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Compliance ★ India, 2012-10-12 10:18 (5009 d 11:09 ago) Posting: # 9400 Views: 2,538 |
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Dear All, Is it necessary to report SAE to the regulatory body (EU) in line with local regulatory body? If yes then can you please suggest me the correct from of reporting to them? Regards, Compliance |
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drgunasakaran1 ★★  2012-10-13 23:23 (5007 d 22:03 ago) @ Compliance Posting: # 9412 Views: 1,966 |
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Dear Mr Compliance, You should report suspected side effects and SAE to either the national medicines regulatory authority in the European Union or the pharmaceutical company that holds the marketing authorisation for the medicine. These reports are then transmitted electronically to EudraVigilance. How to report AE/SAE to Eudravigilance, see here The Agency, on behalf of European Member States, is responsible for the development, maintenance and coordination of EudraVigilance. Pharmaceutical companies that hold the marketing authorisation for a medicine in the European Economic Area (EEA) are also legally required to submit to EudraVigilance all reports of suspected unexpected adverse reactions that are serious and that occurred in a third country (non-EEA) where they hold a marketing authorisation. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
Ing. Helmut Schütz