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.
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HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
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Term
Term Description as defined by the Health Authority
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Code
Code, if any, associated with the term by the Health Authority
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Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
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Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
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| US Context of Use | m1.3.1.4 transfer of obligation |
us_1.3.1.4
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FDA | — |
| US Context of Use | m1.3.1.5 change in ownership of an application or reissuance of license |
us_1.3.1.5
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FDA | — |
| US Context of Use | m1.3.2 field copy certification |
us_1.3.2
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FDA | — |
| EU Context of Use | M1.3.2 Mockup |
100000164033
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EMA | Active |
| Context of Use | M1.3.2 Patient Information |
110049
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SwissMedic | — |
| US Context of Use | m1.3.3 debarment certification |
us_1.3.3
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FDA | — |
| Context of Use | M1.3.3 Packaging Information |
110050
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SwissMedic | — |
| EU Context of Use | M1.3.3 Specimen |
100000164034
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EMA | Active |
| US Context of Use | m1.3.4 financial certification and disclosure |
us_1.3.4
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FDA | — |
| Context of Use | M1.3.4 Information for Professionals from Other Countries |
110051
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SwissMedic | — |
| EU Context of Use | M1.3.4 Report on Consultation Patient Target Group |
100000164035
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EMA | Active |
| EU Context of Use | M1.3.5 Approved Product Information |
100000164036
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EMA | Active |
| US Context of Use | m1.3.5.1 patent information |
us_1.3.5.1
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FDA | — |
| US Context of Use | m1.3.5.2 patent certification |
us_1.3.5.2
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FDA | — |
| US Context of Use | m1.3.5.3 exclusivity claim |
us_1.3.5.3
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FDA | — |
| EU Context of Use | M1.3.6 Braille |
100000164037
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EMA | Active |
| US Context of Use | m1.3.6 tropical disease priority review voucher |
us_1.3.6
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FDA | — |
| Context of Use | M1.4 Information About the Expert |
110052
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SwissMedic | — |
| EU Context of Use | M1.4.1 Expert on Quality |
100000164039
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EMA | Active |
| US Context of Use | m1.4.1 letter of authorization |
us_1.4.1
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FDA | — |
| Context of Use | M1.4.1 Quality |
110053
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SwissMedic | — |
| EU Context of Use | M1.4.2 Expert on Non-Clinical |
100000164040
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EMA | Active |
| Context of Use | M1.4.2 Nonclinical |
110054
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SwissMedic | — |
| US Context of Use | m1.4.2 statement of right of reference |
us_1.4.2
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FDA | — |
| Context of Use | M1.4.3 Clinical |
110055
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SwissMedic | — |
Showing 151–175 of 380 terms . Data sourced from public health authority publications and updated periodically.