298/2003 Coll.
Decree
from day 1. September 2003
the national reference laboratories and reference laboratories
The Ministry of agriculture lays down pursuant to § 78 of Act No. 167/1999 Coll., on the
veterinary care and amending certain related laws (health
Act), as amended by Act No. 131/2003 Coll. (hereinafter the "Act") to perform
§ 51a para. 3 of the Act:
§ 1
This Decree regulates in accordance with the law of the European Communities ^ 1)
and material requirements and) personnel facilities the national reference
laboratories and reference laboratories,
(b)) the focus, organization and methods of work of the national reference
laboratories and reference laboratories.
§ 2
(1) the national reference laboratories are specialized professional
the workplace carrying out veterinary laboratory and diagnostic activities
on selected sections of this activity in the areas of
a) veterinary checks on animal health, prevention and control (control)
diseases and diseases transmissible from animals to man,
b) surveillance of the safety of animal products, animal feed, and
water,
(c) the monitoring of certain substances) and their residues in animals, animal
products, feed, water and environment.
(2) the reference laboratory shall carry out veterinary laboratory and
the diagnostic activity on some of the other sections of this activity, both in the
the areas referred to in paragraph 1, as well as in other areas of veterinary
care for which has not been approved by the national reference laboratory.
§ 3
(1) the national reference laboratories are in compliance with the requirements of the law
Of the European Communities approved for
and the individual disease and sickness) transmitted from animals to man as referred to in
a special legal regulation, ^ 2) as well as for foot-and-mouth disease
classical swine fever, African horse sickness, avian disease, Newcastle disease
poultry, fish diseases, diseases of bivalve molluscs and transmissible spongiform
encephalopathies (TSEs),
(b)) for analysis and testing of meat, meat products, milk, milk products,
fish, fishing products and other products made from them,
(c) discovery of individual residues) or their groups in animals, in
their excrement and body fluids and in tissue, animal
products, feed, water and environment.
(2) reference laboratories are approved to carry out the laboratory
examination with a view to the development of the epidemiological situation, the occurrence of residues in
animal products and other needs of State surveillance.
§ 4
(1) the national reference laboratories referred to in § 3 (1). 1 (b). and)
the scope of its competence according to section 51a of the law
and) coordinate the use of diagnostic methods and standards, optimize
and these methods and standards are updated depending on the development of science and
techniques,
(b)) process used or newly implemented procedures to form
standard operating procedures, provide their accreditation and
control their use when carrying out laboratory tests to
the needs of the State veterinary supervision,
(c) provide support to other laboratories) and technical assistance and training
information, check their level of expertise and help them when you
providing standards and diagnostic reagents,
(d) they shall arrange comparative tests periodically) for each examination and
diagnostic methods and take part in international comparative tests
organised by the relevant European Union reference laboratories,
where appropriate, the other institutions,
e) confirm the positive results of the examination carried out in other
laboratories and provide them with technical assistance in identifying the appropriate
of the disease. In the case of disputed results be issued for the needs of the State
the veterinary supervision of the so-called. the reference result
f) identify and shall hold isolates of the agents of the disease,
originating in confirmed cases of the disease,
g) collaborate with the relevant European Union reference laboratories,
including cooperation in training and retraining of specialists,
h) processed and transmitted to other laboratories technical information
obtained from the relevant European Union reference laboratories, as appropriate,
and from other sources,
I) submitted annual reports on its activities to the Ministry of agriculture
(hereinafter referred to as "the Ministry") and the State Veterinary Administration; These messages are
composed of professional and economic section.
(2) the national reference laboratories referred to in § 3 (1). 1 (b). (b))
the scope of their jurisdiction in addition to the tasks referred to in paragraph 1 (b). (d)), h) and
I), in particular
and coordinate and control activities) of the laboratories carrying out analyses
and tests referred to in particular in specific legislation
lays down the animal health requirements for meat, meat products, milk, milk
other products, fish, fishery products and products thereof, for the purpose of
checks on compliance with the chemical and microbiological standards (standards),
(b) the authorities of the executing State) to provide veterinary supervision training
assistance in the Organization of health inspection
of animal products.
(3) the national reference laboratories referred to in § 3 (1). 1 (b). (c))
the scope of their jurisdiction in addition to the tasks referred to in paragraph 1 (b). (d)), h) and
I)
and coordinate and control activities) other laboratories responsible for the
an investigation of the relevant residue or residue group, in particular, standards
and methods of investigation for each residue or group of residues,
(b) the authorities of the executing State) to provide veterinary supervision training
assistance in drawing up the plan for the monitoring of certain substances and residues thereof
in animals, animal products, animal feed, water and environment
evaluation of the results of implementation of this plan.
