PL EN

EMA: Draft Quality Review of Documents human product information annotated template: revision of the product information

19.07.2012
The purpose of this revision of the Quality Review of Documents human product information is to implement the new provisions from the pharmacovigilance legislation. This consultation aims to present the proposals to be included in the summary of product characteristics and package leaflet regarding the location of the black symbol and the location and wording of the explanatory statement for additional monitoring and of the standardised text to encourage the reporting of adverse reactions.

kapitał ludzki

fundusz społeczny

Narodowe Centrum Badań i Rozwoju

innowacyjna gospodarka

rozwój regionalny