Human medicinal product

Formal requirements

ZL000_00_020e_WL Guidance document Formal requirements HMV4 (PDF, 657 kB, 01.06.2021)

ZL000_00_006e_VZ Directory Overview of documents to be submitted HMV4 (XLS, 278 kB, 01.04.2021)

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

Submissions

www.swissmedicinfo.ch

Product information for human medicinal products and packaging

ZL000_00_021e_WL Guidance document Packaging for human medicinal products HMV4 (PDF, 433 kB, 15.07.2021)

ZL000_00_027e_WL Guidance document Product information for human medicinal products HMV4 (PDF, 840 kB, 01.07.2021)

ZL000_00_041e_VL Product information for human medicinal products detailed HMV4 (DOC, 92 kB, 01.07.2021)

ZL000_00_048d_VL Fachinformation für Humanarzneimittel minimal HMV4 (DOC, 167 kB, 22.10.2019)

ZL000_00_042d_VL Patienteninformation für Humanarzneimittel ausführlich HMV4 (DOC, 185 kB, 01.07.2021)

ZL000_00_049d_VL Patienteninformation für Humanarzneimittel minimal HMV4 (DOC, 165 kB, 22.10.2019)

Questions and answers on Full declaration HMV4

ZL000_00_038d_MB Merkblatt Mustertext NSAR Selbstmedikation PI HMV4 (PDF, 178 kB, 01.01.2019)

ZL000_00_039d_MB Merkblatt Mustertext NSAR Selbstmedikation FI HMV4 (PDF, 141 kB, 01.01.2019)

ZL000_00_040d_MB Merkblatt Mustertext rezeptpflichtige NSAR Fachinformation HMV4 (PDF, 234 kB, 01.01.2019)

ZL000_00_041d_MB Merkblatt Mustertext rezeptpflichtige NSAR Patienteninformation HMV4 (PDF, 215 kB, 01.01.2019)

ZL000_00_042d_MB Mustertext für Acetylsalicylsäure Selbstmedikation Fachinformation (PDF, 680 kB, 01.06.2021)

ZL000_00_043d_MB Merkblatt Mustertext für Paracetamol Selbstmedikation Fachinformation HMV4 (PDF, 606 kB, 01.06.2021)

www.swissmedicinfo.ch

Time limits for authorisation applications

ZL000_00_014e_WL Guidance document Time limits for authorization applications HMV4 (PDF, 322 kB, 01.09.2021)

Applications and meetings

New application

Project Orbis

ZL000_00_048e_WL Guidance document Project Orbis HMV4 (PDF, 1 MB, 01.09.2021)

COVID-19

ZL000_00_044e_WL Guidance document Authorisation procedures for Covid-19 medicinal products during a pandemic (PDF, 284 kB, 15.05.2021)

Questions and answers on the packaging and labelling requirements for medicinal products intended to prevent or combat COVID-19

SwissPAR

ZL000_00_030e_WL Guidance document SwissPAR HMV4 (PDF, 243 kB, 01.03.2021)

Questions and answers Swiss Public Assessment Report (SwissPAR)

Medicinal Product Names

ZL000_00_043e_WL Guidance document Medicinal product name HMV4 (PDF, 221 kB, 15.07.2021)

Authorisation of human medicinal product with new active substance

ZL101_00_005e_WL Guidance document Authorisation of human medicinal product with new active substance HMV4 (PDF, 245 kB, 01.03.2021)

ZL000_00_048e_WL Guidance document Project Orbis HMV4 (PDF, 1 MB, 01.09.2021)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 190 kB, 01.09.2021)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 170 kB, 10.05.2021)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 234 kB, 01.03.2021)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 164 kB, 15.02.2021)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 193 kB, 01.03.2021)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 168 kB, 01.03.2021)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 170 kB, 01.03.2021)

ZL000_00_035e_FO Form DMF HMV4 (DOC, 194 kB, 24.03.2021)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 202 kB, 15.03.2021)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 163 kB, 01.03.2021)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 180 kB, 01.03.2021)

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

ZL000_00_035e_WL Guidance document Minimising the risk of TSE HMV4 (PDF, 147 kB, 01.03.2021)

ZL109_00_001e_WL Guidance document Temporary authorisation for human medicinal products HMV4 (PDF, 352 kB, 01.07.2021)

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

Authorisation of human medicinal product with known active pharmaceutical substance

ZL101_00_007e_WL Guidance document Authorisation of human medicinal product with known active pharmaceutical substance HMV4 (PDF, 412 kB, 01.03.2021)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 190 kB, 01.09.2021)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 170 kB, 10.05.2021)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 234 kB, 01.03.2021)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 164 kB, 15.02.2021)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 193 kB, 01.03.2021)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 168 kB, 01.03.2021)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 170 kB, 01.03.2021)

ZL000_00_035e_FO Form DMF HMV4 (DOC, 194 kB, 24.03.2021)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 202 kB, 15.03.2021)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 163 kB, 01.03.2021)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 180 kB, 01.03.2021)

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

ZL000_00_035e_WL Guidance document Minimising the risk of TSE HMV4 (PDF, 147 kB, 01.03.2021)

