ANMDMR/NAMMDR is Romania's national competent authority for medicines. EU GVP and EudraVigilance provide the common framework, while the national authority remains the source for Romanian implementation, safety communications and local regulatory contacts.
Core official resources
- ANMDMR — national medicines authority.
- EMA GVP.
- EudraVigilance.
Practical use
Use the Romanian authority for current national reporting contacts, safety communications and locally implemented post-authorisation requirements rather than relying on translated historical procedures.