No C 36/28 Official Journal of the European Communities 8. 2. 88 
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 
COM(87) 697 final 
(Submitted by the Commission to the Council on 12 January 1988) 
(88/C 36/04) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100A 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas disparities in the provisions laid down by law, 
regulation or administrative action by Member States may 
hinder trade in medicinal products derived from human 
blood within the Community; 
Whereas the essential aim of any rules governing the 
production, distribution or use of medicinal products must 
be to ensure a high level of protection of public health; 
Whereas the provisions laid down by Directive 65/65/ 
EEC (*), as last amended by Directive 87/21 /EEC (2), and 
Second Directive 75/319/EEC (3), as last amended by 
Directive 83/570/EEC (4) on the approximation of 
provisions laid down by law, regulation or administrative 
action relating to proprietary medicinal products, although 
appropriate, are inadequate for medicinal products derived 
from human blood; 
Whereas, in accordance with Article 5 of Directive 
87/22/EEC (s) on the approximation of national provisions 
relating to the placing on the market of high technology 
medicinal products, particularly those derived from 
biotechnology, the Commission is required to submit 
proposals to harmonize, along the lines of Directive 
75/319/EEC, the conditions for authorizing the 
manufacture and placing on the market of medicinal 
products derived from human blood before 22 December 
1987; 
Whereas the European Community entirely supports the 
efforts of the Council of Europe to promote voluntary and 
non-remunerated blood donation to attain self-sufficiency 
I1) OJ No 22, 9. 2. 1965, p. 369/65. 
;2) OJNoL 15, 17. 1. 1987, p. 36. 
;3) OJ No L 147, 9. 6. 1975, p. 13. 
;<) OJ No L 332, 28. 11. 1983, p. 1. 
;5) OJNoL 15, 17. 1. 1987, p. 38. throughout the Community in the supply of blood products, 
and to ensure the respect of ethical principles in trade of 
therapeutic substances of human origin; 
Whereas the rules designed to guarantee the quality, safety 
and efficacy of medicinal products derived from human 
blood must be applied in the same manner to both public and 
private establishments; 
Whereas, before an authorization to market a medicinal 
product derived from human blood can be granted, the 
manufacturer must demonstrate his ability to guarantee 
batch-to-batch consistency and the absence of viral 
contamination; 
Whereas the Commission should be empowered to adopt any 
necessary changes in the requirements for the testing of 
proprietary medicinal products set out in the Annex to 
Directive 75/318/EEC of 20 May 1975 on the 
approximation of the laws of the Member States relating to 
analytical, pharmaco-toxicological and clinical standards 
and protocols in respect of the testing of proprietary 
medicinal products (6), as last amended by Directive 
87/ 19/EEC of 22 December 1986 (7), to take account of the 
special nature of medicinal products derived from human 
blood in close cooperation with the Committee for the 
Adaptation to Technical Progress of the Directives on the 
Removal of Technical Barriers to Trade in the Proprietary 
Medicinal Products Sector, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. In derogation from Article 34 of Directive 
75/319/EEC, and subject to the provisions of this Directive, 
Directives 65/65/EEC and 75/319/EEC shall apply to 
medicinal products based on blood constituents which are 
prepared industrially by public or private establishments, 
hereinafter referred to as 'medicinal products derived 
from human blood'; these medicinal products include, 
in particular, albumin, coagulating factors and 
immunoglobulins of human origin. 
(6) OJNoL 147,9.6. 1975, p. 1. 
(7) OJNoL 15, 17. 1. 1987, p. 31. 
8. 2. 88 Official Journal of the European Communities No C 36/29 
2. This Directive shall not apply to whole blood, to 
plasma or to blood cells of human origin. 
3. Nothing in the present Directive shall in any way 
derogate from Council Decision 86/346/EEC (*) accepting, 
in the name of the Community, the European Agreement 
relating to the exchange of therapeutic substances of human 
origin. 
Article 2 
1. The quantitative particulars of a medicinal product 
derived from human blood shall be expressed by mass or by 
international units or by units of biological activity as 
appropriate to the product concerned. 
2. In Directives 65/65/EEC and 75/319/EEC, the 
expressions 'qualitative and quantitative particulars of the 
constituents' shall include particulars relating to biological 
activity and 'qualitative and quantitative composition' shall 
include the composition of the product expressed in terms of 
biological activity. 
3. Whenever the name of a medicinal product derived 
from human blood is expressed, the common or the scientific 
name of the active constituents shall also be included. 
Article 3 
In order to prevent the transmission of infectious diseases, 
the Member States shall take into consideration the measures 
recommended within the framework of the Council of 
Europe and the World Health Organization in particular for 
the selection and testing of blood donors. 
Article 4 
1. Member States shall ensure that the manufacturing 
processes used in the manufacture of medicinal products 
derived from human blood are properly validated, attain 
batch-to-batch consistency and guarantee the absence of 
viral contaminants. To this end the competent authority may 
submit samples from up to five in total of the bulk and/or 
finished product batches for testing by a State laboratory or a 
laboratory designated for that purpose, either during the 
examination of the application pursuant to Article 4 of 
Directive 75/319/EEC, of after a marketing authorization 
has been granted. 
2. For the purpose of implementing Article 8 of Directive 
65/65/EEC and Article 27 of Directive 75/319/EEC, 
(') OJ No L 207, 30. 7. 1986, p. 1. Member States may require persons responsible for 
marketing medicinal products derived from human blood to 
submit to a competent authority copies of all the control 
reports signed by the qualified person in accordance with 
Article 22 of Directive 75/319/EEC. 
3. Where it consider it necessary in the interests of public 
health, a Member State may require persons responsible for 
marketing medicinal products derived from human blood to 
submit to a competent authority samples from each batch of 
the bulk and/or finished product for examination by a State 
laboratory or a laboratory designated for that purpose before 
release onto the market, unless the competent authority of 
another Member State has previously examined the batch in 
question and declared it to be in conformity with the 
approved specifications. Member States shall ensure that any 
such examination is completed within 60 days of the receipt 
of the samples. 
Article 5 
Any amendments which are necessary in the testing 
requirements for medicinal products set out in the Annex to 
Directive 75/318/EEC to take account of the extension of 
the scope of Directives 65/65/EEC and 75/319/EEC to 
cover medicinal products derived from human blood shall be 
adopted in accordance with the procedure laid down in 
Article 2c of Directive 75/318/EEC. Any such amendments 
shall come into effect on the same date as this Directive. 
Article 6 
1. Member States shall take the necessary measures to 
comply with this Directive not later than 1 January 1991. 
They shall forthwith inform the Commission thereof. 
2. Requests for marketing authorization for products 
covered by this Directive lodged after the time limit referred 
to in paragraph 1 must comply with the provisions of this 
Directive. 
3. This Directive shall be progressively extended to the 
existing medicinal products derived from human blood 
referred to in Article 1(1) before 31 December 1992. 
Article 7 
This Directive is addressed to the Member States.