-1 (new)

Or. en

Amendment 2

Proposal for a regulation

Recital 30

Recital 1 a (new)

Or. en

Amendment 3

Proposal for a regulation

Recital 362

Or. en

Amendment 4

Proposal for a regulation

Recital 39

Recital 2 a (new)

Or. en

Amendment 5

Proposal for a regulation

Recital 433

Or. en

Amendment 6

Proposal for a regulation

Recital 604

Or. en

Amendment 7

Proposal for a regulation

Recital 675

Or. en

Amendment 8

Proposal for a regulation

Recital 68

Recital 5 a (new)

Or. en

Amendment 9

Proposal for a regulation

Recital 766

Or. en

Amendment 10

Proposal for a regulation

Recital 76 a (new)

Recital 9

Or. en

Amendment 11

Proposal for a regulation

Recital 7712

Or. en

Amendment 12

Proposal for a regulation

Recital 78 a (new)

Recital 13

Or. en

Amendment 13

Proposal for a regulation

Recital 78 b (new)

Recital 15

Or. en

Amendment 14

Proposal for a regulation

Recital 7818 ca (new)

Or. en

Amendment 15

Proposal for a regulation

Recital 7919

Or. en

Amendment 16

Proposal for a regulation

Recital 8020

Or. en

Amendment 17

Proposal for a regulation

Recital 81

Recital 20 a (new)

Or. en

Amendment 18

Proposal for a regulation

Recital 82

Recital 21 a (new)

Or. en

Amendment 19

Proposal for a regulation

Recital 8325

Or. en

Amendment 20

Proposal for a regulation

Recital 84

Recital 26 a (new)

Or. en

Amendment 21

Proposal for a regulation

Recital 9029

Or. en

Amendment 22

Proposal for a regulation

Recital 10230

Or. en

Amendment 23

Proposal for a regulation

Recital 12331

Or. en

Amendment 24

Proposal for a regulation

Recital 129

Recital 31 a (new)

Or. en

Amendment 25

Proposal for a regulation

Recital 133

Recital 33 a (new)

Or. en

Amendment 26

Proposal for a regulation

Recital 13435

Or. en

Amendment 27

Proposal for a regulation

Recital 13536

Or. en

Amendment 28

Proposal for a regulation

Recital 13739

Or. en

Amendment 29

Proposal for a regulation

Recital 14143

Or. en

Amendment 30

Proposal for a regulation

Article 2 – paragraph 2 – point 4

Recital 43 a (new)

Or. en

Amendment 31

Proposal for a regulation

Article 2 – paragraph 2 – point 7

Recital 45 a (new)

Or. en

Amendment 32

Proposal for a regulation

Article 2 – paragraph 2 – point 12

Recital 46

Or. en

Amendment 33

Proposal for a regulation

Article 2 – paragraph 2 – point 14 a (new)

Recital 47

Or. en

Amendment 34

Proposal for a regulation

Article 2 – paragraph 2 – point 14 b (new)

Recital 51 a (new)

Or. en

Amendment 35

Proposal for a regulation

Article 5 – paragraph 2

Recital 53 a (new)

Or. en

Amendment 36

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 1

Recital 54

Or. en

Amendment 37

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 2

Recital 57 a (new)

Or. en

Amendment 38

Proposal for a regulation

Article 6 – paragraph 5 – subparagraph 2

Recital 57 b (new)

Or. en

Amendment 39

Proposal for a regulation

Article 8 – paragraph 1 – point b

Recital 58

Or. en

Amendment 40

Proposal for a regulation

Article 9 – paragraph 2

Recital 60

Or. en

Amendment 41

Proposal for a regulation

Article 10 – paragraph 2

Recital 65

Or. en

Amendment 42

Proposal for a regulation

Article 12 – paragraph 4 – point f

Recital 67

Or. en

Amendment 43

Proposal for a regulation

Article 12 – paragraph 4 – point g

Recital 68 a (new)

Or. en

Amendment 44

Proposal for a regulation

Article 12 – paragraph 4 – point h

Recital 76

Or. en

Amendment 45

Proposal for a regulation

Article 12 – paragraph 4 – point i

Recital 76 a (new)

Or. en

Amendment 46

Proposal for a regulation

Article 12 – paragraph 4 – point j

Recital 77

Or. en

Amendment 47

Proposal for a regulation

Article 12 – paragraph 4 – point m a (new)

Recital 77 a (new)

Or. en

Amendment 48

Proposal for a regulation

Article 12 – paragraph 4 – point m b (new)

Recital 77 b (new)

Or. en

Amendment 49

Proposal for a regulation

Article 13 – paragraph 1 – subparagraph 5

Recital 78 a (new)

Or. en

Amendment 50

Proposal for a regulation

Article 13 – paragraph 1 – subparagraph 6

Recital 78 b (new)

Or. en

Amendment 51

Proposal for a regulation

Article 13 – paragraph 4

Recital 78 c (new)

Or. en

Amendment 52

Proposal for a regulation

Article 15 – paragraph 1 – point d

Recital 79

Or. en

Amendment 53

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 1

Recital 80

Or. en

Amendment 54

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 2 – indent 2

Recital 81

Or. en

Amendment 55

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)

Recital 82

Or. en

Amendment 56

Proposal for a regulation

Article 17 – paragraph 1

Recital 83

Or. en

Amendment 57

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Recital 86

Or. en

Amendment 58

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 2

Recital 88

Or. en

Amendment 59

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 3

Recital 90

Or. en

Amendment 60

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 4

Recital 92

Or. en

Amendment 61

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 4 a (new)

Recital 92 a (new)

Or. en

Amendment 62

Proposal for a regulation

Article 18 – paragraph 2 – subparagraph 2 a (new)

Recital 93

Or. en

Amendment 63

Proposal for a regulation

Article 19 – paragraph 1 – subparagraph 2

Recital 95

Or. en

Amendment 64

Proposal for a regulation

Article 19 – paragraph 3

Recital 103

Or. en

Amendment 65

Proposal for a regulation

Article 19 – paragraph 4

Recital 104

Or. en

Amendment 66

Proposal for a regulation

Article 19 – paragraph 6

Recital 105 a (new)

Or. en

Amendment 67

Proposal for a regulation

Article 19 – paragraph 7 – subparagraph 1 a (new)

Recital 105 b (new)

Or. en

Amendment 68

Proposal for a regulation

Article 19 a (new)

Recital 112

Or. en

Amendment 69

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 1 – introductory part

Recital 126

Or. en

Amendment 70

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 2

Recital 129

Or. en

Amendment 71

Proposal for a regulation

Article 21 – paragraph 1 a (new)

Recital 132 a (new)

Or. en

Amendment 72

Proposal for a regulation

Article 23 – paragraph 1 a (new)

Recital 132 b (new)

