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.
- Receiving , reviewing and assessing the dossier to ensure quality, safety& efficacy of the submitted products to support its launching in the local market
- Preparing and updating of regulations on registration of biological products.
- 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
- Communicating and coordinating with Biological products companies regards missing requirements in registry file and procedures of biological products registration.
- Build an affective relationship with the international authorities and scientific societies.
- Supervising the archiving of biological products files.
- Vaccines which are biological preparations that improve immunity to a particular disease and they include viral vaccines, Bacterial vaccines and combined vaccines
- Plasma derivative products & Extracted products which are products manufactured from human plasma by chromatographic and other fractionation techniques
- Recombinant products are proteins that are produced using recombinant DNA (rDNA) technology
- Normal track according to minstrel decree no 279/2009
- Fast track according to technical committee 2013
- Registration track according t o minstrel decree no 820/2016
- CAPA letter
- Payment fees
- Authorization of the representative
- Valid GMP certificate
- Product labeling that approved from CAPA
- Package leaflet that approved from CAPA
- Batch Release certificate from NRA of country of origin for the batch submitted to NORCB for analysis ( and for Vaccines and blood products only)
- Summary of product characteristics (SmPC)
- 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)
- Valid certificate of pharmaceutical products (CPP certificate)
- In case that human albumin is used as a stabilizer, the company is committed to provide the following additional documents:
- Human albumin batch release certificate from NRA of country of origin.
- 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.
- Plasma master file (PMF) containing plasma pools certificates for human albumin which un registered in EGYPT
- Complete CTD file including quality , pre-clinical & clinical modules
- Updated PSUR (to be submitted to PMS department for archiving)
- 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…….)