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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| EU Context of Use | M1.4.3 Expert on Clinical |
100000164041
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EMA | Active |
| US Context of Use | m1.4.3 list of authorized persons to incorporate by reference |
us_1.4.3
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FDA | — |
| US Context of Use | m1.4.4 cross reference to previously submitted information |
us_1.4.4
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FDA | — |
| Context of Use | M1.5 Data of Bioavailability Studies (Known Active Substance without Innovation) |
110056
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SwissMedic | — |
| EU Context of Use | M1.5.1 Bibliographic |
100000164043
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EMA | Active |
| Context of Use | M1.5.1 Information according to Appendix IV of the Guideline on the Investigation on Bioequivalence |
110057
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SwissMedic | — |
| US Context of Use | m1.5.1 withdrawal of an ind |
us_1.5.1
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FDA | — |
| Context of Use | M1.5.2 Documents on the Reference Product |
110058
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SwissMedic | — |
| EU Context of Use | M1.5.2 Generic, Hybrid or Biosimilar |
100000164044
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EMA | Active |
| US Context of Use | m1.5.2 inactivation request |
us_1.5.2
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FDA | — |
| EU Context of Use | M1.5.3 Data on Market Exclusivity |
100000164045
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EMA | Active |
| US Context of Use | m1.5.3 reactivation request |
us_1.5.3
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FDA | — |
| Context of Use | M1.5.4 Art 14 Sec1 let abis TPA tabular compilation of deviations between product to be authorised in CH and foreign comparator |
110060
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SwissMedic | — |
| EU Context of Use | M1.5.4 Exceptional Circumstances |
100000164046
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EMA | Active |
| US Context of Use | m1.5.4 reinstatement request |
us_1.5.4
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FDA | — |
| EU Context of Use | M1.5.5 Conditional Approval |
100000164047
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EMA | Active |
| US Context of Use | m1.5.5 withdrawal of an unapproved bla nda anda or supplement |
us_1.5.5
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FDA | — |
| US Context of Use | m1.5.6 withdrawal of listed drug |
us_1.5.6
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FDA | — |
| US Context of Use | m1.5.7 withdrawal of approval of an application or revocation of license |
us_1.5.7
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FDA | — |
| Context of Use | M1.6 Environmental Risk Assessment |
110061
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SwissMedic | — |
| US Context of Use | m1.6.1 meeting request |
us_1.6.1
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FDA | — |
| EU Context of Use | M1.6.1 Non-Genetically Modified Organisms |
100000164049
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EMA | Active |
| Context of Use | M1.6.1 Non-GMO |
110062
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SwissMedic | — |
| EU Context of Use | M1.6.2 Genetically Modified Organisms |
100000164050
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EMA | Active |
| Context of Use | M1.6.2 GMO |
110063
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SwissMedic | — |
Showing 176–200 of 380 terms . Data sourced from public health authority publications and updated periodically.