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1–50/137
pooblaščeni laboratorij
1 Objavljeno
RS
Ur. l. RS, št. MP 39
Podatki o zdravstveni ustreznosti živil, odvzetih v okviru notranjega in uradnega nadzora in preiskani v pooblaščenih laboratorijih javnih zdravstvenih zavodov v Republiki Sloveniji v obdobju do leta 2000, so glede števila in izbranih parametrov neprimerljivi z rezultati iz let 2002-2003, ko smo v Republiki Sloveniji pristopili k rednemu programiranemu uradnemu nadzoru nad živili.
Data on the health and hygiene suitability of foodstuffs, taken in the framework of internal and official health control and examined in authorized laboratories of public health institutes in the Republic of Slovenia in the period up to 2000, are not comparable, as concerns the number of selected parameters, with the results from years 2002-2003, when regular planned official control of foodstauffs has been introduced in the Republic of Slovenia.
2 Končna redakcija
gospodarstvo
CELEX: 31999R1493
Imenujejo tudi laboratorije, pooblaščene za opravljanje uradnih analiz na področju vina.
They shall also designate the laboratories authorised to carry out official analyses in the wine sector.
3 Končna redakcija
CELEX: 32004L0027
v členu 114(1) in (2) se izraz “v državnem laboratoriju ali laboratoriju, pooblaščenem za ta namen” nadomesti z “v Uradnem kontrolnem laboratoriju za preskušanje zdravil ali laboratoriju, ki ga je za ta namen pooblastila država članica”;
in Article 114(1) and (2), the terms "by a State laboratory or a laboratory designated for that purpose" shall be replaced by the terms "by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose";
4 Končna redakcija
CELEX: 32004L0028
jemanje vzorcev, vključno za neodvisne analize v uradnem kontrolnem laboratoriju za analizno preskušanje zdravil ali laboratoriju, ki je bil za ta namen pooblaščen s strani države članice;
take samples including with a view to an independent analysis by an Official Medicines Control Laboratory or by a laboratory designated for that purpose by a Member State;
5 Končna redakcija
CELEX: 32004R0648
Vsaka država članica pošlje drugi državi članici in Komisiji seznam odobrenih laboratorijev, z njihovim polnim imenom in naslovom, ki so pristojni in pooblaščeni za izvajanje preskusov, zahtevanih s to uredbo.
Each Member State shall notify to the other Member States and to the Commission the list of approved laboratories, with their full name and address, that are competent and authorised to carry out the tests required by this Regulation.
6 Končna redakcija
DRUGO
opravljajo teste v pooblaščenih laboratorijih na vseh surovinah in končnih izdelkih za preverjanje skladnosti z zahtevami iz Priloge C k Direktivi 92/46/EGS, vključno z mikrobiološkimi merili za izdelke na osnovi mleka.
conduct tests in approved laboratories on all raw and finished products to verify their compliance with the requirements of Annex C to Directive 92/46/EEC, including the microbiological criteria for milk-based products.
7 Končna redakcija
CELEX: 32004L0027
v napovednem stavku se besedilo “členi 8 in 10(1)” nadomesti s “členi 8, 10, 10a, 10b in 10c”;(a) v točki 1 se besedilo “členoma 8 in 10(1)” nadomesti s “členi 8, 10, 10a, 10b in 10c”;(c) v točki 2 se besedilo “državnemu laboratoriju ali laboratoriju, pooblaščenemu za ta namen” nadomesti z “Uradnemu kontrolnemu laboratoriju za analizno preskušanje zdravil ali laboratoriju, ki ga je za ta namen pooblastila država članica”;(a) v točki 3 se besedilo “členov 8(3) in 10(1)” nadomesti z “členov 8(3), 10, 10a, 10b in 10c”;
in the introductory sentence, "Articles 8 and 10(1)" shall be replaced by "Articles 8, 10, 10a, 10b and 10c"; (b) in point 1, "Articles 8 and 10(1)" shall be replaced by "Articles 8, 10, 10a, 10b and 10c"; (c) in point 2, "a State laboratory or a laboratory designated for that purpose" shall be replaced by "an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose"; (d) in point 3, "Articles 8(3) and 10(1)" shall be replaced by "Articles 8(3), 10, 10a, 10b and 10c";
8 Končna redakcija
CELEX: 32004L0028
Pristojni organ zadevne države članice s ponavljajočimi in če je potrebno, z nenajavljenimi inšpekcijskimi pregledi ter, kadar je to primerno, z zahtevo, da uradni državni laboratorij ali laboratorij, pooblaščen za ta namen, opravi preskuse na vzorcih, zagotovi, da se izpolnjujejo pravne zahteve glede zdravil za uporabo v veterinarski medicini.
