01.07.2015

Mandatory usage of Central Repository; updated EMA Dossier Requirements

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Starting from July 01, 2015 the use of the Common Repository is mandatory for all Human Medicinal Product submissions in the Centralized Procedure. All National Competent Authorites will use the Common Repository as their only source for the afore-mentioned submissions. 

Applicants and Sponsors should no longer send CDs/DVDs or upload submissions via CESP to individual Member States for Human Centralized Procedure submissions. Such submissions provided to EMA via the eSubmission Gateway or WebClient are considered delivered to all National Competent Authorities representatives and alternates.

The EMA dossier requirements were updated accordingly and can now be downloaded from the EMA website in revision 20, dated 1 July 2015.

Additional info for applicants:

  • For submissions sent to PRAC and involving PRAC independent scientific experts, an additional separate submission requirement exist for the current scientific expert in France. 
  • For submissions concerning advanced therapy products which involve the CAT (Committee for Advanced Therapies), additional separate submission requirements exist for the CAT representatives of healthcare professionals and patient organisations, respectively.

[Source: EMA / CMB website]

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