EUROPEAN COMMISSION SCRAPS PHARMACOVIGILANCE RED TAPE
February 1st, 2016PHARMACOS no longer (from February 1) have to make special filings alerting regulators to changes to contact details of company qualified persons responsible for pharmaco pharmacovigilance and pharmacovigilance system master files. The European Commission said this information is already logged on the so-called European Union ‘Article 57’ database, established under the EU pharmacovigilance regulation No 726/2004.
*http://ec.europa.eu/health/files/pharmacovigilance/2016_01_18__variations_article_57_database.pdf
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