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Context of Use

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.

eCTD 4.0 Context of Use 26 terms
All agencies EMA FDA ICH SwissMedic
Term Code Agency Status
M1.0 Cover Letter and Tracking Table 100000164029 EMA Active
M1.2 Application Form 100000164030 EMA Active
M1.3.1 SmPC, Labeling, Package Leaflet 100000164032 EMA Active
M1.3.2 Mockup 100000164033 EMA Active
M1.3.3 Specimen 100000164034 EMA Active
M1.3.4 Report on Consultation Patient Target Group 100000164035 EMA Active
M1.3.5 Approved Product Information 100000164036 EMA Active
M1.3.6 Braille 100000164037 EMA Active
M1.4.1 Expert on Quality 100000164039 EMA Active
M1.4.2 Expert on Non-Clinical 100000164040 EMA Active
M1.4.3 Expert on Clinical 100000164041 EMA Active
M1.5.1 Bibliographic 100000164043 EMA Active
M1.5.2 Generic, Hybrid or Biosimilar 100000164044 EMA Active
M1.5.3 Data on Market Exclusivity 100000164045 EMA Active
M1.5.4 Exceptional Circumstances 100000164046 EMA Active
M1.5.5 Conditional Approval 100000164047 EMA Active
M1.6.1 Non-Genetically Modified Organisms 100000164049 EMA Active
M1.6.2 Genetically Modified Organisms 100000164050 EMA Active
M1.7.1 Similarity 100000164052 EMA Active
M1.7.2 Market Exclusivity 100000164053 EMA Active
M1.8.1 Pharmacovigilance System 100000164055 EMA Active
M1.8.2 Risk Management System 100000164056 EMA Active
M1.9 Information Relating to Clinical Trials 100000164057 EMA Active
M1.10 Information Relating to Paediatrics 100000164058 EMA Active
M1.R Responses 100000164059 EMA Active
M1.A Additional Data 100000164060 EMA Active

26 terms shown for EMA. Data sourced from public health authority publications and updated periodically.