natgillin/translations-raw huggingface dataset:
advise on the maximum limits for residues of veterinary medicinal products and biocidal products used in animal husbandry which may be accepted in foodstuffs of animal origin in accordance with Regulation (EC) No 470/2009;
Če takega soglasja ni mogoče doseči, je mnenje sestavljeno iz stališča večine članov in odstopajočih stališč z razlogi, na katerih temeljijo.
provide scientific advice on the use of antimicrobials and antiparasitics in animals in order to minimise the occurrence of resistance in the Union, and update that advice when needed;
V primeru zahteve za ponovni pregled mnenja in kadar je ta možnost določena v pravu Unije, Odbor določi drugega poročevalca in po potrebi soporočevalca in ne istih, kot sta bila imenovana za mnenje.
provide objective scientific opinions to the Member States on the questions which are referred to the Committee.
Postopek ponovnega pregleda lahko obravnava samo posamezne dele mnenja, ki jih na začetku opredeli predlagatelj, in lahko temelji samo na znanstvenih podatkih, ki so bili na voljo, ko je Odbor sprejel mnenje.
The members of the Committee shall ensure that there is appropriate coordination between the tasks of the Agency and the work of competent authorities.
Predlagatelj lahko zahteva, da se Odbor v zvezi s ponovnim pregledom posvetuje z znanstveno svetovalno skupino.
When preparing opinions, the Committee shall use its best endeavours to reach a scientific consensus.
Člen 142
If such consensus cannot be reached, the opinion shall consist of the position of the majority of members and divergent positions, with the grounds on which they are based.
Usklajevalna skupina za postopek vzajemnega priznavanja in decentralizirani postopek za zdravila za uporabo v veterinarski medicini
If there is a request for re-examination of an opinion where this possibility is provided for in the Union law, the Committee shall appoint a different rapporteur and, where necessary, a different co-rapporteur from those appointed for the opinion.
Ustanovi se usklajevalna skupina za postopek vzajemnega priznavanja in decentralizirani postopek za zdravila za uporabo v veterinarski medicini (v nadaljnjem besedilu: usklajevalna skupina).
The re-examination procedure may deal only with the points of the opinion initially identified by the applicant and may be based only on the scientific data available when the Committee adopted the opinion.
Agencija za usklajevalno skupino zagotovi sekretariat, ki pomaga pri operacijah v okviru postopkov koordinacijske skupine in zagotavlja ustrezno povezavo med to skupino, Agencijo in pristojnimi organi.
The applicant may request that the Committee consult a scientific advisory group in connection with the re-examination.
Usklajevalna skupina pripravi svoj poslovnik, ki začne veljati po prejemu pozitivnega mnenja Komisije.
Article 142
Ta poslovnik se objavi.
Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products
Izvršni direktor Agencije ali njegov predstavnik in predstavniki Komisije imajo pravico biti navzoči na vseh srečanjih usklajevalne skupine.
The coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (‘the coordination group’) shall be set up.
Usklajevalna skupina tesno sodeluje s pristojnimi organi in Agencijo.
The Agency shall provide a secretariat for the coordination group to assist in the operations of the procedures of the coordination group and to ensure an appropriate liaison between this group, the Agency and competent authorities.
Člen 143
The coordination group shall draw up its rules of procedure, which shall enter into force after receiving a favourable opinion from the Commission.
Člani usklajevalne skupine
Those rules of procedure shall be made public.
Usklajevalna skupina je sestavljena iz enega predstavnika vsake države članice, imenovanega za obdobje treh let, ki se lahko podaljša za nadaljnja tri leta.
The Executive Director of the Agency or his or her representative and representatives of the Commission shall be entitled to attend all meetings of the coordination group.
Države članice lahko imenujejo njegovega namestnika.
The coordination group shall cooperate closely with the competent authorities and the Agency.
Člane skupine za usklajevanje lahko spremljajo strokovnjaki.
Article 143
Člani usklajevalne skupine in njihovi strokovnjaki se opirajo na znanstvene in regulativne vire, ki so na voljo njihovim pristojnim organom, na ustrezne znanstvene ocene in priporočila Odbora za izpolnjevanje njihovih nalog.
Members of the coordination group
Vsak pristojni organ spremlja kakovost vrednotenj svojega predstavnika in podpira njegove dejavnosti.
The coordination group shall be composed of one representative per Member State appointed for a renewable period of three years.
Člani usklajevalne skupine si po svojih najboljših močeh prizadevajo doseči soglasje o obravnavanih vprašanjih.
Member States may appoint an alternate representative.