The competent authority of the Member State concerned shall ensure, by means of repeated inspections and, if necessary, unannounced inspections, and where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to conduct tests on samples, that the legal requirements relating to veterinary medicinal products are complied with.
9 Končna redakcija
CELEX: 32004L0027
Pristojni organ zadevne države članice s ponavljajočimi inšpekcijskimi pregledi in, če je potrebno, z nenapovedanimi pregledi, ter s prošnjo za testiranje vzorcev, naslovljeno na Uradni kontrolni laboratorij za preskušanje zdravil ali laboratorij, pooblaščen za ta namen, zagotovi, da se pravne zahteve, ki urejajo področje zdravil, izpolnjujejo.
The competent authority of the Member State concerned shall ensure, by means of repeated inspections, and if necessary unannounced inspections, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples, that the legal requirements governing medicinal products are complied with.
10 Končna redakcija
CELEX: 32004R0648
Standardi za akreditacijo, dobra laboratorijska praksa in zaščita živali, povezani z laboratoriji, ki so usposobljeni in pooblaščeni za izvajanje potrebnih storitev preverjanja skladnosti detrgentov z zahtevami te uredbe in njenih prilog
Standards of accreditation, good laboratory practice and animal protection concerning the laboratories that are competent and authorised to provide the necessary service for checking compliance of detergents with the requirements of this Regulation and its Annexes
11 Končna redakcija
gospodarstvo
CELEX: 32002D0106
Če tipizacije virusa ni mogoče v kratkem času opraviti v nacionalnem laboratoriju ali v katerem koli laboratoriju, pooblaščenem za postavljanje diagnoze klasične prašičje kuge, je treba prvotni vzorec ali izolat virusa čim prej poslati v tipizacijo v referenčni laboratorij Skupnosti.
If virus typing cannot be performed in a national laboratory or in any other laboratory authorised to diagnose classical swine fever within a short delay, the original sample or the virus isolate must be sent to the Community Reference Laboratory for typing as soon as possible.
12 Končna redakcija
CELEX: 32004L0028
lahko predložijo zdravilo, njegove vhodne materiale in če je potrebno, vmesne spojine ali druge sestavine v preskušanje uradnemu državnemu laboratoriju za kontrolo zdravil ali laboratoriju, ki je bil za ta namen pooblaščen s strani države članice, da bi zagotovili, da so metode preskušanja, ki jih je uporabil izdelovalec in ki so opisane v predloženi dokumentaciji, v skladu s točko (i) prvega pododstavka člena 12(3), ustrezne;
may submit the medicinal product, its starting materials and if necessary intermediate products or other constituent materials for testing by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose, in order to ensure that the testing methods employed by the manufacturer and described in the application documents, in accordance with point (i) of the first subparagraph of Article 12(3), are satisfactory;
13 Končna redakcija
gospodarstvo
CELEX: 32002D0106
Podatke o tipizaciji in določenem nukleotidnim zaporedjem izolatov virusa klasične prašičje kuge, s katerimi razpolagajo pooblaščeni laboratoriji za ugotavljanje klasične prašičje kuge, je treba posredovati referenčnemu laboratoriju Skupnosti zaradi vnosa teh podatkov v podatkovno bazo tega laboratorija.
The data on typing and sequencing of classical swine fever virus isolates available to the laboratories authorised to diagnose classical swine fever must be forwarded to the Community Reference Laboratory in order that this information is entered into the database kept by this laboratory.
14 Končna redakcija
CELEX: 32004L0028
Na zahtevo pristojnih organov mora imetnik dovoljenja za promet z zdravilom predložiti svoje tehnično poročilo, da omogoči izvajanje analizne metode določanja zaostankov zdravila za uporabo v veterinarski medicini v državnem referenčnem laboratoriju, pooblaščenem v skladu z Direktivo 96/23/ES z dne 29. aprila 1996 o nadzornih ukrepih določenih snovi in njihovih zaostankov v živih živalih in živalskih izdelkih [12].
At the competent authority's request, the marketing authorisation holder shall provide his technical expertise to facilitate the implementation of the analytical method for detecting residues of the veterinary medicinal products in the national reference laboratory designated under Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products(12).
