MEDICINES : MEPS WELCOME UPDATES ON PHARMACOVIGILANCE.
Considered satisfactory by rapporteur Linda McAvan (S&D, UK), the European Commission's two proposals(1) concerning amendments to the Pharmacovigilance Regulation and the Pharmacovigilance Directive do not, for the time being, give rise to numerous proposals for amendments. The adoption, in plenary, of the two draft reports drawn up by McAven, which were the subject of an exchange of views in the European Parliament's Committee on Environment and Public Health (ENVI), on 25 January, is scheduled for 15-16 March or 6-7 April.
In proposing to update rules for these two legislative instruments, the Commission is coming up against identical problems, its objective being to modernise the entire pharmacovigilance system.
While MacAven warmly welcomes the creation of a European Pharmacovigilance Commitee within the EMEA...
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