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MHRA GMP Data Integrity Definitions and Guidance for ...
assets.publishing.service.gov.ukMHRA GMP Data Integrity Definitions and Guidance for Industry March 2015 . Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This document provides MHRA guidance on GMP data integrity expectations for the pharmaceutical industry.
MHRA Guidance Note 8 - GOV.UK
assets.publishing.service.gov.ukThis Guidance explains how, and on what basis, the MHRA decides whether products are medicines or not and clarifies the MHRA’s position on traditional herbal medicinal products. 2. MHRA policy and practice European Community legislation on medicinal products is not fully harmonised and products are classified under national regulations.