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Regulation (EC) No 726/2004 (EMA)
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Article 4
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Regulation (EC) No 726/2004 (EMA)
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Recitals
TITLE I — DEFINITIONS AND SCOPE
Article 1
Article 2
Article 3
Article 4
TITLE II — AUTHORISATION AND SUPERVISION OF MEDICINAL PRODUCTS FOR HUMAN USE
Chapter 1 — Submission and examination of applications — Authorisations
Article 5
Article 6
Article 7
Article 8
Article 9
Article 10
Article 10a
Article 10b
Article 11
Article 12
Article 13
Article 14
Article 14a
Article 14b
Article 15
Chapter 2 — Supervision and penalties
Article 16
Article 16a
Article 16b
Article 17
Article 18
Article 19
Article 20
Article 20a
Chapter 3 — Pharmacovigilance
Article 21
Article 22
Article 23
Article 24
Article 25
Article 25a
Article 26
Article 27
Article 28
Article 28a
Article 28b
Article 28c
Article 28d
Article 28e
Article 28f
Article 29
TITLE III — AUTHORISATION AND SUPERVISION OF VETERINARY MEDICINAL PRODUCTS
Chapter 1 — Submission and examination of applications — Authorisations
TITLE IV — THE EUROPEAN MEDICINES AGENCY — RESPONSIBILITIES AND ADMINISTRATIVE STRUCTURE
Chapter 1 — Tasks of the Agency
Article 55
Article 56
Article 57
Article 58
Article 59
Article 60
Article 61
Article 61a
Article 62
Article 63
Article 64
Article 65
Article 66
Chapter 2 — Financial Provisions
Article 67
Article 68
Article 69
Chapter 3 — General Provisions governing the Agency
Article 71
Article 71a
Article 72
Article 73
Article 73a
Article 74
Article 75
Article 76
Article 77
Article 78
Article 80
TITLE V — GENERAL AND FINAL PROVISIONS
Article 81
Article 82
Article 83
Article 84
Article 84a
Article 85
Article 86
Article 86a
Article 87
Article 87a
Article 87b
Article 88
Article 89
Article 90
ANNEX
ANNEX I
ANNEX II — LIST OF THE OBLIGATIONS REFERRED TO IN ARTICLE 84A
Timeline
Published on: April 30th 2004
In force since: May 20th 2004
Passed by
European Parliament
Council of the European Union
Amended by:
Corrigendum 32010R1235R(01)
Regulation (EC) No 1901/2006
Regulation (EC) No 1394/2007
Regulation (EC) No 219/2009
Regulation (EC) No 470/2009
Regulation (EU) No 1235/2010
Regulation (EU) No 1027/2012
Regulation (EU) 2018/1718
Regulation (EU) 2019/5
Repeals:
Regulation (EEC) No 2309/93
Cites:
Directive 87/22/EEC
Directive 90/220/EEC
Regulation (EEC) No 2377/90
Directive 93/41/EEC
Directive 96/22/EC
Directive 96/23/EC
Decision 1999/468
Regulation (EC) No 1073/1999
Regulation (EC) No 141/2000
Directive 2001/18/EC
Directive 2001/20/EC
Directive 2001/82/EC
Directive 2001/83/EC
Regulation (EC) No 1049/2001
Regulation (EC) No 178/2002
Regulation (EC, Euratom) No 1605/2002
Regulation (EC, Euratom) No 2343/2002
Regulation (EC) No 806/2003
Regulation (EC) No 1029/2003
Regulation (EC) No 1647/2003
Regulation (EC) No 1830/2003
Directive 2004/27/EC
Directive 2004/28/EC
Regulation (EU, Euratom) No 966/2012
Regulation (EU) No 1271/2013
Regulation (EU) No 1296/2013
Regulation (EU) No 1301/2013
Regulation (EU) No 1303/2013
Regulation (EU) No 1304/2013
Regulation (EU) No 1309/2013
Regulation (EU) No 1316/2013
Decision No 541/2014
Regulation (EU) No 223/2014
Regulation (EU) No 283/2014
Regulation (EU, Euratom) 2018/1046
Regulation (EU) 2019/6
Cited by:
Directive 90/385/EEC
Directive 93/42/EEC
Regulation (EC) No 297/95
Directive 2001/82/EC
Directive 2001/83/EC
