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The information here reflects the current status of the procedure
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Identification
Identification procedure
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Reference
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COD/2002/0008
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Title
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Public health: traditional herbal medicinal products (amend. direct. 2001/83/EC)
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Legal Basis
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EC 095 |
| Dossier of the committee |
ENVI/5/16964 |
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Subject(s)
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4.20.04 pharmaceutical products and industry
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Stage reached
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Procedure ended
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Stages
Stages procedure
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Stages
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Documents: references
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Dates
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Source reference
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Equivalent references
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Votes and amendments
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Joint resolution
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of document
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of publication in Official Journal
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Commission/Council: initial legislative document
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EC
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COM(2002)0001
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C5-0026/2002
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17/01/2002
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C 126 28.05.2002, p. 0263 E
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EP: draft report by the committee responsible
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EP
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PE319.342
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03/07/2002
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Economic and Social Committee: opinion, report
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ESC
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CES1008/2002
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18/09/2002
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EP: draft report by the committee responsible
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EP
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PE319.342/REV
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24/09/2002
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EP: decision of the committee responsible, 1st reading/single reading
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05/11/2002
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EP: tabled legislative report, 1st reading or single reading
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EP
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A5-0365/2002
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05/11/2002
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EP: position, 1st reading or single reading
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EP
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T5-0561/2002
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21/11/2002
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C 025 29.01.2004, p. 0222-0361 E
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Commission: modified legislative proposal
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EC
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COM(2003)0161
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C5-0170/2003
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09/04/2003
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Council: statement on common position
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CSL
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13601/2003
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17/10/2003
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Council: common position
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CSL
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12754/1/2003
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C5-0519/2003
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04/11/2003
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C 305 16.12.2003, p. 0052-0060 E
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Commission: communication on the common position
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EC
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SEC(2003)1247
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05/11/2003
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EP: draft report by the committee responsible
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EP
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PE337.042
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14/11/2003
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EP: decision of the committee responsible, 2nd reading
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02/12/2003
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EP: tabled legislative report, 2nd reading
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EP
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A5-0452/2003
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02/12/2003
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EP: position, 2nd reading
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EP
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T5-0579/2003
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17/12/2003
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C 091 15.04.2004, p. 0134-0375 E
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Commission: opinion on the EP position at second reading
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EC
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COM(2004)0114
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C5-0084/2004
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13/02/2004
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Final legislative act
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EU
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32004L0024
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31/03/2004
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L 136 30.04.2004, p. 0085-0090
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Agents
Agents procedure
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European Parliament
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Committee
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Political group
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Appointed
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Environment, Public Health, Consumer Policy (responsible)
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Nisticò Giuseppe
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PPE-DE
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19/02/2002
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European Commission and Council of the Union
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| European Commission DG |
Enterprise and Industry |
Transmission date: 17/01/2002 |
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Competitiveness (Internal Market, Industry and Research)
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meeting: 2570
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of: 11/03/2004
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Links to other sources
Links to other sources procedure
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31/03/2004 - Final legislative act
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PURPOSE : to establish a harmonised legislative framework for traditional herbal medicinal products.
LEGISLATIVE ACT : Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
CONTENT : this Directive aims to guarantee a high level of health protection for European patients by giving them access to medicines of their choice, provided all the necessary safeguards are met. It will also ensure a single market for traditional herbal medicines by introducing harmonised rules and procedures and encouraging cross-border trade in these products, which at the moment is very limited.
This Directive also provides for a simplified registration system for traditional herbal products. The quality requirements which will have to be met are the same as those for all medicinal products. However, to avoid unnecessary testing and burdens on firms, the legislation foresees that new pre-clinical and clinical trials will not be necessary when sufficient knowledge already exists about a particular product.
ENTRY INTO FORCE : 30/04/2004.
IMPLEMENTATION : 30/10/2005.
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List of summaries
List of summaries
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31/03/2004
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Final legislative act
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13/02/2004
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Commission: opinion on the EP position at second reading
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17/12/2003
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EP: position, 2nd reading
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02/12/2003
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EP: decision of the committee responsible, 2nd reading
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05/11/2003
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Commission: communication on the common position
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04/11/2003
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Council: common position
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09/04/2003
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Commission: modified legislative proposal
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21/11/2002
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EP: position, 1st reading or single reading
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05/11/2002
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EP: decision of the committee responsible, 1st reading/single reading
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17/01/2002
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Commission/Council: initial legislative document
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