Or. en

Amendment 73

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 1

Recital 132 c (new)

Or. en

Amendment 74

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 2 – point f

Recital 133

Or. en

Amendment 75

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 2 – point f a (new)

Recital 134

Or. en

Amendment 76

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 3

Recital 135

Or. en

Amendment 77

Proposal for a regulation

Article 24 – paragraph 4

Recital 135 a (new)

Or. en

Amendment 78

Proposal for a regulation

Article 24 – paragraph 4 a (new)

Recital 135 b (new)

Or. en

Amendment 79

Proposal for a regulation

Article 25 – paragraph 1 – subparagraph 3

Recital 136

Or. en

Amendment 80

Proposal for a regulation

Article 26 – paragraph 10

Recital 137

Or. en

Amendment 81

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Recital 138

Or. en

Amendment 82

Proposal for a regulation

Article 30 – paragraph 3 a (new)

Recital 138 a (new)

Or. en

Amendment 83

Proposal for a regulation

Article 31 – paragraph 1 – point b a (new)

Recital 138 b (new)

Or. en

Amendment 84

Proposal for a regulation

Article 32 – paragraph 2 – subparagraph 1

Recital 139 a (new)

Or. en

Amendment 85

Proposal for a regulation

Article 34 – paragraph 1

Recital 140

Or. en

Amendment 86

Proposal for a regulation

Article 35 – paragraph 1 – point d a (new)

Recital 149

Or. en

Amendment 87

Proposal for a regulation

Article 37 – paragraph 1

Recital 155

Or. en

Amendment 88

Proposal for a regulation

Chapter III – title

Article 1 – paragraph 1

Or. en

Amendment 89

Proposal for a regulation

Article 40

Article 2 – paragraph 2 – point 7

Or. en

Amendment 90

Proposal for a regulation

Article 40 a (new)

Article 2 – paragraph 2 – point 8 – point a

Or. en

Amendment 91

Proposal for a regulation

Article 41

Article 2 – paragraph 2 – point 8 – point b

Or. en

Amendment 92

Proposal for a regulation

Article 41 a (new)

Article 2 – paragraph 2 – point 10

Or. en

Amendment 93

Proposal for a regulation

Article 42

Article 2 – paragraph 2 – point 12

Or. en

Amendment 94

Proposal for a regulation

Article 43

Article 2 – paragraph 2 – point 14 a (new)

Or. en

Amendment 95

Proposal for a regulation

Article 452 – paragraph 42 a– point 14 b (new)

Or. en

Amendment 96

Proposal for a regulation

Article 475 – paragraph 15

Or. en

Amendment 97

Proposal for a regulation

Article 486 – paragraph 1 – subparagraph 12

Or. en

Amendment 98

Proposal for a regulation

Article 486 – paragraph 12 – subparagraph 21

Or. en

Amendment 99

Proposal for a regulation

Article 486 – paragraph 5 – subparagraph 2

Or. en

Amendment 100

Proposal for a regulation

Article 487 – paragraph 31

Or. en

Amendment 101

Proposal for a regulation

Article 528 – paragraph 61 – point c a (new)b

Or. en

Amendment 102

Proposal for a regulation

Article 548 – paragraph 41 – subparagraphpoint 1e

Or. en

Amendment 103

Proposal for a regulation

Article 549 – paragraph 61 – subparagraph 2

Or. en

Amendment 104

Proposal for a regulation

Article 559 – paragraph 52

Or. en

Amendment 105

Proposal for a regulation

Article 5810 – paragraph 42

Or. en

Amendment 106

Proposal for a regulation

Article 5812 – paragraph 4 a– (new)point g

Or. en

Amendment 107

Proposal for a regulation

Article 6012 – paragraph 14 – introductorypoint parth

Or. en

Amendment 108

Proposal for a regulation

Article 6012 – paragraph 14 – point ci

Or. en

Amendment 109

Proposal for a regulation

Article 6012 – paragraph 4 – point j a (new)

Or. en

Amendment 110

Proposal for a regulation

Article 6312 – paragraph 14 – point m a (new)

Or. en

Amendment 111

Proposal for a regulation

Article 6512 – paragraph 24 – point cm ab (new)

Or. en

Amendment 112

Proposal for a regulation

Article 6613 – paragraph 1 – subparagraph 5

Or. en

Amendment 113

Proposal for a regulation

Article 6713 – paragraph 31 – point f asubparagraph (new)6

Or. en

Amendment 114

Proposal for a regulation

Article 6813 – paragraph 24

Or. en

Amendment 115

Proposal for a regulation

Article 7015 – paragraph 1 – introductorypoint partd

Or. en

Amendment 116

Proposal for a regulation

Article 7016 – paragraph 13 – pointsubparagraph b1

Or. en

Amendment 117

Proposal for a regulation

Article 7016 – paragraph 3 – subparagraph 2 – indent 2

Or. en

Amendment 118

Proposal for a regulation

Article 7116 – paragraph 3 – subparagraph 2 – pointindent 2 a (new)

Or. en

Amendment 119

Proposal for a regulation

Article 7118 – paragraph 21 – point b aintroductory (new)part

Or. en

Amendment 120

Proposal for a regulation

Article 7118 – paragraph 2 – pointsubparagraph c2 a (new)

Or. en

Amendment 121

Proposal for a regulation

Article 7119 – paragraph 2 a (new)3

Or. en

Amendment 122

Proposal for a regulation

Article 7219 – paragraph 14

Or. en

Amendment 123

Proposal for a regulation

Article 7219 – paragraph 27 – subparagraph 1 a (new)

Or. en

Amendment 124

Proposal for a regulation

Article 7219 – paragraph 48 – point b

Or. en

Amendment 125

Proposal for a regulation

Article 7419 – paragraph 2 – subparagraph 1 –8 pointa b(new)

Or. en

Amendment 126

Proposal for a regulation

Article 7420 – paragraph 31 – subparagraph 1 – point c a (new)

Or. en

Amendment 127

Proposal for a regulation

Article 7520 – paragraph 1 – pointsubparagraph a3

Or. en

Amendment 128

Proposal for a regulation

Article 9420 – paragraph 2 – subparagraph 34

Or. en

Amendment 129

Proposal for a regulation

Article 10424 – paragraph 1 – subparagraph 1 – introductory part

Or. en

Amendment 130

Proposal for a regulation

Article 10424 – paragraph 1 – subparagraph 12 – point cf a (new)

Or. en

Amendment 131

Proposal for a regulation

Article 10424 – paragraph 1 –3 subparagrapha 2(new)

Or. en

Amendment 132

Proposal for a regulation

Article 10424 – paragraph 3 –4 subparagrapha 2(new)

Or. en

Amendment 133

Proposal for a regulation

Article 10524 – paragraph 34 b (new)

