Module 18 - Drug Device Combinations and Other Technologies

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MARKETING AUTHORISATIONS  It is illegal to offer a medicinal product for sale until the relevant government grants a Marketing Authorisation • Separate Authorisation needed for each product  Marketing Authorisations are granted on the basis of evidence of: • SAFETY

• EFFICACY • QUALITY

OKSANA KAZYKINA; @123RF.com

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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MARKETING AUTHORISATIONS

 Legal permission to market drug/medicinal products  Contracts with governments  Government authorities have the power to: • Grant

• Refuse • Revoke • Vary

arian_Vejcik @123RF.com

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

NSF Confidential

22