Module 6

03/10/2024

Agenda

• Control Framework – EU, UK, International

• UK Control (as example)

• Code of Practice

• Complaints procedure

• MHRA vetting of materials

The Organisation for Professionals in Regulatory Affairs

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3

Control Framework – EU and UK

EU Dir 2001/83/EC, Title VIII UK HMR 2012 Other general

Legislation

Competent authority guidelines e.g. ANSM

UK MHRA Blue Guide

Guidelines

Codes of Practice

PMCPA PAGB

EFPIA

EU National

The Organisation for Professionals in Regulatory Affairs

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4

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