Decree No. 298 / 2003 Coll.
Ordinance on national reference laboratories and reference laboratories
Valid
Effective from 17.09.2003
Text versions:
17.09.2003
298
DECLARATION
of 1 September 2003
on national reference laboratories and reference laboratories
The Ministry of Agriculture provides pursuant to Section 78 of Act No. 166 / 1999 Coll., on Veterinary Care and on the amendment of certain related laws (Veterinary Act), as amended by Act No. 131 / 2003 Coll., ("the Act ') for the implementation of Section 51a (3) of the Act:
This decree regulates in accordance with the law of the European Community1)
(a) requirements for material and personnel equipment of the national reference laboratory and reference laboratories;
(b) the focus, organisation and methods of action of national reference laboratories and reference laboratories.
(1) National reference laboratories are specialised centres carrying out veterinary laboratory and diagnostic activities on selected sections of this activity in areas
(a) veterinary checks on animal health, prevention and control of diseases and diseases communicable from animals to humans;
(b) health surveillance of animal products, feed and water;
(c) monitoring of certain substances and residues thereof in animals, animal products, feed, water and environment.
(2) The reference laboratories shall carry out veterinary laboratory and diagnostic activities on certain other sections of that activity both in the areas referred to in paragraph 1 and in other veterinary care areas for which the national reference laboratory has not been approved.
(1) National reference laboratories are approved for:
(a) individual diseases and diseases communicable from animals to humans listed in specific legislation, (2) as well as for foot-and-mouth disease, classical swine fever, African horse sickness, avian influenza, Newcastle disease of poultry, fish diseases, bivalve molluscs and transmissible spongiform encephalopathy (TSE);
(b) analysis and testing of meat, meat products, milk, milk products, fish, other fishery products and products thereof;
(c) the detection of individual residues or groups thereof in animals, in their excrements, body fluids and tissues, in animal products, feed, water and environment.
(2) Reference laboratories are authorised to carry out laboratory tests taking into account the development of the disease situation, the presence of residues in animal products and other needs of national veterinary surveillance.
(1) National reference laboratories referred to in § 3 (1) (a) in their field of competence under § 51a of the Law
(a) coordinate the use of diagnostic methods and standards, optimise and update these methods and standards, depending on the development of science and technology;
(b) process used or newly introduced procedures in the form of standard operating procedures, ensure their accreditation and control their use in carrying out laboratory tests for the purpose of national veterinary supervision;
(c) provide other laboratories with technical and technical assistance and information, check their professional standards and assist them in providing standards and diagnostic reagents;
(d) regularly organise comparative tests for individual examinations and diagnostic methods and participate in international comparative tests organised by the relevant European Union reference laboratories and, where appropriate, other institutions;
(e) confirm the positive results of the tests carried out in other laboratories and provide them with technical assistance in identifying the relevant disease. In the event of disputed results, they shall give a reference result for the needs of national veterinary supervision,
(f) identify and retain isolates of the agents of the relevant disease from confirmed cases of that disease;
(g) cooperate with relevant European Union reference laboratories, including cooperation in the training and retraining of professionals;
(h) process and transmit to other laboratories the technical information obtained from the relevant European Union reference laboratories and, where appropriate, from other sources;
(i) submit annual reports on their activities to the Ministry of Agriculture (hereinafter referred to as the Ministry) and to the State Veterinary Administration; such reports shall consist of the professional and economic part.
(2) The national reference laboratories referred to in § 3 (1) (b) in their field of competence, in addition to the tasks referred to in paragraph 1 (d), (h) and (i) in particular:
(a) coordinate and control the activities of laboratories carrying out analyses and tests referred to in particular in the specific legislation laying down animal health requirements for meat, meat products, milk, milk products, fish, other fishery products and products thereof, in order to check compliance with chemical and microbiological standards (standards);
(b) provide the authorities carrying out national veterinary surveillance with professional assistance in the organisation of a health inspection system for animal products.
(3) National reference laboratories referred to in § 3 (1) (c) in their field of competence, in addition to the tasks referred to in paragraph 1 (d), (h) and (i)
(a) coordinate and control the activities of the other laboratories responsible for investigating the residues or groups of residues concerned, in particular the standards and methods of investigation for individual residues or groups of residues;
(b) provide technical assistance to the authorities carrying out national veterinary surveillance to draw up a monitoring plan for certain substances and residues thereof in animals, animal products, feed, water and the environment and to evaluate the results of the implementation of that plan.
(4) The reference laboratories carry out the tasks referred to in Article 4 in their field of competence, taking due account of the focus, nature and scope of their activities; submit annual reports on their activities to the State Veterinary Administration.
