natgillin/translations-raw huggingface dataset:
Where the related reference product has been authorised by national authorisation or is the subject of an application for such an authorisation, applications for authorisation of a same product shall be submitted in accordance with Article 29(1) of Regulation (EU) No 528/2012 to the competent authority that has granted or is requested to grant the national authorisation of the related reference product.
Kadar je povezanemu referenčnemu proizvodu izdano nacionalno dovoljenje oziroma je bila zanj podana vloga za izdajo takšnega dovoljenja, se vloge za dovoljenje za enak proizvod vložijo v skladu s členom 29(1) Uredbe (EU) št. 528/2012 pristojnemu organu, ki je izdal ali je prejel zahtevek za izdajo nacionalnega dovoljenja za povezani referenčni proizvod.
By way of derogation from paragraphs 2 and 4 of Article 29 of Regulation (EU) No 528/2012, the competent authority shall validate the application within 30 days of accepting it, provided that the information indicated in Article 2 has been submitted.
Ne glede na odstavka 2 in 4 člena 29 Uredbe (EU) št. 528/2012 pristojni organ validira vlogo v 30 dneh po prejemu vloge, pod pogojem da so bile informacije iz člena 2 predložene.
The validation shall include a check that the proposed differences between the same product and the related reference product concern merely information which can be the subject of an administrative change in accordance with Implementing Regulation (EU) No 354/2013.
Validacija vključuje pregled, s katerim se potrdi, da predlagane razlike med enakim proizvodom in povezanim referenčnim proizvodom zadevajo zgolj informacije, ki so lahko predmet upravne spremembe v skladu z Izvedbeno uredbo (EU) št. 354/2013.
Submission and validation of applications for Union authorisation
Vložitev in validacija vlog za dovoljenje Unije
Where the related reference product has been authorised by Union authorisation or is the subject of an application for such an authorisation, applications for authorisation of a same product shall be submitted to the Agency in accordance with Article 43(1) of Regulation (EU) No 528/2012.
Kadar je povezanemu referenčnemu proizvodu izdano dovoljenje Unije oziroma je bila zanj podana vloga za izdajo takšnega dovoljenja, se vloge za dovoljenje za enak proizvod predložijo Agenciji v skladu s členom 43(1) Uredbe (EU) št. 528/2012.
However, the application shall not include a confirmation that the biocidal product would have similar conditions of use across the Union or a reference to an evaluating competent authority.
Vendar vloga ne vključuje potrdila, da bi se biocidni proizvod uporabljal pod podobnimi pogoji v različnih državah Unije, ali sklica na pristojni organ, ki je oceno opravil.
For the purposes of the application of this Article, Article 43(2) of Regulation (EU) No 528/2012 shall be read as requiring the Agency to inform the applicant only.
Za namene uporabe tega člena se člen 43(2) Uredbe (EU) št. 528/2012 razume tako, da se od Agencije zahteva, naj obvesti samo vlagatelja.
By way of derogation from the first and second subparagraphs of Article 43(3) of Regulation (EU) No 528/2012, the Agency shall validate the application within 30 days of accepting it provided that the information indicated in Article 2 has been submitted.
Ne glede na prvi in drugi pododstavek člena 43(3) Uredbe (EU) št. 528/2012 Agencija validira vlogo v 30 dneh po prejemu vloge, pod pogojem da so bile informacije iz člena 2 predložene.
For the purposes of the application of this Article, all references to the evaluating competent authority in the third subparagraph of Article 43(3) and in Article 43(4) and (5) of Regulation (EU) No 528/2012 shall be read as referring to the Agency.
Za namen uporabe tega člena se vsi sklici na pristojni organ, ki je opravil oceno, v tretjem pododstavku člena 43(3) ter v členu 43(4) in (5) Uredbe (EU) št. 528/2012 razumejo tako, da se nanašajo na Agencijo.
