Module 18 - Drug Device Combinations and Other Technologies

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DRUG/MEDICINAL PRODUCT CONTROLS

As well as control of the product itself there are also controls on:

 The product manufacturing sites

 The warehousing and distribution of product

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EU CONTROL OF THE DOSAGE FORM MANUFACTURING SITE

 Manufacturers must hold a Manufacturing/Import Authorisation (MIA)

 Manufacturers must demonstrate proper conditions including adherence to GMP to obtain and keep their MIA

 Must name a Qualified Person

on the MIA

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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