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 )
Date: 1989-05-26
Institutions: European Commission
Subjects: approximation of laws, health policy, marketing, pharmaceutical legislation, pharmaceutical product

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) 

(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 

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 
or  human  plasma  as  a  starting 
material  for  the  manufacture  of 
medicinal  products: 

In respect  of  the u3e of human blood 
or  human 
as  medicinal 
products  or  as  a  starting  material 
such 
for 
products : 

the  manufacture 

plasma 

of 

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 

COM(89)  178  final 

ISSN 0254-1475 

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 

Catalogue  number:  CB-CO-89-207-EN-C 

ISBN  92-77-50040-9 

€ 

COMMISSION OF THE EUROPEAN COMMUNITIES 

26.5.1989