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