Europe – EMA : policy on access to EudraVigilance data for medicinal products for human use

Update of data protection legislation references.

Revision 4: update of references in accordance with Regulation (EU) 2016/679, the
General Data Protection Regulation (GDPR) and Regulation (EU) 2018/1725, the EU Data
Protection legislation (EU DPR).
Revision 3 referred to a minor technical update of Annex B based on experience gained:
Level 1 – public access via the adrreports.eu portal – data elements C.1.8.1 and C.3.2…