Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 39

The EU regulations are far more complex in terms of sponsor and applicant reporting. Some go to the health authority at the national or provincial level and some go to a non-health-authority-designated agency. All cases should go to EudraVigilance. Reporting depends on whether the case comes from an EU member state or from outside the European Union. See the extensive descriptions in Good Pharmacovigilance Practice (GVP) module VI (Collection, management and submission of reports of suspected adverse reactions to medicinal products) at the EMA website (www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp).

The GVP modules are updated from time to time; local updates from member states should also be tracked in case of changes in the requirements.