Or. en

Amendment 134

Proposal for a regulation

Article 113

Article 25 – paragraph 1 – subparagraph 3

Or. en

Amendment 135

Proposal for a regulation

Article 114

Article 26 – paragraph 2

Or. en

Amendment 136

Proposal for a regulation

Article 115

Article 26 – paragraph 3

Or. en

Amendment 137

Proposal for a regulation

Article 11626 – paragraph 14 – pointsubparagraph d2

Or. en

Amendment 138

Proposal for a regulation

Article 11726 – paragraph 16

Or. en

Amendment 139

Proposal for a regulation

Article 11726 – paragraph 210

Or. en

Amendment 140

Proposal for a regulation

Article 11729 – paragraph 31 a (new)

Or. en

Amendment 141

Proposal for a regulation

Article 11832 – paragraph 1 – subparagraph 1

Or. en

Amendment 142

Proposal for a regulation

Article 11832 – paragraph 2 – subparagraph 1

Or. en

Amendment 143

Proposal for a regulation

Article 12032 – paragraph 1 a (new)3

Or. en

Amendment 144

Proposal for a regulation

Article 12033 – paragraph 2

Or. en

Amendment 145

Proposal for a regulation

Article 12136 – paragraph 1 – point b

Or. en

Amendment 146

Proposal for a regulation

Article 12137 – paragraph 2 – point f1

Or. en

Amendment 147

Proposal for a regulation

Article 121 – paragraph 5 – point a

Article 39 a (new)

Or. en

Amendment 148

Proposal for a regulation

Article 122 – paragraph 4 – introductory part

Article 39 b (new)

Or. en

Amendment 149

Proposal for a regulation

Article 12240 – paragraph 61

Or. en

Amendment 150

Proposal for a regulation

Article 12440 – paragraph 2 – subparagraph 2

Or. en

Amendment 151

Proposal for a regulation

Article 12440 – paragraph 32 a (new)

Or. en

Amendment 152

Proposal for a regulation

Article 12540 – paragraph 1 – point c3

Or. en

Amendment 153

Proposal for a regulation

Article 12540 – paragraph 4 – subparagraph 1 – point fa

Or. en

Amendment 154

Proposal for a regulation

Article 12540 – paragraph 14 – pointsubparagraph f1 a– (new)point b

Or. en

Amendment 155

Proposal for a regulation

Article 12740 – paragraph 4 – subparagraph 1 – point b a (new)

Or. en

Amendment 156

Proposal for a regulation

Article 12740 – paragraph 4 – subparagraph 1 – point b b (new)

Or. en

Amendment 157

Proposal for a regulation

Article 12940 – paragraph 14 a (new)

Or. en

Amendment 158

Proposal for a regulation

Article 13041 – paragraph 1 – subparagraph 1 – introductory part

Or. en

Amendment 159

Proposal for a regulation

Article 13041 – paragraph 1 – subparagraph 1 – point a2

Or. en

Amendment 160

Proposal for a regulation

Article 13141 – paragraph 13

Or. en

Amendment 161

Proposal for a regulation

Article 13141 – paragraph 23 a (new)

Or. en

Amendment 162

Proposal for a regulation

Article 13242 – paragraph 1 – point b

Or. en

Amendment 163

Proposal for a regulation

Article 13342 – paragraph 1 – point c2

Or. en

Amendment 164

Proposal for a regulation

Article 13443 – paragraph 1 – introductory part

Or. en

Amendment 165

Proposal for a regulation

Article 13443 – paragraph 21 a (new)

Or. en

Amendment 166

Proposal for a regulation

Article 134 a (new)

Article 45 – paragraph 4 – subparagraph 1

Or. en

Amendment 167

Proposal for a regulation

Article 13847 – paragraph 1 – subparagraph 2 – point a

Or. en

Amendment 168

Proposal for a regulation

Article 13848 – paragraph 1 – subparagraph 2 – point n1

Or. en

Amendment 169

Proposal for a regulation

Article 13848 – paragraph 1 – subparagraph 2 – point zl

Or. en

Amendment 170

Proposal for a regulation

Article 13848 – paragraph 1 – subparagraph 2 – point zl a (new)3

Or. en

Amendment 171

Proposal for a regulation

Article 13848 – paragraph 2 – subparagraph 13

Or. en

Amendment 172

Proposal for a regulation

Article 13852 – paragraph 2 – subparagraph 31 – point a

Or. en

Amendment 173

Proposal for a regulation

Article 14253 – paragraph 1 – point j a (new)2

Or. en

Amendment 174

Proposal for a regulation

Article 14256 – paragraph 1 – point j2 ba (new)

Or. en

Amendment 175

Proposal for a regulation

Article 14258 – paragraph 1 – point j c (new)3

Or. en

Amendment 176

Proposal for a regulation

Article 14258 – paragraph 1 – point k a (new)4

Or. en

Amendment 177

Proposal for a regulation

Article 147 – title

Article 58 – paragraph 4 a (new)

Or. en

Amendment 178

Proposal for a regulation

Article 14760 – paragraph 1 – subparagraphintroductory 1part

Or. en

Amendment 179

Proposal for a regulation

Article 14760 – paragraph 1 – subparagraphpoint 2c

Or. en

Amendment 180

Proposal for a regulation

Article 14760 – paragraph 24 a (new)

Or. en

Amendment 181

Proposal for a regulation

Article 14761 – paragraph 21 a– (new)subparagraph 1

Or. en

Amendment 182

Proposal for a regulation

Article 14761 – paragraph 2 b– (new)subparagraph 1

Or. en

Amendment 183

Proposal for a regulation

Article 14861 – paragraph 32 – point a asubparagraph (new)3

Or. en

Amendment 184

Proposal for a regulation

Article 150 – title

Article 61 – paragraph 2 – subparagraph 3 a (new)

Or. en

Amendment 185

Proposal for a regulation

Article 15062 – paragraph 31 – subparagraph 21

Or. en

Amendment 186

Proposal for a regulation

Article 15362 – paragraph 12

Or. en

Amendment 187

Proposal for a regulation

Article 16262 – paragraph 23

Or. en

Amendment 188

Proposal for a regulation

Article 16663 – paragraph 12

Or. en

Amendment 189

Proposal for a regulation

Article 16664 – paragraph 12 – subparagraph 1 a– (new)point d

Or. en

Amendment 190

Proposal for a regulation

Article 16664 – paragraph 24 – subparagraph 1

Or. en

Amendment 191

Proposal for a regulation

Article 16965 – paragraph 1 – subparagraph 2 – point bc a (new)

Or. en

Amendment 192

Proposal for a regulation

Article 16966 – paragraph 35

Or. en

Amendment 193

Proposal for a regulation

Article 17167 – paragraph 13 – point f a (new)

