Regulatory Europeanization, national autonomy and regulatory effectiveness: marketing authorization for pharmaceuticals
Gespeichert in:
1. Verfasser: | |
---|---|
Format: | Buch |
Sprache: | English |
Veröffentlicht: |
Köln
Max-Planck-Inst. für Gesellschaftsforschung
2002
|
Schriftenreihe: | MPIfG discussion paper
[20]02,6 |
Schlagworte: | |
Online-Zugang: | Inhaltsverzeichnis |
Beschreibung: | Literaturverz. S. 51 - 55. - Zsfassung in engl. und dt. Sprache |
Beschreibung: | 55 S. graph. Darst. |
Internformat
MARC
LEADER | 00000nam a2200000 cb4500 | ||
---|---|---|---|
001 | BV016451185 | ||
003 | DE-604 | ||
005 | 20110609 | ||
007 | t| | ||
008 | 030114s2002 gw d||| |||| 00||| eng d | ||
016 | 7 | |a 965835456 |2 DE-101 | |
035 | |a (OCoLC)76461967 | ||
035 | |a (DE-599)BVBBV016451185 | ||
040 | |a DE-604 |b ger |e rakddb | ||
041 | 0 | |a eng | |
044 | |a gw |c DE | ||
049 | |a DE-473 |a DE-521 |a DE-188 | ||
084 | |a MK 5110 |0 (DE-625)123070: |2 rvk | ||
084 | |a QR 525 |0 (DE-625)142044: |2 rvk | ||
084 | |a 17 |2 sdnb | ||
084 | |a 33 |2 sdnb | ||
084 | |a 42 |2 sdnb | ||
100 | 1 | |a Feick, Jürgen |e Verfasser |0 (DE-588)142888699 |4 aut | |
245 | 1 | 0 | |a Regulatory Europeanization, national autonomy and regulatory effectiveness |b marketing authorization for pharmaceuticals |c Jürgen Feick |
264 | 1 | |a Köln |b Max-Planck-Inst. für Gesellschaftsforschung |c 2002 | |
300 | |a 55 S. |b graph. Darst. | ||
336 | |b txt |2 rdacontent | ||
337 | |b n |2 rdamedia | ||
338 | |b nc |2 rdacarrier | ||
490 | 1 | |a MPIfG discussion paper |v [20]02,6 | |
500 | |a Literaturverz. S. 51 - 55. - Zsfassung in engl. und dt. Sprache | ||
610 | 2 | 7 | |a Europäische Union |0 (DE-588)5098525-5 |2 gnd |9 rswk-swf |
650 | 0 | 7 | |a Anerkennung |0 (DE-588)4128520-7 |2 gnd |9 rswk-swf |
650 | 0 | 7 | |a Arzneimittel |0 (DE-588)4003115-9 |2 gnd |9 rswk-swf |
650 | 0 | 7 | |a Gesundheitsschutz |0 (DE-588)4127850-1 |2 gnd |9 rswk-swf |
650 | 0 | 7 | |a Binnenmarkt |0 (DE-588)4145576-9 |2 gnd |9 rswk-swf |
650 | 0 | 7 | |a Zulassung |0 (DE-588)4127410-6 |2 gnd |9 rswk-swf |
689 | 0 | 0 | |a Europäische Union |0 (DE-588)5098525-5 |D b |
689 | 0 | 1 | |a Arzneimittel |0 (DE-588)4003115-9 |D s |
689 | 0 | 2 | |a Zulassung |0 (DE-588)4127410-6 |D s |
689 | 0 | |5 DE-604 | |
689 | 1 | 0 | |a Europäische Union |0 (DE-588)5098525-5 |D b |
689 | 1 | 1 | |a Binnenmarkt |0 (DE-588)4145576-9 |D s |
689 | 1 | 2 | |a Arzneimittel |0 (DE-588)4003115-9 |D s |
689 | 1 | 3 | |a Zulassung |0 (DE-588)4127410-6 |D s |
689 | 1 | 4 | |a Anerkennung |0 (DE-588)4128520-7 |D s |
689 | 1 | 5 | |a Gesundheitsschutz |0 (DE-588)4127850-1 |D s |
689 | 1 | |5 DE-188 | |
830 | 0 | |a MPIfG discussion paper |v [20]02,6 |w (DE-604)BV006188088 |9 2002,6 | |
856 | 4 | 2 | |m DNB Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010171953&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
943 | 1 | |a oai:aleph.bib-bvb.de:BVB01-010171953 |
Datensatz im Suchindex
_version_ | 1820128485216092160 |
---|---|
adam_text |
FEICK:
MARKETING
AUTHORIZATION
FOR
PHARMACEUTICALS
3
CONTENTS
1
INTRODUCTION
5
2
CONTEXT
AND
GOALS
OF
EUROPEAN
MARKET
ENTRY
REGULATION FOR
PHARMACEUTICALS
9
2.1
THE
CONTEXT
9
2.2
THE
GOALS
11
3
THE
REGULATORY
DEVELOPMENT
AND
THE
CHANGES
IN
1993
12
3.1
THE
NEW
PROCEDURES
OF
1995
/1998
13
3.2
THE
MAIN
CHARACTERISTICS
OF
THE
TWO
EUROPEAN
PROCEDURES
15
THE
CENTRALIZED
PROCEDURE
15
THE
MUTUAL
RECOGNITION
PROCEDURE
-
REALLY
EUROPEAN?
19
4
EUROPEAN
GOVERNING
AND
NATIONAL
AUTONOMY
21
4.1
