Key Benefits:
Decision of 17 December 1997 laying down rules for the use of sera and inoculates (Decision using sera and vaccines)
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
On the proposal of the Minister for Agriculture, Nature Management and Fisheries of 21 July 1997, no. J 977853, 'Legal Affairs Committee';
Having regard to Directive No 64 /432/EEC of the European Communities of 26 June 1964 on animal health problems in intra-Community trade in bovine animals and swine (PbEG L 121), Directive No 80 /217/EEC of the Council of the European Communities of 22 January 1980 establishing Community measures for the control of classical swine fever (PbEG L 47), Directive No 85 /511/EEC of the Council of the European Communities of 18 November 1985 on common measures for the control of foot-and-mouth disease (PbEG L 315), Directive No 90 /677/EEC of the Council of the European Communities of 13 December 1990 on the extension of 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 (PbEG L 373/26), Directive No 92 /35/EEC of the Council of the European Communities of 29 April 1992 laying down control rules and measures for the control of African horse sickness (PbEG L 157), Directive No 92/40 /EEC of 19 May 1992 introducing Community measures for the control of avian influenza (PbEG L 167), Directive No 92 /66/EEC of the Council of the European Communities of 14 July 1992 introducing Community measures for the control of Newcastle disease (PbEG L 260), Directive No 92 /119/EEC of the Council of the European Communities of 17 December 1992 laying down general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease (OJ 1993 L 62) and Directive No 93 /53/EEC of the Council of the European Communities of 24 June 1993 introducing minimum Community measures for the control of certain fish diseases (PbEG L 175);
Having regard to Article 3 (f) of the Animal Health and Welfare Act ;
The Council of State heard (opinion delivered on 15 August 1997, no. W11.97.0504);
Having regard to the further report of the Minister for Agriculture, Nature Management and Fisheries of 10 December 1997, no. J. 9713646, Directorate-General for Legal Affairs;
Have found good and understand:
a. Act: Animal health and welfare law ;
b. serum: veterinary medicinal product prepared from the blood or lymph of animals, whether derived from animal products, and whether or not mixed with other substances, for use in the prevention or cure of an infectious disease or an animal parasitic disease in animals by passive immunisation;
c. Endust: veterinary medicinal product prepared from or using micro-organisms, viruses or parasites and whether or not mixed with other substances, intended for use to prevent or cure an infectious disease or a parasitic disease in animals by active immunisation;
d. Directive No 92 /119/EEC: Directive No 92 /119/EEC of the Council of the European Communities of 17 December 1992 laying down general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease (PbEC 1993, L 62);
e. Directive No 2006 /88/EC: Directive No 2006 /88/EC of the Council of the European Communities of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (PbEG L 328);
Aquaculture animal: aquaculture animal, referred to in Article 3, first paragraph, part b, of Directive No 2006 /88/EC;
g. aquatic animal: aquatic animal, referred to in Article 3, first paragraph, part e, of Directive No 2006 /88/EC.
1 It is prohibited for all categories of animal owners without a waiver from Our Minister, livestock, poultry, bees, mink and others in the Decision Designation animal species infectious animal diseases treat species or categories of animals designated or treated by third parties with live vaccines against the relevant species or categories of animals Article 15, first paragraph, of the Act designated contagious animal diseases, or against other contagious animal diseases designated under ministerial arrangement.
2 A derogation as referred to in paragraph 1 shall cover only the treatment or by means of third parties of the species or categories of animals or animals referred to therein with a living substance designated by Our Minister.
3 A derogation is granted only if there is no risk that the general control methodology of the relevant contagious animal disease will be crossed by the relevant treatment or that the implementation of national legislation would be Health programs are being impeded.
4 The prohibition laid down in paragraph 1 shall not apply to the treatment or by third party treatment of animals against animal diseases designated by Our Minister with a living substance designated by Our Minister.
5 The prohibition set out in paragraph 1 shall not apply to the treatment or treatment of aquaculture animals with live vaccines in the context of scientific studies for the development and testing of vaccines. against the Annex IV, Part II, to Directive No 17; Diseases in aquaculture animals referred to in 2006 /88/EC, provided that:
(a) development and testing is carried out under controlled conditions; and
(b) adequate measures shall be taken to protect other aquatic animals from the harmful effects of the vaccinations carried out in the framework of the studies.
