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What is Reference List for Drug Submissions about?

This document provides a list of regulatory authorities and their online drug databases to use as references when submitting new product requests according to Ministerial Decree 425/2015. It includes authorities such as EMEA, FDA, TGA, MHRA, PMDA, and others. Any submitted request must match an active reference from this list in terms of ingredient, strength, dosage form and administration route. The reference product must also be currently registered and marketed. Modifications to this list of references w

Author

عبدالعزيز بدر

Language

EN