IMPLEMENTATION:
HOW
THE
PROCEDURES ARE
UTILIZED
AND
PERCEIVED
22
THE
CENTRALIZED
PROCEDURE
22
THE
MUTUAL
RECOGNITION
PROCEDURE
23
GENERAL
PERCEPTION
OF
THE TWO
PROCEDURES
25
4.2
EUROPEANIZATION,
NATIONAL
AUTHORITIES,
AND
APPLICANTS
26
THE
CENTRALIZED
PROCEDURE
-
HIERARCHY,
VOICE
AND
NEGOTIATIONS
28
THE
MUTUAL
RECOGNITION
PROCEDURE
-
MISSED
EUROPEANIZATION
POTENTIAL
30
PROCEDURAL
VARIETY:
CONSTRAINTS,
OPPORTUNITIES
AND
INTERESTS
31
5
EFFICACY
AND
EFFICIENCY
OF
EUROPEAN
REGULATION
35
5.1
IMPROVEMENT
OF
PUBLIC
HEALTH
PROTECTION?
35
5.2
THE
SINGLE
MARKET
GOAL
38
CONVERGING
VOLUME
OF
PHARMACEUTICAL
PRODUCTS?
39
A
MORE
HOMOGENEOUS
EUROPEAN
PHARMACEUTICALS
MARKET?
40
5.3
PROCEDURAL
EFFICIENCY:
APPROVAL
TIMES
42
CONVERGENCE
TRENDS
BEFORE
1995
43
THE
NEW
EUROPEAN
PROCEDURES
44
6
CONCLUSIONS
AND
OUTLOOK
47
ABBREVIATIONS
50
REFERENCES
51 |
any_adam_object | 1 |
author | Feick, Jürgen |
author_GND | (DE-588)142888699 |
author_facet | Feick, Jürgen |
author_role | aut |
author_sort | Feick, Jürgen |
author_variant | j f jf |
building | Verbundindex |
bvnumber | BV016451185 |
classification_rvk | MK 5110 QR 525 |
ctrlnum | (OCoLC)76461967 (DE-599)BVBBV016451185 |
discipline | Politologie Wirtschaftswissenschaften |
format | Book |
fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>00000nam a2200000 cb4500</leader><controlfield tag="001">BV016451185</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">20110609</controlfield><controlfield tag="007">t|</controlfield><controlfield tag="008">030114s2002 gw d||| |||| 00||| eng d</controlfield><datafield tag="016" ind1="7" ind2=" "><subfield code="a">965835456</subfield><subfield code="2">DE-101</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)76461967</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV016451185</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">rakddb</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="044" ind1=" " ind2=" "><subfield code="a">gw</subfield><subfield code="c">DE</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-473</subfield><subfield code="a">DE-521</subfield><subfield code="a">DE-188</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">MK 5110</subfield><subfield code="0">(DE-625)123070:</subfield><subfield code="2">rvk</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">QR 525</subfield><subfield code="0">(DE-625)142044:</subfield><subfield code="2">rvk</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">17</subfield><subfield code="2">sdnb</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">33</subfield><subfield code="2">sdnb</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">42</subfield><subfield code="2">sdnb</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Feick, Jürgen</subfield><subfield code="e">Verfasser</subfield><subfield code="0">(DE-588)142888699</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Regulatory Europeanization, national autonomy and regulatory effectiveness</subfield><subfield code="b">marketing authorization for pharmaceuticals</subfield><subfield code="c">Jürgen Feick</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Köln</subfield><subfield code="b">Max-Planck-Inst. für Gesellschaftsforschung</subfield><subfield code="c">2002</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">55 S.</subfield><subfield code="b">graph. Darst.