약학회지

ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)

Table. 1.

Table. 1. Common Technical Documents Module 1 (Labeling) Submission dossier among South Korea, United States and European Union
South Korea United States European Union
Module Number Submission dossier Module Number Submission dossier Module Number Submission dossier
1.10 Package Leaflet (Draft) 1.14 Labeling 1.3 Product information
1.14.1 Draft Labeling 1.3.1 SmPC, labelling and package leaflet
1.14.1.1 Draft carton and container labels 1.3.2 Mock-up
1.14.1.2 Annotated draft labeling text 1.3.3 Specimen
1.14.1.3 Draft labeling text 1.3.4 Consultation with target patient groups
1.14.1.4 Label comprehension studies 1.3.5 Product information already approved in the Member States
1.14.1.5 Labeling history 1.3.6 Braille
1.14.2 Final labeling
1.14.2.1 Final carton or container labels
1.14.2.2 Final package insert (package inserts, patient information, medication guides)
1.14.2.3 Final labeling text
1.14.3 Listed drug labeling
1.14.3.1 Annotated comparison with listed drug
1.14.3.2 Approved labeling text for listed drug
1.14.3.3 Labeling text for reference listed drug
1.14.4 Investigational drug labeling
1.14.4.1 Investigational brochure
1.14.4.2 Investigational drug labeling
1.14.5 Foreign labeling
1.14.6 Product labeling for 2253 submissions
Yakhak Hoeji 2023;67:404-14 https://doi.org/10.17480/psk.2023.67.6.404
© 2023 Yakhak Hoeji