Regulation (EC) No 998/2003
Directive 2004/28/EC
Decision 2005/387
Decision 2005/594
Directive 2005/28/EC
Directive 2005/94/EC
Regulation (EC) No 1091/2005
Regulation (EC) No 1236/2005
Regulation (EC) No 1905/2005
Regulation (EC) No 2049/2005
Decision 2006/147
Decision 2006/148
Directive 2006/88/EC
Regulation (EC) No 507/2006
Regulation (EC) No 816/2006
Regulation (EC) No 1177/2006
Regulation (EC) No 1902/2006
Regulation (EC) No 1907/2006
Regulation (EC) No 1920/2006
Regulation (EC) No 1950/2006
Decision 2007/590
Decision 2007/598
Decision 2007/638
Directive 2007/47/EC
Regulation (EC) No 658/2007
Decision 2008/285
Decision 2008/646
Decision 2008/735
Decision 2008/838
Decision 2008/980
Regulation (EC) No 312/2008
Regulation (EC) No 1234/2008
Decision 2009/75
Decision 2009/461
Directive 2009/53/EC
Directive 2009/120/EC
Regulation (EC) No 249/2009
Regulation (EC) No 668/2009
Decision 2010/189
Decision No 1/2010
Directive 2010/84/EU
Regulation (EU) No 37/2010
Regulation (EU) No 261/2010
Regulation (EU) No 438/2010
Regulation (EU) No 605/2010
Regulation (EU) No 758/2010
Regulation (EU) No 759/2010
Regulation (EU) No 761/2010
Regulation (EU) No 890/2010
Regulation (EU) No 914/2010
Directive 2011/24/EU
Directive 2011/62/EU
Directive 2011/69/EU
Directive 2011/78/EU
Directive 2011/80/EU
Regulation (EU) No 143/2011
Regulation (EU) No 301/2011
Regulation (EU) No 362/2011
Regulation (EU) No 363/2011
Regulation (EU) No 1152/2011
Decision 2012/110
Decision 2012/229
Decision 2012/828
Directive 2012/26/EU
Directive 2012/38/EU
Regulation (EU) No 84/2012
Regulation (EU) No 85/2012
Regulation (EU) No 86/2012
Regulation (EU) No 107/2012
Regulation (EU) No 122/2012
Regulation (EU) No 123/2012
Regulation (EU) No 201/2012
Regulation (EU) No 202/2012
Regulation (EU) No 221/2012
Regulation (EU) No 222/2012
Regulation (EU) No 273/2012
Regulation (EU) No 436/2012
Regulation (EU) No 466/2012
Regulation (EU) No 488/2012
Regulation (EU) No 520/2012
Regulation (EU) No 528/2012
Regulation (EU) No 712/2012
Regulation (EU) No 1161/2012
Regulation (EU) No 1186/2012
Regulation (EU) No 1191/2012
Decision 2013/33
Decision 2013/455
Decision 2013/651
Decision No 1082/2013
Directive 2013/5/EU
Directive 2013/6/EU
Regulation (EU) No 59/2013
Regulation (EU) No 115/2013
Regulation (EU) No 116/2013
Regulation (EU) No 122/2013
Regulation (EU) No 198/2013
Regulation (EU) No 220/2013
Regulation (EU) No 394/2013
Regulation (EU) No 406/2013
Regulation (EU) No 489/2013
Regulation (EU) No 576/2013
Regulation (EU) No 1032/2013
Regulation (EU) No 1035/2013
Regulation (EU) No 1036/2013
Regulation (EU) No 1056/2013
Regulation (EU) No 1057/2013
Regulation (EU) No 1235/2013
Regulation (EU) No 19/2014
Regulation (EU) No 20/2014
Regulation (EU) No 90/2014
Regulation (EU) No 91/2014
Regulation (EU) No 92/2014
Regulation (EU) No 93/2014
Regulation (EU) No 94/2014
Regulation (EU) No 200/2014
Regulation (EU) No 201/2014
Regulation (EU) No 272/2014
Regulation (EU) No 334/2014
Regulation (EU) No 357/2014
Regulation (EU) No 418/2014
Regulation (EU) No 437/2014
Regulation (EU) No 536/2014
Regulation (EU) No 658/2014
Regulation (EU) No 676/2014
Regulation (EU) No 677/2014
Regulation (EU) No 681/2014
Regulation (EU) No 682/2014
Regulation (EU) No 683/2014
Regulation (EU) No 967/2014
Regulation (EU) No 1091/2014
Regulation (EU) No 1277/2014
Regulation (EU) No 1359/2014
Regulation (EU) No 1390/2014
Decision (EU) 2015/892
Decision (EU) 2015/2367
Regulation (EU) 2015/149
Regulation (EU) 2015/150
