(19) Directive 2001/83/EC and Regulation (EU) No.726/2004 on the community code relating to medicinal products for human use and establishing a European Medicines Agency, provide regulatory authorities with the mandate to promote and protect public health by authorising the use of safe and effective vaccines, and by continuously assessing their benefit and risk profile following the granting of marketing authorisation.
(19) Direktivom 2001/83/EZ i Uredbom (EU) br. 726/2004 o zakoniku Zajednice o lijekovima za humanu primjenu i uspostavi Europske agencije za lijekove, regulatornim tijelima daje se mandat za promicanje i zaštitu javnog zdravlja odobravanjem upotrebe sigurnih i djelotvornih cjepiva te trajnom procjenom njihovih prednosti i profila rizika nakon izdavanja odobrenja za stavljanje na tržište.