Module 18 - Drug Device Combinations and Other Technologies

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EU MARKETING AUTHORISATIONS

Who reviews applications, grants authorisations and inspects facilities?

EU:

European Medicines Agency (EMA) or National Competent Authorities Medicines & Healthcare products Regulatory Agency (MHRA)

UK:

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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US MARKETING AUTHORISATIONS

Who reviews applications and grants authorisations?

Food and Drug Administration (FDA)

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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