Člen 144
Members of the coordination group may arrange to be accompanied by experts.
Naloge usklajevalne skupine
Members of the coordination group and their experts shall rely on the scientific and regulatory resources available to their competent authorities, on the relevant scientific assessments and on the recommendations of the Committee for the fulfilment of their tasks.
Usklajevalna skupina ima naslednje naloge:
Each competent authority shall monitor the quality of the evaluations carried out by their representative and facilitate their activities.
preučitev vprašanj v zvezi s postopkom vzajemnega priznavanja in decentraliziranim postopkom;
Members of the coordination group shall use their best endeavours to reach consensus on matters under discussion.
preučitev nasvetov delovne skupine za farmakovigilanco Odbora glede ukrepov za obvladovanje tveganj pri farmakovigilanci, povezanih z zdravili za uporabo v veterinarski medicini, odobrenih v državah članicah, ter izdajanje priporočil državam članicam in po potrebi imetnikom dovoljenj za promet;
Article 144
preučitev vprašanj v zvezi s spremembami pogojev dovoljenj za promet, ki jih izdajo države članice;
Tasks of the coordination group
priprava priporočil za države članice o tem, ali se posebno zdravilo za uporabo v veterinarski medicini ali skupina zdravil za uporabo v veterinarski medicini šteje za zdravilo za uporabo v veterinarski medicini, ki spada v področje uporabe te uredbe;
The coordination group shall have the following tasks:
usklajevanje izbora vodilnega organa, pristojnega za ocenjevanje rezultatov postopka obravnave signala iz člena 81(4);
examine questions concerning mutual recognition and decentralised procedures;
priprava in objava letnega seznama referenčnih zdravil za uporabo v veterinarski medicini, ki se harmonizira z glavnimi značilnostmi zdravil v skladu s členom 70(3).
examine advice from the pharmacovigilance working party of the Committee concerning risk management measures in pharmacovigilance related to veterinary medicinal products authorised in Member States and issue recommendations to the Member States and to the marketing authorisation holders, as necessary;
POGLAVJE XI
examine questions concerning variations to the terms of marketing authorisations granted by Member States;
SKUPNE IN POSTOPKOVNE DOLOČBE
provide recommendations to Member States whether a specific veterinary medicinal product or a group of veterinary medicinal products is to be considered a veterinary medicinal product within the scope of this Regulation;
Člen 145
coordinate the selection of the lead authority responsible for the assessment of the results of the signal management process referred to in Article 81(4);
Stalni odbor za zdravila za uporabo v veterinarski medicini
draw up and publish an annual list of reference veterinary medicinal products which shall be subject to harmonisation of the summaries of product characteristics in accordance with Article 70(3).
Komisiji pomaga Stalni odbor za zdravila za uporabo v veterinarski medicini (v nadaljnjem besedilu: Stalni odbor).
CHAPTER XI
Stalni odbor je odbor v smislu Uredbe (EU) št. 182/2011.
COMMON AND PROCEDURAL PROVISIONS
Pri sklicevanju na ta odstavek se uporablja člen 5 Uredbe (EU) št. 182/2011.
Article 145
Člen 146
Standing Committee on Veterinary Medicinal Products
Spremembe Priloge II
The Commission shall be assisted by the Standing Committee on Veterinary Medicinal Products (‘the Standing Committee’).
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 147(2) za spremembo Priloge II s prilagoditvijo zahtev glede tehnične dokumentacije o kakovosti, varnosti in učinkovitosti zdravil za uporabo v veterinarski medicini tehničnemu in znanstvenemu napredku.
The Standing Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
Komisija sprejme delegirane akte v skladu s členom 147(3) za spremembo Priloge II, da bi dosegla ustrezno raven podrobnosti za zagotovitev pravne varnosti in harmonizacijo ter potrebne posodobitve, pri tem pa preprečila nepotrebno zmedo glede Priloge II, tudi v zvezi z uvedbo posebnih zahtev za zdravila za uporabo v veterinarski medicini za nove terapije.
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Komisija pri sprejemanju teh delegiranih aktov ustrezno upošteva zdravje živali in javno zdravje ter okoljske vidike.
Article 146
Člen 147
Amendments to Annex II
Izvajanje prenosa pooblastila
The Commission is empowered to adopt delegated acts in accordance with Article 147(2) in order to amend Annex II by adapting the requirements regarding the technical documentation on the quality, safety and efficacy of veterinary medicinal products to technical and scientific progress.
Pooblastilo za sprejemanje delegiranih aktov je preneseno na Komisijo pod pogoji, določenimi v tem členu.
