Human medicinal product TPO4

Formal requirements TPO4

ZL000_00_020e_WL Guidance document Formal requirements HMV4 (PDF, 1 MB, 01.08.2020)

ZL000_00_006e_VZ Directory Overview of documents to be submitted HMV4 (XLS, 270 kB, 20.01.2020)

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 TPO4

ZL000_00_021e_WL Guidance document Packaging for human medicinal products HMV4 (PDF, 618 kB, 02.03.2020)

ZL000_00_027e_WL Guidance document Product information for human medicinal products HMV4 (PDF, 867 kB, 01.06.2020)

ZL000_00_041e_VL Product information for human medicinal products detailed HMV4 (DOC, 194 kB, 11.07.2019)

ZL000_00_048d_VL Fachinformation für Humanarzneimittel minimal HMV4 (DOC, 176 kB, 22.10.2019)

ZL000_00_042d_VL Patienteninformation für Humanarzneimittel ausführlich HMV4 (DOC, 165 kB, 24.06.2019)

ZL000_00_049d_VL Patienteninformation für Humanarzneimittel minimal HMV4 (DOC, 174 kB, 22.10.2019)

Questions and answers on Full declaration

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, 602 kB, 01.01.2019)

ZL000_00_043d_MB Merkblatt Mustertext für Paracetamol Selbstmedikation Fachinformation HMV4 (PDF, 606 kB, 01.01.2019)

www.swissmedicinfo.ch

Time limits for authorisation applications TPO4

ZL000_00_014e_WL Guidance document Time limits for authorization applications HMV4 (PDF, 364 kB, 13.05.2019)

Applications and meetings TPO4

New application TPO4

SwissPAR TPO4

ZL000_00_030e_WL Guidance document SwissPAR HMV4 (PDF, 599 kB, 19.08.2019)

Questions and answers Swiss Public Assessment Report (SwissPAR)

Medicinal Product Names HMV4

ZL000_00_043e_WL Guidance document Medicinal product name HMV4 (PDF, 531 kB, 22.04.2020)

Authorisation of human medicinal product with new active substance TPO4

ZL101_00_005e_WL Guidance document Authorisation of human medicinal product with new active substance HMV4 (PDF, 345 kB, 01.01.2019)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 206 kB, 02.07.2020)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 172 kB, 15.03.2020)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 224 kB, 04.06.2020)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 163 kB, 03.07.2020)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 173 kB, 01.01.2019)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 163 kB, 01.01.2019)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 149 kB, 01.01.2019)

ZL000_00_035e_FO Form DMF HMV4 (DOC, 181 kB, 04.06.2020)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 196 kB, 01.07.2020)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 284 kB, 01.01.2019)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 177 kB, 04.06.2020)

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, 204 kB, 01.01.2019)

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 TPO4

ZL101_00_007e_WL Guidance document Authorisation of human medicinal product with known active pharmaceutical substance HMV4 (PDF, 784 kB, 01.08.2020)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 206 kB, 02.07.2020)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 172 kB, 15.03.2020)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 224 kB, 04.06.2020)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 163 kB, 03.07.2020)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 173 kB, 01.01.2019)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 163 kB, 01.01.2019)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 149 kB, 01.01.2019)

ZL000_00_035e_FO Form DMF HMV4 (DOC, 181 kB, 04.06.2020)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 196 kB, 01.07.2020)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 284 kB, 01.01.2019)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 177 kB, 04.06.2020)

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, 204 kB, 01.01.2019)

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 TPO4

ZL104_00_002e_WL Guidance document Fast-track authorisation procedure HMV4 (PDF, 519 kB, 23.09.2019)

Procedure with prior notification TPO4

ZL101_00_013e_WL Guidance document Procedure with prior notification HMV4 (PDF, 541 kB, 01.07.2020)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 163 kB, 03.07.2020)

Paediatric investigation plan TPO4

ZL000_00_023e_WL Guidance document Paediatric investigation plan HMV4 (PDF, 296 kB, 08.04.2019)

ZL000_00_034e_FO Form Paediatric investigation plan HMV4 (DOC, 175 kB, 04.06.2020)

Questions and answers on the Paediatric Investigation Plan HMV4

Document protection TPO4

ZL000_00_024e_WL Guidance document Document protection HMV4 (PDF, 516 kB, 01.08.2020)

