natgillin/translations-raw huggingface dataset:
Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing oxamyl to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC.
Brez poseganja v obveznosti, opredeljene v Direktivi 91/414/EGS kot posledica vključitve aktivne snovi v Prilogo I, je državam članicam treba dovoliti, da v roku šestih mesecev po vključitvi snovi pregledajo obstoječe registracije za fitofarmacevtska sredstva, ki vsebujejo oksamil, da zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13 in ustreznih pogojev iz Priloge I. Po potrebi države članice v skladu z določbami Direktive 91/414/EGS obstoječe registracije spremenijo, nadomestijo ali prekličejo.
Member States shall adopt and publish, by 31 January 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice najpozneje do 31. januarja 2007 sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo.
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Komisiji takoj posredujejo besedila teh predpisov in primerjalno tabelo med temi predpisi in direktivo.
They shall apply those provisions from 1 February 2007.
Te predpise začnejo uporabljati od 1. februarja 2007.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing oxamyl as an active substance by 31 January 2007.
Države članice v skladu z Direktivo 91/414/EGS do 31. januarja 2007 po potrebi spremenijo ali prekličejo obstoječe registracije za fitofarmacevtska sredstva, ki kot aktivno snov vsebujejo oksamil.
By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to oxamyl are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
Do tega datuma zlasti preverijo, če so izpolnjeni pogoji iz Priloge I k navedeni direktivi v zvezi z oksamilom, razen tistih iz dela B besedila, ki se nanaša na navedeno aktivno snov, in če ima imetnik registracije dokumentacijo ali dostop do dokumentacije, ki izpolnjuje zahteve iz Priloge II k navedeni direktivi v skladu s pogoji iz člena 13.
By derogation from paragraph 1, for each authorised plant protection product containing oxamyl as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 July 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning oxamyl.
Z odstopanjem od odstavka 1 države članice najpozneje do 30. julija 2006 znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje oksamil bodisi kot edino aktivno snov bodisi kot eno izmed več aktivnih snovi, naštetih v Prilogi I k Direktivi 91/414/EGS, v skladu z enotnimi načeli iz Priloge VI k Direktivi 91/414/EGS na podlagi dokumentacije, ki izpolnjuje zahteve iz Priloge III k navedeni direktivi, in ob upoštevanju dela B besedila, ki se nanaša na oksamil, iz Priloge I k navedeni direktivi.
in the case of a product containing oxamyl as the only active substance, where necessary, amend or withdraw the authorisation by 30 July 2010 at the latest; or
po potrebi najpozneje do 30. julija 2010 spremenijo ali prekličejo registracijo, če sredstvo vsebuje oksamil kot edino aktivno snov; ali
in the case of a product containing oxamyl as one of several active substances, where necessary, amend or withdraw the authorisation by 30 July 2010 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
po potrebi spremenijo ali prekličejo registracijo, če fitofarmacevtsko sredstvo vsebuje oksamil kot eno izmed več aktivnih snovi, in sicer najpozneje do 30. julija 2010 ali do datuma, določenega za tako spremembo ali preklic registracije v ustrezni direktivi ali direktivah, s katero(-imi) je bila zadevna snov ali so bile zadevne snovi dodana(-e) v Prilogo I k Direktivi 91/414/EGS, pri čemer se upošteva kasnejši datum.
This Directive shall enter into force on 1 August 2006.
Ta direktiva začne veljati 1. avgusta 2006.
EFSA Scientific Report (2005) 26, 1-78, Conclusion on the peer review of the pesticide risk assessment of the active substance Oxamyl (finalised: 14 January 2005).
Znanstveno poročilo EFSA (2005) 26, 1–78, Sklep o strokovnem pregledu ocene nevarnosti aktivne snovi oksamila (finalizirano: 14. januarja 2005).
The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC
Na konec tabele v Prilogi I k Direktivi 91/414/EGS se doda naslednje besedilo
Expiration of inclusion
Potek uvrstitve
CAS No 23135-22-0
Št. CAS 23135-22-0
CIPAC No 342
Št. CIPAC 342
N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide
N,N-dimetil-2-metilkarbamoiloksiimino-2-(metiltio) acetamid
1 August 2006
avgust 2006
31 July 2016
julij 2016
Only uses as nematicide and insecticide may be authorised.
Registrira se lahko samo kot nematicid ali insekticid.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on oxamyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2005 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za oksamil, in zlasti dodatkov I in II k poročilu, kot je bilo dokončno oblikovano v Stalnem odboru za prehranjevalno verigo in zdravje živali 15. julija 2005.
In this overall assessment,
V tej celoviti oceni
Member States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations.
morajo države članice posvetiti posebno pozornost zaščiti ptic in sesalcev, deževnikov, vodnih organizmov, površinskih voda in podtalnice v občutljivih razmerah.
Conditions of authorisation should include risk mitigation measures, where appropriate.
Pogoji registracije morajo po potrebi vključevati ukrepe za zmanjšanje tveganja,
Member States must pay particular attention to the operator safety.
države članice morajo posvetiti posebno pozornost zaščiti izvajalcev.
Conditions of authorisation should include protective measures, where appropriate.
Pogoji registracije morajo po potrebi vključevati zaščitne ukrepe.
The concerned Member States shall request the submission of further studies to confirm the risk assessment for ground water contamination in acidic soils, birds and mammals and earthworms.