The Commission shall adopt delegated acts in accordance with Article 147(3) amending Annex II in order to achieve a sufficient level of detail that ensures legal certainty and harmonisation as well as any necessary updating, while avoiding unnecessary disruption with Annex II, including as regards the introduction of specific requirements for novel therapy veterinary medicinal products.
Prenos pooblastila se samodejno podaljšuje za enako dolga obdobja, razen če Evropski parlament ali Svet nasprotuje temu podaljšanju najpozneje tri mesece pred koncem vsakega obdobja.
When adopting those delegated acts, the Commission shall have due regard to animal and public health and environmental considerations.
Pooblastilo za sprejemanje delegiranih aktov iz člena 146(2) se prenese na Komisijo za obdobje od 27. januarja 2019 do 28. januarja 2022.
Article 147
Prenos pooblastila iz členov 37(4), 57(3), 106(6), 109(1), 115(3), 118(2), 136(7) ter 146(1) in (2) lahko kadar koli prekliče Evropski parlament ali Svet.
The power to adopt delegated acts referred to in Articles 37(4), 57(3), 106(6), 109(1), 115(3), 118(2), 136(7) and 146(1) and (2) shall be conferred on the Commission for a period of five years from 27 January 2019.
Sklep ne vpliva na veljavnost že veljavnih delegiranih aktov.
The delegation of power shall be tacitly extended for the periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Komisija takoj po sprejetju delegiranega akta o njem sočasno uradno obvesti Evropski parlament in Svet.
The power to adopt delegated acts referred to in Article 146(2) shall be conferred on the Commission for a period from 27 January 2019 until 28 January 2022.
Delegirani akt, sprejet na podlagi členov 37(4), 57(3), 106(6), 109(1), 115(3), 118(2), 136(7) ter 146(1) in (2), začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu o tem aktu ali če pred iztekom tega roka tako Evropski parlament kot Svet obvestita Komisijo, da mu ne bosta nasprotovala.
The delegation of power referred to in Articles 37(4), 57(3), 106(6), 109(1), 115(3), 118(2), 136(7) and 146(1) and (2) may be revoked at any time by the European Parliament or by the Council.
Ta rok se na pobudo Evropskega parlamenta ali Sveta podaljša za dva meseca.
A decision to revoke shall put an end to the delegation of the power specified in that decision.
Člen 148
It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein.
Varstvo podatkov
It shall not affect the validity of any delegated acts already in force.
Države članice za obdelavo osebnih podatkov v državah članicah v skladu s to uredbo uporabljajo Uredbo (EU) 2016/679 Evropskega parlamenta in Sveta.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law Making.
Komisija in Agencija za obdelavo osebnih podatkov v skladu s to uredbo uporabljata Uredbo (EU) 2018/1725 Evropskega parlamenta in Sveta.
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
POGLAVJE XII
A delegated act adopted pursuant to Articles 37(4), 57(3), 106(6), 109(1), 115(3), 118(2), 136(7) and 146(1) and (2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
PREHODNE IN KONČNE DOLOČBE
That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Člen 149
Article 148
Razveljavitev
Data protection
Direktiva 2001/82/ES se razveljavi.
Member States shall apply Regulation (EU) 2016/679 of the European Parliament and of the Council to the processing of personal data carried out in the Member States pursuant to this Regulation.
Sklicevanje na razveljavljeno direktivo se šteje za sklicevanje na to uredbo in se bere v skladu s korelacijsko tabelo iz Priloge IV.
Regulation (EU) 2018/1725 of the European Parliament and of the Council shall apply to the processing of personal data carried out by the Commission and the Agency pursuant to this Regulation.
Člen 150
CHAPTER XII
Povezanost z drugimi akti Unije
TRANSITIONAL AND FINAL PROVISIONS
Nobena določba v tej uredbi ne vpliva na določbe iz Direktive 96/22/ES.
Article 149
Uredba Komisije (ES) št. 1234/2008 se ne uporablja za zdravila za uporabo v veterinarski medicini, ki jih zajema ta uredba.
Repeal
Uredba Komisije (ES) št. 658/2007 se ne uporablja za zdravila za uporabo v veterinarski medicini, ki jih zajema ta uredba.
Directive 2001/82/EC is repealed.
Člen 151
References to the repealed Directive shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex IV.
Predhodne vloge
Article 150
Postopki glede vlog za pridobitev ali za spremembe dovoljenj za promet z zdravilom za uporabo v veterinarski medicini, potrjenih v skladu z Uredbo (ES) št. 726/2004 pred 28. januarjem 2022, se zaključijo v skladu z Uredbo (ES) št. 726/2004.
