EudraVigilance sera la seule source d ’ information, mais l ’ autorité compétente de l ’ État membre dans lequel l ’ effet indésirable présumé s ’ est produit, sera informée simultanément, ce qui est très important.
EudraVigilance will be the only source of information, but the competent authority in the Member State where it is suspected that an adverse reaction has occurred will be informed at the same time, which is very important.