Links a CTD table-of-contents heading to the document(s) placed under it. Module 1 codes are regionally defined; Modules 2-5 are ICH-defined.
| Term | Code | Agency | Status |
|---|---|---|---|
| M1 CH Regional Information | 110001 | SwissMedic | — |
| M1.0 Cover Letter | 110002 | SwissMedic | — |
| M1.2 Application for Marketing Authorisation and Variation | 110003 | SwissMedic | — |
| M1.2.1 Form - Application | 110004 | SwissMedic | — |
| M1.2.2 Forms - Additional | 110005 | SwissMedic | — |
| M1.2.2.1 Form Full Declaration | 110006 | SwissMedic | — |
| M1.2.2.2 Form Manufacturer Information | 110007 | SwissMedic | — |
| M1.2.2.3 Form Status Marketing Authorisations Abroad | 110008 | SwissMedic | — |
| 1.2.2.4++ | 110009 | SwissMedic | — |
| 1.2.2.5++ | 110010 | SwissMedic | — |
| 1.2.2.6++ | 110011 | SwissMedic | — |
| 1.2.2.7++ | 110012 | SwissMedic | — |
| M1.2.2.8 Form Substances of Animal or Human Origin | 110013 | SwissMedic | — |
| 1.2.2.9++ | 110014 | SwissMedic | — |
| 1.2.2.10++ | 110015 | SwissMedic | — |
| 1.2.2.11++ | 110016 | SwissMedic | — |
| 1.2.2.12++ | 110017 | SwissMedic | — |
| M1.2.2.13 Form Change of Marketing Authorisation Holder | 110018 | SwissMedic | — |
| 1.2.2.14++ | 110019 | SwissMedic | — |
| .2.2.15++ | 110020 | SwissMedic | — |
| M1.2.2.16 Form PSUR/PBRER for Human Medicines | 110021 | SwissMedic | — |
| M1.2.2.17 Form Declaration Radiopharmaceuticals | 110022 | SwissMedic | — |
| M1.2.2.18 Form Confirmation Regarding Substances from GMO | 110023 | SwissMedic | — |
| M1.2.2.19 Form DMF | 110024 | SwissMedic | — |
| M1.2.2.20 Form Information Relating to Applications under Art. 13 TPA | 110025 | SwissMedic | — |
| 1.2.2.21++ | 110026 | SwissMedic | — |
| 1.2.2.22++ | 110027 | SwissMedic | — |
| M1.2.2.23 Form Application for Recognition of Orphan Drug Status | 110028 | SwissMedic | — |
| 1.2.2.24++ | 110029 | SwissMedic | — |
| M1.2.2.25 Form PIP | 110030 | SwissMedic | — |
| M1.2.2.26 GCP Inspections | 110031 | SwissMedic | — |
| M1.2.2.99 Other Forms [extensional sections allowed] | 110032 | SwissMedic | — |
| M1.2.3 Annexes - Documents on Drug Quality | 110033 | SwissMedic | — |
| M1.2.3.1 DMF Letter of Access | 110034 | SwissMedic | — |
| M1.2.3.2 Ph. Eur. Certificate of Suitability for Active Substance | 110035 | SwissMedic | — |
| M1.2.3.3 Ph. Eur. Certificate of Suitability for TSE | 110036 | SwissMedic | — |
| M1.2.3.4 EMA Certificate for Plasma Master File (PMF) | 110037 | SwissMedic | — |
| M1.2.3.5 EMA Certificate for Vaccine Antigen Master File (VAMF) | 110038 | SwissMedic | — |
| M1.2.4 Annexes – Manufacturing | 110039 | SwissMedic | — |
| M1.2.4.1 GMP Certificate or Other GMP Documents | 110040 | SwissMedic | — |
| M1.2.4.2 Documentation Concerning Manufacturing Authorisation | 110041 | SwissMedic | — |
| M1.2.4.3 Complete Manufacturing Information with Flow Chart | 110042 | SwissMedic | — |