Relation with other Union acts
Postopki glede vlog za pridobitev dovoljenj za promet z zdravilom za uporabo v veterinarski medicini, potrjenih v skladu z Direktivo 2001/82/ES pred 28. januarjem 2022, se zaključijo v skladu z navedeno direktivo.
Nothing in this Regulation shall be understood to affect the provisions of Directive 96/22/EC.
Postopki, sproženi v skladu s členi 33, 34, 35, 39, 40 in 78 Direktive 2001/82/ES pred 28. januarjem 2022, se zaključijo v skladu z navedeno direktivo.
Commission Regulation (EC) No 1234/2008 shall not apply to veterinary medicinal products covered by this Regulation.
Člen 152
Commission Regulation (EC) No 658/2007 shall not apply to veterinary medicinal products covered by this Regulation.
Obstoječa zdravila za uporabo v veterinarski medicini, dovoljenja za promet in registracije
Article 151
Za dovoljenja za promet za zdravila za uporabo v veterinarski medicini in registracije homeopatskih zdravil za uporabo v veterinarski medicini, izdana v skladu z Direktivo 2001/82/ES ali Uredbo (ES) št. 726/2004 pred 28. januarjem 2022, se šteje, da so bila izdana v skladu s to uredbo, zato zanje veljajo ustrezne določbe te uredbe.
Prior applications
Prvi pododstavek tega odstavka se ne uporablja za dovoljenja za promet za protimikrobna zdravila za uporabo v veterinarski medicini, ki vsebujejo protimikrobne snovi in ki so bila rezervirana za zdravljenje ljudi skladno z izvedbenimi akti iz člena 37(5).
The procedures concerning the applications for marketing authorisations for veterinary medicinal products or for variations that have been validated in accordance with Regulation (EC) No 726/2004 before 28 January 2022 shall be completed in accordance with Regulation (EC) No 726/2004.
Zdravila za uporabo v veterinarski medicini, dana v promet v skladu z Direktivo 2001/82/ES ali Uredbo (ES) št. 726/2004, se lahko še naprej dajejo na voljo do 29. januarja 2027, tudi če niso v skladu s to uredbo.
The procedures concerning the applications for marketing authorisations for veterinary medicinal products that have been validated in accordance with Directive 2001/82/EC before 28 January 2022 shall be completed in accordance with that Directive.
Z odstopanjem od odstavka 1 tega člena se obdobja varstva iz člena 39 ne uporabljajo za referenčna zdravila za uporabo v veterinarski medicini, za katera je bilo dovoljenje izdano pred 28. januarjem 2022, temveč se namesto tega še naprej uporabljajo ustrezne določbe razveljavljenih aktov iz odstavka 1 tega člena.
Procedures initiated on the basis of Articles 33, 34, 35, 39, 40 and 78 of Directive 2001/82/EC before 28 January 2022 shall be completed in accordance with that Directive.
Člen 153
Article 152
Prehodne določbe v zvezi z delegiranimi in izvedbenimi akti
Existing veterinary medicinal products, marketing authorisations and registrations
Brez poseganja v datum začetka uporabe te uredbe Komisija sprejme delegirane akte iz členov 57(3) in 146(2) ter izvedbene akte iz členov 55(3) in 60(1) najpozneje do 27. januarja 2021 Ti delegirani in izvedbeni akti se uporabljajo od 28. januarja 2022.
Marketing authorisations of veterinary medicinal products and registrations of homeopathic veterinary medicinal products granted in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 before 28 January 2022 shall be deemed to have been issued in accordance with this Regulation, and are, as such, subject to the relevant provisions of this Regulation.
Komisija pri sprejemanju delegiranih in izvedbenih aktov iz tega člena zagotovi dovolj časa med njihovim sprejetjem in začetkom uporabe.
The first subparagraph of this paragraph shall not apply to marketing authorisations for antimicrobial veterinary medicinal products containing antimicrobials which have been reserved for treatment in humans in accordance with implementing acts referred to in Article 37(5).
Člen 154
Veterinary medicinal products placed on the market in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 may continue to be made available until 29 January 2027, even if they are not in compliance with this Regulation.
Vzpostavitev zbirke podatkov o farmakovigilanci ter zbirke podatkov o proizvodnji in prometu na debelo
Transitional provisions regarding delegated and implementing acts
Začetni prispevek pristojnih organov k zbirki podatkov o zdravilih
Without prejudice to the date of application of this Regulation, the Commission shall adopt the delegated acts referred to in Article 37(4) at the latest by 27 September 2021.
