eCTD Filing Types for GCC
Calyx RIM provides the following filing types for all application types associated with Gulf Cooperation Council (GCC). This table lists the eCTD code and the applicable DTD or Schema for each Filing Type.
| Filing Type (Display) | Applicable DTD/Schema | eCTD Code | Available for Application Types |
|---|---|---|---|
| GCC Responses | gc-1-2 | responses | MAA |
| GCC Variation Type 1 | gc-1-2 | var-type1 | MAA |
| GCC Variation Type 2 | gc-1-2 | var-type2 | MAA |
| MAA - Biological | gc-1-2 | new-bio | MAA |
| MAA - Generic (Multisource) | gc-1-2 | new-gen | MAA |
| MAA - Health | gc-1-2 | new-hea | MAA |
| MAA - Herbal | gc-1-2 | new-her | MAA |
| MAA - New Chemical Entity | gc-1-2 | new-nce | MAA |
| MAA - Radiopharmaceuticals | gc-1-2 | new-rad | MAA |
| MAA - Veterinary | gc-1-2 | new-vet | MAA |
| Periodic Safety Update Report | gc-1-2 | psur | MAA |
| Renewal Filing | gc-1-2 | renewal | MAA |
| Transfer MA Filing | gc-1-2 | transfer-ma | MAA |
| Withdrawal Filing | gc-1-2 | withdrawal | MAA |
| ASMF Filing | gc-1-5 | asmf | MAA |
| Extension Filing | gc-1-5 | extension | MAA |
| GCC Variation Type 1 | gc-1-5 | var-type1 | MAA |
| GCC Variation Type 2 | gc-1-5 | var-type2 | MAA |
| MAA - Biological | gc-1-5 | new-bio | MAA |
| MAA - Generic (Multisource) | gc-1-5 | new-gen | MAA |
| MAA - New Chemical Entity | gc-1-5 | new-nce | MAA |
| MAA - Radiopharmaceuticals | gc-1-5 | new-rad | MAA |
| None | gc-1-5 | none | MAA |
| Periodic Safety Update Report | gc-1-5 | psur | MAA |
| Plasma Master File | gc-1-5 | pmf | MAA |
| PSUR single assessment procedure | gc-1-5 | psusa | MAA |
| Renewal Filing | gc-1-5 | renewal | MAA |
| Risk Management Plan Filing | gc-1-5 | rmp | MAA |
| Transfer MA Filing | gc-1-5 | transfer-ma | MAA |
| USR Filling | gc-1-5 | usr | MAA |
| Withdrawal Filing | gc-1-5 | withdrawal | MAA |