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Position and Processing of Adverse Drug Reactions Directly Submitted by Patients to National Regulatory Authorities in Europe

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Position and Processing of Adverse Drug Reactions Directly Submitted by Patients to National Regulatory Authorities in Europe

Adverse drug reaction (ADR) reports submitted by patients to national regulatory authorities should be directly accepted since July 2012 when new pharmacovigilance legislation was implemented. This questionnairebased analysis and review was conducted to evaluate the position of ADR reports submitted by patients and to compare ADR reporting by patients and healthcare professionals (HPs). National pharmacovigilance systems in Europe were established in the 1960s. Pharmacovigilance activities are maintained by national regulatory authorities responsible for collecting adverse drug reaction (ADR) reports from healthcare professionals (HPs), marketing authorization holders, patients, and other sources.

Citation: Srba J, Vlcek J (2014) Position and Processing of Adverse Drug Reactions Directly Submitted by Patients to National Regulatory Authorities in Europe. J Pharmacovigilance 2:122. doi: 10.4172/2329-6887.1000122

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