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Greek Pharmacovigilance Legislation

National Organization for Medicines Circular 64745/7-7-2014

Circular providing clarifications regarding local requirements for the management and reporting of safety information arising from clinical trials. A short description of the obligations of the investigators and the sponsors is included. Relevant requirements previously mentioned in Circular 10301/11-2-2010 are superseded by the requirements set within this Circular.

[Original text:GR]

For the full translation of the texts in English, please contact us at medworkinfo@medwork.gr



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