Questions and answers on document protection

Authorisation human medicinal product under Art. 13 ATP TPO4

ZL000_00_019e_WL Guidance document Authorisation human medicinal product under Art. 13 ATP HMV4 (PDF, 403 kB, 05.05.2020)

Questions and answers Art. 13 TPA

ZL000_00_011e_VZ List of all countries with comparable human medicinal product control HMV4 (PDF, 346 kB, 01.05.2020)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 196 kB, 01.07.2020)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 163 kB, 03.07.2020)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 206 kB, 02.07.2020)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 172 kB, 15.03.2020)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 224 kB, 04.06.2020)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 173 kB, 01.01.2019)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 163 kB, 01.01.2019)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 149 kB, 01.01.2019)

ZL000_00_035e_FO Form DMF HMV4 (DOC, 181 kB, 04.06.2020)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 284 kB, 01.01.2019)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 177 kB, 04.06.2020)

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 TPO4

ZL000_00_022e_WL Guidance document Authorisation in accordance with Art. 14 para. 1 abis-quater TPA HMV4 (PDF, 290 kB, 01.06.2020)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 206 kB, 02.07.2020)

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 TPO4

ZL000_00_032e_WL Guidance document Authorisation of allergen product HMV4 (PDF, 316 kB, 01.01.2019)

Authorisation of antidote TPO4

ZL000_00_031e_WL Guidance document Authorisation of antidote HMV4 (PDF, 295 kB, 01.01.2019)

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, 284 kB, 01.01.2019)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 177 kB, 04.06.2020)

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

Authorisation of antivenin TPO4

ZL000_00_033e_WL Guidance document Authorisation of antivenin HMV4 (PDF, 302 kB, 01.01.2019)

ZL000_00_033e_FO Form New authorisation variation antivenin HMV4 (DOC, 173 kB, 03.07.2020)

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 TPO4

ZL101_00_012e_WL Guidance document Authorisation biosimilar HMV4 (PDF, 629 kB, 01.01.2020)

Questions and answers on the authorisation of biosimilars

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 206 kB, 02.07.2020)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 172 kB, 15.03.2020)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 224 kB, 04.06.2020)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 163 kB, 03.07.2020)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 173 kB, 01.01.2019)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 163 kB, 01.01.2019)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 149 kB, 01.01.2019)

ZL000_00_035e_FO Form DMF HMV4 (DOC, 181 kB, 04.06.2020)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 196 kB, 01.07.2020)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 284 kB, 01.01.2019)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 177 kB, 04.06.2020)

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, 204 kB, 01.01.2019)

Authorisation of co-marketing medicinal product TPO4

ZL108_00_002e_WL Guidance document Authorisation of co-marketing medicinal product HMV4 (PDF, 512 kB, 01.01.2019)

Questions and answers on co-marketing

ZL108_00_002e_FO Form New authorisation for co-marketing of medicinal product HMV4 (DOC, 183 kB, 26.09.2019)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 172 kB, 15.03.2020)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 224 kB, 04.06.2020)

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 TPO4

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 206 kB, 02.07.2020)

ZL106_00_002e_FO Form Importation of a medicinal product in accordance with Art. 14 para. 2 TPA (parallel import) HMV4 (DOC, 171 kB, 04.06.2020)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 284 kB, 01.01.2019)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 177 kB, 04.06.2020)

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

Temporary authorisation for human medicinal products TPO4

ZL109_00_001e_WL Guidance document Temporary authorisation for human medicinal products HMV4 (PDF, 314 kB, 01.04.2020)

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, 206 kB, 02.07.2020)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 172 kB, 15.03.2020)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 224 kB, 04.06.2020)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 196 kB, 01.07.2020)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 163 kB, 03.07.2020)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 284 kB, 01.01.2019)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 177 kB, 04.06.2020)

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 TPO4

ZL000_00_016e_WL Guidance document Authorisation of medicinal gas HMV4 (PDF, 278 kB, 01.01.2019)

Authorisation radiopharmaceutical TPO4

ZL000_00_034e_WL Guidance document Authorisation radiopharmaceutical HMV4 (PDF, 683 kB, 01.01.2019)

ZL000_00_042e_WL Guidance document Maintenance and updating of Annex 1 HMV4 (PDF, 229 kB, 01.01.2019)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 163 kB, 01.01.2019)

