1st Edition

Pharmacetical Applications in the European Union
A Guide Through the Registration Maze



ISBN 9781574910643
Published February 28, 1998 by CRC Press
278 Pages

USD $375.00

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Book 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

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Author(s)

Biography

Lowe\, Cheng Yee