Or. en

Amendment 194

Proposal for a regulation

Article 17268 – paragraph 1 – introductory part

Or. en

Amendment 195

Proposal for a regulation

Article 18068 – paragraph 131 – point a

Or. en

Amendment 196

Proposal for a regulation

Annex I – point 3

Article 68 – paragraph 2

Or. en

Amendment 197

Proposal for a regulation

Annex II – point 25 a (new)

Article 69 – paragraph 2 – subparagraph 1

Or. en

Amendment 198

Proposal for a regulation

Annex II – point 25 b (new)

Article 69 – paragraph 3 – subparagraph 1

Or. en

Amendment 199

Proposal for a regulation

Annex II – point 25 c (new)

Article 69 – paragraph 4

Or. en

Amendment 200

Proposal for a regulation

Annex II – point 25 d (new)

Article 69 – paragraph 6

Or. en

Amendment 201

Proposal for a regulation

Article 70 – paragraph 1 – point a

Amendment 202

Proposal for a regulation

Article 70 – paragraph 1 – point b

Amendment 203

Proposal for a regulation

Article 70 – paragraph 3

Amendment 204

Proposal for a regulation

Article 71 – paragraph 2 – point b

Amendment 205

Proposal for a regulation

Article 71 – paragraph 2 – point c

Amendment 206

Proposal for a regulation

Article 71 – paragraph 5

Amendment 207

Proposal for a regulation

Article 71 – paragraph 6

Amendment 208

Proposal for a regulation

Article 72 – paragraph 1

Amendment 209

Proposal for a regulation

Article 73 a (new)

Amendment 210

Proposal for a regulation

Article 73 b (new)

Amendment 211

Proposal for a regulation

Article 74 – paragraph 2 – subparagraph 1 – point b

Amendment 212

Proposal for a regulation

Article 74 – paragraph 3

Amendment 213

Proposal for a regulation

Article 75 – paragraph 1 – point b

Amendment 214

Proposal for a regulation

Article 75 – paragraph 3

Amendment 215

Proposal for a regulation

Article 75 – paragraph 3 a (new)

Amendment 216

Proposal for a regulation

Article 81 – paragraph 3

Amendment 217

Proposal for a regulation

Article 84 – paragraph 1 a (new)

Amendment 218

Proposal for a regulation

Article 84 – paragraph 2 – subparagraph 1

Amendment 219

Proposal for a regulation

Article 84 – paragraph 2 a (new)

Amendment 220

Proposal for a regulation

Article 84 – paragraph 2 b (new)

Amendment 221

Proposal for a regulation

Article 88 – paragraph 1

Amendment 222

Proposal for a regulation

Article 91 – paragraph 3

Amendment 223

Proposal for a regulation

Article 101 – paragraph 1 – subparagraph 3

Amendment 224

Proposal for a regulation

Article 101 – paragraph 2 – subparagraph 5

Amendment 225

Proposal for a regulation

Article 101 – paragraph 2 – subparagraph 6

Amendment 226

Proposal for a regulation

Article 101 – paragraph 3 a (new)

Amendment 227

Proposal for a regulation

Article 104 – paragraph 1 – subparagraph 1 – introductory part

Amendment 228

Proposal for a regulation

Article 104 – paragraph 1 – subparagraph 1 – point c

Amendment 229

Proposal for a regulation

Article 104 – paragraph 1 – subparagraph 1 – point h

Amendment 230

Proposal for a regulation

Article 104 – paragraph 1 – subparagraph 1 – point i

Amendment 231

Proposal for a regulation

Article 104 – paragraph 1 – subparagraph 1 – point j

Amendment 232

Proposal for a regulation

Article 104 – paragraph 1 – subparagraph 2

Amendment 233

Proposal for a regulation

Article 104 – paragraph 2

Amendment 234

Proposal for a regulation

Article 104 – paragraph 3 – subparagraph 1

Amendment 235

Proposal for a regulation

Article 104 – paragraph 3 – subparagraph 2

Amendment 236

Proposal for a regulation

Article 105 – paragraph 3

Amendment 237

Proposal for a regulation

Article 109 – paragraph 2

Amendment 238

Proposal for a regulation

Article 111 – paragraph 1

Amendment 239

Proposal for a regulation

Article 113 – paragraph 1 – introductory part

Amendment 240

Proposal for a regulation

Article 113 – paragraph 3

Amendment 241

Proposal for a regulation

Article 113 – paragraph 4 – subparagraph 1

Amendment 242

Proposal for a regulation

Article 113 – paragraph 5

Amendment 243

Proposal for a regulation

Article 113 – paragraph 6

Amendment 244

Proposal for a regulation

Article 113 – paragraph 8 – subparagraph 1 – point b

Amendment 245

Proposal for a regulation

Article 113 – paragraph 9

Amendment 246

Proposal for a regulation

Article 114 – paragraph 2

Amendment 247

Proposal for a regulation

Article 114 – paragraph 3

Amendment 248

Proposal for a regulation

Article 115 – paragraph 1 – subparagraph 2

Amendment 249

Proposal for a regulation

Article 115 – paragraph 4

Amendment 250

Proposal for a regulation

Article 116 – paragraph 1 – introductory part

Amendment 251

Proposal for a regulation

Article 116 – paragraph 1 – point c

Amendment 252

Proposal for a regulation

Article 116 – paragraph 1 – point d

Amendment 253

Proposal for a regulation

Article 117 – paragraph 1

Amendment 254

Proposal for a regulation

Article 117 – paragraph 2

Amendment 255

Proposal for a regulation

Article 118 – paragraph 1 – subparagraph 1

Amendment 256

Proposal for a regulation

Article 118 – paragraph 1 a (new)

Amendment 257

Proposal for a regulation

Article 118 – paragraph 2

Amendment 258

Proposal for a regulation

Article 120 – paragraph 1

Amendment 259

Proposal for a regulation

Article 120 – paragraph 1 a (new)

Amendment 260

Proposal for a regulation

Article 121 – paragraph 1 – point -a (new)

Amendment 261

Proposal for a regulation

Article 121 – paragraph 1 – point b

Amendment 262

Proposal for a regulation

Article 121 – paragraph 1 – point b a (new)

Amendment 263

Proposal for a regulation

Article 121 – paragraph 1 – point c a (new)

Amendment 264

Proposal for a regulation

Article 121 – paragraph 1 – point c b (new)

Amendment 265

Proposal for a regulation

Article 121 – paragraph 2 – point f

Amendment 266

Proposal for a regulation

Article 121 – paragraph 2 a (new)

Amendment 267

Proposal for a regulation

Article 121 – paragraph 5 – point a

Amendment 268

Proposal for a regulation

Article 121 – paragraph 5 – point d

Amendment 269

Proposal for a regulation

Article 121 – paragraph 6

Amendment 270

Proposal for a regulation

Article 121 a (new)