15 Končna redakcija
CELEX: 32004R0021
Komisija bi morala, zlasti v zvezi s postopki, ki jih vodi Skupno raziskovalno središče, pripraviti podrobne tehnične smernice, opredelitve in postopke za tehnične značilnosti identifikacijskih oznak in čitalcev, preskusne postopke, merila sprejemljivosti in vzorce certificiranja za pooblaščene testne laboratorije, za nabavo primernih identifikacijskih oznak in čitalcev, za nameščanje identifikacijskih oznak, njihovo odčitavanje in odvzem, kodifikacijo identifikacijskih oznak, enotno terminologijo, podatkovni slovar in komunikacijske standarde.
The Commission, in particular in the light of the proceedings conducted by its Joint Research Centre, should also provide detailed technical guidelines, definitions and procedures for the technical characteristics of identifiers and readers, test procedures, acceptance criteria and the certification model for approved test laboratories, the procurement of appropriate identifiers and readers, the application of identifiers, their reading and recovery, the codification of identifiers, a common glossary, a data dictionary and communication standards.
16 Pravna redakcija
DRUGO
začetnega tipskega preskušanja proizvoda, ki ga opravi pooblaščeni laboratorij;
initial type-testing of the product by an approved laboratory;
17 Pravna redakcija
DRUGO
Odobreni/pooblaščeni laboratorij (za namen te direktive), odgovoren za izvajanje preskusov:
Approved/recognized laboratory (for the purpose of this Directive) responsible for carrying out the test.
18 Pravna redakcija
finance
CELEX: 31995L0054
Odobreni/pooblaščeni laboratorij (za namen te direktive), odgovoren za izvajanje preskusov:
Approved/recognized laboratory (for the purpose of this Directive) responsible for carrying out the tests:
19 Pravna redakcija
DRUGO
"pooblaščeni laboratorij" je laboratorij na ozemlju države članice, ki ga pristojni veterinarski organ pooblasti za opravljanje diagnostičnihpreiskav, predvidenih s to direktivo;
'approved laboratory' shall mean a laboratory located in the territory of a Member State, approved by the competent veterinary authority, under its responsibility, for the purpose of carrying out the diagnostic tests provided for in this Directive;
20 Pravna redakcija
DRUGO
"pooblaščeni laboratorij" pomeni laboratorij, ki se nahaja na ozemlju države članice in ki ga pristojni organ pooblasti, da pod njegovo odgovornostjo izvaja preiskave, predvidene v tej odločbi.
'approved laboratory' shall mean a laboratory located in the territory of a Member State, designated by the competent authority, under its responsibility, to carry out the examinations provided for in this Decision.
21 Pravna redakcija
finance
CELEX: 32003R2003
Pooblaščeni Pristojni laboratoriji
Competent laboratories
22 Pravna redakcija
DRUGO
Pooblaščeni nacionalni referenčni laboratorij mora:
The designated national reference laboratory is to:
23 Pravna redakcija
DRUGO
mikrobiološki pregledi vsebine in posod v laboratoriju obrata ali v drugem pooblaščenem laboratoriju;
microbiological examination of contents and containers in the establishment's laboratory or in another approved laboratory;
24 Pravna redakcija
DRUGO
seznam laboratorijev, pooblaščenih za izvajanje analiz na namene nadzora,
a list of laboratories entrusted with conducting analyses for the purposes of controls,
25 Pravna redakcija
DRUGO
svoje sezname laboratorijev, pooblaščenih za izvajanje analiz v skladu s členom 22 (2);
their lists of laboratories authorised to perform analyses in accordance with Article 22(2);
26 Pravna redakcija
DRUGO
spremljajo in nadzirajo kakovost vseh reagentov, ki jih uporabljajo pooblaščeni laboratoriji;
they monitor the quality of all the reagents used by the approved laboratories;
27 Pravna redakcija
DRUGO
lahko pooblaščenim laboratorijem dobavljajo reagente, ki so potrebni za diagnostičnopreiskave;
they may supply approved laboratories with the reagents needed for diagnostic testing;
28 Pravna redakcija
DRUGO
"pooblaščeni diagnostični laboratorij" pomeni laboratorij na ozemlju države članice ali tretje države, ki ga je pooblaščeni veterinarski organ odobril za opravljanje diagnostičnih testov, določenih v tej direktivi.
'approved diagnostic laboratory' means a laboratory situated in the territory of a Member State or third country approved by the competent veterinary authority to carry out the diagnostic tests laid down in this Directive.
