COUNCIL DIRECTIVE
of 13 December 1990
extending the scope of Directive 81/851/EEC on the   approximation of the laws of the Member States   relating to veterinary medicinal products and laving   down additional provisions for immunological   veterinary medicinal products
( 90/677/EEC )
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 (1) ,
In cooperation with the European Parliament (2) ,
Having * opinion of the Economic and Social   Committee (3) ,
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 Directive 81/851/EEC (4) as last   amended by Directive 90/676/EEC (5) , although   appropriate , are not adequate for veterinary medicinal   products used in order to produce active immunity , to   diagnose the state of immunity or to produce passive   immunity ( immunological 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 biotechnology (6) , the Commission is required   to submit proposals to harmonize the conditions for   authorizing the manufacture and placing on the market of   immunological veterinary medicinal products ;
Whereas , before an authorization to market an   immunological veterinary medicinal product can be granted ,   the manufacturer must demonstrate his ability to attain   batch-to-batch consistency ;
Whereas the competent authorities should also be   empowered to prohibit the use of an immunological   veterinary medicinal product when the immunological   responses of the treated animal will interfere with a   national or Community programme for the diagnosis ,   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-toxicological and clinical standards   and protocols in respect of the testing of veterinary   medicinal products (7) , as amended by   Directive 87/20/EEC (8) , 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 ,
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 administered to animals   in order to produce active or passive immunity or to   diagnose the state of immunity .
3 . This Directive and Directive 81/851/EEC shall not   apply to inactivated immunological veterinary medicinal   products which are manufactured from pathogens and   antigens obtained from an animal or animals from a holding   and used for the treatment of that animal or the animals of   that holding in the same locality .
4 . Member States may provide that this Directive does   not apply to non-activated immunological veterinary   medicinal products of the type referred to in   paragraph 3 .
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 the number of germs or by specific protein content   where possible , as appropriate to the product   concerned .
2 . In respect of immunological veterinary medicinal   products , in Directive 81/851/EEC the expression   " qualitative and quantitative composition of the   constituents " shall include particulars relating to   biological activity or to protein content and the   expression " qualitative and quantitative 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   immunological veterinary medicinal product is expressed ,   the full common or scientific name of the active   constituents shall also be included at least once .
1 . Member States shall take all appropriate measures to   ensure that the manufacturing processes used in the   manufacture of immunological veterinary medicinal   products are completely validated and batch-to-batch   consistency is ensured , in accordance with Article 34 of   Directive 81/851/EEC .
2 . For the purpose of implementing Article 35 of   Directive 81/851/EEC , Member States may require persons   responsible for placing immunological veterinary medicinal   products on the market to submit to the competent   authorities 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 placing immunological   veterinary medicinal products on the market shall ensure   that an adequate number of representative samples of   each batch of finished products is held in stock at   least up to the expiry date , and provide samples   promptly to the competent authorities on request .
3 . Where it considers it necessary , a Member State may   require persons responsible for placing immunological   veterinary medicinal products on the market to submit   samples from the batches of the bulk and/or finished product   for examination by a State laboratory or an approved   laboratory before entry in free circulation . In the case   of a batch manufactured in another Member State ,   examined by the competent authority of another   Member State and declared to be in conformity with   national specifications , such a control may be carried   out only after the control reports of the batch in   question have been examined , after the Commission   has been informed , and where the difference in   veterinary conditions between the two Member States   concerned justifies it . Except where the Commission has   been informed that a longer period is necessary to complete   the analyses , Member States shall ensure that any such   examination is completed within 60 days of receipt of the   samples . The person responsible for placing the product   on the market shall be notified of the results of the   examination within the same time limit . Before   1 January 1992 , the Member States shall notify the   Commission of the immunological veterinary medicinal   products subject to compulsory official control before   being placed on the market .
In the absence of specific Community legislation   concerning the use of immunological veterinary medicinal   products for the eradication or control of animal   disease , a Member State may , in accordance with its   national legislation , prohibit the manufacture ,   import , possession , sale , supply and/or use of   immunological veterinary medicinal products on the whole   or part of its territory if it is established that :
( a ) the administration of the product to animals will   interfere with the implementation of a national   programme for the diagnosis , control or eradication of   animal disease , or will cause difficulties in   certifying the absence of contamination in live animals   or in foodstuffs or other products obtained from   treated animals ;
( b ) the disease to which the product is intended to   conter immunity is largely absent from the territory in   question .
The competent authorities of the Member States shall   inform the Commission of all instances in which the   provisions of this Article are applied .
The amendments which need to be made to 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 .
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 indicated   in the first subparagraph shall be put back to one year   after the date of adoption of those amendments .
2 . When Member States adopt the measures referred to in   paragraph 1 , they shall contain a reference to this   Directive or shall be accompanied by such reference on   the occasion of their official publication . The methods   of making such a reference shall be laid down by the   Member States .
3 . Requests for marketing authorization for products   covered by this Directive lodged after the date indicated in   paragraph 1 must comply with the provisions of this   Directive .
4 . Within five years of the date indicated in the first   subparagraph of paragraph 1 , this Directive shall apply to   existing immunological veterinary medicinal products .
This Directive is addressed to the Member States .