Regulation (EU) 2015/151
Regulation (EU) 2015/152
Regulation (EU) 2015/262
Regulation (EU) 2015/394
Regulation (EU) 2015/406
Regulation (EU) 2015/407
Regulation (EU) 2015/417
Regulation (EU) 2015/419
Regulation (EU) 2015/446
Regulation (EU) 2015/490
Regulation (EU) 2015/984
Regulation (EU) 2015/985
Regulation (EU) 2015/1078
Regulation (EU) 2015/1079
Regulation (EU) 2015/1080
Regulation (EU) 2015/1308
Regulation (EU) 2015/1491
Regulation (EU) 2015/1492
Regulation (EU) 2015/1727
Regulation (EU) 2015/1731
Regulation (EU) 2015/1759
Regulation (EU) 2015/1820
Regulation (EU) 2015/2062
Decision (EU) 2016/1774
Regulation (EU) 2016/105
Regulation (EU) 2016/124
Regulation (EU) 2016/125
Regulation (EU) 2016/129
Regulation (EU) 2016/131
Regulation (EU) 2016/161
Regulation (EU) 2016/305
Regulation (EU) 2016/312
Regulation (EU) 2016/461
Regulation (EU) 2016/576
Regulation (EU) 2016/710
Regulation (EU) 2016/793
Regulation (EU) 2016/885
Regulation (EU) 2016/1068
Regulation (EU) 2016/1083
Regulation (EU) 2016/1084
Regulation (EU) 2016/1088
Regulation (EU) 2016/1089
Regulation (EU) 2016/1090
Regulation (EU) 2016/1444
Regulation (EU) 2016/1834
Regulation (EU) 2016/1930
Regulation (EU) 2016/1937
Regulation (EU) 2016/2045
Regulation (EU) 2016/2074
Regulation (EU) 2016/2288
Regulation (EU) 2016/2289
Decision (EU) 2017/715
Directive (EU) 2017/1572
Regulation (EU) 2017/12
Regulation (EU) 2017/201
Regulation (EU) 2017/556
Regulation (EU) 2017/612
Regulation (EU) 2017/745
Regulation (EU) 2017/746
Regulation (EU) 2017/794
Regulation (EU) 2017/795
Regulation (EU) 2017/796
Regulation (EU) 2017/880
Regulation (EU) 2017/1273
Regulation (EU) 2017/1274
Regulation (EU) 2017/1275
Regulation (EU) 2017/1558
Regulation (EU) 2017/1559
Regulation (EU) 2017/1569
Regulation (EU) 2017/2001
Regulation (EU) 2017/2005
Regulation (EU) 2017/2101
Regulation (EU) 2017/2326
Regulation (EU) 2018/92
Regulation (EU) 2018/470
Regulation (EU) 2018/471
Regulation (EU) 2018/520
Regulation (EU) 2018/523
Regulation (EU) 2018/613
Regulation (EU) 2018/721
Regulation (EU) 2018/722
Regulation (EU) 2018/772
Regulation (EU) 2018/782
Regulation (EU) 2018/1076
Regulation (EU) 2018/1129
Regulation (EU) 2018/1130
Regulation (EU) 2018/1292
Regulation (EU) 2018/1298
Regulation (EU) 2018/1967
Regulation (EU) 2018/2005
Directive (EU) 2019/1937
Regulation (EU) 2019/6
Regulation (EU) 2019/125
Regulation (EU) 2019/238
Regulation (EU) 2019/480
Regulation (EU) 2019/1009
Regulation (EU) 2019/1243
Regulation (EU) 2019/1871
Regulation (EU) 2019/1881
Regulation (EU) 2019/2090
Regulation (EU) 2020/42
Regulation (EU) 2020/43
Regulation (EU) 2020/422
Regulation (EU) 2020/1043
Regulation (EU) 2020/1086
Regulation (EU) 2021/953
Regulation (EU) 2021/2045
Regulation (EU) 2021/2282
Directive (EU) 2022/642
Regulation (EU) 2022/123
Regulation (EU) 2022/510
Regulation (EU) 2022/839
Regulation (EU) 2022/1034
Regulation (EU) 2022/1520
Topics
marketing
European Medicines Agency
medicament
drug surveillance
veterinary drug
Lexparency.org
lexp
Languages
Deutsch
Español
Regulation (EC) No 726/2004 (EMA)
Status
European Medicines Agency (EMA)
Article 4
go to article
Version
Article 4
1.
Applications for the marketing authorisations referred to in Article
3
shall be submitted to the Agency.
2.
The
►M8
Union
◄
shall grant and supervise marketing authorisations for medicinal products for human use in accordance with Title
II
.
▼M8
—————
▼B
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