Module 18 - Drug Device Combinations and Other Technologies

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MARKETING AUTHORISATIONS

 Known in the EU as:

MA Marketing Authorisation

 Known in UK as:

PL Product Licence

 Known in the USA as:

NDA New Drug Application ANDA Abbreviated New Drug Application NADA New Animal Drug Application BLA Biologics Licence Application

 Specific format defined by ICH M4 and M8

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 – CTD FORMAT

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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