Human medicinal product

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)

Submissions

www.swissmedicinfo.ch

Product information for human medicinal products 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_050e_WL Guidance document Mobile technologies (PDF, 1 MB, 01.10.2023)

ZL000_00_040e_FO Mobile technologies (DOCX, 372 kB, 01.09.2024)

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

ZL000_00_049d_VL Patienteninformation für Humanarzneimittel (DOCX, 165 kB, 01.03.2023)

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, 729 kB, 01.05.2023)

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 (PDF, 676 kB, 01.09.2024)

Applications and meetings

New application

Project Orbis

ZL000_00_048e_WL Guidance document Project Orbis (PDF, 707 kB, 24.05.2023)

SwissPAR

ZL000_00_030e_WL Guidance document SwissPAR (PDF, 385 kB, 01.10.2024)

Questions and answers Swiss Public Assessment Report (SwissPAR)

Medicinal Product Names

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

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)

Authorisation of human medicinal product with new active substance

ZL101_00_005e_WL Guidance document Authorisation of human medicinal product with new active substance (PDF, 406 kB, 01.09.2024)

ZL000_00_048e_WL Guidance document Project Orbis (PDF, 707 kB, 24.05.2023)

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 191 kB, 01.09.2024)

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)

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_029e_FO Form Declaration of radiopharmaceuticals (DOCX, 151 kB, 29.06.2023)

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_035e_WL Guidance document Minimising the risk of TSE (PDF, 240 kB, 24.05.2023)

ZL109_00_001e_WL Guidance document Temporary authorisation for human medicinal products (PDF, 571 kB, 15.10.2024)

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

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 (PDF, 683 kB, 01.11.2024)

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 191 kB, 01.09.2024)

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)

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_029e_FO Form Declaration of radiopharmaceuticals (DOCX, 151 kB, 29.06.2023)

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_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)

Fast-track authorisation procedure

ZL104_00_002e_WL Guidance document Fast-track authorisation procedure (PDF, 442 kB, 15.10.2024)

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

Procedure with prior notification

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)

Paediatric investigation plan

ZL000_00_023e_WL Guidance document Paediatric investigation plan (PDF, 523 kB, 23.05.2023)

ZL000_00_034e_FO Form Paediatric investigation plan (DOCX, 332 kB, 21.09.2023)

Questions and answers on the Paediatric Investigation Plan

Document protection

ZL000_00_024e_WL Guidance document Document protection (PDF, 366 kB, 01.07.2023)

Questions and answers on document protection

Authorisation human medicinal product under Art. 13 TPA

ZL000_00_019e_WL Guidance document Authorisation human medicinal product under Art. 13 TPA (PDF, 3 MB, 15.01.2024)

Questions and answers Art. 13 TPA

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

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

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 191 kB, 01.09.2024)

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)

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

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals (DOCX, 151 kB, 29.06.2023)

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)

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

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 (PDF, 2 MB, 15.01.2024)

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 191 kB, 01.09.2024)

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

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

Authorisation of allergen product

ZL000_00_032e_WL Guidance document Authorisation of allergen product (PDF, 300 kB, 24.05.2023)

Authorisation of antidote

ZL000_00_031e_WL Guidance document Authorisation of antidote (PDF, 253 kB, 23.05.2023)

Toxinfo Suisse

MU101_20_004d_FO UAW Antidota Antivenine (DOCX, 195 kB, 26.10.2022)

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)

Authorisation of antivenin

ZL000_00_033e_WL Guidance document Authorisation of antivenin (PDF, 273 kB, 24.05.2023)

ZL000_00_033e_FO Form New authorisation variation antivenin (DOCX, 161 kB, 11.07.2023)

Toxinfo Suisse

MU101_20_004d_FO UAW Antidota Antivenine (DOCX, 195 kB, 26.10.2022)

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

Authorisation biosimilar

ZL101_00_012e_WL Guidance document Authorisation biosimilar (PDF, 560 kB, 15.11.2023)

Questions and answers on the authorisation of biosimilars

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 191 kB, 01.09.2024)

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)

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_029e_FO Form Declaration of radiopharmaceuticals (DOCX, 151 kB, 29.06.2023)

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_035e_WL Guidance document Minimising the risk of TSE (PDF, 240 kB, 24.05.2023)

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)

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)

Autorisation of parallel import

ZL106_00_888e_WL Guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (PDF, 517 kB, 01.05.2024)

Questions and answers Parallel imports of human medicinal products

ZL106_00_002e_FO Form Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) (DOCX, 169 kB, 01.01.2024)

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)

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

Temporary authorisation for human medicinal products

ZL109_00_001e_WL Guidance document Temporary authorisation for human medicinal products (PDF, 571 kB, 15.10.2024)

Questions and answers on temporary authorisation human medicinal products

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

MU103_10_001e_WL Guidance document RMP / ICH E2E – Information for submission of RMP HMP (PDF, 2 MB, 01.11.2023)

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 191 kB, 01.09.2024)

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)

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

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

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)

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

Authorisation of medicinal gas

ZL000_00_016e_WL Guidance document Authorisation of medicinal gas (PDF, 337 kB, 15.10.2024)

Authorisation radiopharmaceutical

ZL000_00_034e_WL Guidance document Authorisation radiopharmaceutical (PDF, 463 kB, 24.05.2023)

ZL000_00_042e_WL Guidance document Maintenance and updating of Annex 1 (PDF, 251 kB, 24.05.2023)

ZL000_00_029e_FO Form Declaration of radiopharmaceuticals (DOCX, 151 kB, 29.06.2023)

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

BW107_00_003d_FO Gesuch befristete Vertriebsbewilligung Radiopharmazeutika (DOCX, 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 (DOCX, 191 kB, 01.09.2024)

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_031e_FO Form Substances of animal and human origin (DOCX, 170 kB, 11.07.2023)

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

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_029e_FO Form Declaration of radiopharmaceuticals (DOCX, 151 kB, 29.06.2023)

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 after first authorisation

ZL300_00_003e_FO Form Variations and extensions HAM (DOCX, 706 kB, 01.07.2024)

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

Authorisation under the MAGHP procedure

ZL000_00_047e_WL Guidance document MAGHP Procedure (PDF, 446 kB, 25.05.2023)

Variations and extensions

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

ZL000_00_048e_WL Guidance document Project Orbis (PDF, 707 kB, 24.05.2023)

ZL300_00_003e_FO Form Variations and extensions HAM (DOCX, 706 kB, 01.07.2024)

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_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_029e_FO Form Declaration of radiopharmaceuticals (DOCX, 151 kB, 29.06.2023)

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_019e_WL Guidance document Authorisation human medicinal product under Art. 13 TPA (PDF, 3 MB, 15.01.2024)

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)

Approval variation of authorisation holder

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, 191 kB, 01.09.2024)

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 or 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

ZL201_00_008e_FO Form Renewal of authorisation (DOCX, 160 kB, 19.07.2023)

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

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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