Module 18 - Drug Device Combinations and Other Technologies

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EU GOOD MANUFACTURING PRACTICE

 Key requirement for grant of Manufacturing Authorisation  EU Directives 2017/1572 (human) and 91/412 (vet) marketed medicines  EU Regulation 2017/1569 for IMPs  EudraLex Volume 4 • Part 1 and Annexes – Medicinal Product • Annex 1 (Steriles), Annex 2 (Biologics), etc. • Part 2 –API (ICHQ7) • Part 3 – Supporting documents • Part 4 –ATMP

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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EU CONTROL OF DRUG PRODUCT DISTRIBUTION SITES Distributors must hold a Wholesale Distribution Authorisation ( WDA ) • Site Authorisation • Certificates issued after GDP inspections • Site listed on EudraGMDP database • Requires a ‘ Responsible Person ’ = RP

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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