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 TPO4

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, 206 kB, 02.07.2020)

ZL103_00_003e_FO Form New authorisation variation in notification procedure KPTPO HMV4. (DOC, 189 kB, 25.02.2019)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 172 kB, 15.03.2020)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 163 kB, 03.07.2020)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 173 kB, 01.01.2019)

ZL000_00_035e_WL Guidance document Minimising the risk of TSE HMV4 (PDF, 204 kB, 01.01.2019)

Renewal of autorisation TPO4

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 172 kB, 15.03.2020)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 224 kB, 04.06.2020)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 163 kB, 01.01.2019)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 149 kB, 01.01.2019)

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 TPO4

ZL300_00_003e_FO Form Variations and extensions HMV4 (DOC, 671 kB, 01.07.2020)

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

Variations and extensions TPO4

ZL300_00_001e_WL Guidance document Variations and extensions HMV4 (PDF, 673 kB, 01.12.2019)

ZL300_00_003e_FO Form Variations and extensions HMV4 (DOC, 671 kB, 01.07.2020)

Questions and answers on variations and extensions HMV4

ZL000_00_035e_WL Guidance document Minimising the risk of TSE HMV4 (PDF, 204 kB, 01.01.2019)

ZL000_00_032e_FO Form Full declaration HMV4 (DOC, 172 kB, 15.03.2020)

ZL000_00_037e_FO Form Manufacturer information HMV4 (DOC, 224 kB, 04.06.2020)

ZL000_00_030e_FO Form Status of authorisation applications abroad HMV4 (DOC, 163 kB, 03.07.2020)

ZL000_00_031e_FO Form Substances of animal and human origin HMV4 (DOC, 173 kB, 01.01.2019)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals HMV4 (DOC, 163 kB, 01.01.2019)

ZL000_00_028e_FO Form Confirmation regarding substances from GMO HMV4 (DOC, 149 kB, 01.01.2019)

ZL000_00_035e_FO Form DMF HMV4 (DOC, 181 kB, 04.06.2020)

ZL000_00_019e_WL Guidance document Authorisation human medicinal product under Art. 13 ATP HMV4 (PDF, 403 kB, 05.05.2020)

ZL101_00_004e_FO Form Information for application Art.13 TPA HMV4 (DOC, 196 kB, 01.07.2020)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers HMV4 (PDF, 284 kB, 01.01.2019)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers HMV4 (DOC, 177 kB, 04.06.2020)

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

Approval variation of authorisation holder TPO4

ZL404_00_001e_WL Guidance documentTransfer of marketing authorisation HMV4 (PDF, 472 kB, 01.01.2019)

ZL100_00_001e_FO Form New authorisation of human medicinal products HMV4 (DOC, 206 kB, 02.07.2020)

ZL404_00_001e_FO Form Transfer of authorisation HMV4 (DOC, 277 kB, 04.06.2020)

BW303_00_002e_WL Guidance document Change name or domicile of the authorisation holder HMV4 (PDF, 417 kB, 11.02.2019)

Renewal and discontinuation of authorisation on change of status (main authorisation/export licence) TPO4

ZL201_00_001e_WL Guidance document Renewal and discontinuation of authorisation on change of status (main authorisation/export licence) HMV4 (PDF, 385 kB, 04.03.2019)

Questions and answers on authorisation renewals

ZL109_00_001e_WL Guidance document Temporary authorisation for human medicinal products HMV4 (PDF, 314 kB, 01.04.2020)

ZL201_00_008e_FO Form Renewal of authorisation HMV4 (DOC, 174 kB, 04.06.2020)

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 TPO4

ZL203_00_002e_WL Guidance document No marketing / interruption of distribution HMV4 (PDF, 209 kB, 01.01.2019)

ZL203_00_002e_FO Form No marketing / interruption of distribution HMV4 (DOC, 182 kB, 04.06.2020)

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

Valid until 31.12.2018
Supplementary information

Human medicinal product

Archiving of specification documents

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Human medicinal product TPO4

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

Swissmedic

Human medicinal product TPO4

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 TPO4

Orphan drug application TPO4

Fast-track application TPO4

Procedure with prior notification TPO4

Temporary authorisation TPO4

Company meetings relating to authorisation TPO4

Valid until 31.12.2018

Supplementary information