Demand for pharmaceutical translations is steadily increasing due to the free movement of medicinal products in the European Union as a result of the expanded import market.
The Marketing Authorization (MA) of the medicinal product is granted in Italy by AIFA (Agenzia Italiana del Farmaco, Italian Medicines Agency) or by the European Commission, which evaluate its quality, safety and efficacy. The introduction in Italy of medicines produced and distributed in other European countries follows an authorization procedure called Parallel Import (AIP).
Pharmaceutical translations: for what documents are they needed?
The pharmaceutical translation is a delicate phase that is part of the research, production and distribution process of a new drug. The figure of the medical-scientific translator is indispensable in the stages of clinical research preceding the production and drafting of regulatory documents and certificates.
The documents needed to apply for an AIP are the drug labels, the Summary of Product Characteristics (SmPC), and the Package Leaflet (PL).
The Summary of Product Characteristics is the drug’s identity card, which contains information about its clinical use, contraindications, warnings and precautions for use. It is intended for physicians, pharmacists, nurses and healthcare professionals, and contains specific terminology regarding the composition of the medicinal product, the diseases for which it is indicated, its action mechanisms, and so on. The translation must be done by a specialized translator.
The Package Insert is intended for the patient and describes the correct and safe use of the medicinal product; therefore, the translation must be in a language that can be understood by all and must be carefully reviewed to avoid errors and inaccuracies.
Of no less importance are the translations of scientific articles for journals and publications in the sector.
Certified translations for the pharmaceutical industry
In order to submit the application for authorization to import the drug, the translation of the SmPC and PL must be certified, i.e., accompanied by a “Certification of Translation Accuracy” issued by a translation agency that takes responsibility for it. The Certificate of Translation Accuracy is a statement attesting to the fidelity of the translated content to the original documents.
The specialized translator guarantees maximum attention and conformity of content, is familiar with medical terminology and is constantly updated on the regulations governing the international drug system..
Translation for the pharmaceutical industry is a complex area that should only be entrusted to translation companies that employ experienced linguists and put in place stringent quality controls.