CELEX: 51988PC0779(03)
Language: en
Date: 1989-02-09
Title: PROPOSAL FOR A COUNCIL DIRECTIVE EXTENDING THE SCOPE OF DIRECTIVE 81/851/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO VETERINARY MEDICINAL PRODUCTS AND LAYING DOWN ADDITIONAL PROVISIONS FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS

No C 61/20                             Official Journal of the European Communities                                   10. 3. 89
              Proposal for a Council Directive extending the scope of Directive 81/851/EEC on the approxi-
              mation of the laws of the Member States relating to veterinary medicinal products and laying
                       down additional provisions for immunological veterinary medicinal products
                                               COM(88)    779 final — SYN 190
                                     (Submitted by the Commission on 10 January 1989)
                                                        (89/C 61/09)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                           responses of the treated animals will interfere with the
                                                                   operation of a national or Community programme for
Having regard to the Treaty establishing the European              the eradication or control of animal disease;
Economic Community, and in particular Article 100A
thereof,                                                           Whereas changes will be required to the requirements for
                                                                   the testing of veterinary medicinal products laid down in
Having regard to the proposal from the Commission,                 Annex I to Council Directive 81/852/EEC of 28
                                                                   September 1981 on the approximation of the laws of the
                                                                   Member States relating to analytical, pharmaco-toxico-
In cooperation with the European Parliament,
                                                                   logical and clinical standards and protocols in respect of
                                                                   the testing of veterinary medicinal products (3), as
Having regard to the opinion of the Economic and                   amended by Directive 87/20/EEC (4), to take account of
Social Committee,                                                  the special nature of immunological veterinary medicinal
                                                                   products; whereas        the    Commission      should    be
Whereas disparities in the provisions laid down by law,            empowered to adopt the necessary changes in close
regulation or administrative action by Member States               cooperation with the Committee for the Adaptation to
may hinder trade in immunological veterinary medicinal             Technical Progress of the Directives on the Removal of
products within the Community;                                     Technical Barriers to Trade in the Veterinary Medicinal
                                                                   Products Sector, thus ensuring greater quality, safety and
Whereas the essential aim of any rules governing the               effectiveness,
production, distribution or use of veterinary medicinal
products must be to ensure a high level of protection of
                                                                   HAS ADOPTED THIS DIRECTIVE:
public health;
Whereas      the   provisions     of    Council    Directive                                 Article 1
81/851/EEC ('), although appropriate, are not adequate
                                                                   1.    Subject to the provisions of this Directive, Directive
for veterinary medicinal products used in order to
                                                                   81/851/EEC shall apply to immunological veterinary
produce active immunity, to diagnose the state of
                                                                   medicinal products.
immunity and to produce passive immunity (immuno-
logical veterinary medicinal products);
                                                                   2.    For the purposes of this Directive, 'immunological
                                                                   veterinary medicinal product' means a veterinary
Whereas, in accordance with Article 5 of Council
                                                                   medicinal product used in order to produce active
Directive 87/22/EEC of 22 December 1986 on the
                                                                   immunity, diagnose the state of immunity or produce
approximation of national provisions relating to" the
                                                                   passive immunity.
placing on the market of high-technology medicinal
products, particularly those derived from biotech-
nology O , the Commission is required to submit                    3.    This Directive and Directive 81/851/EEC shall not
proposals to harmonize the conditions for authorizing              apply to autogenous vaccines which are manufactured
the manufacture and placing on the market of immuno-               from the organisms found in discharges from the body of
logical veterinary medicinal products;                             an animal and used for the treatment of the individual
                                                                   animal from which the organisms are derived.
Whereas, before an authorization to market an immuno-
logical veterinary medicinal product can be granted, the                                     Article 2
manufacturer must demonstrate his ability to attain
                                                                    1.   The quantitative particulars of an immunological
batch-to-batch consistency;
                                                                   veterinary medicinal product shall be expressed by mass
                                                                   or by international units or by units of biological activity
Whereas the competent authorites should also be                    or by specific protein content where possible as appro-
empowered to prohibit the use of an immunological                  priate to the product concerned.
veterinary medicinal product when the immunological
 (*) OJ No L 317, 6. 11. 1981, p. 1.                               O OJ No L 317, 6. 11. 1981, p. 16.
