Recommended Translations of Scientific Terms
The Agency for Medicinal Products and Medical Devices (HALMED) publishes instructions for marketing authorisation holders related to translations of scientific terms recommended for use when preparing the Summary of Product Characteristics (SmPC) and Package Leaflet (PL).
Table with recommended translations of scientific terms accessible here.
The table will be regularly updated and below you will find a few general notices that a marketing authorisation holder should take into account when preparing the Summary of Product Characteristics, Package Leaflet, Patient's Card and Labelling.
Summary of Product Characteristics
The text of the Summary of Product Characteristics is intended for healthcare professionals - doctors, pharmacists etc. and it is written in a scientific language. Therefore, the most precise and clearest translations from the original language providing to specialists an appropriate, scientific and unbiased information, should be used in the Croatian translation. Whenever possible, terms according to the tenth revision of the International Classification of Diseases (ICD-10).
The text of the package leaflet is intended for patients and it is written in Layman's language, which is widely understandable ("patient friendly"). Therefore, it is recommended that appropriate translations that through their simplicity provide understanding of the necessary information be used in Croatian translations. In this way, potential misunderstandings of important data written in the texts of the Summary of Product Characteristics in scientific terminology (i.e. indications, contraindications, special precautions for use, adverse reactions etc.) are avoided.
The text of the Patient's card is intended for patients and it is written in a patient understandable way and it is recommended that the most understandable terms for the wider population be used in Croatian translations.
Labelling of the medicinal product
The text of the outer and inner labelling of the medicinal product contains pharmaceutical terms from the current Croatian Pharmacopoeia.