Complementary medicinal product

Ordinances
Appendices

Verordnung des Schweizerischen Heilmittelinstituts über die vereinfachte Zulassung und das Meldeverfahren von Komplementär- und Phytoarzneimitteln (Komplementär- und Phytoarzneimittelverordnung, KPAV; SR 812.212.24)

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

Liste Teedrogen (PDF, 199 kB, 21.09.2018)KPAV, Anhang 4 (Art. 12)

Liste «Bonbons» (PDF, 219 kB, 01.07.2021)KPAV, Anhang 5 (Art. 13)

Liste HAS

KPAV (SR 812.212.24), Anhang 6 (Art. 15 Abs. 1, 20 Bst. a, 27 Bst. a und 39 Abs. 1 Bst. d), 01.07.2025

Liste SC (Schüsslersalze)

KPAV (SR 812.212.24), Anhang 7 (Art. 15 Abs. 2 und 28), 01.07.2025

Stoffliste Gemmotherapie (PDF, 90 kB, 01.07.2021)KPAV, Anhang 8 (Art. 27 Bst. b und 35 Abs. 2)

Liste der Standardwerke (PDF, 129 kB, 01.07.2023)KPAV, Anhang 9 (Art. 30 Abs. 2 und 31 Abs. 2)

Liste TAS

KPAV (SR 812.212.24), Anhang 10 (Art. 31 Abs. 1, 32 und 45 Abs. 2), 01.07.2025

Formal requirements

ZL000_00_020e_WL Guidance document Formal requirements (PDF, 1 MB, 01.09.2025)

ZL000_00_006e_VZ Directory Overview of documents to be submitted (XLSX, 137 kB, 01.09.2025)

OS000_00_004e_VL Priorisation sheet (DOCX, 156 kB, 14.02.2017)

eCTD

OS000_00_007e_AA Swiss Module 1 Specification for eCTD Version 1.5 (PDF, 1 MB, 18.07.2024)

OS000_00_008e_AA Swiss eCTD Validation Criteria v1.5 (XLSX, 75 kB, 01.04.2020)

OS000_00_004e_WL Guidance Industry eCTD (PDF, 4 MB, 11.03.2024)

OS000_00_004e_MB Questions & Answers Swissmedic eCTD Implementation (PDF, 281 kB, 19.07.2023)

OS000_00_005e_WL Guidance Article 13 TPA final Version 1.6 (PDF, 514 kB, 01.03.2024)

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

eCTD

eDok

OS000_00_003e_WL Guidance eDok (PDF, 431 kB, 02.09.2025)

Paper

Portal

Submissions

www.swissmedicinfo.ch

Product information and packaging

ZL000_00_021e_WL Guidance document Packaging for human medicinal products (PDF, 719 kB, 01.12.2025)

ZL000_00_027e_WL Guidance document Product information for human medicinal products (PDF, 1 MB, 01.09.2025)

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, 55 kB, 13.03.2025)

ZL000_00_046d_VL Patienteninformation für Komplementärarzneimittel (DOCX, 74 kB, 15.11.2024)Available in German, French or Italian only.

ZL000_00_050e_WL Guidance document Mobile technologies (PDF, 305 kB, 15.08.2025)

Questions and answers on Full declaration HMV4

www.swissmedicinfo.ch

Time limits for authorization applications

ZL000_00_014e_WL Guidance document Time limits for authorization applications (PDF, 677 kB, 01.09.2025)

Applications and meetings

Procedure with prior notification

ZL101_00_013e_WL Guidance document Procedure with prior notification (PDF, 325 kB, 01.11.2025)

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

Company meetings relating to authorisation

ZL105_00_003e_WL Guidance document Meetings for applicants for authorisation procedures (PDF, 331 kB, 01.10.2025)

ZL105_00_004e_FO Form Meeting for applicants for authorisation procedures (DOCX, 384 kB, 01.12.2025)

ZL105_00_006e_FO Form Company meeting record (DOCX, 155 kB, 01.10.2025)

New application

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, 312 kB, 01.01.2026)

Authorisation of complementary 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)

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 190 kB, 01.10.2025)

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 01.01.2025)

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, 449 kB, 14.07.2025)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 08.09.2025)

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)

Authorisation of complementary 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, 190 kB, 01.10.2025)

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 01.01.2025)

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, 193 kB, 01.01.2025)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 449 kB, 14.07.2025)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 08.09.2025)

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)

Procedure with prior notification

ZL101_00_013e_WL Guidance document Procedure with prior notification (PDF, 325 kB, 01.11.2025)

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

Document protection

ZL000_00_024e_WL Guidance document Document protection (PDF, 369 kB, 01.01.2025)

Questions and answers on document protection

Authorisation of complementary medicinal product under Art. 13 ATP

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

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

ZL101_00_004e_FO Form Information for application Art.13 TPA (DOCX, 193 kB, 01.01.2025)

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, 190 kB, 01.10.2025)

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 01.01.2025)

