Marketing Authorization Department

What is Marketing Authorization ?

The Process of receiving , reviewing and assessing the dossier to support licensing, registration or approval of biological product in the market is called marketing authorization (MA) .

The MA department at NORCB works effectively in cooperation with NORCB laboratories to assure the compliance of product to the required WHO standards & international guidelines, and to achieve the regulatory balance  between transparency , accountability & risk management , flexibility & empowerment through applying different mechanisms of Good Review Practice (GRP) to ensure quality of operating procedures & satisfy all partners & stakeholders.  

The Marketing authorization department is subjected to quality management system that has been accredited by ISO 9001/2015 from TUV (the certified body) , and this allows the implementation of all standards including risk benefit analysis , control of documents , issuing department policy & different procedures.

  1. Receiving , reviewing and assessing the dossier to ensure quality, safety& efficacy of the submitted products to support its launching in the local market
  2. Preparing and updating of regulations on registration of biological products.
  3. Issuing certificate of analysis &Technical assessment report for newly registered products is performed according to the timeframes stated in ministerial decree 297/2009 &ministerial decree 820/2016
  4. Communicating and coordinating with Biological products companies regards missing requirements in registry file and procedures of biological products registration.
  5. Build an affective relationship with the international authorities and scientific societies.
  6. Supervising the archiving of biological products files.
  1. Vaccines which are biological preparations that improve immunity to a particular disease and they include viral vaccines, Bacterial vaccines and combined vaccines
  2. Plasma derivative products & Extracted products which are products manufactured from human plasma by chromatographic and other fractionation techniques
  3. Recombinant products are proteins that are produced using recombinant DNA (rDNA) technology

  1. Normal track according to minstrel decree no 279/2009
  2. Fast track according to technical committee 2013
  3. Registration track according t o minstrel decree no 820/2016

 

  1. CAPA letter
  2. Payment fees
  3. Authorization of the representative
  4. Valid GMP certificate
  5. Product labeling that approved from CAPA
  6. Package leaflet that approved from CAPA
  7. Batch Release certificate from NRA of country of origin for the batch submitted to NORCB for analysis ( and for Vaccines and blood products only)
  8. Summary of product characteristics (SmPC)
  9. Summary protocol for the batch submitted to NORCB for analysis & at least 3 batch analysis required for evaluation of CTD file( in case of vaccines, plasma derivative products) 
  10. Valid certificate of pharmaceutical products (CPP certificate)
  11. In case that human albumin is used as a stabilizer, the company is committed to provide the following additional documents:
  12. Human albumin batch release certificate from NRA of country of origin.
  13. The document that proves the use of the same human albumin batch for which a release certificate is submitted in the manufacture of the final product of the batch in release request.
  14. Plasma master file (PMF) containing plasma pools certificates for human albumin which un registered in EGYPT
  15. Complete CTD file including quality , pre-clinical & clinical modules
  16. Updated PSUR (to be submitted to PMS department for archiving)
  17. The required number of samples sufficient for analysis according to certificate of analysis of the finished product and the requirements of the tests (references, reagents…….)         

 

 

Our Creative Team

Dr. Heba Khalil

Department Manager

Ph. Sara Magdy

Department deputy

Ph. Shimaa Seddik

Department quality manager

Ph. Amal Mohamed

Viral vaccine teamleader

Ph. Basma Abd El Latif

Recombinant team leader

Ph. Dina A Elnaiem

Bacterial & combined vaccine team leader, Safety monitor evaluator

Ph. Dina M Mahdy

Blood &Extract product team leader

Ph. Doaa A Wahed

Staff member

Ph. Alaa Osama

Staff member

Ph. Hoda Elsaeed

Staff member

Ph. Marina Emad

Staff member

Ph. Doha Hazem

Staff member

Ph. Amira Elsayed

Staff member

Ph. Dalia Galal

Staff member

Ph. Nada Hamdy

Staff member

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