Amendment 271

Proposal for a regulation

Article 122 – paragraph 1

Amendment 272

Proposal for a regulation

Article 122 – paragraph 1 a (new)

Amendment 273

Proposal for a regulation

Article 122 – paragraph 2 a (new)

Amendment 274

Proposal for a regulation

Article 122 – paragraph 4 – introductory part

Amendment 275

Proposal for a regulation

Article 122 – paragraph 6

Amendment 276

Proposal for a regulation

Article 123 – paragraph 2

Amendment 277

Proposal for a regulation

Article 123 – paragraph 4

Amendment 278

Proposal for a regulation

Article 123 – paragraph 4 – subparagraph 1 a (new)

Amendment 279

Proposal for a regulation

Article 124 – paragraph 2 – subparagraph 2

Amendment 280

Proposal for a regulation

Article 124 – paragraph 3

Amendment 281

Proposal for a regulation

Article 125 – paragraph 1 – point a

Amendment 282

Proposal for a regulation

Article 125 – paragraph 1 – point f

Amendment 283

Proposal for a regulation

Article 126 – paragraph 2 a (new)

Amendment 284

Proposal for a regulation

Article 127 – paragraph 1

Amendment 285

Proposal for a regulation

Article 128 – paragraph 2

Amendment 286

Proposal for a regulation

Article 129 – paragraph 1

Amendment 287

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – point a

Amendment 288

Proposal for a regulation

Article 130 – paragraph 2 – subparagraph 1 – point b

Amendment 289

Proposal for a regulation

Article 130 – paragraph 5

Amendment 290

Proposal for a regulation

Article 130 – paragraph 6 a (new)

Amendment 291

Proposal for a regulation

Article 131 – paragraph 1

Amendment 292

Proposal for a regulation

Article 131 – paragraph 2

Amendment 293

Proposal for a regulation

Article 132 – paragraph 1

Amendment 294

Proposal for a regulation

Article 132 – paragraph 1 a (new)

Amendment 295

Proposal for a regulation

Article 132 – paragraph 1 b (new)

Amendment 296

Proposal for a regulation

Article 134 – paragraph 1 – introductory part

Amendment 297

Proposal for a regulation

Article 134 – paragraph 1 – point -a (new)

Amendment 298

Proposal for a regulation

Article 134 – paragraph 1 – point c a (new)

Amendment 299

Proposal for a regulation

Article 134 – paragraph 1 – point c b (new)

Amendment 300

Proposal for a regulation

Article 134 – paragraph 1 a (new)

Amendment 301

Proposal for a regulation

Article 134 – paragraph 2

Amendment 302

Proposal for a regulation

Article 134 – paragraph 3

Amendment 303

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 1

Amendment 304

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – introductory part

Amendment 305

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point a

Amendment 306

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point a a (new)

Amendment 307

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point b

Amendment 308

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point c

Amendment 309

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point n

Amendment 310

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point zc

Amendment 311

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point ze

Amendment 312

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point zl a (new)

Amendment 313

Proposal for a regulation

Article 138 – paragraph 2 – subparagraph 1

Amendment 314

Proposal for a regulation

Article 138 – paragraph 2 – subparagraph 2 – point b a (new)

Amendment 315

Proposal for a regulation

Article 138 – paragraph 2 – subparagraph 3

Amendment 316

Proposal for a regulation

Article 142 – paragraph 1 – point l

Amendment 317

Proposal for a regulation

Article 143 – paragraph 1 – subparagraph 2

Amendment 318

Proposal for a regulation

Article 143 – paragraph 2 – subparagraph 2

Amendment 319

Proposal for a regulation

Article 143 – paragraph 4

Amendment 320

Proposal for a regulation

Article 143 – paragraph 4 a (new)

Amendment 321

Proposal for a regulation

Article 146 – paragraph 8 – subparagraph 1

Amendment 322

Proposal for a regulation

Article 147 – title

Amendment 323

Proposal for a regulation

Article 147 – paragraph 1 – subparagraph 2

Amendment 324

Proposal for a regulation

Article 147 – paragraph 2

Amendment 325

Proposal for a regulation

Article 147 – paragraph 2 a (new)

Amendment 326

Proposal for a regulation

Article 147 – paragraph 2 b (new)

Amendment 327

Proposal for a regulation

Article 147 – paragraph 2 c (new)

Amendment 328

Proposal for a regulation

Article 150 – title

Amendment 329

Proposal for a regulation

Article 150 – paragraph 2 – subparagraph 3

Amendment 330

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 1 – point b a (new)

Amendment 331

Proposal for a regulation

Article 150 – paragraph 3 a (new)

Amendment 332

Proposal for a regulation

Article 150 – paragraph 5 a (new)

Amendment 333

Proposal for a regulation

Article 151 – paragraph 3 – subparagraph 1

Amendment 334

Proposal for a regulation

Article 152 – paragraph 2 – subparagraph 2

Amendment 335

Proposal for a regulation

Article 153 – paragraph 1

Amendment 336

Proposal for a regulation

Article 154 – paragraph 4

Amendment 337

Proposal for a regulation

Article 162 – paragraph 2

Amendment 338

Proposal for a regulation

Article 163 – paragraph 1

Amendment 339

Proposal for a regulation

Article 164 – paragraph 5

Amendment 340

Proposal for a regulation

Article 165 – paragraph 3 a (new)

Amendment 341

Proposal for a regulation

Article 166 – paragraph 1

Amendment 342

Proposal for a regulation

Article 166 – paragraph 1 – subparagraph 1 a (new)

Amendment 343

Proposal for a regulation

Article 166 – paragraph 2

Amendment 344

Proposal for a regulation

Article 167 – paragraph 2

Amendment 345

Proposal for a regulation

Article 168 – paragraph 1

Amendment 346

Proposal for a regulation

Article 169 – paragraph 1 – subparagraph 2 – point b

Amendment 347

Proposal for a regulation

Article 171 – paragraph 1

Amendment 348

Proposal for a regulation

Article 172 – paragraph 5 – point b a (new)

Amendment 349

Proposal for a regulation

Article 172 – paragraph 5 – point b b (new)

Amendment 350

Proposal for a regulation

Article 172 – paragraph 5 – point b c (new)

Amendment 351

Proposal for a regulation

Article 172 – paragraph 5 – point b d (new)

Amendment 352

Proposal for a regulation

Article 172 – paragraph 5 – point b e (new)

Amendment 353

Proposal for a regulation

Article 172 – paragraph 5 – point b f (new)

Amendment 354

Proposal for a regulation

Article 172 – paragraph 5 – point b g (new)

Amendment 355

Proposal for a regulation

Article 172 – paragraph 5 – point b h (new)

