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HORN Pharmaceutical Consulting
CMC – GMP – Regulatory Affairs
Dr. Hiltrud Horn
Am Alten Schloß 1
D-76646 Bruchsal
Germany

Phone: +49 (0) 7251/305 527
Fax: +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
e-mail: info@horn-pharma.de
Internet: www.horn-pharma.de

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19.12.2022
EU Update regarding Deadlines of Nitrosamine Impurities
More
01.09.2022
EU-GMP Annex 1 finally published
More
26.08.2022
New Deadlines and Chances for Nitrosamines
More

EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?

EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.