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DIRECTIVE 89/381/EEC |
Council Directive 89/381/EEC
of 14 June 1989 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 special
provisions for medicinal products derived from human blood or human plasma
Official Journal L 181 ,
Finnish special edition....: Chapter 13 Volume 19 p. 18
Swedish special edition...: Chapter 13 Volume 19 p. 18
Amendments:
Incorporated by 294A0103(52) (OJ L
001 03.01.1994 p.263)
COUNCIL DIRECTIVE
of
THE COUNCIL OF THE EUROPEAN
COMMUNITIES,
Having regard to the Treaty establishing the
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas disparities in the laws, regulations or administrative provisions of
Member States may hinder trade in medicinal products derived from human blood
or human plasma 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 (4), as last amended by
Directive 87/21/EEC (5), and by Directive 75/319/EEC (6), as last amended by
Directive 83/570/EEC (7), both concerning the approximation of provisions laid
down by law, regulation or administrative action relating to proprietary
medicinal products, although appropriate, are inadequate with regard to
medicinal products derived from human blood or human plasma;
Whereas in accordance with Article 5 of Council Directive 87/22/EEC of 22
December 1986 on the approximation of national provisions relating to the
placing on the market of high-technology medicinal products, particularly those
derived from biotechnology (8); 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 or human plasma;
Whereas the Community entirely supports the efforts of the Council of Europe to
promote voluntary unpaid blood and plasma donation to attain self-sufficiency
throughout the Community in the supply of blood products, and to ensure respect
for ethical principles in trade in therapeutic substances of human origin;
Whereas the rules designed to guarantee the quality, safety and efficacy of
medicinal products derived from human blood or human plasma must be applied in
the same manner to both public and private establishments, and to blood and
plasma imported from third countries;
Whereas, before an authorization to market a medicinal product derived from
human blood or human plasma can be granted, the manufacturer must demonstrate
his ability to guarantee batch-to-batch consistency and the absence of specific
viral contamination, to the extent that the state of technology permits;
Whereas the Commission should be empowered to adopt, in close cooperation with
the Committee for the Adaptation to Technical Progress of the Directives on the
Removal of Technical Barriers to Trade in Medicinal Products, any necessary
changes in the requirements for the testing of proprietary medicinal products set
out in the Annex to Council 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 (1), as last amended by Directive
87/19/EEC (2), to take account of the special nature of medicinal products
derived from human blood or human plasma so as to ensure a higher level of
quality, safety and efficacy,
HAS ADOPTED THIS DIRECTIVE:
Article
1
1. By way of 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 aplly 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 or human plasma'; these medicinal products include, in particular
albumin, coagulating factors and immunoglobulins of human origin.
2. This Directive shall not apply to whole blood, to
plasma or to blood cells of human origin.
3.
This
Directive shall be without prejudice to Council Decision 86/346/EEC of
Article 2
1. The quantitative particulars of a medicinal product
derived from human blood or human plasma 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. In any document drawn up for the purposes of this
Directive, where the name of a medicinal product derived from human blood or
human plasma is expressed, the common or scientific name of the active
constituents shall also be included at least once; it may be abbreviated in the
remaining references.
Article 3
In respect of the use of human blood or human plasma as a starting material for
the manufacture of medicinal products:
1. Member States shall take the necessary measures to
prevent the transmission of infectious diseases. Insofar as this is covered by
the amendments referred to in Article 6, as well as the application of the
monographs of the European Pharmacopoeia regarding blood and plasma, these
measures shall comprise those recommended by the Council of Europe and the
World Health Organization, particularly with reference to the selection and
testing of blood and plasma donors;
2. Member States shall take the necessary measures to
ensure that human blood and human plasma donors and donation centres are always
clearly identifiable;
3. All the safety guarantees referred to in paragraphs 1
and 2 must also be given by importers of human blood or human plasma from third
countries;
4. Member States shall take the necessary measures to
promote Community self-sufficiency in human blood or human plasma. For this
purpose, they shall encourage the voluntary unpaid donation of blood and plasma
and shall take the necessary measures to develop the production and use of
products derived from human blood or human plasma coming from voluntary unpaid
donations. They shall notify the Commission of such measures.
Article 4
1. Member States shall take all necessary measures to
ensure that the manufacturing and purifying processes used in the preparation
of medicinal products derived from human blood or human plasma are properly
validated, attain batch-to-batch consistency and guarantee, insofar as the
state of technology permits, the absence of specific viral contamination. To
this end manufacturers shall notify the competent authorities of the method
used to reduce or eliminate pathogenic viruses liable to be transmitted by
medicinal products derived from human blood or human plasma. The ocmpetent
authority may submit samples of the bulk and/or finished product 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, or 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, Member States may require manufacturers of medicinal products
derived from human blood or human plasma 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, in the interests of public health, the laws of
a Member State so provide, the competent authorities may require persons
responsible for marketing medicinal products derived from human blood or human
plasma to submit samples from each batch of the bulk and/or finished product
for testing by a State laboratory or a laboratory designated for that purpose
before being released into free circulation, unless the competent authorities
of another Member State have 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 sixty days of the
receipt of the samples.
Article 5
The procedure laid down in Directive 87/22/EEC shall be extended as necessary
to cover medicinal products derived from human blood or human plasma.
Article
6
Any necessary amendments to 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 or human plasma shall be adopted in accordance with the
procedure laid down in Article 2c of Directive 75/318/EEC.
Article 7
1.
Save
in the case provided for in paragraph 2, Member States shall take the necessary
measures to comply with this Directive before
2.
In
the event of the amendments to Directive 75/318/EEC referred to in Article 6
not being adopted by the date referred to in paragraph 1, this date shall be
replaced by the date of adoption of the said amendments.
3.
Requests
for marketing authorization for the products concerned lodged after the date of
application of this Directive shall comply with the provisions thereof.
4.
This
Directive shall be progressively extended, before
Article 8
This Directive is addressed to the Member States.
Done at
For the Council
The President
P. SOLBES
(1) OJ No C 308, 3. 12. 1988, p. 21.
(2) OJ No C 290, 14. 12. 1988, p. 134 and
OJ No C 120, 16. 5. 1989.
(3) OJ No C 208, 8. 8. 1988, p. 64.
(4) OJ No 22, 9. 2. 1965, p. 369/65.
(5) OJ No L 15, 17. 1. 1987, p. 36.
(6) OJ No L 147, 9. 6. 1975, p. 13.
(7) OJ No L 332, 28. 11. 1983, p. 1.
(8) OJ No L 15, 17. 1. 1987, p. 38.
(1) OJ No L 147, 9. 6. 1975, p. 1.
(2) OJ No L 15, 17. 1. 1987, p. 31.
(3) OJ No L 207, 30. 7. 1986, p. 1.
End of the document