</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">n</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">nc</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="490" ind1="1" ind2=" "><subfield code="a">MPIfG discussion paper</subfield><subfield code="v">[20]02,6</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Literaturverz. S. 51 - 55. - Zsfassung in engl. und dt. Sprache</subfield></datafield><datafield tag="610" ind1="2" ind2="7"><subfield code="a">Europäische Union</subfield><subfield code="0">(DE-588)5098525-5</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Anerkennung</subfield><subfield code="0">(DE-588)4128520-7</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Arzneimittel</subfield><subfield code="0">(DE-588)4003115-9</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Gesundheitsschutz</subfield><subfield code="0">(DE-588)4127850-1</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Binnenmarkt</subfield><subfield code="0">(DE-588)4145576-9</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Zulassung</subfield><subfield code="0">(DE-588)4127410-6</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="689" ind1="0" ind2="0"><subfield code="a">Europäische Union</subfield><subfield code="0">(DE-588)5098525-5</subfield><subfield code="D">b</subfield></datafield><datafield tag="689" ind1="0" ind2="1"><subfield code="a">Arzneimittel</subfield><subfield code="0">(DE-588)4003115-9</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2="2"><subfield code="a">Zulassung</subfield><subfield code="0">(DE-588)4127410-6</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="689" ind1="1" ind2="0"><subfield code="a">Europäische Union</subfield><subfield code="0">(DE-588)5098525-5</subfield><subfield code="D">b</subfield></datafield><datafield tag="689" ind1="1" ind2="1"><subfield code="a">Binnenmarkt</subfield><subfield code="0">(DE-588)4145576-9</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="2"><subfield code="a">Arzneimittel</subfield><subfield code="0">(DE-588)4003115-9</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="3"><subfield code="a">Zulassung</subfield><subfield code="0">(DE-588)4127410-6</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="4"><subfield code="a">Anerkennung</subfield><subfield code="0">(DE-588)4128520-7</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2="5"><subfield code="a">Gesundheitsschutz</subfield><subfield code="0">(DE-588)4127850-1</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="1" ind2=" "><subfield code="5">DE-188</subfield></datafield><datafield tag="830" ind1=" " ind2="0"><subfield code="a">MPIfG discussion paper</subfield><subfield code="v">[20]02,6</subfield><subfield code="w">(DE-604)BV006188088</subfield><subfield code="9">2002,6</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="m">DNB Datenaustausch</subfield><subfield code="q">application/pdf</subfield><subfield code="u">http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010171953&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA</subfield><subfield code="3">Inhaltsverzeichnis</subfield></datafield><datafield tag="943" ind1="1" ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-010171953</subfield></datafield></record></collection> |
id | DE-604.BV016451185 |
illustrated | Illustrated |
indexdate | 2025-01-02T09:23:07Z |
institution | BVB |
language | English |
oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-010171953 |
oclc_num | 76461967 |
open_access_boolean | |
owner | DE-473 DE-BY-UBG DE-521 DE-188 |
owner_facet | DE-473 DE-BY-UBG DE-521 DE-188 |
physical | 55 S. graph. Darst. |
publishDate | 2002 |
publishDateSearch | 2002 |
