The rules governing medicinal products for human use in the European Community

Directorate-General For Translation European Commission

Description

Health policy
Approximation of legislation
Consumers' health

Sujets

• Pharmaceutical drug
• Pharmaceutical industry
• Drug
• Pharmacology
• Health care system
• Member state of the European Union

Informations

• Publié par: EUROPEAN-COMMISSION
• Nombre de lectures: 34
• Langue: English
• Poids de l'ouvrage: 3 Mo

Extrait

THE RULES GOVERNING MEDICINAL
PRODUCTS IN THE EUROPEAN
COMMUNITY
Volume I
The rules governing medicinal products
for human use in the European Community
¡0S0& vH':
*«*gs*
COMMISSION
OF THE EUROPEAN
COMMUNITIES This document has been prepared for use within the Commission. It does not
necessarily represent the Commission's official position.
This publication is also available in the following languages:
ES ISBN 92-825-9559-5
DA ISBN 92-825-9560-9
DE ISBN 92-825-9561-7
GR ISBN 92-825-9562-5
FR ISBN 92-825-9564-1
IT ISBN 92-825-9565-X
NL ISBN 92-825-9566-8
PT ISBN 92-825-9567-6
Cataloguing data can be found at the end of this publication
Luxembourg: Office for Official Publications of the European Communities, 1989
ISBN 92-825-9563-3
Catalogue number: CB-55-89-706-EN-C
© ECSC-EEC-EAEC, Brussels · Luxembourg. 1989
Reproduction is authorized, except for commercial purposes, provided the source
is acknowledged.
Printed in Belgium Commission of the European Communities
The Rules Governing Medicinal Products
in the European Community
Volume I
The rules governing Medicinal Products for
human use in the
European Community
Document This document has been prepared for use within the Commission. It does not
necessarily represent the Commission's official, position.
Copyright ECSC-EEC-EAEC, Brussel - Luxembourg, 1989
Reproduction is authorized, except for commercial purposes, provided the
source is acknowledged. This document has been prepared for use within the Commission. It is put at
the disposal of the public, but it has no lega! force and in case of doubt,
the original Community Directives should be consulted.
January 1989 THE RULES GOVERNING MEDICINAL PRODUCTS
IN THE EUROPEAN COMMUNITY.
Presentation of volumes
The rules governing medicinal products for Volume I
human use in the European Community
VoI ume I I Notice to applicants for marketing
authorizations for medicinal products for
human use In the Member States of the
European Community
Guidelines on the Quality, Safety and VoI ume I I I
Efficacy of medicinal products for human
use
Guide to Good Manufacturing Practice for VoI ume I V
the manufacture of medicinal products
The rules governing medicinal products for Volume V
veterinary use in the European Community
January 1989 COMMI SS ION
OF THE EUROPEAN
COMMUNITIES
THE RULES GOVERN ING
MED ICI NAL PRODUCTS
HUMAN USE IN THE FOR
C OMMUN I EURO Ρ ΕΑΝ Τ Y
JANUARY 1989