Evaluation and decision on applications for national authorisation
Ocena in odločitev v zvezi z vlogami za nacionalno dovoljenje
By way of derogation from Article 30 of Regulation (EU) No 528/2012, the receiving competent authority shall decide whether to grant or refuse authorisation of a same product in accordance with Article 19 of that Regulation within 60 days from the validation of the application in accordance with Article 3, or, where applicable, from the subsequent date of adoption of the corresponding decision concerning the related reference product.
Ne glede na člen 30 Uredbe (EU) št. 528/2012 pristojni organ, ki vlogo prejme, odloči, ali bo izdal ali zavrnil dovoljenje za enak proizvod v skladu s členom 19 navedene uredbe v 60 dneh od validacije vloge v skladu s členom 3 ali, če je primerno, od poznejšega datuma sprejetja odločitve v zvezi s povezanim referenčnim proizvodom.
Evaluation and decision on applications for Union authorisation
Ocena in odločitev v zvezi z vlogami za dovoljenje Unije
By way of derogation from Article 44(1), (2) and (3) of Regulation (EU) No 528/2012 the Agency shall prepare and submit to the Commission an opinion on the application within 30 days from the validation of the application in accordance with Article 4 of this Regulation, or, where applicable, on the subsequent date of submission of an opinion on the related reference product in accordance with Article 44(3) of Regulation (EU) No 528/2012.
Ne glede na člen 44(1), (2) in (3) Uredbe (EU) št. 528/2012 Agencija pripravi in predloži Komisiji mnenje o vlogi v 30 dneh od validacije vloge v skladu s členom 4 te uredbe ali, če je to primerno, na poznejši datum predložitve mnenja v zvezi s povezanim referenčnim proizvodom v skladu s členom 44(3) Uredbe (EU) št. 528/2012.
If the Agency recommends the authorisation of the biocidal product, the opinion shall contain at least both the following elements:
Če Agencija priporoči izdajo dovoljenja za biocidni proizvod, mnenje vsebuje najmanj oba naslednja elementa:
a statement on whether the conditions laid down in Article 19 of Regulation (EU) No 528/2012 are fulfilled, and a draft summary of biocidal products characteristics, as referred to in Article 22(2) of that Regulation;
izjavo, ali so pogoji iz člena 19 Uredbe (EU) št. 528/2012 izpolnjeni, in osnutek povzetka lastnosti biocidnega proizvoda, kot navaja člen 22(2) navedene uredbe;
where relevant, details of any terms and conditions which should be imposed on the making available on the market and use of the biocidal product.
po potrebi podrobnosti določil in pogojev, ki bi jih bilo treba uvesti za dostopnost na trgu in uporabo biocidnega proizvoda.
Authorisations and changes of same products
Dovoljenja in spremembe enakih proizvodov
A same product shall have a different authorisation number than that of the related reference product.
Enak proizvod ima drugačno številko dovoljenja kot povezani referenčni proizvod.
On all other aspects, the content of the authorisation of a same product shall be identical with that of the related reference product except in terms of the information in respect of which the products differ.
V zvezi z vsem ostalim pa mora biti vsebina dovoljenja za enak proizvod identična vsebini dovoljenja za povezani referenčni proizvod, razen kar zadeva tiste informacije, pri katerih se proizvoda razlikujeta.
The Register for Biocidal Products shall show a link between same products and related reference products.
V registru biocidnih proizvodov je razvidna povezava med enakimi proizvodi in povezanimi referenčnimi proizvodi.
Changes of a same product or of a related reference product shall be notified or applied for in accordance with Implementing Regulation (EU) No 354/2013 independently of each other.
O spremembah enakega proizvoda ali povezanega referenčnega proizvoda se obvesti oziroma se vloge za te spremembe predloži v skladu z Izvedbeno uredbo (EU) št. 354/2013, in sicer za vsako spremembo posamično.
Authorisations of a same product or of a related reference product may be changed or cancelled independently of each other.
Dovoljenja za enak proizvod ali povezani referenčni proizvod se lahko spremenijo ali prekličejo za vsak proizvod posamično.
