Herbal medicinal

Verordnung des Schweizerischen Heilmittelinstituts über die vereinfachte Zulassung und das Meldeverfahren von Komplementär- und Phytoarzneimitteln (Komplementär- und Phytoarzneimittelverordnung, KPAV; SR 812.212.24)

Verordnung des Schweizerischen Heilmittelinstituts über die Anforderungen an die Zulassung von Arzneimitteln (Arzneimittel-Zulassungsverordnung, AMZV; SR 812.212.22)

Information sheets, Forms, Checklists

Formal requirements

ZL000_00_001e_WL Formal requirements (PDF, 1 MB, 28.05.2018)

ZL000_00_002e_VZ Overview of documents to submitted (XLS, 66 kB, 19.11.2018)Additional table, formal requirements

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOC, 159 kB, 14.02.2017)

Submissions

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Product information for human medicinal products and packaging

ZL000_00_016d_MB Erläuterungen zur Patienteninformation (PDF, 853 kB, 02.07.2018)

ZL000_00_017d_MB Erläuterungen zur Fachinformation (PDF, 507 kB, 11.06.2018)

ZL000_00_023df_FO Anmeldung AIPS / Inscription AIPS (DOC, 153 kB, 19.11.2012)

ZL305_00_001d_MB Zulassung kostenlose Musterpackungen im Meldeverfahren (PDF, 124 kB, 19.05.2017)

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Time limits for authorisation applications

ZL000_00_006e_WL Guidance document Time limits for authorisation applications (PDF, 363 kB, 18.07.2018)

ZL000_00_001e_VZ Time limits for authorisation applications (PDF, 270 kB, 01.10.2017)

Applications and company meetings

Procedure with prior notification

ZL101_00_002e_WL Guidance document Procedure with prior notification (PDF, 307 kB, 01.07.2017)

ZL000_00_007e_FO Status of marketing authorisations abroad (DOC, 163 kB, 01.03.2014)

Company meetings relating to authorisation

ZL105_00_001e_WL Guidance document Meetings for applicants held with the Authorisation sector (PDF, 329 kB, 30.05.2017)

ZL105_00_001e_FO Meeting with applicants (DOC, 160 kB, 19.05.2014)

ZL105_00_002e_FO List of questions meeting with applicants application in the area of Authorisation (DOC, 151 kB, 01.03.2014)

ZL105_00_003e_FO Meeting record Meeting with applicants (DOC, 154 kB, 01.03.2014)

New application – herbal medicinal products and major variations

Authorisation of herbal medicinal products with new active substance, in accordance with Art. 13 TPA, traditional herbal medicinal products and major variation

Anleitung zum Einreichen von Zulassungsgesuchen für pflanzliche Arzneimittel der Humanmedizin (Phyto-Anleitung) (PDF, 75 kB, 01.10.2006)

Erläuterungen zur Anleitung zum Einreichen von Zulassungsgesuchen für pflanzliche Arzneimittel der Humanmedizin (Phyto-Anleitung) (PDF, 226 kB, 01.10.2006)

ZL000_00_010e_CL Formal control of application authorisation human medicines (DOC, 202 kB, 01.04.2015)

ZL000_00_003e_FO Application for Authorisation / Variation human medicines (DOC, 180 kB, 15.01.2018)

ZL000_00_024e_FO Application for authorisation / variation Veterinary medicines (DOC, 179 kB, 01.07.2017)

ZL000_00_027d_MB Extraktdeklaration pflanzlicher Arzneimittel (PDF, 317 kB, 11.04.2013)

ZL000_00_005e_FO Full declaration (DOC, 151 kB, 01.03.2014)

ZL000_00_011e_MB Confirmation regarding substances from GMO (PDF, 283 kB, 26.06.2013)

ZL000_00_013e_FO Confirmation regarding substances from GMO (DOC, 158 kB, 01.03.2014)

