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Herbal medicinal product

Complementary and Herbal Medicinal Products Ordinance (PDF, 238 kB, 21.09.2018)Verordnung des Schweizerischen Heilmittelinstituts über die vereinfachte Zulassung und das Meldeverfahren von Komplementär- und Phytoarzneimitteln (KPAV) vom 7. September 2018

Ordinance on the requirements for the authorisation of medicinal products (PDF, 416 kB, 21.09.2018)Verordnung des Schweizerischen Heilmittelinstituts über die Anforderungen an die Zulassung von Arzneimitteln | Änderung vom 7. September 2018

Formal requirements

ZL000_00_020e_WL Guidance document Formal requirements (PDF, 899 kB, 01.07.2024)

ZL000_00_006e_VZ Directory Overview of documents to be submitted (XLSX, 128 kB, 01.09.2024)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOCX, 361 kB, 19.07.2023)

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Product information and packaging

ZL000_00_021e_WL Guidance document Packaging for human medicinal products (PDF, 801 kB, 01.08.2024)

ZL000_00_027e_WL Guidance document Product information for human medicinal products (PDF, 1 MB, 15.11.2024)

ZL000_00_049e_WL Guidance document Involvement of patient organisation in the review of Patient Information (PDF, 1 MB, 21.07.2023)

ZL000_00_048e_VL Product information for human medicinal products (DOCX, 58 kB, 01.03.2023)

ZL000_00_047d_VL Patienteninformation für Phytoarzneimittel HMV4 (DOCX, 71 kB, 15.03.2023)

ZL000_00_050e_WL Guidance document Mobile technologies (PDF, 1 MB, 01.10.2023)

Questions and answers on Full declaration HMV4

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Time limits for authorisation applications

ZL000_00_014e_WL Guidance document Time limits for authorization applications (PDF, 676 kB, 01.09.2024)

Applications and meetings

Procedure with prior notification TPO4

ZL101_00_013e_WL Guidance document Procedure with prior notification (PDF, 282 kB, 01.06.2023)

ZL000_00_030e_FO Form Status of authorisation applications abroad (DOCX, 155 kB, 01.04.2024)

Company meetings relating to authorisation TPO4

ZL105_00_003e_WL Guidance document Meetings for applicants held with the Authorisation sector (PDF, 474 kB, 01.06.2024)

ZL105_00_004e_FO Form Company meeting (DOCX, 381 kB, 15.10.2024)

ZL105_00_006e_FO Form Company meeting record (DOCX, 153 kB, 30.06.2023)

Authorisation of herbal medicinal products

ZL101_00_008e_WL Guidance document Authorisation of herbal medicinal products HMV4 (PDF, 347 kB, 05.12.2019)

ZL000_00_043e_WL Guidance document Medicinal product name (PDF, 1 MB, 01.10.2023)

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 192 kB, 01.12.2024)

ZL100_00_002e_FO Form New authorisation of veterinary medicinal products (DOCX, 178 kB, 29.06.2023)

ZL101_00_013e_WL Guidance document Procedure with prior notification (PDF, 282 kB, 01.06.2023)

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 11.07.2023)

ZL000_00_040e_WL Guidance document Details required regarding manufacturers of herbal active substances (PDF, 284 kB, 24.05.2023)

ZL000_00_037e_FO Form Manufacturer information (DOCX, 198 kB, 11.09.2023)

ZL000_00_030e_FO Form Status of authorisation applications abroad (DOCX, 155 kB, 01.04.2024)

ZL000_00_031e_FO Form Substances of animal and human origin (DOCX, 170 kB, 11.07.2023)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO (DOCX, 152 kB, 30.06.2023)

ZL000_00_035e_FO Form DMF (DOCX, 166 kB, 01.06.2024)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 479 kB, 15.04.2024)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 01.11.2023)

ZL000_00_011e_VZ Directory List countries with comparable control of human medicinal products (PDF, 390 kB, 01.01.2024)

ZL000_00_035e_WL Guidance document Minimising the risk of TSE (PDF, 240 kB, 24.05.2023)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOCX, 361 kB, 19.07.2023)

Authorisation of co-marketing medicinal product

ZL108_00_002e_WL Guidance document Authorisation of co-marketing medicinal product (PDF, 288 kB, 01.05.2023)

Questions and answers on co-marketing

ZL108_00_002e_FO Form New authorisation for co-marketing of medicinal product HMV4 (DOCX, 163 kB, 30.06.2023)

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 192 kB, 01.12.2024)

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 11.07.2023)

ZL000_00_037e_FO Form Manufacturer information (DOCX, 198 kB, 11.09.2023)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOCX, 361 kB, 19.07.2023)

Authorisation of individual teas, cough and throat lozenges and pastilles in the notification procedure

