The European Medicines Agency has finalised the revision of its guideline on the processing of renewals in the centralised procedure. This guideline has been revised in order to reflect the provisions of the new pharmacovigilance legislation, which begins to apply today.


The Agency has finalised this guidance document after considering the comments received during the public consultation period in March and April 2012.


The final version was adopted by the Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2012.


This guideline applies to all renewal applications submitted as of today, 2 July 2012.


Posted on the EMA website on 2 July 2012