30. člen

(1)Za obveščanje o resnih neželenih učinkih zdravil v kliničnem preskušanju zdravila (SARs) je odgovoren sponzor. Sponzor o tem obvešča organ, pristojen za zdravila.

(2)Obveščanje mora potekati v skladu s tem pravilnikom in priporočili Evropske komisije, v njihovem vsakokrat veljavnem besedilu:

-     'Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use', European Commission, Enterprise Directorate – General – Pharmaceuticals;

-     'Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions', European Commission, Enterprise Directorate – General – Pharmaceuticals (spletna stran Evropske komisije: http://dg3.eudra.org ali spletna stran EMEA-e: http://www.emea.eu.int).