ZL000_00_015e_MB Details required regarding manufactures of herbal active substances (PDF, 213 kB, 25.01.2016)

ZL000_00_037e_MB Explanations concerning the Manufacturer information form (PDF, 273 kB, 18.11.2016)

ZL000_00_002e_FO Manufacturer information (DOC, 178 kB, 18.11.2016)

BW105_00_002e_VZ List Countries with recognised GMP control systems (PDF, 215 kB, 29.05.2018)

ZL000_00_025e_FO Responsible Person Declaration (DOC, 165 kB, 25.07.2016)

ZL000_00_007e_FO Status of marketing authorisations abroad (DOC, 163 kB, 01.03.2014)

ZL000_00_013d_WL Anleitung betreffend Minimierung des Risikos der Übertragung transmissibler spongiformer Enzephalopathien tierischen Ursprungs durch Human- und Tierarzneimittel (TSE-Anleitung) (PDF, 88 kB, 31.01.2002)

ZL000_00_010e_FO Substances of animal or human origin (DOC, 200 kB, 01.03.2014)

ZL000_00_014e_FO DMF for first authorisation / variation (DOC, 167 kB, 25.07.2016)

Authorisation of co-marketing medicinal product

ZL108_00_001e_WL Guidance document Authorisation Co-Marketing Medicine (PDF, 288 kB, 24.05.2017)

ZL108_00_001e_FO Co-marketing confirmation (DOC, 151 kB, 01.03.2014)

ZL000_00_003e_FO Application for Authorisation / Variation human medicines (DOC, 180 kB, 15.01.2018)

ZL000_00_027d_MB Extraktdeklaration pflanzlicher Arzneimittel (PDF, 317 kB, 11.04.2013)

ZL000_00_005e_FO Full declaration (DOC, 151 kB, 01.03.2014)

ZL000_00_015e_MB Details required regarding manufactures of herbal active substances (PDF, 213 kB, 25.01.2016)

ZL000_00_037e_MB Explanations concerning the Manufacturer information form (PDF, 273 kB, 18.11.2016)

ZL000_00_002e_FO Manufacturer information (DOC, 178 kB, 18.11.2016)

Renewal of authorisation

ZL000_00_003e_FO Application for Authorisation / Variation human medicines (DOC, 180 kB, 15.01.2018)

ZL000_00_027d_MB Extraktdeklaration pflanzlicher Arzneimittel (PDF, 317 kB, 11.04.2013)

ZL000_00_005e_FO Full declaration (DOC, 151 kB, 01.03.2014)

ZL000_00_011e_MB Confirmation regarding substances from GMO (PDF, 283 kB, 26.06.2013)

ZL000_00_013e_FO Confirmation regarding substances from GMO (DOC, 158 kB, 01.03.2014)

ZL000_00_015e_MB Details required regarding manufactures of herbal active substances (PDF, 213 kB, 25.01.2016)

ZL000_00_037e_MB Explanations concerning the Manufacturer information form (PDF, 273 kB, 18.11.2016)

ZL000_00_002e_FO Manufacturer information (DOC, 178 kB, 18.11.2016)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOC, 159 kB, 14.02.2017)

QR restrictions after first authorisation

ZL000_00_003e_FO Application for Authorisation / Variation human medicines (DOC, 180 kB, 15.01.2018)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOC, 159 kB, 14.02.2017)

MR / restrictions

ZL000_00_003e_FO Application for Authorisation / Variation human medicines (DOC, 180 kB, 15.01.2018)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOC, 159 kB, 14.02.2017)

Variation requiring approval / Approval variation of authorisation holder

Variation requiring approval

ZL302_00_001e_WL Guidance document Variation related quality changes requiring approval (PDF, 372 kB, 30.05.2017)

ZL000_00_003e_FO Application for Authorisation / Variation human medicines (DOC, 180 kB, 15.01.2018)

ZL302_00_001e_FO Quality variation requiring approval (DOC, 327 kB, 01.01.2015)

