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Being a Member State of the European Union (EU), the Republic of Cyprus through the Department of Pharmaceutical Services has mandated the submission of the medicinal products for human use through the Common European Submission Platform (CESP).
The CESP is an initiative available for all the EU Member States, authorization applicants and holders, and for both human and veterinary medicinal products. It is aimed at establishing a single portal for electronic submissions to multiple competent authorities in the context of European registration and post-approval procedures covering, National, Mutual Recognition Procedure (MRP), and Decentralized Procedure (DCP). The implementation of the mandatory submissions through CESP has already begun since Jan 1st, 2020, for the following activities and applications:
- New Marketing Authorization Application (DCP/MRP/National)
- Variation Type IA/IB/II (MRP/National)
- Line Extension of MA (DCP/MRP/National)
- Renewal (MPR/National)
- Notifications (National notification/Art.61(3))
- Active Substance Master File (ASMF) (Initial submission or variation of ASMF)
- Responses etc.
However, there is no mandate on the medicinal products authorized via the centralized procedure, for marketing authorizations under exception circumstances or parallel importations. Also, purely national submissions of MRP/DCP for Regulatory activities like Marketing Authorization Holder (MAH) Transfer, change of a local representative, and change of mock-up designs are handled outside the eCTD and submissions must be provided electronically, via CESP.
Key Considerations:
- Now that the electronic submissions through CESP are under implementation, it might reduce the burden for both industry and the regulators for submitting/handling applications on CD-ROM and DVD
- Submissions through CESP provides a simple and secure mechanism for exchange of submission information between applicants and agencies
- During the CESP submissions, Marketing Authorization Holders (MAHs) must complete all the information required for the effective evaluation of the submitted data
- MAH’s should also document all the required information to link the appropriate medicinal product with the Department of Pharmaceutical Services database and correlate the submitted data with the appropriate Regulatory activity
- In an effort for a future of only electronic workflow, the Department of Pharmaceutical Services adapted digital signatures and is now accepting scanned signatures within Electronic Application Forms (eAFs)
To conclude, preparing the electronic submissions through MRP/DCP procedures is a difficult task, hence organizations should be keen on streamlining their Regulatory submissions management process, right from dossier development, submission planning, tracking, publishing until final submissions. Also, due to the continuous change of the Regulatory environment, adaptation to new and more challenging requirements should be taken into consideration to be compliant all through. Stay informed. Stay compliant.
