08.03.2015

EMA issues another update of the Post-Authorisation Procedural Advice

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EMA has released a new update of the "Post-Authorisation Procedural Advice for Users of the Centralised Procedure" (Human Medicines). The new version Rev.47 is dated "February 2015" and contains numerous updates in several chapters. 

The following is a short excerpt only - for details please see the procedural advice documents.

Besides some minor editorial changes and usage of more consistent wording the majority of changes was necessary to implement EMA's new weekly start dates for the assessment of the majority of Type II variation applications in March 2015. (Chapter 3; chapter 3.6). As one of the consequences, timetables were revised.

Additional clarification is provided on which type II variation applications will continued to follow the monthly-start timetables (chapter 3.6).

Another set of changes made in February deal with the Pharmacovigilance System Master Files (PSMFs) in chapter 17. Among these changes a new question 17.7 has been introduced to clarify whether the information on Deputy QPPV are required as part of the PSMFs (short answer is "no - this information is not required as part of the PSMF").

The updated procedural advice is available as clean and track change version from the website of the Agency.

[Source: EMA website]

 

 

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