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Veterinary medicinal product

Ordinances
Appendices

Verordnung über die Arzneimittel (Arzneimittelverordnung, VAM; SR 812.212.21)

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

Verordnung des Schweizerischen Heilmittelinstituts über die vereinfachte Zulassung von Arzneimitteln und die Zulassung von Arzneimitteln im Meldeverfahren (VAZV; SR 812.212.23)

Liste der Änderungen bei Tierarzneimitteln nach den Artikeln 25a und 25b VAM (PDF, 162 kB, 28.01.2022)AMZV (812.212.22), Anhang 7a (Art. 22a)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

Zulässige Wirkstoffe für die Zulassung von Tierarzneimitteln im Meldeverfahren (PDF, 151 kB, 01.07.2020)VAZV (RS 812.212.23), Anhang 2 (Art. 39)

Formal requirements

ZL000_00_020e_WL Guidance document Formal requirements (PDF, 6 MB, 01.01.2024)

ZL000_00_006e_VZ Directory Overview of documents to be submitted (XLSX, 129 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)

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Swiss Compendium of Veterinary Medicinal Products (in German)

Product information for veterinary medicinal products and packaging

ZL000_00_029e_WL Guidance document Packaging texts for veterinary medicinal products (PDF, 2 MB, 01.12.2023)

ZL000_00_028e_WL Guidance document Product information for veterinary medicinal products (PDF, 236 kB, 23.05.2023)

ZL000_00_043d_VL Fachinformation Tierarzneimittel HMV4 (DOCX, 230 kB, 01.01.2023)

ZL000_00_044d_VL Packungsbeilage Tierarzneimitte (DOCX, 101 kB, 01.06.2023)

ZL000_00_054d_VL Fachinformation immunologisches Tierarzneimittel (DOCX, 116 kB, 01.01.2023)

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

Swiss Compendium of Veterinary Medicinal Products (in German)

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Time limits for authorisation applications

ZL000_00_014e_WL Guidance document Time limits for authorization applications (PDF, 834 kB, 28.02.2024)

Applications and meetings

Application MUMS status TPO4

ZL102_00_003e_FO Form Recognition of MUMS status (DOCX, 161 kB, 29.06.2023)

Questions and answers on orphan drug/MUMS

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

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

Temporary authorisation TPO4

ZL109_00_002e_WL Guidance document Temporary authorisation of veterinary medicinal products (PDF, 319 kB, 01.05.2023)

Company meetings relating to authorisation TPO4

ZL105_00_003e_WL Guidance document Meeting for applicants held with the Authorisation sector (PDF, 1 MB, 01.05.2023)

ZL105_00_004e_FO Form Company meeting HMV4 (DOCX, 185 kB, 01.07.2021)

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

New application

Authorisation of veterinary medicinal products

ZL000_00_017e_WL Guidance document Authorisation of veterinary medicinal products (PDF, 315 kB, 22.05.2023)

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

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)

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, 29.06.2023)

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, 162 kB, 29.06.2023)

BW105_00_002e_VZ List Countries with recognised GMP control systems (PDF, 127 kB, 26.06.2023)

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 veterinary medicinal product with known API

ZL101_00_006e_WL Guidance document Authorisation of veterinary medicinal product with known API (PDF, 268 kB, 01.05.2023)

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

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)

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, 29.06.2023)

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, 162 kB, 29.06.2023)

BW105_00_002e_VZ List Countries with recognised GMP control systems (PDF, 127 kB, 26.06.2023)

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)

Simultaneous Review

ZL000_00_945e_WL Guidance Switzerland-United Kingdom Regulatory Cooperation: Guidance on Veterinary Medicines Simultaneous Reviews (PDF, 1 MB, 18.07.2023)

Simultaneous Review

Document protection

ZL000_00_024e_WL Guidance document Document protection HMV4 (PDF, 565 kB, 01.01.2023)

Questions and answers on document protection

Authorisation veterinary medicinal product under Art. 13 TPA

ZL000_00_018e_WL Guidance document Authorisation veterinary medicinal product under Art. 13 TPA (PDF, 329 kB, 22.05.2023)

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_002e_FO Form New authorisation of veterinary medicinal products (DOCX, 178 kB, 29.06.2023)