29 Pravna redakcija
DRUGO
Ta pregled se opravi bodisi v proizvodnem obratu, če to dovoli pristojni organ, ali pa v pooblaščenem laboratoriju.
These tests must be carried out either in the production plant, if it is recognized by the competent authority, or in an approved laboratory.
30 Pravna redakcija
DRUGO
“Namenjeni kontrolni vzorec se lahko pregleda samo v laboratoriju, pooblaščenem za opravljanje kontrolnih analiz.
'The reserved control sample may be examined only by a laboratory authorised to carry out control analyses.
31 Pravna redakcija
DRUGO
Če se pojavi kužna bolezen perutnine, je rezultate laboratorijskih preiskav treba nemudoma sporočiti pooblaščenemu veterinarju.
Where a contagious poultry disease occurs, the results of laboratory tests must be communicated immediately to the authorized veterinarian.
32 Pravna redakcija
DRUGO
Treba je zagotoviti kakovost in primerljivost rezultatov analiz, ki jih pridobijo pooblaščeni laboratoriji za uraden nadzor ostankov.
It is necessary to ensure the quality and comparability of the analytical results generated by laboratories approved for official residue control.
33 Pravna redakcija
DRUGO
Še več, pooblaščeni laboratoriji morajo dokazati njihovo pristojnost z redno in uspešno udeležbo v ustreznih programih preskusov strokovne usposobljenosti, ki jih priznavajo ali organizirajo nacionalni referenčni laboratoriji ali referenčni laboratoriji Skupnosti.
Moreover, approved laboratories must prove their competence by regular and successful participation in adequate proficiency testing schemes recognised or organised by the national or Community reference laboratories.
34 Pravna redakcija
obramba
CELEX: 32003D0493
- nekateri laboratoriji, pooblaščeni za izvajanje analiz za namene izvoznega potrjevanja, ne dajejo točnih ali zanesljivih rezultatov,
- some laboratories entitled to perform analysis for the purposes of export certification do not produce accurate or dependable results,
35 Pravna redakcija
DRUGO
Odgovorna oseba preskuševalnega laboratorija pomeni osebo, ki je pooblaščena in je odgovorna za organizacijo in delovanje preskuševalnega laboratorija v skladu s temi načeli dobre laboratorijske prakse.
Test facility management means the person(s) who has the authority and formal responsibility for the organisation and functioning of the test facility according to these principles of good laboratory practice.
36 Pravna redakcija
gospodarstvo
CELEX: 31992D0608
Spoštovati jih morajo pristojne oblasti držav članic in pooblaščeni laboratoriji, ki so zadolženi za vzorčenje in preskušanje mleka.
Competent authorities of Member States and enforcement laboratories charged with the sampling and testing of milk must respect these provisions.
37 Pravna redakcija
promet
Seznam organov, agencij in laboratorijev, ki so pooblaščeni za izpolnjevanje potrdila iz točke 1.5, pogodbenici pripravita skupaj in si ga izmenjata.
The list of the authorities, agencies and laboratories authorised to complete the certificate referred to in point 1.5 shall be drawn up jointly and exchanged between the Parties.
38 Pravna redakcija
DRUGO
jemanje vzorcev za analizo v laboratoriju, pooblaščenem s strani pristojnih organov, zaradi preverjanja skladnosti s standardi, določenimi v tej direktivi,
taking samples for analysis in a laboratory accredited by the responsible official body for the purpose of checking compliance with the standards established by this Directive,
39 Pravna redakcija
DRUGO
prenos vzorcev do pooblaščenega laboratorija, kjer se opravi virološka in/ali serološka preiskava za odkrivanje virusa IHN in, kadar je potrebno, virusa VHS;
the transfer of samples to an approved laboratory for submission there to a virological and/or serological examination for the detection of IHN and, where relevant, VHS viruses;
40 Pravna redakcija
DRUGO
Pri vsakem vzorčenem deležu je treba v pooblaščeni analitični laboratorij skupaj s potrebnimi podatki za analitika čim hitreje poslati vsaj en končni vzorec.
For each sample portion at least one final sample shall be sent as quickly as possible to an authorized analytical laboratory, together with the information necessary for the analyst.
41 Pravna redakcija
DRUGO
Kakor hitro se pojavi sum na bolezen, mora pooblaščeni veterinar pooblaščenemu laboratoriju poslati vzorce, ki so potrebni za določitev ali potrditev diagnoze.
