CELEX: 51989PC0178
Language: en
Date: 1989-05-26
Title: RE-EXAMINED PROPOSAL FOR A COUNCIL DIRECTIVE EXTENDING THE SCOPE OF DIRECTIVES 65/65/EEC AND 75/319/EEC ON THE APPROXIMATION OF PROVISIONS LAID DOWN BY LAW, REGULATION OR ADMINISTRATIVE ACTION RELATING TO PROPRIETARY MEDICINAL PRODUCTS AND LAYING DOWN ADDITIONAL PROVISIONS FOR MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD OR HUMAN PLASMA ( COM/88/663FINAL - SYN 114 )

COMMISSION OF THE EUROPEAN COMMUNITIES
                                          COM (89) 178 final SYN 114
                                          Brussels, 26 May 1989
                     RE-EXAMINED PROPOSAL
                   for a Council Directive
 extending the scope of Directives 65/65/EEC and 75/319/EEC on
 the approximation of provisions laid down by law, regulation
  or administrative action relating to proprietary Medicinal
 products and laying down additional provisions for Medicinal
      products derived fro» huaan blood or huaan plasaa.
                (COM (88) 663 final - SYN 114)
                 (presented by the Coaaission
      pursuant to Article 149 (2) (d) of the EEC Treaty)
 ---pagebreak---                                                       (3^> Wf f
               Proposal for a Council Directive
 extending the scope of Directives 65/65/EEC and 75/319/EEC on
 the approximation of provisions laid down by law, regulation
  or administrative action relating to proprietary aedicinal
 products and laying down additional provisions for aedicinal
       products derived froa huaan blood or huaan plasaa
On 12 April 1989 the European Parliaaent aaended the Coaaon
Position adopted by the Council on 21 December 1988 in respect
of the above-aentioned proposal. The aaendaent adopted by the
Parliaaent is contained in the annex.
In accordance with Article 149 (2) (d) of the Treaty the
Coaaission has re-exaained its proposal and has decided not to
accept the aaendaent for the following reason.
In the opinion of the Coaaission the amendment constitutes a
major change in the scope of Article 3, a change which is
incompatible with the terms of Article 1 (2). Article 1(2) t
which has not been amended by the Parliament, defines the
scope of the directive in the following terms:
   "This Directive shall not apply to whole blood, to    plasma
    or to blood cells of human origin."
The amendment approved by the Parliament would extend        the
scope of Article 3 to cover precisely these products         and
cannot be accepted by the Commission.
The Commission therefore maintains its proposal in the form
set out in the common position of the Council of 21 December
1988.
                                                                 i
 ---pagebreak---             PRODUCTS DERIVED FROM HUMAN BLOOD
           Common position of the Council
    Common position of the Council             Text amended by Parliament
                                           Article; 3, introductory phrase
In respect of the use of human blood       In respect of the u3e of human blood
or   human   plasma   as   a   starting    or   human    plasma   as   medicinal
material   for   the   manufacture   of    products or as a starting material
medicinal products:                        for    the   manufacture    of   such
                                           products :
 ---pagebreak--- Commission of the European Communities
COM(89) 178 final
Re-examined proposal for a
COUNCIL DIRECTIVE
extending the scope of Directives 65/65/EEC and 75/319/EEC on the
approximation of provisions laid down by law, regulation or administra-
tive action relating to proprietary medicinal products and laying down
additional provisions for medicinal products derived from human blood or
human plasma (COM(88) 663 final)
(presented by the Commission pursuant to Article 149<2)(d) of the EEC
Treaty)
26.5.1989
Office for Official Publications of the European Communities
L - 2985 Luxembourg
Series: DOCUMENTS
 1989 — 3 pp. — Format: 21.0 x 29.7 cm
EN
ISSN 0254-1475
ISBN 92-77-50040-9
Catalogue number: CB-CO-89-207-EN-C
 ---pagebreak---                                                 ISSN 0254-1475
COM(89) 178 final
DOCUMENTS
Re-examined proposal for a
COUNCIL DIRECTIVE
extending the scope of Directives 65/65/EEC and
75/319/EEC on the approximation of provisions laid
down by law, regulation or administrative action
relating to proprietary medicinal products and laying
down additional provisions for medicinal products
derived from human blood or human plasma
(COM(88) 663 final)
(presented by the Commission pursuant to Article
 149(2)(d) of the EEC Treaty)
06      05                                     26.5.1989
Catalogue number: CB-CO-89-207-EN-C
ISBN 92-77-50040-9
€
COMMISSION OF THE EUROPEAN COMMUNITIES