Pharmacetical Applications in the European Union: A Guide Through the Registration Maze, 1st Edition (Hardback) book cover

Pharmacetical Applications in the European Union

A Guide Through the Registration Maze, 1st Edition

By Cheng Yee Lowe

CRC Press

278 pages

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Hardback: 9781574910643
pub: 1998-02-28
$335.00
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Description

Written by an expert with twenty years' experience in regulatory affairs in a number of multi-national companies, this book guides readers through the legislative minefield of registering medicinal products in the European Union. Taking a step-by-step approach, the book demystifies all of the regulatory requirements and gives a clear understanding of how to achieve compliance. The author gathers all the relevant requirements, puts them into context, and provides regulatory information in an easily accessible format. Headings, subheadings, and key points organized in tabular format make the information easy for readers to find and the book easy for readers to use.

Table of Contents

Introduction

THE EUROPEAN UNION

Member States

"Pillars" of the European Union

Institutions of the European Union

The Legislative Process

The Primary Objective of the Rules Governing Medicinal Products

PHARMACEUTICAL LEGISLATION

Instruments Governing the Legislation of Medicine

Council/Commission Directives/Regulations

The Regulatory Framework

New Products

New Requirements

New Procedures

Recast of EU Legislation

MARKETING AUTHORISATION

The Application Dossier

REGISTRATION PROCEDURES

National Procedure

Mutual Recognition Procedure

Centralised Procedure

ABRIDGED APPLICATIONS

Essentially Similar Procedures

Not "Essentially Similar"

Expert Reports

VARIATIONS

Changes Concerning Manufacturing Aspects

Changes to Labelling and Package Aspects

Commission Regulations on Variations

Non-Variations

Mutual Recognition Procedure

Centralised Procedure

RENEWALS

"Converted Mutual Recognition"

Mutual Recognition Procedure

Centralised Procedure

COMMUNITY REFERRAL

Scope

Check-in Procedure

Decision-Making Process: Internal Commission Consultation

Decision-Making Process: Standing Committee

Appendix 1: Abbreviations and Acronyms Commonly Used

Appendix 2: Addresses of Regulatory Agencies

Appendix 3: Glossary

Appendix 4: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

References

Index

Decision-Making Process

Appendices

Subject Categories

BISAC Subject Codes/Headings:
TEC021000
TECHNOLOGY & ENGINEERING / Material Science
TEC059000
TECHNOLOGY & ENGINEERING / Biomedical