05.05.2015

EMA releases further updates to Procedural Advices for Users of the Centralized Procedure

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The European Medicines Agency has recently been very busy in producing updates to their "procedural advice for users of the centralised procedure". In April two updates, revision 49 and revision 50 (which followed 3 days later), of the post-authorisation procedural advice were published followed by a new release, dated "April 2015" of the pre-authorisation procedural advice (for reasons unknown, the latter one does traditionally not have any revision numbers but only a version date). The updates concern the following new / updated information:

Post-authorisation procedural advice

  • Revision 49: Two new chapters 22.8 and 22.9 have been introduced at the end of the guidance that deal with the question who the relevant contact at the Agency is for applicants during different phases of an evaluation procedure.

    Acc. to this a corresponding "Procedure Manager (PM)" will be allocated for each post-authorisation procedure upon receipt of the procedure. This PM will validate the application (if applicable), oversees all aspects of the management of the specific procedure and will serve as the primary contact for applicants during the corresponding procedure until Commission Decision (if applicable). Contact details of the PM will be forwarded to the applicant as part of the validation process or by notification of the start of the procedure.

    In case of questions that arise outside any evaluation procedure the EMA product lead (EPL) serves as the primary contact for the applicant. The EPL may also be involved in direct communication to the applicant during particular complex procedures.

    In case applicants need procedural advice or have questions prior to a submission these should be addressed to the Pre-submission Queries Service (PQS).
  • Revision 50: The chapter dealing with "Post-Authorisation Measures (PAMs)", chapter 12 has underwent some major revisions. Some sections have been completely re-written.

Further details can be obtained from the recent version of the post-authorisation procedural advice that is available as clean and track-change document. Only the latest revision (currently revision 50) is officially available for download from the EMA any longer which means that the revisions made in rev 49 are no longer available as a track change version. Readers of our blog can request a copy of it by email (see contact info in the footer).

Pre-authorisation procedural advice:

  • New chapters 8 and 9 have been introduced in the "April 2015" version (with the consequence that all following chapters were re-numbered). Chapter 8 explains in detail the role of the EMA product team during the evaluation of Marketing Authorization Applications (MAAs) in the Centralized Procedure. Chapter 9 details with the contact persons at EMA during a MAA procedure. Similar to Post-authorization procedures (see above) the Procedure Manager (PM) will serve as the primary contact to the applicant.

Further details can be obtained from the "April 2015" version of the procedural advice which is available as clean and track change document.

[Source: EMA]

 

 

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