The National Reference Laboratories And Reference Laboratories

Original Language Title: o národních referenčních laboratořích a referenčních laboratořích

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=55873&nr=298~2F2003~20Sb.&ft=txt

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.