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 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 : 
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 
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 
Catalogue number: CB-CO-89-207-EN-C 
ISBN 92-77-50040-9 26.5.1989 
€ 
COMMISSION OF THE EUROPEAN COMMUNITIES