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)
|
|---|---|---|---|---|
| US Context of Use | m1.16.2.2 draft rems |
us_1.16.2.2
|
FDA | — |
| US Context of Use | m1.16.2.3 rems assessment |
us_1.16.2.3
|
FDA | — |
| US Context of Use | m1.16.2.4 rems assessment methodology |
us_1.16.2.4
|
FDA | — |
| US Context of Use | m1.16.2.5 rems correspondence |
us_1.16.2.5
|
FDA | — |
| US Context of Use | m1.16.2.6 rems modification history |
us_1.16.2.6
|
FDA | — |
| US Context of Use | m1.17.1 correspondence regarding postmarketing commitments |
us_1.17.1
|
FDA | — |
| US Context of Use | m1.17.2 correspondence regarding postmarketing requirements |
us_1.17.2
|
FDA | — |
| US Context of Use | m1.18.1 proprietary name |
us_1.18.1
|
FDA | — |
| US Context of Use | m1.18.2 biological proper name suffix |
us_1.18.2
|
FDA | — |
| US Context of Use | m1.19 pre eua and eua |
us_1.19
|
FDA | — |
| Context of Use | M1.2 Application for Marketing Authorisation and Variation |
110003
|
SwissMedic | — |
| EU Context of Use | M1.2 Application Form |
100000164030
|
EMA | Active |
| US Context of Use | m1.2 cover letters |
us_1.2
|
FDA | — |
| Context of Use | M1.2.1 Form - Application |
110004
|
SwissMedic | — |
| Context of Use | M1.2.2 Forms - Additional |
110005
|
SwissMedic | — |
| Context of Use | M1.2.2.1 Form Full Declaration |
110006
|
SwissMedic | — |
| Context of Use | M1.2.2.13 Form Change of Marketing Authorisation Holder |
110018
|
SwissMedic | — |
| Context of Use | M1.2.2.16 Form PSUR/PBRER for Human Medicines |
110021
|
SwissMedic | — |
| Context of Use | M1.2.2.17 Form Declaration Radiopharmaceuticals |
110022
|
SwissMedic | — |
| Context of Use | M1.2.2.18 Form Confirmation Regarding Substances from GMO |
110023
|
SwissMedic | — |
| Context of Use | M1.2.2.19 Form DMF |
110024
|
SwissMedic | — |
| Context of Use | M1.2.2.2 Form Manufacturer Information |
110007
|
SwissMedic | — |
| Context of Use | M1.2.2.20 Form Information Relating to Applications under Art. 13 TPA |
110025
|
SwissMedic | — |
| Context of Use | M1.2.2.23 Form Application for Recognition of Orphan Drug Status |
110028
|
SwissMedic | — |
| Context of Use | M1.2.2.25 Form PIP |
110030
|
SwissMedic | — |
Showing 101–125 of 380 terms . Data sourced from public health authority publications and updated periodically.