| M1.2.4.4 Confirmation on GMP Conformity | 110043 | SwissMedic | — |
| M1.2.5 Annexes – Others | 110044 | SwissMedic | — |
| M1.2.5.1 Comparison of Approved Information for Professionals with EU SmPC (for PSURs) | 110045 | SwissMedic | — |
| M1.2.5.2 Company Core Data Sheet (for PSURs) | 110046 | SwissMedic | — |
| M1.3 Product Information and Packaging Material | 110047 | SwissMedic | — |
| M1.3.1 Information for Professionals | 110048 | SwissMedic | — |
| M1.3.2 Patient Information | 110049 | SwissMedic | — |
| M1.3.3 Packaging Information | 110050 | SwissMedic | — |
| M1.3.4 Information for Professionals from Other Countries | 110051 | SwissMedic | — |
| M1.4 Information About the Expert | 110052 | SwissMedic | — |
| M1.4.1 Quality | 110053 | SwissMedic | — |
| M1.4.2 Nonclinical | 110054 | SwissMedic | — |
| M1.4.3 Clinical | 110055 | SwissMedic | — |
| M1.5 Data of Bioavailability Studies (Known Active Substance without Innovation) | 110056 | SwissMedic | — |
| M1.5.1 Information according to Appendix IV of the Guideline on the Investigation on Bioequivalence | 110057 | SwissMedic | — |
| M1.5.2 Documents on the Reference Product | 110058 | SwissMedic | — |
| 1.5.3++ | 110059 | SwissMedic | — |
| M1.5.4 Art 14 Sec1 let abis TPA tabular compilation of deviations between product to be authorised in CH and foreign comparator | 110060 | SwissMedic | — |
| M1.6 Environmental Risk Assessment | 110061 | SwissMedic | — |
| M1.6.1 Non-GMO | 110062 | SwissMedic | — |
| M1.6.2 GMO | 110063 | SwissMedic | — |
| M1.7 Decisions of Foreign Authorities | 110064 | SwissMedic | — |
| M1.7.1 Responses to LoQ | 110065 | SwissMedic | — |
| M1.7.2 Assessment Report | 110066 | SwissMedic | — |
| M1.7.3 EU Decision | 110067 | SwissMedic | — |
| M1.7.4 FDA Decision | 110068 | SwissMedic | — |
| M1.7.5 Decisions of Other Foreign Authorities | 110069 | SwissMedic | — |
| M1.7.6 Article 13 TPA Additional Documentation | 110070 | SwissMedic | — |
| M1.8 Information Relating to Pharmacovigilance | 110071 | SwissMedic | — |
| M1.8.1 Pharmacovigilance System | 110072 | SwissMedic | — |
| M1.8.2 Risk-Management System | 110073 | SwissMedic | — |
| M1.9 Fast Track Status Decision | 110074 | SwissMedic | — |
| M1.10 Information Relating to Paediatrics | 110075 | SwissMedic | — |
| M1.11 Orphan Drug Status Decision | 110076 | SwissMedic | — |
| M1.12 Art 14 Sec 1 let abis-quater TPA Documents | 110077 | SwissMedic | — |
| M1.12.1 Proof of 10 Years EU/EFTA Authorisation | 110078 | SwissMedic | — |
| 1.12.2++ | 110079 | SwissMedic | — |
| M1.12.3 Proof of 30 Years Overall Medical Use - 15 Years Medical Use EU/EFTA | 110080 | SwissMedic | — |
| M1.12.4 Proof of 15 Years Cantonal Authorisation | 110081 | SwissMedic | — |
| Responses to Swissmedic LoQ | 110082 | SwissMedic | — |
| Additional Information | 110083 | SwissMedic | — |
83 terms shown for SwissMedic. Data sourced from public health authority publications and updated periodically.