However, in the evaluation of a proposed change of a same product or of a related reference product, the receiving competent authority or, where relevant, the Agency shall consider the appropriateness of cancelling or amending the authorisation of other products to which the product is linked in the Register for Biocidal Products as referred to in the second subparagraph of paragraph 1.
Vendar pristojni organ, ki vlogo prejme, ali, če je to ustrezno, Agencija pri oceni predlagane spremembe enakega proizvoda ali povezanega referenčnega proizvoda preuči primernost preklica ali spremembe dovoljenja za druge proizvode, s katerimi je proizvod povezan v registru biocidnih proizvodov, kot navaja drugi pododstavek odstavka 1.
OJ L 109, 19.4.2013, p. 4.
UL L 109, 19.4.2013, str. 4.
Commission Regulation (EU) No 415/2013
Uredba Komisije (EU) št. 415/2013
laying down additional responsibilities and tasks for the EU reference laboratories for rabies, bovine tuberculosis and bee health, amending Regulation (EC) No 737/2008 and repealing Regulation (EU) No 87/2011
o določitvi dodatnih pristojnosti in nalog referenčnih laboratorijev EU za steklino, govejo tuberkulozo in zdravstveno varstvo čebel, o spremembi Uredbe (ES) št. 737/2008 in razveljavitvi Uredbe (EU) št. 87/2011
Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and welfare rules [1], and in particular Article 32(6) thereof,
ob upoštevanju Uredbe (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali [1], ter zlasti člena 32(6) Uredbe,
Regulation (EC) No 882/2004 lays down the general functions and duties for the EU reference laboratories for food and feed and for animal health set out in Annex VII thereto.
Uredba (ES) št. 882/2004 določa splošne naloge in dolžnosti za referenčne laboratorije EU za živila in krmo ter zdravstveno varstvo živali, ki so določeni v Prilogi VII.
In addition, Regulation (EC) No 882/2004 provides that the Commission may include in Annex VII thereto other EU reference laboratories relevant to the areas falling within the scope of that Regulation.
Poleg tega Uredba (ES) št. 882/2004 določa, da Komisija lahko vključi v Prilogo VII druge referenčne laboratorije EU, pomembne za območja, ki spadajo v področje uporabe navedene uredbe.
Regulation (EC) No 882/2004 also provides that, in addition to the general functions and duties of EU reference laboratories in the animal health sector laid down therein, additional responsibilities and tasks for those EU reference laboratories may be laid down by the Commission.
Uredba (ES) št. 882/2004 določa tudi, da poleg glavnih nalog in dolžnosti referenčnih laboratorijev EU za zdravstveno varstvo živali, ki so v njej določene, Komisija lahko določi dodatne pristojnosti in naloge referenčnih laboratorijev EU.
By Commission Regulation (EC) No 737/2008 of 28 July 2008 designating the Community reference laboratories for crustacean diseases, rabies and bovine tuberculosis, laying down additional responsibilities and tasks for the Community reference laboratories for rabies and bovine tuberculosis and amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council [2], the Commission designated, inter alia, the EU reference laboratories for rabies and bovine tuberculosis and, consequently, inserted the relevant entries concerning those laboratories in Annex VII to Regulation (EC) No 882/2004.
Z Uredbo Komisije (ES) št. 737/2008 z dne 28. julija 2008 o imenovanju referenčnih laboratorijev Skupnosti za bolezni rakov, steklino in govejo tuberkulozo, določitvi dodatnih pristojnosti in nalog referenčnih laboratorijev Skupnosti za steklino in govejo tuberkulozo ter spremembi Priloge VII k Uredbi (ES) št. 882/2004 Evropskega parlamenta in Sveta [2] je Komisija med drugim imenovala referenčne laboratorije EU za steklino in govejo tuberkulozo ter posledično vstavila ustrezne vnose o navedenem laboratoriju v Prilogo VII k Uredbi (ES) št. 882/2004.
