10 Small Submissions
No more than 10 Documents per submission
GCC eCTD (Gulf Cooperation Council)
Country: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates
Health Authority: Gulf Central Committee/Saudi SFDA
eCTD, Accepted Since: December 2011
eCTD Version: Module 1 Specification v1.5, M2-M5 – v3.2.2
Types of Applications
- asmf: Active Substance Master File
- extension: Extension Submission
- new-bio: AA - Biological
- new-gen: MAA - Generic (Multisource)
- new-nce: MAA - New chemical Entity
- new-rad: MAA - Radiopharmaceuticals
- none: In the exceptional case 'None' must be stated. The submission unit will identify the sub-activity related to the product.
- pmf: Plasma Master File
- psur: Periodic Safety Update Report
- psusa: PSUR Single Assessment Procedure
- renewal: Renewal of Marketing Authorization
- rmp: Risk Management Plan
- transfer-ma: Transfer of Marketing Authorization
- usr: Urgent Safety Restriction
- var-type1: Variation Type 1
- var-type2: Variation Type 2
- withdrawal: Withdrawal
Process to be followed in making a GCC eCTD submission
- Learn about the eCTD submission/Nees submissions requirements
- Review the eCTD submission/Nees submissions guidance
- Submit administrative forms and compliant PDFs
- Request for the application number
- Submit the eCTD submission via electronic media
How can Freyr help?
- Guarantee your ROI with an eCTD software that optimizes cost-per-submission
- Integration with inbuilt eCTD validator and PDF manager, submissions tracker and HA query management tool
- eCTD software solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment.
For more information on the same, consult us
Other Countries
USA, EU, Health Canada, Switzerland, South Africa, Australia, EAEU, Jordan, Thailand, ASEAN, NMPA
