general table of contents - swissmedic · deckblätter / pages de garde / cover sheets nta kpa...
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![Page 1: General Table of Contents - Swissmedic · Deckblätter / pages de garde / cover sheets NTA KPA VM-ID: OS000_00_011dfe_VL - Vorlage / V1.0 / mra / ni / 01.01.2019 1 Swissmedic •](https://reader034.vdocument.in/reader034/viewer/2022051409/60207b848a975a57916147e1/html5/thumbnails/1.jpg)
VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
VM-ID: OS000_00_011dfe_VL - Vorlage / V1.0 / mra / ni / 01.01.2019 1
Swissmedic • Hallerstrasse 7 • 3012 Bern • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
General Table of Contents
K001
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 2
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1 - Table of Contents
K002
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 3
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
Part 1
K003
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 4
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1a Administrative Information
K004
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 5
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1a1 Additional Information
K005
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 6
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1a2 Cover Letter
K006
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 7
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1a3 Decision of Foreign Authorities
K007
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 8
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1a4 Documentation on Product Quality
K008
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 9
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1a5 Forms
K009
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 10
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
Other Forms
K018
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 11
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
GCP Inspections
C237
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 12
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1a6 Manufacturing
K027
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 13
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1b Summary of Product Characteristics, Label and Package Insert
K028
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 14
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1b1 Packaging Material
K029
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 15
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1b2 Summary of Product Characteristics
K030
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 16
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
1z Summaries
K031
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 17
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
Part 2
K032
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 18
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2 - Table of Contents
K033
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 19
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2a Composition
K034
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 20
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2b Manufacturing
K035
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 21
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2c Control of Starting Material
K036
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 22
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2c1 General
K037
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 23
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2c2 Starting Materials
K038
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 24
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2c3 Active Substance(s)
K039
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 25
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2c4 Mother Tintures/Solutions/First Triturations
K040
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 26
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2c5 Organic Components
K041
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 27
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2c6 Nosodes
K042
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NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 28
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2c7 Excipients
K043
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 29
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2c8 Container Finished Product
K044
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VO-Template Deckblätter / pages de garde / cover sheets
NTA KPA
QM-Ident: OS000_00_007dfe_VL / V1.0 / wkn / wja / 01.01.2019 30
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2d Control Tests of Intermediate Products
K045
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2e Control Tests on the Finished Products
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2f Stability
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
2q Summaries
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
3 - Table of Contents
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
Part 3
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
3a General
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
3a1 Toxicology of Known Substances
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
3a2 Toxicology of New Substances
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
3b no title
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3z Summaries
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4 - Table of Contents
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
Part 4
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
4 General
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
4a Clinical
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
4a1 Requirements Homeopathic Medicinal Products
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
4a1.1 Single Drugs and Homaccords
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
4a1.2 Complexes
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
4a2 Requirements Anthroposophical Medicinal Products
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
4a3 Documentation Prov. Therapeutic Benefit
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4b Proof of Tolerance
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4b1 General
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
4b2 Medicinal Products for Peroral Administration
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
4b3 Medicinal Products for Topical Use
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
4b4 Medicinal Products for Parenteral Administration
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Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
4b5 Nosodes and Organ Preparations
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4z Summaries
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