Pregled pravil za oceno tveganja za okolje
Such delegated acts shall apply from 28 January 2022.
Komisija Evropskemu parlamentu in Svetu do 28. januarja 2022 predloži poročilo o študiji izvedljivosti o sistemu za pregledovanje učinkovin (monografij) in drugih morebitnih načinih za oceno tveganja za okolje pri zdravilih za uporabo v veterinarski medicini ter tej študiji po potrebi priloži zakonodajni predlog.
Without prejudice to the date of application of this Regulation, the Commission shall adopt the delegated acts referred to in Articles 57(3) and 146(2) and the implementing acts referred to in Articles 55(3) and 60(1) at the latest by 27 January 2021.
Člen 157
Such delegated and implementing acts shall apply from 28 January 2022.
Poročilo Komisije o tradicionalnih zdravilih rastlinskega izvora, ki se uporabljajo za zdravljenje živali
Without prejudice to the date of application of this Regulation, the Commission shall adopt the delegated acts referred to in Article 109(1) and the implementing acts referred to in Articles 17(2) and (3), 93(2), 109(2) and 115(5) at the latest by 29 January 2025.
Komisija do 29. januarja 2027 poroča Evropskemu parlamentu in Svetu o tradicionalnih zdravilih rastlinskega izvora, ki se v Uniji uporabljajo za zdravljenje živali.
Such delegated and implementing acts shall apply at the earliest on 28 January 2022.
Komisija po potrebi pripravi zakonodajni predlog za uvedbo poenostavljenega sistema za registracijo tradicionalnih zdravil rastlinskega izvora, ki se uporabljajo za zdravljenje živali.
Without prejudice to the date of application of this Regulation, the Commission is empowered to adopt delegated and implementing acts provided for in this Regulation as from 27 January 2019.
Države članice Komisiji zagotovijo informacije o takih tradicionalnih zdravilih rastlinskega izvora na svojih ozemljih.
Such delegated and implementing acts, unless otherwise provided in this Regulation, shall apply from 28 January 2022.
Člen 158
When adopting the delegated and implementing acts referred to in this Article, the Commission shall allow sufficient time between their adoption and their start of application.
Pregled ukrepov glede živali iz vrst enoprstih kopitarjev
Article 154
Komisija najpozneje 29. januarja 2025 Evropskemu parlamentu in Svetu predloži poročilo o oceni razmer glede zdravljenja živali iz vrst enoprstih kopitarjev z zdravili in njihove izključitve iz prehranske verige, vključno v zvezi z uvozom živali iz vrst enoprstih kopitarjev iz tretjih držav, ki ga spremlja ustrezen ukrep Komisije, pri čemer se upoštevajo zlasti javno zdravje, dobrobit živali, tveganja za goljufije in enaki konkurenčni pogoji s tretjimi državami.
Establishment of the pharmacovigilance database and of the manufacturing and wholesale distribution database
Člen 159
Without prejudice to the date of application of this Regulation, the Agency, in collaboration with the Member States and the Commission, shall, in accordance with Articles 74 and 91 respectively, ensure the establishment of the pharmacovigilance database and of the manufacturing and wholesale distribution database at the latest by 28 January 2022.
Prehodne določbe v zvezi z nekaterimi potrdili o dobri proizvodni praksi
Article 155
Brez poseganja v datum začetka uporabe te uredbe se obveznosti v zvezi s potrdili o dobri proizvodni praksi za inaktivirana imunološka zdravila za uporabo v veterinarski medicini, ki se proizvajajo iz patogenov in antigenov iz ene ali več živali v epidemiološki enoti in se uporabljajo za zdravljenje te živali ali teh živali v isti epidemiološki enoti ali za zdravljenje te živali ali teh živali v enoti, ki ima potrjeno epidemiološko povezavo, začnejo uporabljati šele od datuma začetka uporabe izvedbenih aktov, ki določajo posebne ukrepe o dobri proizvodni praksi za zdravila za uporabo v veterinarski medicini iz člena 93(2).
Initial input to the product database by competent authorities
Člen 160
At the latest by 28 January 2022, the competent authorities shall submit, electronically, information on all veterinary medicinal products authorised in their Member State at that time to the Agency, using the format referred to in point (a) of Article 55(3).
Začetek veljavnosti in uporaba
Article 156
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
Review of rules for environmental risk assessment
Uporablja se od 28. januarja 2022.