In addition, Annexes I and II to Regulation (EC) No 737/2008 set out certain specific responsibilities and tasks linked to the characteristics of the pathogens.
Poleg tega prilogi I in II k Uredbi (ES) št. 737/2008 določata nekatere posebne pristojnosti in naloge glede značilnosti patogenov.
Those responsibilities and tasks are additional to those laid down in Regulation (EC) No 882/2004.
Navedene pristojnosti in naloge so dodane k tistim iz Uredbe (ES) št. 882/2004.
By Commission Regulation (EU) No 87/2011 of 2 February 2011 designating the EU reference laboratory for bee health, laying down additional responsibilities and tasks for that laboratory and amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council [3], the Commission designated the EU reference laboratory for bee health and, consequently, inserted the relevant entry concerning that laboratory in Annex VII to Regulation (EC) No 882/2004.
Komisija je z Uredbo Komisije (EU) št. 87/2011 z dne 2. februarja 2011 o imenovanju referenčnega laboratorija EU za zdravstveno varstvo čebel, določitvi dodatnih pristojnosti in nalog navedenega laboratorija ter spremembi Priloge VII k Uredbi (ES) št. 882/2004 Evropskega parlamenta in Sveta [3] imenovala referenčni laboratorij EU za zdravstveno varstvo čebel in posledično vstavila ustrezni vnos o navedenem laboratoriju v Prilogo VII k Uredbi (ES) št. 882/2004.
In addition, the Annex to Regulation (EU) No 87/2011 sets out certain specific responsibilities and tasks linked to the characteristics of the agents liable to affect bee health.
Poleg tega Priloga k Uredbi (EU) št. 87/2011 določa nekatere posebne pristojnosti in naloge glede značilnosti povzročiteljev bolezni, ki bi lahko vplivali na zdravstveno varstvo čebel.
The definition of certain tasks of the EU reference laboratory for bee health in the Annex to Regulation (EU) No 87/2011 needs to be amended as regards serological tests because they are not applicable to testing on bees.
Opredelitev nekaterih nalog referenčnega laboratorija EU za zdravstveno varstvo čebel v Prilogi k Uredbi (EU) št. 87/2011 je treba spremeniti, kar zadeva serološke teste, ker se ne uporabljajo za testiranje na čebelah.
As well the mention of colony collapse disorder (CCD) should be modified in order to ensure consistency with the terminology used in the surveillance studies on bee mortality established in Commission Implementing Decision 2012/362/EU [4].
Spremeniti je treba tudi navedbo kolaps čebeljega roja (CCD), da se zagotovi usklajenost s terminologijo, ki se uporablja pri študijah spremljanja pogina čebel, določeno v Izvedbenem sklepu Komisije 2012/362/EU [4].
In the interest of clarity and simplification of Union legislation, it is appropriate that the provisions concerning those additional responsibilities and tasks of the EU reference laboratories for rabies, bovine tuberculosis and bee health be set out in only one act.
Zaradi jasnosti in poenostavitve zakonodaje Unije je zato primerno, da so določbe o navedenih dodatnih pristojnostih in nalogah referenčnih laboratorijev EU za steklino, govejo tuberkulozo in zdravstveno varstvo čebel določene le v enem pravnem aktu.
Regulation (EC) No 737/2008 should therefore be amended accordingly and Regulation (EU) No 87/2011 be repealed.
Uredbo (ES) št. 737/2008 bi bilo zato treba ustrezno spremeniti, Uredbo (EU) št. 87/2011 pa razveljaviti.
In addition to the general functions and duties of EU reference laboratories in the animal health sector laid down in Article 32(2) of Regulation (EC) No 882/2004, the EU reference laboratory for rabies set out in point 16 of Part II of Annex VII to that Regulation shall also have the responsibilities and tasks set out in Annex I to this Regulation.