Amendment 356

Proposal for a regulation

Article 175 a (new) – paragraph 1 – point 1

Regulation (EC) No 851/2004

Articles 11a a (new) and 11a b (new)

Amendment 357

Proposal for a regulation

Article 175 a (new) – paragraph 1 – point 2

Regulation (EC) No 851/2004

Article 13 – paragraph 1 – point b a (new)

Amendment 358

Proposal for a regulation

Article 175 a (new) – paragraph 1 – point 3

Regulation (EC) No 851/2004

Article 16 – paragraph 2 – point d a (new)

Amendment 359

Proposal for a regulation

Article 175 a (new) – paragraph 1 – point 4

Regulation (EC) No 851/2004

Articles 17 a (new) and 17 b (new)

Amendment 360

Proposal for a regulation

Article 175 a (new) – paragraph 1 – point 5

Regulation (EC) No 851/2004

Article 19

Amendment 361

Proposal for a regulation

Article 181 – paragraph 3 a (new)

Amendment 362

Proposal for a regulation

Annex II – point 16

Amendment 363

Proposal for a regulation

Annex II – point 25 a (new)

Amendment 364

Proposal for a regulation

Annex II – point 25 b (new)

Amendment 365

Proposal for a regulation

Annex IV – Part III – paragraph 1 – point 2 – point e

Amendment 366

Proposal for a regulation

Annex IV – Part V – paragraph 1 – point 2 – point d a (new)

Amendment 367

Proposal for a regulation

Annex IV – Part V a (new)

Or. en

EXPLANATORY STATEMENT

ANNEX: LIST OF ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

The following list is drawnPursuant upto onArticle a8 purelyof voluntaryAnnex basisI underto the exclusive responsibilityRules of Procedure, the rapporteur.rapporteur Thedeclares rapporteurthat he has received input from the following entities or persons in the preparation of the draft report:report , until the adoption thereof in committee:

The list above is drawn up under the exclusive responsibility of the rapporteur.

22.2.2024

OPINION OF THE COMMITTEE ON INDUSTRY, RESEARCH AND ENERGY

for the Committee on the Environment, Public Health and Food Safety

on 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

(COM(2023)0193 – C90144/2023 – 2023/0131(COD))

Rapporteur for opinion (*): Henna Virkkunen

(*) Associated committee – Rule 57 of the Rules of Procedure

SHORT JUSTIFICATION

The "Pharmaceutical Package" consists of the new Regulation and Directive, representing a long-awaited overhaul of pharmaceutical legislation, an integral part of building the European Health Union. As multiple legislative reforms impact the pharmaceutical sector at the same time, assessing their collective impact on the EU's global competitiveness, innovation, and medicine availability is crucial.

The Rapporteur supports the Pharmaceutical reform's objectives, aiming to foster a competitive and innovation-friendly R&D environment in Europe, enhance strategic autonomy, address antimicrobial resistance, and improve medicine accessibility. Nonetheless, some methodologies require refinement.

A significant concern is the potential migration of the pharmaceutical industry from Europe. To remain globally competitive, Europe must maintain an innovation-friendly regulatory framework. The Rapporteur emphasizes the need for legislation that is predictable, transparent, stable, and clear to enhance the attractiveness of the EU for research, development, and production of medicines.

Transferable exclusivity vouchers

Antimicrobial resistance (AMR) is a pressing global health crisis that requires immediate EU intervention before it becomes a more severe issue. The current market for developing new medicines to combat AMR is inadequate. These products must be used carefully to maintain their effectiveness, making them less profitable for companies to invest in research and development.

The Commission has proposed Transferable Exclusivity Vouchers (TEV) to stimulate the creation of new antimicrobial drugs. The Rapporteur supports TEV as a positive development. However, the strict conditions outlined for TEV could reduce its effectiveness, particularly considering it extends only Regulatory Data Protection (RDP) and not Supplementary Protection Certificates (SPC) or patent protection. The conditions for TEV should be reconsidered, as recommended by the Rapporteur.

Unmet medical needs

Medical progress aims to address Unmet Medical Needs (UMN), which can vary and change rapidly. Classifying some UMN as "high" can be ethically problematic because it may diminish the importance of other UMN. A comprehensive understanding of UMN is needed since it can take many forms.

Debates about UMN or High Unmet Medical Needs (HUMN) are part of broader challenges related to the availability, accessibility, affordability of new medicines, and the sustainability of healthcare systems. The patient's viewpoint is often overlooked, and the potential for transforming patients' lives with new treatments is not fully acknowledged.

Restricting incentives to treatments that fit a narrow definition of UMN or HUMN today could hinder the development of vital therapies for future patients. This might decrease predictability for companies and discourage them from investing in research and development in the EU to address UMN.

The Regulatory Sandbox

In recent years, scientific progress has rapidly increased, leading to new medicines, devices, diagnostics, and combinations of these beyond what current regulations anticipated. To ensure high-quality, safe, and effective products reach patients, regulators need flexibility and collaboration with developers. A regulatory sandbox can achieve this goal.

However, the Commission's sandbox proposal only covers pharmaceuticals. Many modern products include medical devices, diagnostics, and digital tools, each with separate regulations. The Rapporteur believes it's essential to expand the sandbox's scope to accommodate future developments in these areas.

Addressing medicine shortages

Medicine shortages are a serious issue, often caused by unexpected surges in demand. The Commission proposes extending the notification period for temporary shortages from two to six months and making shortage prevention plans mandatory for all medicines in the proposed Regulation.

To improve medicine availability, it's crucial to create an efficient system without imposing excessive administrative burdens on regulators and marketing authorization holders (MAHs). Instead of requiring shortage plans for all medicines, it would be better to focus on critical ones after assessing their necessity and specific risks.

Extending the notification period too much might lead to unnecessary "just in case" notifications. In Rapporteur's opinion It's wiser to concentrate on making demand transparent across Europe and using data and digital tools to identify and prevent shortages.

Conclusion

The Rapporteur supports "The Pharmaceutical Package" and agrees with many of the Commission's proposed priorities. It is essential for this reform to protect the competitiveness of the European Union and the security of its pharmaceutical supply chain.

Given the constraints of time in preparing this initial draft report, the Rapporteur retains the prerogative to make further amendments, enhancements, and elucidations to this draft report. For a comprehensive list of entities or individuals with whom the Rapporteur has interacted or from whom input has been received during the process, please refer to the Annex at the conclusion of this draft report.

