Version 2 of Recommended Translations of Clinical, Non-Clinical, Pharmacovigilance and Quality Scientific Terms Available on HALMED's Website
16.08.2016
The Version 2 of Recommended Translations of Clinical, Non-Clinical, Pharmacovigilance and Quality Scientific Terms, the use of which is recommended in the preparation of the Summary of Product Characteristics (SmPC) and Package Leaflet (PL), has been published on the website of the Agency for Medicinal Products and Medical Devices of Croatia (HALMED), in the segment Medicinal Products/Instructions for Applicants.
Recommended translations of clinical, non-clinical, pharmacovigilance and quality scientific terms do not include terms encompassed in the English-Croatian Dictionary of Scientific Terminology used in translations for Croatian Pharmacopoeia, as well as standard terms published on the website of the Council of Europe's European Directorate for the Quality of Medicines and HealthCare (EDQM), which should additionally be adhered to when preparing SmPCs and PLs as well as labelling.