(1) The Ministry shall approve, pursuant to Article 44 (2) of the Act, the State Institute, the institution or any other establishment as a national reference laboratory if that Institute, institution or establishment is authorised to carry out the relevant type of examination; and
(a) it has:
1. adequate spatial, instrumentation and material equipment;
2. qualified staff, trained and sufficiently experienced in carrying out the diagnostic or analytical methods used and in evaluating their results;
3. technical and personnel conditions for addressing relevant professional issues at the highest possible level;
(b) carry out routine laboratory tests in the relevant field on a sufficient number of samples verified by reference methods and have the appropriate capacity to investigate the expected quantity of samples;
c) applies in its activities up-to-date knowledge and methods, as well as the exchange of expert information with a similar focus in the Czech Republic and abroad;
(d) make use of the possibility of processing and statistical evaluation of the results, as well as the remote transmission of digitised data within the framework of the Ministry's and State Veterinary Administration's information systems;
(e) comply with the rules on the protection of information and results of a confidential nature in accordance with a specific legal regulation.3)
(2) Where a national reference laboratory has not been approved for the relevant part of the veterinary laboratory and diagnostic activity, the competent national reference laboratory of a Member State of the European Union may be used by agreement.
(3) The application for approval of the national reference laboratory is submitted to the Ministry by a natural or legal person who is the laboratory operator.
(1) The State Veterinary Administration shall, in accordance with § 48 (1) (e) of the Act, approve the State Veterinary Institute, the Veterinary Institution or any other veterinary establishment authorised to carry out the appropriate type of examination as a reference laboratory if:
(a) it has adequate spatial, material, technical and personnel equipment for this activity;
(b) apply current knowledge and methods in its activities and is involved in the information system of the State Veterinary Administration.
(2) The application for approval of the reference laboratory is submitted by the natural or legal person operating the laboratory to the State Veterinary Administration.
(1) The Ministry publishes approved national reference and reference laboratories in the Bulletin of the Ministry of Agriculture of the Czech Republic pursuant to § 44 (2) of the Act.
(2) In determining the amount of funds provided from the State budget for the activities of the national reference laboratory or reference laboratory, account shall be taken of the extent and complexity of the anticipated activities of that laboratory in the relevant calendar year and of the report on its activities in the previous calendar year.
This decree shall take effect on the day of its publication.
Minister:
Ing. Palas v. r.
1) Council Directive 92 / 119 / EEC of 17.12.1992 introducing general Community measures for the control of certain animal diseases and specific measures in relation to swine vesicular disease. Council Directive 2000 / 75 / EC of 20.11.2000 laying down specific provisions for the control and eradication of bluetongue. Council Directive 2001 / 89 / EC of 23.10.2001 introducing Community measures for the control of classical swine fever. Council Directive 85 / 511 / EEC of 18.11.1985 introducing Community measures for the control of foot-and-mouth disease. Council Directive 92 / 40 / EEC of 19.5.1992 introducing Community measures for the control of avian influenza. Council Directive 92 / 66 / EEC of 14.7.1992 introducing Community measures for the control of Newcastle disease (pseudomonor of poultry). Council Directive 92 / 35 / EEC of 29.4.1992 laying down rules and measures to combat African horse sickness. Council Directive 93 / 53 / EEC of 24.6.1993 introducing minimum Community measures for the control of certain fish diseases. Council Directive 95 / 70 / EC of 22 December 1995 introducing minimum Community measures for the control of certain diseases affecting bivalve molluscs. Council Directive 92 / 117 / EEC of 17.12.1992 concerning measures to protect against certain zoonoses and specified zoonotic agents in animals and products of animal origin in order to prevent outbreaks of infection and intoxication caused by food. Council Directive 90 / 539 / EEC of 15.10.1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs. Council Directive 92 / 46 / EEC of 16.6.1992 laying down health rules for the production and marketing of raw milk, heat-treated milk and milk products. Council Directive 96 / 23 / EC of 29.4.1996 laying down the principles for the monitoring of certain substances and residues thereof in live animals and products of animal origin and repealing Directives 85 / 358 / EEC and 86 / 469 / EEC and Decisions 89 / 187 / EEC and 91 / 664 / EEC.
2) Annexes 1 and 20 to Decree No. 299 / 2003 Coll., on measures to prevent and control diseases and diseases communicable from animals to humans.
3) For example Act No. 101 / 2000 Coll., on the Protection of Personal Data and on the Amendment of Certain Acts, as amended by Act No. 227 / 2000 Coll., Act No. 177 / 2001 Coll., Act No. 450 / 2001 Coll., Act No. 107 / 2002 Coll., Act No. 309 / 2002 Coll., Act No. 310 / 2002 Coll. and Act No. 517 / 2002 Coll.
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Regulation Information
| Citation | Decree No. 298 / 2003 Coll., on national reference laboratories and reference laboratories |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 17.09.2003 |
|---|---|
| Effective from | 17.09.2003 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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