Beispiele FO Genehmigungspflichtige Änderungen Qualität (PDF, 76 kB, 01.01.2015)

ZL000_00_027d_MB Extraktdeklaration pflanzlicher Arzneimittel (PDF, 317 kB, 11.04.2013)

ZL000_00_005e_FO Full declaration (DOC, 151 kB, 01.03.2014)

ZL000_00_011e_MB Confirmation regarding substances from GMO (PDF, 283 kB, 26.06.2013)

ZL000_00_013e_FO Confirmation regarding substances from GMO (DOC, 158 kB, 01.03.2014)

ZL000_00_015e_MB Details required regarding manufactures of herbal active substances (PDF, 213 kB, 25.01.2016)

ZL000_00_037e_MB Explanations concerning the Manufacturer information form (PDF, 273 kB, 18.11.2016)

ZL000_00_002e_FO Manufacturer information (DOC, 178 kB, 18.11.2016)

BW105_00_002e_VZ List Countries with recognised GMP control systems (PDF, 215 kB, 29.05.2018)

ZL000_00_025e_FO Responsible Person Declaration (DOC, 165 kB, 25.07.2016)

ZL000_00_007e_FO Status of marketing authorisations abroad (DOC, 163 kB, 01.03.2014)

ZL000_00_013d_WL Anleitung betreffend Minimierung des Risikos der Übertragung transmissibler spongiformer Enzephalopathien tierischen Ursprungs durch Human- und Tierarzneimittel (TSE-Anleitung) (PDF, 88 kB, 31.01.2002)

ZL000_00_010e_FO Substances of animal or human origin (DOC, 200 kB, 01.03.2014)

ZL000_00_011e_FO Pharmaceutical information product information, parenteral preparations (DOC, 167 kB, 01.03.2014)

ZL000_00_014e_FO DMF for first authorisation / variation (DOC, 167 kB, 25.07.2016)

ZL101_00_001e_MB Information relating to quality, applications under Art. 13, TPA (PDF, 204 kB, 31.10.2011)

ZL101_00_003e_FO Information relating to quality for applications under Art. 13, TPA (DOC, 168 kB, 01.03.2014)

Transfer of authorisation and change to name and address of authorisation holder

ZL000_00_003e_FO Application for Authorisation / Variation human medicines (DOC, 180 kB, 15.01.2018)

BW303_00_001d_WL Änderung von Name oder Domizil der Zulassungsinhaberin (PDF, 201 kB, 01.09.2016)

QR restrictions after variation requiring approval

ZL000_00_003e_FO Application for Authorisation / Variation human medicines (DOC, 180 kB, 15.01.2018)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOC, 159 kB, 14.02.2017)

Extension / no extension

Extension of authorised products

ZL000_00_003e_FO Application for Authorisation / Variation human medicines (DOC, 180 kB, 15.01.2018)

ZL000_00_027d_MB Extraktdeklaration pflanzlicher Arzneimittel (PDF, 317 kB, 11.04.2013)

ZL000_00_005e_FO Full declaration (DOC, 151 kB, 01.03.2014)

ZL000_00_011e_MB Confirmation regarding substances from GMO (PDF, 283 kB, 26.06.2013)

ZL000_00_013e_FO Confirmation regarding substances from GMO (DOC, 158 kB, 01.03.2014)

Notification of no-marketing or interruption to distribution

ZL203_00_001d_WL Nicht-Inverkehrbringen / Vertriebsunterbruch (PDF, 133 kB, 25.08.2014)

ZL203_00_001e_FO Notification No marketing / Interruption to distribution / Placing on the market / Resumption of distribution (DOC, 159 kB, 28.01.2016)

Supplementary information

Archiving of specification documents

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Herbal medicinal

Information sheets, Forms, Checklists

Procedure with prior notification

Company meetings relating to authorisation

Extension of authorised products

Supplementary information