CELEX: 51987PC0697(03)
Language: en
Date: 1988-01-04
Title: 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

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