Poleg glavnih nalog in dolžnosti referenčnih laboratorijev EU za zdravstveno varstvo živali iz člena 32(2) Uredbe (ES) št. 882/2004 ima referenčni laboratorij EU za steklino iz točke 16 dela II Priloge VII k navedeni uredbi tudi pristojnosti in naloge, določene v Prilogi I k tej uredbi.
In addition to the general functions and duties of EU reference laboratories in the animal health sector laid down in Article 32(2) of Regulation (EC) No 882/2004, the EU reference laboratory for bovine tuberculosis set out in point 17 of Part II of Annex VII to that Regulation shall also have the responsibilities and tasks set out in Annex II to this Regulation.
Poleg glavnih nalog in dolžnosti referenčnih laboratorijev EU za zdravstveno varstvo živali iz člena 32(2) Uredbe (ES) št. 882/2004 ima referenčni laboratorij EU za govejo tuberkulozo iz točke 17 dela II Priloge VII k navedeni uredbi tudi pristojnosti in naloge, določene v Prilogi II k tej uredbi.
In addition to the general functions and duties of EU reference laboratories in the animal health sector laid down in Article 32(2) of Regulation (EC) No 882/2004, the EU reference laboratory for bee health set out in point 18 of Part II of Annex VII to that Regulation shall also have the responsibilities and tasks set out in Annex III to this Regulation.
Poleg glavnih nalog in dolžnosti referenčnih laboratorijev EU za zdravstveno varstvo živali iz člena 32(2) Uredbe (ES) št. 882/2004 ima referenčni laboratorij EU za zdravstveno varstvo čebel iz točke 18 dela II Priloge VII k navedeni uredbi tudi pristojnosti in naloge, določene v Prilogi III k tej uredbi.
Regulation (EC) No 737/2008 is amended as follows:
Uredba (ES) št. 737/2008 se spremeni:
Articles 2 and 3 are deleted;
člena 2 in 3 se črtata;
Regulation (EU) No 87/2011 is repealed.
Uredba (EU) št. 87/2011 se razveljavi.
Responsibilities and tasks of the EU reference laboratory for rabies, additional to those laid down in Article 32(2) of Regulation (EC) No 882/2004
Pristojnosti in naloge referenčnega laboratorija EU za steklino, poleg tistih, določenih v členu 32(2) Uredbe (ES) št. 882/2004
The EU reference laboratory for rabies shall coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing rabies, in particular by:
Referenčni laboratorij EU za steklino po posvetovanju s Komisijo uskladi metode, ki se v državah članicah uporabljajo za diagnosticiranje stekline, zlasti:
preparing, controlling and supplying international standard sera and other reference reagents to the national reference laboratories in order to standardise the tests and reagents used in the Member States;
s pripravo, nadzorom in dobavljanjem mednarodnih standardnih serumov in drugih referenčnih reagentov nacionalnim referenčnim laboratorijem za standardizacijo testov in reagentov, ki se uporabljajo v državah članicah;
building up and maintaining a sera bank and a collection of rabies virus, and maintaining a database of strains isolated across the Union, including typing;
z vzpostavitvijo in vzdrževanjem banke serumov, zbiranjem virusa stekline ter vzdrževanjem podatkovne baze izoliranih sevov v vsej Uniji, vključno s tipizacijo;
organising periodical comparative tests of diagnostic procedures at Union level and operating laboratory proficiency tests of national reference laboratories;
z organizacijo rednih primerjalnih testov diagnostičnih postopkov na ravni Unije ter testov strokovnosti nacionalnih referenčnih laboratorijev;
collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Union;
z zbiranjem in primerjanjem podatkov in informacij o uporabljenih metodah diagnosticiranja in rezultatih testov, opravljenih v Uniji;
characterising rabies virus by the most up-to-date methods available to allow a greater understanding of the epidemiology of that disease;
z opredelitvijo virusa stekline z uporabo najsodobnejših razpoložljivih metod za izboljšanje razumevanja epidemiologije navedene bolezni;
The EU reference laboratory for rabies shall also:
Referenčni laboratorij EU za steklino tudi:
facilitate the harmonisation of techniques throughout the Union, in particular by specifying standard test methodologies;
pospešuje uskladitev tehnik v Uniji, zlasti z določanjem standardnih metod testov;
organise workshops for the benefit of national reference laboratories as agreed in the work programme and estimated budget referred to in Article 2 of Commission Implementing Regulation (EU) No 926/2011 [1], including training of experts from the Member States and, as appropriate, from third countries, in new analytical methodologies;
organizira delavnice za nacionalne referenčne laboratorije, kakor je določeno v delovnem programu in oceni proračuna iz člena 2 Izvedbene uredbe Komisije (EU) št. 926/2011 [1], vključno z usposabljanjem strokovnjakov držav članic in po potrebi tretjih držav o novih analitskih metodah;
provide technical assistance to the Commission and, upon its request, participate in international forums relating to rabies, concerning in particular the standardisation of analytical diagnostic methods and their implementation.
