Translation of PI
If the Marketing Authorization Holder (MAH) is interested in launching its medicinal product to the Polish market, high-quality translations of Product information into Polish language must be prepared and submitted to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (in Polish: Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, URPLWMiPB). Their evaluation is carried out by the Wydział Oceny Druków Informacyjnych (WODI), which verifies the correctness of the translations. The Product information of medicinal products includes:
- Summary of Product Characteristics is a document that contains the most important information about a medicinal product, including type and composition of the drug, which conditions it is recommended for, dosage, possible side effects. This document is addressed to professional medical personnel (including doctors, nurses).
- Package Leaflet is a simplified set of information contained in the Characteristics of the medicinal product, addressed to a patient. It includes, among others, a name of the drug and active substances, indications for use, information necessary before using the drug.
- Labelling of Packages of Medicinal Products is an information placed on the immediate packaging in direct contact with the medicinal product (e.g. blisters) or on the outer packaging of the medicinal product (e.g. a box).
How does the translation of the product information look like?
The above-mentioned documents are prepared by translating the Product information prepared by MAH from English into Polish language. In the case of European procedures, i.e. the Decentralized Procedure – DCP, the Mutual Recognition Procedure – MRP, the Repeat Use Procedure – RUP, it will be a translation of the “common” forms – common for all countries participating in a given registration procedure. Submitting translations to URPLWMiPB is obligatory at the final stage of European procedures – during the national stage. Product information in the national registration procedure in Poland must be also submitted to URPLWMiPB in Polish language.
What to pay special attention to?
Translations of the Product Information must be prepared in accordance with the QRD template (Quality Review of Documents) and relevant guidelines. It is important that both: the template used and the content of the proposed forms comply with the current guidelines, which change from time to time. Particular attention should be also paid to professional medical nomenclature. The QRD guidelines can be found here.
Why is it worth to use our experience?
Our experts have many years of experience in Product information translations preparation. Pharmaceutical companies interested in obtaining a marketing authorization for their medicinal product in Poland have used our support many times and often come back to us, which undoubtedly proves the high quality of services provided by SciencePharma. We serve clients from all over the world, helping them to register medicinal products in Poland quickly and efficiently.
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