6 The fifth paragraph shall not apply to:
a. ornamental aquatic animals cultivated in non-commercial aquariums,
(b) wild or caught aquatic animals directly intended for the food chain; and
c. Water animals caught for the production of fishmeal, fish feed, fish oil and similar products.
1 It is prohibited for all categories of animal owners, poultry, mink and other animals in the Decision Designation animal species infectious animal diseases treat species or categories of animals designated or treated by third parties with non-living vaccines and antisera for foot-and-mouth disease, swine fever, African horse sickness, avian influenza, Aujeszky's disease, Annex I to Directive No 92 /119/EEC and the animal diseases listed in Annex IV, Part II, to Directive 91 /66/EEC, Disease in aquaculture animals, or against other contagious animal diseases designated under the Ministerial procedure, unless our Minister has authorised the use of certain non-living vaccines and sera in designated areas have been granted a derogation in respect of certain animals, animal species or animal categories or our Minister.
2 The prohibition set out in paragraph 1 shall not apply to the treatment or use of third-party treatment of aquaculture animals with non-living vaccines and sera in the context of scientific studies for the purpose of development and testing. Vaccines against the vaccines listed in Annex IV, Part II, to Directive No Diseases in aquaculture animals referred to in 2006 /88/EC, provided that:
(a) development and testing is carried out under controlled conditions; and
(b) adequate measures shall be taken to protect other aquatic animals from the harmful effects of the vaccinations carried out in the framework of the studies.
3 The second paragraph shall not apply to:
a. ornamental aquatic animals cultivated in non-commercial aquariums,
(b) wild or caught aquatic animals directly intended for the food chain; and
c. Water animals caught for the production of fishmeal, fish feed, fish oil and similar products.
Applications for a derogation as referred to in the Articles 2 and 3 must be submitted to our Minister.
Rules may be attached to the exemption. It may be subject to restrictions.
1 Our Minister designates as inocentants as intended Article 2, second and fourth paragraphs , and Article 3 Animal Aujeszky's disease in animals is only those based on a virus strain which is missing the gE protein, and which induce antibodies to be distinguished from the antibodies that occur after an infection with the virus of the virus. Aujeszky's disease using laboratory methods which show the prescribed results by the standard sera panel named "gE Aujeszky".
2 Without prejudice to the first paragraph, our Minister shall designate as vaccines for Article 2, second and fourth paragraphs , and Article 3 to Aujeszky's disease in pigs only those inoculum which have been shown to the satisfaction of Our Minister that, with respect to both pigs and pigs without maternal antibodies to the virus of the disease of the disease, Aujeszky, the relevant inoculant with regard to limiting field virus excretion is as effective as, or more effective than an inocular composed of 10 5 -6 plaque forming units from the third to the tenth passage (on pig cells) of strain 783 dissolved in adjuvant 25% oil in water emulsion.
Our Minister points to demand as vaccines and sera as intended in the Articles 2 and 3 in any case, those vaccines and reagents, where the applicant is able to produce information obtained from tests or analyses carried out for the purpose of permitting an inoculum or serum in another Member State of the European Union, a State party to the Agreement on the European Economic Area or a third country, relating to the same contagious animal disease and to the comparable use of that inoculum according to which serum is present at the time of the agreement on the the country concerned.
After the entry into force of this Decision, the rules adopted pursuant to the Decision shall be based on the use of sera and inoculating substances and other acts adopted in this Decision.
The Decision shall be repealed with the use of sera and vaccines.
This Decision shall enter into force from the day following the date of issuance of the Official Journal in which it is placed.
This Decision is cited as: Decision using sera and inoculings .
Charges and orders that this Decision will be placed in the Official Journal by means of the note of explanatory note accompanying it.
' s-Gravenhage, 17 December 1997
Beatrix
The Minister for Agriculture, Nature Management and Fisheries,
J. J. van Aartsen
Published twenty-ninth December 1997The Minister of Justice,
W. Sorgdrager
