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4 August 2014 EMA/759287/2009 Revision 1Inspections and Human Medicines Pharmacovigilance DivisionRevision of EudraVigilance access policy for medicines for human use DraftAgreement on principles
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Anyone who is involved in pharmacovigilance and reporting adverse drug reactions (ADRs) in the European Union needs the draft revision of Eudravigilance.
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This includes pharmaceutical companies, drug regulatory authorities, healthcare professionals, and marketing authorization holders (MAHs).
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The draft revision of Eudravigilance provides a structured platform for gathering, managing, and analyzing ADR data to ensure the safety of medicines in the EU market.
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It is an essential tool for improving pharmacovigilance practices and maintaining public health by promptly identifying and addressing any potential risks associated with pharmaceutical products.
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The draft revision of eudravigilance is a document that includes proposed changes to the existing pharmacovigilance system.
Marketing authorization holders (MAHs) are required to file the draft revision of eudravigilance.
The draft revision of eudravigilance can be filled out electronically through the eudravigilance system following the guidelines provided by the regulatory authorities.
The purpose of the draft revision of eudravigilance is to ensure the continuous improvement of pharmacovigilance activities and compliance with regulatory requirements.
The draft revision of eudravigilance must include updated information on the safety profile of the medicinal product, changes in risk management plans, and any other relevant pharmacovigilance data.
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