AMENDMENTS

The Committee on Industry, Research and Energy calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to take the following into account:

Amendment 1

Proposal for a regulation

Recital 1 a (new)

Amendment 2

Proposal for a regulation

Recital 2

Amendment 3

Proposal for a regulation

Recital 2 a (new)

Amendment 4

Proposal for a regulation

Recital 3

Amendment 5

Proposal for a regulation

Recital 5 a (new)

Amendment 6

Proposal for a regulation

Recital 5 b (new)

Amendment 7

Proposal for a regulation

Recital 9

Amendment 8

Proposal for a regulation

Recital 26 a (new)

Amendment 9

Proposal for a regulation

Recital 29

Amendment 10

Proposal for a regulation

Recital 30 a (new)

Amendment 11

Proposal for a regulation

Recital 36

Amendment 12

Proposal for a regulation

Recital 39

Amendment 13

Proposal for a regulation

Recital 42 a (new)

Amendment 14

Proposal for a regulation

Recital 43

Amendment 15

Proposal for a regulation

Recital 45 a (new)

Amendment 16

Proposal for a regulation

Recital 51

Amendment 17

Proposal for a regulation

Recital 79

Amendment 18

Proposal for a regulation

Recital 79 a (new)

Amendment 19

Proposal for a regulation

Recital 80

Amendment 20

Proposal for a regulation

Recital 87 a (new)

Amendment 21

Proposal for a regulation

Recital 96 a (new)

Amendment 22

Proposal for a regulation

Recital 102

Amendment 23

Proposal for a regulation

Recital 104

Amendment 24

Proposal for a regulation

Recital 105 a (new)

Amendment 25

Proposal for a regulation

Recital 126

Amendment 26

Proposal for a regulation

Recital 129

Amendment 27

Proposal for a regulation

Recital 132 a (new)

Amendment 28

Proposal for a regulation

Recital 132 b (new)

Amendment 29

Proposal for a regulation

Recital 132 c (new)

Amendment 30

Proposal for a regulation

Recital 133

Amendment 31

Proposal for a regulation

Recital 134

Amendment 32

Proposal for a regulation

Recital 135

Amendment 33

Proposal for a regulation

Recital 136

Amendment 34

Proposal for a regulation

Recital 137

Amendment 35

Proposal for a regulation

Recital 138

Amendment 36

Proposal for a regulation

Recital 138 a (new)

Amendment 37

Proposal for a regulation

Recital 138 b (new)

Amendment 38

Proposal for a regulation

Recital 138 c (new)

Amendment 39

Proposal for a regulation

Recital 138 d (new)

Amendment 40

Proposal for a regulation

Article 2 – paragraph 2 – point 4

Amendment 41

Proposal for a regulation

Article 2 – paragraph 2 – point 8 a (new)

Amendment 42

Proposal for a regulation

Article 2 – paragraph 2 – point 8 b (new)

Amendment 43

Proposal for a regulation

Article 2 – paragraph 2 – point 12

Amendment 44

Proposal for a regulation

Article 2 – paragraph 2 – point 12 a (new)

Amendment 45

Proposal for a regulation

Article 2 – paragraph 2 – point 12 b (new)

Amendment 46

Proposal for a regulation

Article 4 – title

Amendment 47

Proposal for a regulation

Article 4 – paragraph 1 – point a

Amendment 48

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2

Amendment 49

Proposal for a regulation

Article 6 – paragraph 2 – subparagraph 1

Amendment 50

Proposal for a regulation

Article 6 – paragraph 4

Amendment 51

Proposal for a regulation

Article 6 – paragraph 5 – subparagraph 2

Amendment 52

Proposal for a regulation

Article 40 – paragraph 1

Amendment 53

Proposal for a regulation

Article 40 – paragraph 2

Amendment 54

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – introductory part

Amendment 55

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point a

Amendment 56

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point b

Amendment 57

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point c

Amendment 58

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 2

Amendment 59

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 1 – point a

Amendment 60

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 1 – point b

Amendment 61

Proposal for a regulation

Article 40 a (new)

Amendment 62

Proposal for a regulation

Article 41 – paragraph 1 – subparagraph 2

Amendment 63

Proposal for a regulation

Article 68 – paragraph 2

Amendment 64

Proposal for a regulation

Article 68 – paragraph 2 a (new)

Amendment 65

Proposal for a regulation

Article 70

Amendment 66

Proposal for a regulation

Article 71 – paragraph 2 – point a

Amendment 67

Proposal for a regulation

Article 71 – paragraph 2 – point b

Amendment 68

Proposal for a regulation

Article 71 – paragraph 2 – point b a (new)

Amendment 69

Proposal for a regulation

Article 71 – paragraph 2 – point c

Amendment 70

Proposal for a regulation

Article 71 – paragraph 2 – point c a (new)

Amendment 71

Proposal for a regulation

Article 71 – paragraph 3

Amendment 72

Proposal for a regulation

Article 72 – paragraph 1 – subparagraph 2

Amendment 73

Proposal for a regulation

Article 72 – paragraph 2 – subparagraph 1

Amendment 74

Proposal for a regulation

Article 72 – paragraph 2 – subparagraph 2

Amendment 75

Proposal for a regulation

Article 72 – paragraph 2 a (new)

Amendment 76

Proposal for a regulation

Article 72 – paragraph 2 b (new)

Amendment 77

Proposal for a regulation

Article 72 – paragraph 2 c (new)

Amendment 78

Proposal for a regulation

Article 72 – paragraph 2 d (new)

Amendment 79

Proposal for a regulation

Article 72 – paragraph 2 e (new)

Amendment 80

Proposal for a regulation

Article 72 – paragraph 3

Amendment 81

Proposal for a regulation

Article 96 – paragraph 1

Amendment 82

Proposal for a regulation

Article 113 – paragraph 1 – point b a (new)

Amendment 83

Proposal for a regulation

Article 113 – paragraph 2 – subparagraph 1

Amendment 84

Proposal for a regulation

Article 113 – paragraph 3

Amendment 85

Proposal for a regulation

Article 113 – paragraph 5

Amendment 86

Proposal for a regulation

Article 115 – paragraph 4

Amendment 87

Proposal for a regulation

Article 115 – paragraph 5 a (new)

Amendment 88

Proposal for a regulation

Article 116 – paragraph 1 a (new)

Amendment 89

Proposal for a regulation

Article 117 – paragraph 1

Amendment 90

Proposal for a regulation

Article 117 – paragraph 2

Amendment 91

Proposal for a regulation

Article 120 – paragraph 1

Amendment 92

Proposal for a regulation

Article 120 – paragraph 2

Amendment 93

Proposal for a regulation

Article 120 – paragraph 2 – subparagraph 1 (new)

Amendment 94

Proposal for a regulation

Article 121 – paragraph 1 – point b

Amendment 95

Proposal for a regulation

Article 121 – paragraph 1 – point c a (new)

Amendment 96

Proposal for a regulation

Article 121 – paragraph 2 – point f

Amendment 97

Proposal for a regulation

Article 121 – paragraph 2 a (new)