 O OJ No L 15, 17. 1. 1987, p. 38.                                  (4) OJ No L 15, 17. 1. 1987, p. 34.
 ---pagebreak--- 10. 3. 89                              Official Journal of the European Communities                           No C 61/21
2.    In respect of immunological veterinary medicinal           in the whole or part of the territory of the Community
products, in Directive 81/851 / E E C the expressions            or a Member State if it is established that:
'qualitative and quantitative particulars of the consti-
tuents' shall include particulars relating to biological         (a) the administration of the product to animals will
activity or to protein content and 'qualitative and quanti-          interfere with the operation of a national or
tative composition' shall include the composition of the             Community programme for the control or eradi-
product expressed in terms of the biological activity or of          cation of animal disease; or
protein content.
                                                                 (b) the disease against which the product is intended to
3.    In any document established in accordance with                 confer immunity is substantially absent from the
Directive 81/851/EEC in which the name of an immu-                   territory in question; or
nological veterinary medicinal product is expressed, the
common or scientific name of the active constituents             (c) the administration of the product will cause diffi-
shall also be included at least once; it may be abbreviated          culties in certifying the absence of contamination of
in the remaining references.                                         foodstuffs obtained from treated animals.
                          Article 3                              The competent authorities of the Member States shall
                                                                 inform the Commission of all instances in which the
1.    The competent authorities shall ensure that the            provisions of this Article are applied.
manufacturing processes used in the manufacture of
immunological veterinary medicinal products are
properly validated and attain batch-to-batch consistency.                                  Article 5
2.    For the purpose of implementing Article 35 of              The amendments which are necessary in the testing
Directive 81/851/EEC, the competent authorities may              requirements for veterinary medicinal products set out in
require persons responsible for marketing immunological          the Annex to Directive 81/852/EEC to take account of
veterinary medicinal products to submit to a competent           the extension of the scope of Directive 81/851/EEC to
authority copies of all the control reports signed by the        cover immunological veterinary medicinal products shall
qualified person in accordance with Article 30 of                be adopted in accordance with the procedure laid down
Directive 81/851/EEC.                                            in Article 2c of Directive 81/852/EEC.
The person responsible for marketing may be required to
provide the competent authorities with a sample of each                                    Article 6
batch of immunological veterinary medicinal products              1.   Member States shall take the necessary measures to
manufactured, or to hold such samples in stock up to the         comply with this Directive not later than 1 January 1992.
expiry date for provision upon request to the competent          They shall forthwith inform the Commission thereof.
authorities.
                                                                 In the event of the amendments referred to in Article 5
3.    Where in the interests of human or animal health,          not being adopted by 1 January 1991, the date set out in
the legislation of a Member State so provides, the               the first subparagraph shall be postponed to a date one
competent authorities may require persons responsible            year later than the date of adoption of those
for marketing the immunological veterinary medicinal             amendments.
products to submit to a competent authority samples
from each batch of the bulk and/or finished product for          2.    Requests for marketing authorization for products
examination by a State laboratory or a laboratory                covered by this Directive lodged after the date set out in
designated for this purpose before release onto the              the first subparagraph of paragraph 1 must comply with
market, unless another competent authority within the            the provisions of this Directive.
Community has previously examined the batch in
question and declared it to be in conformity with the
approved specification. Any such examination shall be            3.    Within three years of the date set out in the first
completed within 60 days of the receipt of the samples.          subparagraph of paragraph 1 this Directive shall be
                                                                 progressively extended to existing immunological
                                                                 veterinary products.
                          Article 4
In the absence of specific Community legislation and in                                    Article 7
accordance with national legislation, the use of an immu-
nological veterinary medicinal product may be prohibited         This Directive is addressed to the Member States.