10 Small Submissions
No more than 10 Documents per submission
Jordan Food and Drug Administration (Jordan eCTD)
Country: Jordan
Health Authority: Jordan Food & Drug Administration
eCTD, Accepted Since: March 1, 2019
eCTD Version: Module 1 Specification v1.1, M2-M5 – v3.2.2 and M1-M5 – v4.0
Types of Applications
- Asmf - Active Substance Master File
- Cep - Certification of suitability of Monographs of the European Pharmacopoeia
- Extension - Extension Submission
- Ord - MAA - Originator Drug
- Orv - MAA - Originator Vitamin Drug
- Orn - MAA - Originator Narcotics
- Bgd - MAA - Generic Drug
- Bgv - MAA - Generic Vitamin Drug
- Bgn - MAA - Generic Narcotics
- Mnd - MAA - New Drug
- Nvd - MAA - New Vitamin Drug
- Nnd - MAA - New Narcotics
- Rrp - MAA - Radiopharmaceutical Ready-for-use Radioactive Product
- Rnr - MAA - Radiopharmaceutical Non-Radioactive Components (kits)
- Hrd - MAA - Herbal Drug
- Bld - MAA - Biological Drug
- Blv - MAA - Biological Vaccine
- Blb - MAA- Biological Blood Product
- Bla - MAA - Biological Allergen
- Bls - MAA - Biological Bio-similar
- Vam - MAA - Value added medicine
- Vtr - MAA - Veterinary Drug*
- None - In the exceptional case of reformatting the application no regulatory activity is allowed. Therefore, ‘none’ must be stated. The submission unit will identify the sub-activity related to the product.
- Pmf - Plasma Master File
- Pbrer - Periodic Benefit-Risk Evaluation Report
- Psur - Periodic Safety Update Report
- Psusa - PSUR single assessment procedure
- Renewal - Renewal of Marketing Authorization (every 5 years)
- Rmp - Risk Management Plan
- Transfer-ma - Transfer of Marketing Authorization
- Usr - Urgent Safety Restriction
- Var-tca - Technical Committee Approval
- Var-ra - Registration Department Approval
- Var-n1 - Notification without pricing
- Var-n2 - Notification with pricing
- Withdrawal - Withdrawal of a marketing authorization in regard to a strength or dosage form or entirely. This submission type shall not be used to withdraw a regulatory activity
Process to be followed to make a Jordan eCTD submission
- Learn about the Jordan M1 Specification for eCTD requirements
- Review the eCTD submission guidance
- Submit administrative forms and compliant PDFs
- Request for the application number for Jordan eCTD submission
- Submit the eCTD submission via electronic media
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