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_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, 449 kB, 14.07.2025)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 08.09.2025)

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, 190 kB, 01.10.2025)

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 co-marketing medicinal product

ZL108_00_002e_WL Guidance document Authorisation of co-marketing medicinal product (PDF, 346 kB, 09.05.2025)

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, 01.01.2025)

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)

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

Authorisation of Homeopathics, anthroposophics and other complementary medicinal products

ZL101_00_016e_WL Guidance document Authorisation of Homeopathics, anthroposophics and other complementary medicinal products (PDF, 648 kB, 01.07.2025)

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 190 kB, 01.10.2025)

ZL100_00_002e_FO Form New authorisation of veterinary medicinal products (DOCX, 180 kB, 01.10.2025)

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 01.01.2025)

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_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 449 kB, 14.07.2025)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 08.09.2025)

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

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

Authorisation of reduced dossier for homeopathics and anthroposophics

ZL101_00_016e_WL Guidance document Authorisation of Homeopathics, anthroposophics and other complementary medicinal products (PDF, 648 kB, 01.07.2025)

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 190 kB, 01.10.2025)

ZL100_00_002e_FO Form New authorisation of veterinary medicinal products (DOCX, 180 kB, 01.10.2025)

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 01.01.2025)

ZL101_00_017e_WL Guidance document Simplified information requirements on the form for manufacturer information for the reduced dossier (PDF, 267 kB, 01.05.2021)

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_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 449 kB, 14.07.2025)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 08.09.2025)

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

HOMANT Asia - Notification procedure for Asian medicinal products

ZL101_00_009e_WL Guidance document Authorisation of Asian medicinal products (PDF, 415 kB, 01.05.2025)

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

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_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_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 449 kB, 14.07.2025)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 08.09.2025)

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

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

Authorisation of Asian medicinal products

ZL101_00_009e_WL Guidance document Authorisation of Asian medicinal products (PDF, 415 kB, 01.05.2025)

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 190 kB, 01.10.2025)

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 01.01.2025)

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_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_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 449 kB, 14.07.2025)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 08.09.2025)

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

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

HOMANT - FBD / master dossier / Authorisation for homeopathic and anthroposophic medicinal products and medicinal products for gemmotherapy without indication in the notification procedure

ZL103_00_002e_WL Guidance document Authorisation for homeopathic and anthroposophic medicinal products and medicinal products for gemmotherapy without indication in the notification procedure (PDF, 769 kB, 01.05.2025)

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

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_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_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 449 kB, 14.07.2025)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 08.09.2025)

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

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

Renewal of autorisation (without notification procedure)

ZL000_00_032e_FO Form Full declaration (DOCX, 152 kB, 01.01.2025)

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_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, 707 kB, 01.02.2025)valid until 31 January 2026 and for the correction of applications received by Swissmedic until 31 January 2026

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, 305 kB, 15.08.2025)

ZL000_00_040e_FO Mobile technologies (DOCX, 377 kB, 15.10.2025)

Questions and answers on mobile technologies

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, 707 kB, 01.02.2025)valid until 31 January 2026 and for the correction of applications received by Swissmedic until 31 January 2026

ZL300_00_003e_FO Form Variations and extensions HAM (DOCX, 816 kB, 01.02.2026)valid from 1 February 2026

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, 01.01.2025)

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_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, 193 kB, 01.01.2025)

ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers (PDF, 449 kB, 14.07.2025)

ZL000_00_038e_FO Form Declaration by the Responsible Person for foreign manufacturers (DOCX, 163 kB, 08.09.2025)

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

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

ZL000_00_050e_WL Guidance document Mobile technologies (PDF, 305 kB, 15.08.2025)

ZL000_00_040e_FO Mobile technologies (DOCX, 377 kB, 15.10.2025)

Approval variation of authorisation holder

ZL404_00_001e_WL Guidance document Transfer of marketing authorisation (PDF, 282 kB, 01.07.2025)

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

ZL100_00_001e_FO Form New authorisation of human medicinal products (DOCX, 190 kB, 01.10.2025)

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, 388 kB, 01.09.2025)

Questions and answers on authorisation renewals

ZL109_00_001e_WL Guidance document Temporary authorisation for human medicinal products (PDF, 550 kB, 01.06.2025)

ZL104_00_001e_FO Decision minutes Accelerated Application Hearing (DOCX, 173 kB, 01.04.2025)

ZL201_00_008e_FO Form Renewal of authorisation (DOCX, 159 kB, 01.09.2025)

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, 253 kB, 01.10.2025)

ZL203_00_002e_FO Form No marketing / interruption of distribution HAM (DOCX, 161 kB, 01.10.2025)

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

Criteria Annexes 4–10 KPTPO

ZL103_00_004e WL Guidance document Criteria Annexes 4–10 KPTPO (PDF, 310 kB, 01.06.2025)

Supplementary information

Archiving of specification documents

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Complementary medicinal product

Ordinances

Appendices

Procedure with prior notification

Company meetings relating to authorisation

Supplementary information