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

Fast-track authorisation procedure

ZL104_00_002e_WL Guidance document Fast-track authorisation procedure HMV4 (PDF, 282 kB, 01.07.2021)

ZL104_00_001e_FO Decision minutes Accelerated Application Hearing HMV4 (DOC, 183 kB, 15.04.2021)

Procedure with prior notification

ZL101_00_013e_WL Guidance document Procedure with prior notification HMV4 (PDF, 220 kB, 01.03.2021)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 164 kB, 15.02.2021)

Paediatric investigation plan

ZL000_00_023e_WL Guidance document Paediatric investigation plan HMV4 (PDF, 205 kB, 01.03.2021)

ZL000_00_034e_FO Form Paediatric investigation plan HMV4 (DOC, 182 kB, 01.03.2021)

Questions and answers on the Paediatric Investigation Plan HMV4

Document protection

ZL000_00_024e_WL Guidance document Document protection HMV4 (PDF, 206 kB, 01.08.2021)

Questions and answers on document protection

Authorisation human medicinal product under Art. 13 ATP

ZL000_00_019e_WL Guidance document Authorisation human medicinal product under Art. 13 ATP HMV4 (PDF, 373 kB, 01.03.2021)

Questions and answers Art. 13 TPA

ZL000_00_011e_VZ List of all countries with comparable human medicinal product control HMV4 (PDF, 271 kB, 01.12.2020)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 202 kB, 15.03.2021)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 164 kB, 15.02.2021)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 190 kB, 01.09.2021)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 170 kB, 10.05.2021)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 234 kB, 01.03.2021)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 193 kB, 01.03.2021)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 168 kB, 01.03.2021)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 170 kB, 01.03.2021)

ZL000_00_035e_FO Form DMF HMV4 (DOC, 194 kB, 24.03.2021)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 163 kB, 01.03.2021)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 180 kB, 01.03.2021)

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

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

Authorisation in accordance with Art. 14 para. 1 abis-quater TPA

ZL000_00_022e_WL Guidance document Authorisation in accordance with Art. 14 para. 1 abis-quater TPA HMV4 (PDF, 299 kB, 01.09.2021)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 190 kB, 01.09.2021)

Questions and answers on Art. 14 para. 1 letter abis-quater TPA HMV4

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

Authorisation of allergen product

ZL000_00_032e_WL Guidance document Authorisation of allergen product HMV4 (PDF, 241 kB, 01.03.2021)

Authorisation of antidote

ZL000_00_031e_WL Guidance document Authorisation of antidote HMV4 (PDF, 190 kB, 01.03.2021)

Toxinfo Suisse

MU101_20_004d_FO UAW Antidota Antivenine (DOC, 196 kB, 01.08.2015)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 163 kB, 01.03.2021)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 180 kB, 01.03.2021)

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

Authorisation of antivenin

ZL000_00_033e_WL Guidance document Authorisation of antivenin HMV4 (PDF, 214 kB, 01.01.2021)

ZL000_00_033e_FO Form New authorisation variation antivenin HMV4 (DOC, 181 kB, 01.03.2021)

Toxinfo Suisse

MU101_20_004d_FO UAW Antidota Antivenine (DOC, 196 kB, 01.08.2015)

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

Authorisation biosimilar

ZL101_00_012e_WL Guidance document Authorisation biosimilar HMV4 (PDF, 279 kB, 01.03.2021)

Questions and answers on the authorisation of biosimilars

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 190 kB, 01.09.2021)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 170 kB, 10.05.2021)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 234 kB, 01.03.2021)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 164 kB, 15.02.2021)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 193 kB, 01.03.2021)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 168 kB, 01.03.2021)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 170 kB, 01.03.2021)

ZL000_00_035e_FO Form DMF HMV4 (DOC, 194 kB, 24.03.2021)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 202 kB, 15.03.2021)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 163 kB, 01.03.2021)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 180 kB, 01.03.2021)

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

ZL000_00_035e_WL Guidance document Minimising the risk of TSE HMV4 (PDF, 147 kB, 01.03.2021)

Authorisation of co-marketing medicinal product

ZL108_00_002e_WL Guidance document Authorisation of co-marketing medicinal product HMV4 (PDF, 206 kB, 18.08.2021)

Questions and answers on co-marketing

ZL108_00_002e_FO Form New authorisation for co-marketing of medicinal product HMV4 (DOC, 86 kB, 10.05.2021)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 170 kB, 10.05.2021)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 234 kB, 01.03.2021)

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

Autorisation of parallel import

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 190 kB, 01.09.2021)

ZL106_00_002e_FO Form Importation of a medicinal product in accordance with Art. 14 para. 2 TPA (parallel import) HMV4 (DOC, 176 kB, 01.03.2021)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 163 kB, 01.03.2021)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 180 kB, 01.03.2021)

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

Temporary authorisation for human medicinal products

ZL109_00_001e_WL Guidance document Temporary authorisation for human medicinal products HMV4 (PDF, 352 kB, 01.07.2021)

ZL104_00_001e_FO Decision minutes Accelerated Application Hearing HMV4 (DOC, 183 kB, 15.04.2021)

