General Table of Contents - Swissmedic · Deckblätter / pages de garde / cover sheets NTA KPA...

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

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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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Part 1

K003

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1a Administrative Information

K004

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1a1 Additional Information

K005

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1a2 Cover Letter

K006

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1a3 Decision of Foreign Authorities

K007

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1a4 Documentation on Product Quality

K008

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1a5 Forms

K009

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Other Forms

K018

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GCP Inspections

C237

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1a6 Manufacturing

K027

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1b Summary of Product Characteristics, Label and Package Insert

K028

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1b1 Packaging Material

K029

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1b2 Summary of Product Characteristics

K030

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1z Summaries

K031

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Part 2

K032

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K033

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2a Composition

K034

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2b Manufacturing

K035

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2c Control of Starting Material

K036

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2c1 General

K037

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2c2 Starting Materials

K038

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2c3 Active Substance(s)

K039

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2c4 Mother Tintures/Solutions/First Triturations

K040

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2c5 Organic Components

K041

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2c6 Nosodes

K042

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2c7 Excipients

K043

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2c8 Container Finished Product

K044

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2d Control Tests of Intermediate Products

K045

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2e Control Tests on the Finished Products

K046

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2f Stability

K047

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2q Summaries

K048

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K049

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Part 3

K050

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3a General

K051

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3a1 Toxicology of Known Substances

K052

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3a2 Toxicology of New Substances

K053

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3b no title

K054

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3z Summaries

K055

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K056

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Part 4

K057

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4 General

K058

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4a Clinical

K059

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4a1 Requirements Homeopathic Medicinal Products

K060

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4a1.1 Single Drugs and Homaccords

K061

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4a1.2 Complexes

K062

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4a2 Requirements Anthroposophical Medicinal Products

K063

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4a3 Documentation Prov. Therapeutic Benefit

K064

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4b Proof of Tolerance

K065

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4b1 General

K066

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4b2 Medicinal Products for Peroral Administration

K067

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4b3 Medicinal Products for Topical Use

K068

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4b4 Medicinal Products for Parenteral Administration

K069

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4b5 Nosodes and Organ Preparations

K070

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VM-ID: OS000_00_011dfe_VL - Vorlage / V1.0 / mra / ni / 01.01.2019 56

Swissmedic • Hallerstrasse 7 • 3012 Bern • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12

4z Summaries

K071

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General Table of Contents - Swissmedic · Deckblätter / pages de garde / cover sheets NTA KPA...

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