Module 18 - Drug Device Combinations and Other Technologies

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UK Medicines Legislation

European Union (Withdrawal) Act 2018 Medicines and Medical Devices Act 2021

UK Regulations ‐ Statutory Instruments

EU Guidance • GMP • GCP • GDP

• Pharmacovigilance

Product Licence

Manufacturing Licence

• SAFETY • QUALITY • EFFICACY

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USA Drug Regulation

Food and Drug Administration (1931) Federal Food Drug and Cosmetics Act –FD and C (1938) Code of Federal Regulations –CFR (Pub. Annually)

Title 21 Food and Drugs

• Food Stuffs • Cosmetics

• Drugs • Devices

Drug Applications

GMP Regulations

• Adulteration • Misbranding

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

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