Amendment 98

Proposal for a regulation

Article 121 – paragraph 5 – point d

Amendment 99

Proposal for a regulation

Article 122 – paragraph 1 a (new)

Amendment 100

Proposal for a regulation

Article 122 – paragraph 4 – introductory part

Amendment 101

Proposal for a regulation

Article 122 – paragraph 6

Amendment 102

Proposal for a regulation

Article 122 – paragraph 6 a (new)

Amendment 103

Proposal for a regulation

Article 124 – paragraph 3

Amendment 104

Proposal for a regulation

Article 125 – paragraph 1 – point f a (new)

Amendment 105

Proposal for a regulation

Article 129 – paragraph 1

Amendment 106

Proposal for a regulation

Article 129 – paragraph 1 – subparagraph 1 (new)

Amendment 107

Proposal for a regulation

Article 164 – paragraph 5

Amendment 108

Proposal for a regulation

Article 167 – paragraph 2

ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR for the OPINION HAS RECEIVED INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur for the opinion declares that she has received input from the following entities or persons in the preparation of the opinion, until the adoption thereof in committee:

The list above is drawn up under the exclusive responsibility of the rapporteur for the opinion.

PROCEDURE – COMMITTEE ASKED FOR OPINION

FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION

23.2.2024

LETTER OF THE COMMITTEE ON BUDGETS

Mr Pascal Canfin

Chair

Committee on the Environment, Public Health and Food Safety

BRUSSELS

Subject: Opinion on Opinion on the Commission proposal on a Regulation of the European Parliament and of the Council on for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency COM(2023)0193; (2023/0131(COD)).

Dear Mr Chair,

Under the procedure referred to above, the Committee on Budgets’ Coordinators decided at their meeting of 23 May 2023 to adopt an opinion in the form of a letter. The committee adopted the opinion at its meeting on 14/02/2024 and mandated me to convey the position set out below.

Background to the proposal

The general objective of the proposal is to guarantee a high level of public health by ensuring the quality, safety and efficacy of medicines for EU patients and harmonise the internal market and more specifically to:

1. Promote innovation, in particular for unmet medical needs, including for rare disease patients and children.

2. Create a balanced system for pharmaceuticals in the EU that promotes affordability for health systems while rewarding innovation.

3. Ensure access to innovative and established medicines for patients, with special attention to enhancing security of the supply across the EU.

4. Reduce the environmental impact of the pharmaceutical product life cycle.

5. Reduce the regulatory burden and provide a flexible regulatory framework.

According to the legislative financial statement accompanying the Proposal on a Regulation of the European Parliament and of the Council on for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, the budgetary implications are mainly related to additional tasks to be carried out by the European Medicines Agency in terms of providing scientific, administrative and IT support in the following main areas:

– enhanced pre-authorisation scientific and regulatory support;

– decision-making on orphan designations and management of the Union Register of designated orphan medicinal products;

– active substance master file assessment and certification;

– inspection capacities for inspections in third countries and support to Member States;

– environmental risk assessment strengthening;

– shortage management and security of supply.

The proposal foresees that most of the foreseen additional tasks of EMA will be carried out by 54 additional Temporary Agents funded by fees while other 6 additional Temporary Agents and the costs for the incentives to “not-for-profit” entities will be financed through an increase of the appropriations from the EU budget in the years 2026 and 2027 by 4.4 million EUR and an internal redeployment within heading 2b, i.e. by an equal reduction of EU4Health programme. According to the information provided by the Commission at different budgetary trilogues, this constitutes the second reinforcement of EMA since the start of the MFF and the third reduction of the EU4Health programme since the start of the MFF.

Position of the Committee on Budgets

The BUDG committee is of the general opinion that entrusting new tasks to decentralised agencies should be financed from fresh resources and should not lead to reduce other equally important priorities to be implemented in other programmes even if in the same policy area, in this case Health. Thus, redeployments from the EU4Health programme should be limited and examined with due care. Furthermore, the overall proposed increase in temporary agents is significant (around 7% above the level agreed in the 2024 budget) which deserves special attention as no full coverage by fees as planned would significantly further impact the Union budget.

In this context, we deem useful to provide the ENVI Committee with technical support throughout the process including with a view to assessing the budgetary impact of any decisions of the co-legislators and prevent further carve-outs from the U4Health programme.

In the event of new evidence or changes to this approach introduced by the co-legislators during the negotiations, the Committee on Budgets stands ready to assess the potential budgetary consequences.

Yours sincerely,

Johan Van Overtveldt

ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

The rapporteur declares under his exclusive responsibility that he did not receive input from any entity or person to be mentioned in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.

09.01.2024

LETTER OF THE COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT

Mr Pascal Canfin

Chair of the Committee on the Environment, Public Health and Food Safety

Brussels

IPOL-COM-AGRI D(2023) 43992

Subject: Opinion on the Proposal for a Regulation 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 (COM(2023)0193 – C90144 – 2023/0131(COD))

Dear Mr Canfin,

Under the procedure referred to above, the Committee on Agriculture and Rural Development (AGRI) has been asked to submit an opinion to your committee. At its meeting of 23 May 2023, the committee decided to issue an opinion in the form of a letter and adopted it on 24 January 2023.

The main reason the AGRI Committee send an opinion relates to its competence over veterinary matters as set out in paragraph 3(a) of Annex VI(XIII) of the Rules of Procedures.

 Governance of the European Medicinal Agency

AGRI Committee welcomes the simplification of functionning of the Agency which can bring benefits to its work, inclusing in veterinary medicinal products; recalls that appropriate funding is important to ensure effective regulatory control, while enabling innovation and availability of medicinal products.

 Antimicrobial resistance and prudent use of veterinary medecines

AGRI Committee welcomes the incentives for developing ‘priority antimicrobials’; stresses that in order for all users to have continued recourse to a full range of effective antimicrobials, for both human and animal health, antibiotics should be developped, marketed, delivered and used responsibly and prudently in line with the “One Health” approach and Regulations (EU) 2019/5 and (EU) 2019/6; highlights the urgent need to bring new antibiotics onto the market, while maintaining high levels of health and safety; calls for better implementing existing approaches against antimicrobial resistance including prevention and surveillance, and innovating new ones;

 Free Trade Agreements and reciprocity of norms.

AGRI Committee strongly calls for equivalent measures to those laid down in this proposal, on veterinary products for Union trade partners, to be inserted when negotiating free trade agreements; considers that no veterinary products nor animal products should be imported without a strict reciprocity of norms.

I would be grateful if the ENVI committee could take into account the above considerations in view of the adoption of its report on the Commission proposal in question.

Yours sincerely,

Norbert Lins

ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

The rapporteur declares under his exclusive responsibility that he did not receive input from any entity or person to be mentioned in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.

PROCEDURE – COMMITTEE RESPONSIBLE

FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE