Guideline for the translations of the Product Information

Our Institute has published a new guideline to improve the quality of translations of the Product Information. Applicants are requested to use this guideline in order to keep the 30 days deadline during national phase.

Recommendations for the translations of the Product Information submitted to the National Institute for Quality- and Organizational Development in Healthcare and Medicines Directorate General of National Institute of Pharmacy (Summary of Product Characteristics, Package Leaflet, Labelling) - version 3.

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