NEW RULES ON PHARMACOVIGILANCE.

PositionLegislation - Brief article

New Community legislation devoted to reinforcing the pharmacovigilance for medicinal products for human use will enter into force on 20 January, after publication in the Official Journal of the European Union, on 31 December 2010. Regulation 1235 and Directive 2010/84/EC will reinforce monitoring of the risk of undesirable effects resulting from the use of authorised medicinal products. Their main contributions are as follows: 1. possibility for the patient to directly report secondary effects to the national competent...

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