Module 18 - Drug Device Combinations and Other Technologies

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US CONTROLS OF MANUFACTURING AND DISTRIBUTION SITES  Manufacturing sites are required to REGISTER with the FDA • Sites inspected for compliance with cGMP  Wholesale distributors are required to REGISTER with the FDA • There is no GDP guideline in the US

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BREXIT IMPACT

 Product moving from GB to EU impact is: • UK is now a ‘third country’ • Product from GB needs to be re ‐ tested on entering EU • Need an EU QP to certify batches • Need CTA or MA held by legal entity in the EU

REG2000 © 2020 NSF Intl. These materials may not be used, copied, distributed or altered other than as permitted by NSF Intl. All rights reserved.

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