Last edited by Gonos
Thursday, July 16, 2020 | History

3 edition of The Rules governing medicinal products in the European Community. found in the catalog.

The Rules governing medicinal products in the European Community.

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Published by Office for Official Publications of the European Communities in Luxembourg .
Written in English


Edition Notes

CB-55-89-843-EN-C.

SeriesDocument / Commission of the European Communities
ContributionsCommission of the European Communities.
The Physical Object
Pagination248p. ;
Number of Pages248
ID Numbers
Open LibraryOL22346386M
ISBN 109282596192

The Rules Governing Medicinal Products in the European Union EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Introduction Document History The first edition of the Guide was published, including an annex on the manufacture of . The Rules Governing Medicinal Products in the European Community vol III: Guidelines on Quality, Safety and efficacy of medicinal products for human use, Cited by: 1.

Description Contents Cover This spiral-bound, " x " book is a compilation of regulations and guidance documents from the US, EU and Canada governing the cleaning of drug and biological product manufacturing equipment. ( pages) How is this Book Used? • As a training aid for new and existing staff • As an on-the. guidance recognizes the practice (Volume 9 of the Rules Governing Medicinal Products in the European Community (‘Volume 9’), Part 1, paragraph ), but the responsibility for compliance, as a matter of law, continues to rest with the MAH.

EU Regulation /93 contains 74 parts, that is, Articles 1 to Article 1 provides that, “[t]he purpose of this Regulation is to lay down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and to establish a European Agency for the Evaluation of Medicinal Products.”. European legislation governing the authorization of veterinary medicinal products with particular reference to the use of drugs for the control of honey bee Author: Franco Mutinelli.


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These questions and answers (Q&As) provide an overview of the European Medicines Agency's (EMA) advice on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the application phase.

This guidance should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants and pre-submission. One major consequence of this has been that neither the tests and trials carried out to obtain authorization nor batch controls need be repeated within the European community.

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Commission of the European Communities. Book. English. 2nd ed]. Published Luxembourg: Office.Commission of the European Communities The Rules governing Medicinal Products in the European Community Volume IV Guide to Good Manufacturing Practice for Medicinal Products Document - 3 - CONTENTS PAGE INTRODUCTION 7 GLOSSARY 9 CHAPTER 1: OUALITY MANAGEMENT 15 .