A Practical Guide to European Pharmaceutical Regulations for Human Medicines

Medical Law

A Practical Guide to European Pharmaceutical Regulations for Human Medicines

By Cliodhna McDonough
Law Brief Publishing September 2019

Specifications

ISBN-13
9781912687268
Publisher
Law Brief Publishing
Publication
September 2019
Format
Paperback
Jurisdiction
U.K. ? Countri(es) for reference only

Details

The life sciences industry represents one of the dominant economic sectors in the UK. Given the complexity of the European Regulatory Framework relating to the supply of human medicinal products this book gives an authoritative overview of the law as it currently stands.

This practical guide will address the regulatory procedures and day to day challenges for the authorisation and use of human medicinal products in the EU’s most regulated industry.

User-friendly, practical and pragmatic this book will prove an invaluable source of information for those who work in industry, regulatory authorities and for all persons who need to familiarise themselves with the relevant legislation in this fast moving industry sector.

Table of Contents

Chapter One – Regulating Human Medicines in the European Union
The Legal Basis of Medicines for Human Use
The Quality, Safety and Efficacy of a Medicine
The History and Progress of EU Regulation for Human Medicines
The European Medicines Agency Scientific Committees
The Future of Medicines in Europe?
Chapter Two – Clinical Trials for Human Medicines
Background
Clinical Trial legal framework
Clinical Trial Protocol
Clinical Trial Agreements
Clinical Trial Patient Confidentiality and Informed Consent
Subject withdrawal from the Clinical Trial
Qualified Person (QP) Certification
Clinical Trial Stages
Chapter Three – Pharmaceutical Quality Systems
Introduction
Various types of GxP
Good Pharmacovigilance Legislation
Chapter Four – Pharmacovigilance in Human Medicines
The Need for Pharmacovigilance
The Pharmacovigilance Process
Pharmacovigilance Systems and Risk Assessment
Periodic Benefit Risk Evaluation (PBRER)
Periodic Safety Update Reports (PSURs)
Pharmacovigilance Legislation
Reporting of Adverse Reactions
European EudraVigilance
European-Wide Monitoring of Medicines
Safety Recalls
Chapter Five – Marketing Authorisation and Variation Procedures for Human Medicinal Products
The Requirement for a Marketing Authorisation
The Marketing Authorisation Holder (MAH)
Marketing Authorisation Applications (MAA)
The Common Technical Document (CTD)
Marketing Authorisation Procedures
Alternative Approval Pathways for Medicines
Advanced Therapy Medicinal Products (ATMP)
Marketing Authorisation Renewal and Transfer
Variations and Extensions of a Marketing Authorisation
Urgent safety restrictions
Extensions of a Marketing Authorisation
Chapter Six – Data Exclusivity and Market Protection for Human Medicines
Background
Extension of Market Protection and Data Exclusivity
Duties and Powers of National Regulatory Authorities and National Courts governing Data Exclusivity
Supplementary Protection Certificate (SPC)
Proposed European Export Manufacturing Waiver
Chapter Seven – The Advertising of Prescribed Human Medicines
Introduction
Legislative framework
Voluntary Codes of Practice – The European Federation of Pharmaceutical Industries and Associations (EFPIA)
Control of Medicine Advertisement by the MHRA
The Advertising Standards Authority (ASA)
Additional Legislation Governing the Advertising of Medicines in the UK
Chapter Eight – The Pricing and Reimbursement of Human Medicines
Introduction
The Transparency Directive 89/105/EEC
Health Technology Assessment (HTA)
The National Institute for Health and Clinical Excellence (NICE)
Generic medicines
Patient Access Scheme (PAS)
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