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)

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, 29.06.2023)

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, 162 kB, 29.06.2023)

ZL000_00_012e_VZ ZL000_00_012e_VZ Directory List countries with comparable control of veterinary medicinal products HMV4 (PDF, 127 kB, 01.12.2020)

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_002e_FO Form New authorisation of veterinary medicinal products (DOCX, 178 kB, 29.06.2023)

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)

Notification procedure for veterinary medicinal products

ZL112_00_002e_WL Guidance document Notification procedure for veterinary medicinal products (PDF, 1 MB, 01.08.2023)

ZL112_00_002e_FO Form New authorisation by notification procedure veterinary medicinal products (DOCX, 166 kB, 30.06.2023)

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

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

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

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, 162 kB, 29.06.2023)

BW105_00_002e_VZ List Countries with recognised GMP control systems (PDF, 127 kB, 26.06.2023)

Temporary authorisation of veterinary medicinal products

ZL109_00_002e_WL Guidance document Temporary authorisation of veterinary medicinal products (PDF, 319 kB, 01.05.2023)

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

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)

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, 162 kB, 29.06.2023)

BW105_00_002e_VZ List Countries with recognised GMP control systems (PDF, 127 kB, 26.06.2023)

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

Authorisation of immunological veterinary medicinal products in the event of an epizootic outbreak

ZL000_00_986e_WL Guidance document Authorisation of immunological veterinary medicinal products in the event of an epizootic outbreak (PDF, 1 MB, 15.01.2024)

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_004e_FO Variations TAM (DOCX, 681 kB, 15.10.2023)

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, 371 kB, 01.10.2023)

Variations

ZL300_00_002e_WL Guidance document Variations TAM (PDF, 1 MB, 01.06.2023)

Questions and answers on variations VMP

ZL300_00_004e_FO Variations TAM (DOCX, 681 kB, 15.10.2023)

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_028e_FO Form Confirmation regarding substances from GMO (DOCX, 152 kB, 30.06.2023)

ZL000_00_035e_FO Form DMF (DOCX, 166 kB, 29.06.2023)

ZL000_00_018e_WL Guidance document Authorisation veterinary medicinal product under Art. 13 TPA (PDF, 329 kB, 22.05.2023)

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, 162 kB, 29.06.2023)

BW105_00_002e_VZ List Countries with recognised GMP control systems (PDF, 127 kB, 26.06.2023)

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

ZL000_00_040e_FO Mobile technologies (DOCX, 371 kB, 01.10.2023)

ZL000_00_945e_WL Guidance Switzerland-United Kingdom Regulatory Cooperation: Guidance on Veterinary Medicines Simultaneous Reviews (PDF, 1 MB, 18.07.2023)

Approval variation of authorisation holder

ZL404_00_001e_WL Guidance documentTransfer of marketing authorisation (PDF, 238 kB, 01.05.2023)

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

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

ZL404_00_001e_FO Form Transfer of authorisation (DOCX, 162 kB, 17.07.2023)

BW303_00_003e_WL Guidance document Change name or domicile of the authorisation holder (PDF, 476 kB, 23.02.2023)

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, 327 kB, 01.05.2023)

Questions and answers on authorisation renewals

ZL109_00_002e_WL Guidance document Temporary authorisation of veterinary medicinal products (PDF, 319 kB, 01.05.2023)

ZL201_00_007e_FO Form Renewal of authorisation by notification procedure veterinary medicinal products (DOCX, 157 kB, 19.07.2023)

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

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, 244 kB, 01.05.2023)

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

Signals / PSUR Signal Management

ZL404_00_004e_WL Guidance document Drug Safety Signals VMP (PDF, 1 MB, 20.09.2023)

ZL404_00_002e_FO Signal Notification Form VMP (DOCX, 373 kB, 20.09.2023)

ZL404_00_003e_WL Guidance document PSUR Signal Management TAM (PDF, 281 kB, 01.05.2023)

Questions and answers immunological veterinary medicinal products

Questions and answers Regarding the transfer of immunological veterinary medicinal products to Swissmedic

Supplementary information

Archiving of specification documents

https://www.swissmedic.ch/content/swissmedic/en/home/services/documents/tierarzneimittel_hmv4.html