(4) the reference laboratories in the field of their jurisdiction, the tasks referred to in §
4, mutatis mutandis, with regard to the focus, the nature and extent of their
activity; shall submit annual reports on its activities to the State Veterinary
Administration.
§ 5
(1) the Ministry shall approve, pursuant to section 44 para. 2 of the Act the State Institute,
institution, or other device, such as a national reference laboratory
If this Institute, institutions or establishments is competent to carry out
the appropriate type of medical examination and
and to do so)
1. appropriate spatial and material equipment, instrumentation,
2. qualified personnel, trained and sufficiently experienced in the implementation of the
diagnosis or analytical methods and evaluation
their results,
3. technical and personnel prerequisites for the solution of relevant professional
questions at the highest possible level,
(b)) performs in the field in routine laboratory tests on
a sufficient number of samples verified reference methods and has
adequate capacity for the investigation of the suspected number of samples,
c) applies in his activities of current knowledge and methods, as well as
mutual exchange of information with a similar focus in the workplace
The Czech Republic and abroad,
(d)) uses the processing and statistical evaluation options
the results, as well as the long-range transmission of digitized data within the
the information systems of the Ministry and the State Veterinary Administration,
e) adheres to the rules of protection of information and the results of a confidential nature according to the
special legislation. ^ 3)
(2) If for the given section of the veterinary laboratory and diagnostic
activities approved by the national reference laboratory, can be based on
the agreement used the services of competent national reference laboratories
a Member State of the European Union.
(3) an application for the approval of the national reference laboratories shall submit
the Ministry of the natural or legal person who is the operator of
the lab.
§ 6
(1) the State Veterinary Administration pursuant to § 48 para. 1 (b). (e))
the law of the State Veterinary Institute, health institution or other
veterinary equipment, authorised to carry out the corresponding type
reference laboratory tests, such as, if
and for this activity) has a corresponding spatial, material, technical and
personnel equipment
(b)) applies in his activities of current knowledge and methods, and is involved in the
the information system of the State Veterinary Administration.
(2) an application for the approval of reference laboratories shall submit to the State
the Veterinary Administration of the natural or legal person who is the
operator of the lab.
§ 7
(1) the Ministry shall publish pursuant to § 44 para. 2 of the law approved by the national
reference and reference laboratory in the Department of agriculture
Of the Czech Republic.
(2) in determining the amount of funds provided from the State budget on the
the activities of the national reference laboratory or a reference laboratory
take into account the extent and intensity of the projected activities of the laboratory
in the calendar year and to report on its activities in
preceding calendar year.
§ 8
This Decree shall take effect on the date of its publication.
Minister:
Ing. Palas in r.
1) Council Directive 92/119/EEC of 17.12.1992 misleading General
Community measures for the control of certain animal diseases, as well as
specific measures in relation to swine vesicular disease.
Council Directive 2000/75/EC establishing the specific 20.11.2000
provisions for the control and eradication of bluetongue.
Council Directive 2001/89/EC of 23.10.2001 misleading measures
The community for the eradication of classical swine fever.
Council Directive 85/511/EEC of 18.11.1985 misleading measures
Community for the control of foot-and-mouth.
Council Directive 92/40/EEC of 19.5.1992 misleading measures
Community for the control of avian influenza.
Council Directive 92/66/EEC of 14.7.1992 misleading measures
Community for the control of Newcastle disease (pseudomoru).
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 misleading minimum measures
Community for the control of certain fish diseases.
Council Directive 95/70/EC of 22.12.1995 misleading minimum measures
Community for the control of certain diseases of bivalve molluscs.
Council Directive 92/117/EEC of 17.12.1992 concerning measures to
protection against certain zoonoses and specific designers of zoonoses in animals and
products of animal origin in order to prevent food-borne infections and
intoxication caused by foodstuffs.
Council Directive 90/539/EEC of 15.10.1990, concerns animal health
the conditions governing trade in poultry and hatching eggs
within the community and imports from third countries.
Council Directive 92/46/EEC of 16.6.1992 laying down hygiene
rules for the production and placing on the market of raw milk, heat-treated
milk and milk products.
Council Directive 96/23/EC of 29.4.1996, which lays down the principles
the monitoring of certain substances and residues thereof in live animals and in
products of animal origin, and repealing directives 85/358/EEC and
86/469/EEC and decisions 89/187/EEC and 91/664/EEC.
2) Annex No. 1 and 20 to Decree No 296/2003 Coll., on measures for the
the prevention and control of diseases and diseases transmissible from animals to humans.
3) for example, Act No. 101/2000 Coll., on the protection of personal data and on amendments
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. 312/2002 Coll. and Act No. 517/2002 Sb.