Module 18 - Drug Device Combinations and Other Technologies

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BREXIT IMPACT

 Product moving from EU to GB impact is: • No need to re ‐ test imports from the EU, EEA or MRA countries • No need for UK QP to certify product from EU or EEA • Need an RPi to verify it has been QP certified in EEA • Centrally Authorised Products have been given GB PL • Centralised MAs still valid in NI until 2025

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SUMMARY – IN THE EU & UK

Investigational medicinal products need a Clinical Trial Authorisation

Medicinal products must have a Marketing Authorisation to be commercialised

The site where product is made or imported must have a Manufacturing/Import Authorisation

Distribution sites must have a Wholesale Distribution Authorisation

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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