zagotavlja tehnično pomoč Komisiji in na njeno zahtevo sodeluje pri mednarodnih razpravah v zvezi s steklino, zlasti pri standardizaciji analitskih diagnostičnih metod in njihovega izvajanja.
In addition, the EU reference laboratory for rabies shall perform research activities and, whenever possible, coordinate research activities directed towards the improved control and eradication of rabies, in particular by:
Poleg tega referenčni laboratorij EU za steklino izvaja raziskovalne dejavnosti in, kadar je možno, usklajuje raziskovalne dejavnosti za izboljšanje nadzora in izkoreninjenje stekline, zlasti:
carrying out or collaborating with national reference laboratories in carrying out test validation trials;
s potrjevanjem testov ali sodelovanjem z nacionalnimi referenčnimi laboratoriji pri potrjevanju;
providing scientific advice to the Commission and collecting information and reports associated with the activities of the EU reference laboratory.
z znanstvenim svetovanjem Komisiji ter zbiranjem informacij in poročil o dejavnostih referenčnega laboratorija EU.
Responsibilities and tasks of the EU reference laboratory for bovine tuberculosis, additional to those laid down in Article 32(2) of Regulation (EC) No 882/2004
Pristojnosti in naloge referenčnega laboratorija EU za govejo tuberkulozo, poleg tistih, določenih v členu 32(2) Uredbe (ES) št. 882/2004
The EU reference laboratory for bovine tuberculosis shall coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing bovine tuberculosis, in particular by:
Referenčni laboratorij EU za govejo tuberkulozo po posvetu s Komisijo usklajuje metode, ki se v državah članicah uporabljajo za diagnosticiranje goveje tuberkuloze, zlasti:
typing, storing and supplying strains of Mycobacterium sp. causing tuberculosis in animals;
s tipizacijo, shranjevanjem in dobavljanjem sevov Mycobacterium sp., ki povzroča tuberkulozo pri živalih;
preparing, controlling and supplying reference reagents to the national reference laboratories in order to standardise the tests and reagents used in the Member States;
s pripravo, nadzorom in dobavljanjem referenčnih reagentov nacionalnim referenčnim laboratorijem za standardizacijo testov in reagentov, ki se uporabljajo v državah članicah;
building up and maintaining a collection of Mycobacterium sp. causing tuberculosis in animals, and maintaining a database of strains isolated across the Union including typing;
z vzpostavitvijo in vzdrževanjem banke Mycobacterium sp., ki povzroča tuberkulozo pri živalih, ter vzdrževanjem podatkovne baze izoliranih sevov v vsej Uniji, vključno s tipizacijo;
characterising Mycobacterium sp. causing tuberculosis in animals by the most up-to-date methods available to allow a greater understanding of the epidemiology of that disease;
z opredelitvijo Mycobacterium sp., ki povzroča tuberkulozo pri živalih, z uporabo najsodobnejših razpoložljivih metod za izboljšanje razumevanja epidemiologije navedene bolezni;