MU103_10_001e_WL Guidance document RMP / ICH E2E – Information for submission of RMP HMV4 (PDF, 173 kB, 15.07.2019)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 190 kB, 01.09.2021)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 170 kB, 10.05.2021)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 234 kB, 01.03.2021)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 202 kB, 15.03.2021)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 164 kB, 15.02.2021)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 163 kB, 01.03.2021)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 180 kB, 01.03.2021)

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

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

Authorisation of medicinal gas

ZL000_00_016e_WL Guidance document Authorisation of medicinal gas HMV4 (PDF, 176 kB, 01.01.2019)

Authorisation radiopharmaceutical

ZL000_00_034e_WL Guidance document Authorisation radiopharmaceutical HMV4 (PDF, 409 kB, 31.08.2021)

ZL000_00_042e_WL Guidance document Maintenance and updating of Annex 1 HMV4 (PDF, 160 kB, 01.03.2021)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 168 kB, 01.03.2021)

BW107_00_002d_PB Befristete Vertriebsbewilligung Radiopharmazeutika (PDF, 203 kB, 01.02.2016)

BW107_00_003d_FO Gesuch befristete Vertriebsbewilligung Radiopharmazeutika (DOC, 170 kB, 04.04.2016)

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)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 190 kB, 01.09.2021)

ZL103_00_003e_FO Form New authorisation variation in notification procedure KPTPO HMV4. (DOC, 103 kB, 01.03.2021)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 170 kB, 10.05.2021)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 164 kB, 15.02.2021)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 193 kB, 01.03.2021)

ZL000_00_035e_WL Guidance document Minimising the risk of TSE HMV4 (PDF, 147 kB, 01.03.2021)

Renewal of autorisation

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 170 kB, 10.05.2021)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 234 kB, 01.03.2021)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 168 kB, 01.03.2021)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 170 kB, 01.03.2021)

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

ZL300_00_003e_FO Form Variations and extensions HMV4 (DOC, 511 kB, 01.09.2021)

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

Authorisation under the MAGHP procedure

ZL000_00_047e_WL Guidance document MAGHP Procedure (PDF, 961 kB, 01.03.2021)

Variations and extensions

ZL300_00_001e_WL Guidance document Variations and extensions HMV4 (PDF, 312 kB, 01.08.2021)

ZL000_00_048e_WL Guidance document Project Orbis HMV4 (PDF, 1 MB, 01.09.2021)

ZL300_00_003e_FO Form Variations and extensions HMV4 (DOC, 511 kB, 01.09.2021)

Questions and answers on variations and extensions HMV4

ZL000_00_035e_WL Guidance document Minimising the risk of TSE HMV4 (PDF, 147 kB, 01.03.2021)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 170 kB, 10.05.2021)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 234 kB, 01.03.2021)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 164 kB, 15.02.2021)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 193 kB, 01.03.2021)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 168 kB, 01.03.2021)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 170 kB, 01.03.2021)

ZL000_00_035e_FO Form DMF HMV4 (DOC, 194 kB, 24.03.2021)

ZL000_00_019e_WL Guidance document Authorisation human medicinal product under Art. 13 ATP HMV4 (PDF, 373 kB, 01.03.2021)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 202 kB, 15.03.2021)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 163 kB, 01.03.2021)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 180 kB, 01.03.2021)

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

Approval variation of authorisation holder

ZL404_00_001e_WL Guidance documentTransfer of marketing authorisation HMV4 (PDF, 175 kB, 21.05.2021)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 190 kB, 01.09.2021)

ZL404_00_001e_FO Form Transfer of authorisation HMV4 (DOC, 168 kB, 21.05.2021)

BW303_00_003e_WL Guidance document Change name or domicile of the authorisation holder HMV4 (PDF, 156 kB, 21.10.2020)

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

ZL201_00_001e_WL Guidance document Renewal and discontinuation of authorisation on change of status (main authorisation/export licence) HMV4 (PDF, 263 kB, 01.03.2021)

Questions and answers on authorisation renewals

ZL201_00_008e_FO Form Renewal of authorisation HMV4 (DOC, 183 kB, 01.03.2021)

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

No marketing / interruption of distribution

ZL203_00_002e_WL Guidance document No marketing / interruption of distribution HMV4 (PDF, 178 kB, 01.03.2021)

ZL203_00_002e_FO Form No marketing / interruption of distribution HMV4 (DOC, 193 kB, 01.03.2021)

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

Supplementary information

Archiving of specification documents

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Human medicinal product

Schweizerisches Heilmittelinstitut
Institut suisse des produits thérapeutiques
Istituto svizzero per gli agenti terapeutici
Swiss Agency for Therapeutic Products

Swissmedic

Human medicinal product

Orphan drug application TPO4

Fast-track application TPO4

Procedure with prior notification TPO4

Temporary authorisation TPO4

Company meetings relating to authorisation TPO4

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Human medicinal product

Orphan drug application TPO4

Fast-track application TPO4

Procedure with prior notification TPO4

Temporary authorisation TPO4

Company meetings relating to authorisation TPO4

Supplementary information