ZL103_00_003e_WL Guidance document Authorisation of individual teas, cough and throat lozenges and pastilles in the notification procedure HMV4 (PDF, 306 kB, 29.01.2019)

ZL103_00_003e_FO Form New authorisation variation in notification procedure KPTPO (DOCX, 178 kB, 29.06.2023)

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 11.07.2023)

ZL000_00_030e_FO Form Status of authorisation applications abroad (DOCX, 155 kB, 01.04.2024)

ZL000_00_040e_WL Guidance document Details required regarding manufacturers of herbal active substances (PDF, 284 kB, 24.05.2023)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 479 kB, 15.04.2024)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 01.11.2023)

BW105_00_002e_VZ List Countries with recognised GMP control systems (PDF, 190 kB, 04.09.2024)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOCX, 361 kB, 19.07.2023)

Renewal of autorisation

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 11.07.2023)

ZL000_00_037e_FO Form Manufacturer information (DOCX, 198 kB, 11.09.2023)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO (DOCX, 152 kB, 30.06.2023)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOCX, 361 kB, 19.07.2023)

QR restrictions

ZL300_00_003e_FO Form Variations and extensions HAM (DOCX, 705 kB, 01.12.2024)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOCX, 361 kB, 19.07.2023)

Mobile technologies

ZL000_00_050e_WL Guidance document Mobile technologies (PDF, 1 MB, 01.10.2023)

ZL000_00_040e_FO Mobile technologies (DOCX, 372 kB, 01.09.2024)

Variations and extensions

ZL300_00_001e_WL Guidance document Variations and extensions HAM (PDF, 2 MB, 01.06.2024)

ZL300_00_003e_FO Form Variations and extensions HAM (DOCX, 705 kB, 01.12.2024)

Questions and answers on variations and extensions HMP

ZL000_00_035e_WL Guidance document Minimising the risk of TSE (PDF, 240 kB, 24.05.2023)

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 11.07.2023)

ZL000_00_040e_WL Guidance document Details required regarding manufacturers of herbal active substances (PDF, 284 kB, 24.05.2023)

ZL000_00_037e_FO Form Manufacturer information (DOCX, 198 kB, 11.09.2023)

ZL000_00_030e_FO Form Status of authorisation applications abroad (DOCX, 155 kB, 01.04.2024)

ZL000_00_031e_FO Form Substances of animal and human origin (DOCX, 170 kB, 11.07.2023)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO (DOCX, 152 kB, 30.06.2023)

ZL000_00_035e_FO Form DMF (DOCX, 166 kB, 01.06.2024)

ZL101_00_004e_FO Form Information for application Art.13 TPA (DOCX, 194 kB, 15.01.2024)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 479 kB, 15.04.2024)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 01.11.2023)

BW105_00_002e_VZ List Countries with recognised GMP control systems (PDF, 190 kB, 04.09.2024)

ZL000_00_050e_WL Guidance document Mobile technologies (PDF, 1 MB, 01.10.2023)

ZL000_00_040e_FO Mobile technologies (DOCX, 372 kB, 01.09.2024)

AE-Gesuche ZL-Inhaberin

ZL404_00_001e_WL Guidance document Transfer of marketing authorisation (PDF, 330 kB, 01.10.2024)

Questions and answers on the transfer of authorisation and orphan drug status

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 192 kB, 01.12.2024)

ZL404_00_001e_FO Form Transfer of authorisation (DOCX, 162 kB, 01.11.2024)

BW303_00_003e_WL Guidance document Change name or domicile of the authorisation holder (PDF, 797 kB, 06.05.2024)

Renewal and discontinuation of authorisation on change of status (main authorisation/export licence)

ZL201_00_001e_WL Guidance document Renewal and discontinuation of authorisation or change of status (main authorisation/export licence) (PDF, 505 kB, 15.06.2024)

Questions and answers on authorisation renewals

ZL109_00_001e_WL Guidance document Temporary authorisation for human medicinal products (PDF, 1 MB, 01.12.2024)

ZL104_00_001e_FO Decision minutes Accelerated Application Hearing (DOCX, 172 kB, 01.09.2024)

ZL201_00_010e_FO_Renewal of authorisation CHM (DOCX, 163 kB, 28.06.2023)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOCX, 361 kB, 19.07.2023)

No marketing / interruption of distribution

ZL203_00_002e_WL Guidance document No marketing / interruption of distribution (PDF, 282 kB, 01.09.2024)

ZL203_00_002e_FO Form No marketing / interruption of distribution (DOCX, 159 kB, 01.09.2024)

OS000_00_001e_FO Technical Validation eCTD - Part1 (Swiss eCTD Validation Criteria v 1.2) (DOCX, 361 kB, 19.07.2023)

Supplementary information

Archiving of specification documents

https://www.swissmedic.ch/content/swissmedic/en/home/services/documents/phytoarzneimittel_hmv4.html