As soon as disease is suspected, the authorized veterinarian must send the samples needed for making or confirming the diagnosis to an approved laboratory.
42 Pravna redakcija
DRUGO
Komisija lahko na podlagi rezultatov pripravi seznam laboratorijev, pooblaščenih za izvajanje serološke titracije pri mesojedih živalih, cepljenih proti steklini.
The Commission can draw up a list, based on appraisal results, of laboratories authorised to carry out serological titration on carnivores vaccinated against rabies.
43 Pravna redakcija
gospodarstvo
CELEX: 32004D0233
(8) Komisija lahko na podlagi rezultatov ocene pripravi seznam laboratorijev, pooblaščenih za izvajanje serološke titracije pri mesojedih živalih, cepljenih proti steklini.
(8) The Commission can draw up a list, based on appraisal results, of laboratories authorised to carry out serological titration on carnivores vaccinated against rabies.
44 Pravna redakcija
finance
CELEX: 32003R2003
B. STANDARDI ZA AKREDITACIJO LABORATORIJEV, KI SO POOBLAŠČENI ZA OPRAVLJANJE POTREBNIH STORITEV PRI PREVERJANJU GNOJIL ES GLEDE IZPOLNJEVANJA ZAHTEV TE UREDBE IN PRILOG K UREDBI
B. STANDARDS OF ACCREDITATION CONCERNING THE LABORATORIES THAT ARE COMPETENT TO PROVIDE THE NECESSARY SERVICE FOR CHECKING COMPLIANCE OF EC FERTILISERS WITH THE REQUIREMENTS OF THIS REGULATION AND ITS ANNEXES
45 Pravna redakcija
promet
V začetnem obdobju iz člena 11 pooblaščeni organi v Skupnosti preverijo skladnost izraelskih preskuševalnih laboratorijev z DLP, kakor je opisano v priloženem potrjenem zapisniku.
During the initial period referred to in Article 11, the empowered authorities in the Community shall verify conformity of the test facilities with GLP in Israel, as described in the attached Agreed Minutes.
46 Pravna redakcija
promet
Organi, pooblaščeni ali imenovani na svojih ozemljih za preverjanje skladnosti preskuševalnih laboratorijev z načeli dobre laboratorijske prakse, so navedeni v Prilogi II k temu sporazumu.
The authorities empowered or designated in their respective territories to verify the conformity of the test facilities with the principles of good laboratory practice are listed in Annex II to this Agreement.
47 Pravna redakcija
DRUGO
lahko zaprosi, da v državnem laboratoriju ali pooblaščenem laboratoriju preskusijo zdravilo, njegove vhodne snovi, in če je treba, njegove vmesne spojine ali druge sestavine, da se zagotovi ustreznost kontrolnih metod, ki jih uporablja izdelovalec in so opisane v dokumentaciji vloge;
may ask for a State laboratory or a laboratory designated for this purpose to test the medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials in order to ensure that the control methods employed by the manufacturer and described in the application documents are satisfactory;
48 Pravna redakcija
finance
CELEX: 32003R2003
Za vsak vzorčeni delež se pooblaščenemu analitskemu laboratoriju ali ustanovi za preskušanje, skupaj s potrebnimi podatki za analizo ali preskus, čim hitreje pošlje vsaj en končni vzorec.
For each sample portion at least one final sample shall be sent as quickly as possible to an authorised analytical laboratory or to the test institution, together with the information necessary for the analysis or the test.
49 Pravna redakcija
DRUGO
Država članica lahko zahteva, če meni, da je potrebno, da imetnik dovoljenja za promet z imunološkim zdravilom predloži vzorce vsake serije, iz zbirnega vsebnika in/ali zdravila v preskušanje državnemu laboratoriju, ali pooblaščenemu laboratoriju, preden se zdravilo sprosti v promet.
Where it considers it necessary, a Member State may require the marketing authorization holder for immunological products to submit samples from the batches of the bulk and/or medical product for examination by a State laboratory or an approved laboratory before entry into circulation.
50 Pravna redakcija
DRUGO
pristojni organ jemlje vzorce za analizo v pooblaščenem laboratoriju za preverjanje učinkovitosti metod čiščenja in razkuževanja ter za preverjanje skladnosti s standardi, ki jih določa ta direktiva;
taking samples for analysis in an approved laboratory by the competent authority for the purpose of checking cleaning and disinfection methods and for the purpose of checking compliance with the standards established by this Directive;
Prevodi: sl > en
1–50/137
pooblaščeni laboratorij