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Laboratories Receive Deadline Extensions on Drug Licenses
The National Agency for Medicines and Health Products announced an exceptional extension for the submission deadlines of drug promotion license applications, aiming to transition to the unified electronic format for technical files. The timeline for extensions has been adjusted so that laboratories are allowed to resubmit their files in the new format until December 31, 2026, for applications submitted during 2025, and until March 31, 2027, for applications submitted during 2026. Additionally, the agency has permitted the continued submission of renewal applications in the current submission format until the end of 2026. Starting in 2027, electronic submissions will become mandatory. The agency will also provide guidance and technical assistance to minimize errors in preparing the files.
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