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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