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.
|
HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
|
Term
Term Description as defined by the Health Authority
|
Code
Code, if any, associated with the term by the Health Authority
|
Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
|
Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
|
|---|---|---|---|---|
| Context of Use | M1.3.2 Patient Information |
110049
|
SwissMedic | — |
| EU Context of Use | M1.3.2 Mockup |
100000164033
|
EMA | Active |
| US Context of Use | m1.3.2 field copy certification |
us_1.3.2
|
FDA | — |
| US Context of Use | m1.3.1.5 change in ownership of an application or reissuance of license |
us_1.3.1.5
|
FDA | — |
| US Context of Use | m1.3.1.4 transfer of obligation |
us_1.3.1.4
|
FDA | — |
| US Context of Use | m1.3.1.3 change in sponsor |
us_1.3.1.3
|
FDA | — |
| US Context of Use | m1.3.1.2 change in contact agent |
us_1.3.1.2
|
FDA | — |
| US Context of Use | m1.3.1.1 change of address or corporate name |
us_1.3.1.1
|
FDA | — |
| EU Context of Use | M1.3.1 SmPC, Labeling, Package Leaflet |
100000164032
|
EMA | Active |
| Context of Use | M1.3.1 Information for Professionals |
110048
|
SwissMedic | — |
| Context of Use | M1.3 Product Information and Packaging Material |
110047
|
SwissMedic | — |
| US Context of Use | m1.20 general investigational plan for initial ind |
us_1.20
|
FDA | — |
| Context of Use | M1.2.5.2 Company Core Data Sheet (for PSURs) |
110046
|
SwissMedic | — |
| Context of Use | M1.2.5.1 Comparison of Approved Information for Professionals with EU SmPC (for PSURs) |
110045
|
SwissMedic | — |
| Context of Use | M1.2.5 Annexes – Others |
110044
|
SwissMedic | — |
| Context of Use | M1.2.4.4 Confirmation on GMP Conformity |
110043
|
SwissMedic | — |
| Context of Use | M1.2.4.3 Complete Manufacturing Information with Flow Chart |
110042
|
SwissMedic | — |
| Context of Use | M1.2.4.2 Documentation Concerning Manufacturing Authorisation |
110041
|
SwissMedic | — |
| Context of Use | M1.2.4.1 GMP Certificate or Other GMP Documents |
110040
|
SwissMedic | — |
| Context of Use | M1.2.4 Annexes – Manufacturing |
110039
|
SwissMedic | — |
| Context of Use | M1.2.3.5 EMA Certificate for Vaccine Antigen Master File (VAMF) |
110038
|
SwissMedic | — |
| Context of Use | M1.2.3.4 EMA Certificate for Plasma Master File (PMF) |
110037
|
SwissMedic | — |
| Context of Use | M1.2.3.3 Ph. Eur. Certificate of Suitability for TSE |
110036
|
SwissMedic | — |
| Context of Use | M1.2.3.2 Ph. Eur. Certificate of Suitability for Active Substance |
110035
|
SwissMedic | — |
| Context of Use | M1.2.3.1 DMF Letter of Access |
110034
|
SwissMedic | — |
Showing 226–250 of 380 terms . Data sourced from public health authority publications and updated periodically.