publishDateSort | 2002 |
publisher | Max-Planck-Inst. für Gesellschaftsforschung |
record_format | marc |
series | MPIfG discussion paper |
series2 | MPIfG discussion paper |
spelling | Feick, Jürgen Verfasser (DE-588)142888699 aut Regulatory Europeanization, national autonomy and regulatory effectiveness marketing authorization for pharmaceuticals Jürgen Feick Köln Max-Planck-Inst. für Gesellschaftsforschung 2002 55 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier MPIfG discussion paper [20]02,6 Literaturverz. S. 51 - 55. - Zsfassung in engl. und dt. Sprache Europäische Union (DE-588)5098525-5 gnd rswk-swf Anerkennung (DE-588)4128520-7 gnd rswk-swf Arzneimittel (DE-588)4003115-9 gnd rswk-swf Gesundheitsschutz (DE-588)4127850-1 gnd rswk-swf Binnenmarkt (DE-588)4145576-9 gnd rswk-swf Zulassung (DE-588)4127410-6 gnd rswk-swf Europäische Union (DE-588)5098525-5 b Arzneimittel (DE-588)4003115-9 s Zulassung (DE-588)4127410-6 s DE-604 Binnenmarkt (DE-588)4145576-9 s Anerkennung (DE-588)4128520-7 s Gesundheitsschutz (DE-588)4127850-1 s DE-188 MPIfG discussion paper [20]02,6 (DE-604)BV006188088 2002,6 DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010171953&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
spellingShingle | Feick, Jürgen Regulatory Europeanization, national autonomy and regulatory effectiveness marketing authorization for pharmaceuticals MPIfG discussion paper Europäische Union (DE-588)5098525-5 gnd Anerkennung (DE-588)4128520-7 gnd Arzneimittel (DE-588)4003115-9 gnd Gesundheitsschutz (DE-588)4127850-1 gnd Binnenmarkt (DE-588)4145576-9 gnd Zulassung (DE-588)4127410-6 gnd |
subject_GND | (DE-588)5098525-5 (DE-588)4128520-7 (DE-588)4003115-9 (DE-588)4127850-1 (DE-588)4145576-9 (DE-588)4127410-6 |
title | Regulatory Europeanization, national autonomy and regulatory effectiveness marketing authorization for pharmaceuticals |
title_auth | Regulatory Europeanization, national autonomy and regulatory effectiveness marketing authorization for pharmaceuticals |
title_exact_search | Regulatory Europeanization, national autonomy and regulatory effectiveness marketing authorization for pharmaceuticals |
title_full | Regulatory Europeanization, national autonomy and regulatory effectiveness marketing authorization for pharmaceuticals Jürgen Feick |
title_fullStr | Regulatory Europeanization, national autonomy and regulatory effectiveness marketing authorization for pharmaceuticals Jürgen Feick |
title_full_unstemmed | Regulatory Europeanization, national autonomy and regulatory effectiveness marketing authorization for pharmaceuticals Jürgen Feick |
title_short | Regulatory Europeanization, national autonomy and regulatory effectiveness |
title_sort | regulatory europeanization national autonomy and regulatory effectiveness marketing authorization for pharmaceuticals |
title_sub | marketing authorization for pharmaceuticals |
topic | Europäische Union (DE-588)5098525-5 gnd Anerkennung (DE-588)4128520-7 gnd Arzneimittel (DE-588)4003115-9 gnd Gesundheitsschutz (DE-588)4127850-1 gnd Binnenmarkt (DE-588)4145576-9 gnd Zulassung (DE-588)4127410-6 gnd |
topic_facet | Europäische Union Anerkennung Arzneimittel Gesundheitsschutz Binnenmarkt Zulassung |
url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010171953&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
volume_link | (DE-604)BV006188088 |
work_keys_str_mv | AT feickjurgen regulatoryeuropeanizationnationalautonomyandregulatoryeffectivenessmarketingauthorizationforpharmaceuticals |