|Download document||Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency|
|Status||draft: consultation open|
|Consultation start date||05/06/2014|
|Consultation end date||27/07/2014|
|Email address for email@example.com|
Scientific and medical literature is an important source of information on suspected adverse-reaction case reports (also referred to as individual case safety reports). This detailed guide describes the technical aspects of the literature-monitoring services to be provided by the Agency in line with the requirements set out in Article 27 of Regulation (EC) 726/2004 and good-pharmacovigilance-practice guideline, module VI, 'management and reporting of adverse reactions to medicinal products'.