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 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 . 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 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 . Article 3 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 . Article 4 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 . Article 5 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 . 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 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 . Article 7 This Directive is addressed to the Member States . Done at Brussels , 13 December 1990 . For the Council The President P. ROMITA (1) OJ No C 61 , 10 . 3 . 1989 , p. 20 and OJ No C 131 , 30 . 5 . 1990 , p. 20 . (2) OJ No C 96 , 17 . 4 . 1990 , p. 111 and Decision of 21 November 1990 ( not yet published in the Official Journal ) . (3) OJ No C 201 , 7 . 8 . 1989 , p. 1 . (4) OJ No L 317 , 6 . 11 . 1981 , p. 1 . (5) See page 15 of this Official Journal . (6) OJ No L 15 , 17 . 1 . 1987 , p. 38 . (7) OJ No L 317 , 6 . 11 . 1981 , p. 16 . (8) OJ No L 15 , 17 . 1 . 1987 , p. 34 .
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 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 . Article 3 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 . Article 4 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 . Article 5 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 . 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 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 . Article 7 This Directive is addressed to the Member States . Done at Brussels , 13 December 1990 . For the Council The President P. ROMITA (1) OJ No C 61 , 10 . 3 . 1989 , p. 20 and OJ No C 131 , 30 . 5 . 1990 , p. 20 . (2) OJ No C 96 , 17 . 4 . 1990 , p. 111 and Decision of 21 November 1990 ( not yet published in the Official Journal ) . (3) OJ No C 201 , 7 . 8 . 1989 , p. 1 . (4) OJ No L 317 , 6 . 11 . 1981 , p. 1 . (5) See page 15 of this Official Journal . (6) OJ No L 15 , 17 . 1 . 1987 , p. 38 . (7) OJ No L 317 , 6 . 11 . 1981 , p. 16 . (8) OJ No L 15 , 17 . 1 . 1987 , p. 34 .
Article 3 
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 . Article 4 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 . Article 5 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 . 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 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 . Article 7 This Directive is addressed to the Member States . Done at Brussels , 13 December 1990 . For the Council The President P. ROMITA (1) OJ No C 61 , 10 . 3 . 1989 , p. 20 and OJ No C 131 , 30 . 5 . 1990 , p. 20 . (2) OJ No C 96 , 17 . 4 . 1990 , p. 111 and Decision of 21 November 1990 ( not yet published in the Official Journal ) . (3) OJ No C 201 , 7 . 8 . 1989 , p. 1 . (4) OJ No L 317 , 6 . 11 . 1981 , p. 1 . (5) See page 15 of this Official Journal . (6) OJ No L 15 , 17 . 1 . 1987 , p. 38 . (7) OJ No L 317 , 6 . 11 . 1981 , p. 16 . (8) OJ No L 15 , 17 . 1 . 1987 , p. 34 .
Article 4 
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 . Article 5 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 . 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 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 . Article 7 This Directive is addressed to the Member States . Done at Brussels , 13 December 1990 . For the Council The President P. ROMITA (1) OJ No C 61 , 10 . 3 . 1989 , p. 20 and OJ No C 131 , 30 . 5 . 1990 , p. 20 . (2) OJ No C 96 , 17 . 4 . 1990 , p. 111 and Decision of 21 November 1990 ( not yet published in the Official Journal ) . (3) OJ No C 201 , 7 . 8 . 1989 , p. 1 . (4) OJ No L 317 , 6 . 11 . 1981 , p. 1 . (5) See page 15 of this Official Journal . (6) OJ No L 15 , 17 . 1 . 1987 , p. 38 . (7) OJ No L 317 , 6 . 11 . 1981 , p. 16 . (8) OJ No L 15 , 17 . 1 . 1987 , p. 34 .
Article 5 
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 . 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 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 . Article 7 This Directive is addressed to the Member States . Done at Brussels , 13 December 1990 . For the Council The President P. ROMITA (1) OJ No C 61 , 10 . 3 . 1989 , p. 20 and OJ No C 131 , 30 . 5 . 1990 , p. 20 . (2) OJ No C 96 , 17 . 4 . 1990 , p. 111 and Decision of 21 November 1990 ( not yet published in the Official Journal ) . (3) OJ No C 201 , 7 . 8 . 1989 , p. 1 . (4) OJ No L 317 , 6 . 11 . 1981 , p. 1 . (5) See page 15 of this Official Journal . (6) OJ No L 15 , 17 . 1 . 1987 , p. 38 . (7) OJ No L 317 , 6 . 11 . 1981 , p. 16 . (8) OJ No L 15 , 17 . 1 . 1987 , p. 34 .
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 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 . Article 7 This Directive is addressed to the Member States . Done at Brussels , 13 December 1990 . For the Council The President P. ROMITA (1) OJ No C 61 , 10 . 3 . 1989 , p. 20 and OJ No C 131 , 30 . 5 . 1990 , p. 20 . (2) OJ No C 96 , 17 . 4 . 1990 , p. 111 and Decision of 21 November 1990 ( not yet published in the Official Journal ) . (3) OJ No C 201 , 7 . 8 . 1989 , p. 1 . (4) OJ No L 317 , 6 . 11 . 1981 , p. 1 . (5) See page 15 of this Official Journal . (6) OJ No L 15 , 17 . 1 . 1987 , p. 38 . (7) OJ No L 317 , 6 . 11 . 1981 , p. 16 . (8) OJ No L 15 , 17 . 1 . 1987 , p. 34 .
Article 7 
This Directive is addressed to the Member States