Zadevne države članice zahtevajo predložitev nadaljnjih študij za potrditev ocene tveganja za onesnaženje podtalnice pri kislih tleh ter za ptice, sesalce in deževnike.
They shall ensure that the notifiers at whose request oxamyl has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.’
Zagotovijo, da prijavitelji, na katerih zahtevo je bil oksamil vključen v to prilogo, te študije predložijo Komisiji v 2 letih od začetka veljavnosti te direktive.“
Commission Directive 2006/17/EC
Direktiva Komisije 2006/17/ES
implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
o izvajanju Direktive 2004/23/ES Evropskega parlamenta in Sveta o nekaterih tehničnih zahtevah za darovanje, pridobivanje in testiranje človeških tkiv in celic
Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(a) thereof,
ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti in zlasti člena 152(4)(a) Pogodbe,
Having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [1], and in particular points (b), (d), (e), (f), and (i) of Article 28 thereof,
ob upoštevanju Direktive 2004/23/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o določitvi standardov kakovosti in varnosti za darovanje, pridobivanje, testiranje, predelavo, konzerviranje, shranjevanje in razdeljevanje človeških tkiv in celic [1], in zlasti točk (b), (d), (e), (f) in (i) člena 28 Direktive,
Directive 2004/23/EC lays down standards of quality and safety for the donation, procurement and testing of all human tissues and cells intended for human applications, and of manufactured products derived from human tissues and cells intended for human applications, so as to ensure a high level of human health protection.
Direktiva 2004/23/ES določa standarde kakovosti in varnosti za darovanje, pridobivanje in testiranje vseh človeških tkiv in celic, namenjenih za zdravljenje ljudi, ter industrijskih izdelkov na podlagi človeških tkiv in celic, namenjenih za zdravljenje ljudi, da se zagotovi visoka raven varovanja zdravja ljudi.
In order to prevent the transmission of diseases by human tissues and cells for human applications and to ensure an equivalent level of quality and safety, Directive 2004/23/EC calls for the establishment of specific technical requirements for each one of the steps in the human tissue and cell application process.
Za preprečitev prenosa bolezni s človeškimi tkivi in celicami za zdravljenje ljudi ter za zagotovitev enake ravni kakovosti in varnosti, Direktiva 2004/23/ES poziva k vzpostavitvi posebnih tehničnih zahtev za vsak posamezen korak v postopku uporabe človeških tkiv in celic.
The use of tissues and cells for application in the human body carries a risk of disease transmission and other potential adverse effects in recipients.
Pri uporabi tkiv in celic za zdravljenje ljudi obstaja tveganje za prenos bolezni in druge morebitne neželene učinke za prejemnike.
That risk can be reduced by careful donor selection, testing of each donation and the application of procedures to procure tissues and cells in accordance with rules and processes established and updated according to the best available scientific advice.
To tveganje se lahko zmanjša s pazljivo izbiro darovalcev, testiranjem vsakega darovanja in uporabo postopkov za pridobivanje tkiv in celic v skladu s pravili in postopki, določenimi in posodobljenimi ob upoštevanju najboljših razpoložljivih znanstvenih priporočil.
Therefore, all tissues and cells, including those used as starting material for the manufacture of medicinal products, to be used in the Community should meet the quality and safety requirements laid down in this Directive.
Zato morajo vsa tkiva in celice, vključno s tistimi, ki se uporabljajo kot začetni material za proizvodnjo zdravil, namenjenih za uporabo v Skupnosti, ustrezati zahtevam v zvezi s kakovostjo in varnostjo iz te direktive.
Reproductive cells have, due to the specific nature of their application, specific quality and safety characteristics that are taken into account in this Directive.
Reproduktivne celice imajo zaradi posebne narave njihove uporabe posebne kakovostne in varnostne značilnosti, ki so upoštevane v tej direktivi.
For the donation of reproductive cells between partners that have an intimate physical relationship, it is justified to require less stringent biological testing, given that in this case the risk for the recipient is considered less than for donation from third parties.
Pri darovanju reproduktivnih celic med partnerjema, ki imata intimen fizičen odnos, je upravičeno, da se zahteva manj bioloških testov, glede na to, da je v tem primeru tveganje za prejemnika načeloma manjše, kot pri darovanju tretjih oseb.
In order to minimise the risk of cross-contamination, biological testing of the donor will be necessary only when the donated cells will be processed, cultured or stored.
Za zmanjšanje tveganj za navzkrižno kontaminacijo je biološko testiranje darovalca potrebno samo, če so darovane celice predelane, gojene ali shranjene.
This Directive is based on international experience drawn upon through an extensive consultation, the Council of Europe’s Guide to safety and quality assurance for organs, tissues and cells, the European Convention on Human Rights, the Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4.IV.1997), with its additional protocols, and recommendations from the World Health Organisation.
Ta direktiva temelji na mednarodnih izkušnjah, pridobljenih prek obsežnega posvetovanja, Navodil za zagotavljanje varnosti in kakovosti organov, tkiv in celic, Evropske konvencije o človekovih pravicah, Konvencije o varstvu človekovih pravic in dostojanstva človeškega bitja v zvezi z uporabo biologije in medicine: Konvencije o človekovih pravicah v zvezi z biomedicino (Oviedo, 4.IV.1997) Sveta Evrope ter njenih dodatnih protokolov in priporočil Svetovne zdravstvene organizacije.
In particular, with regard to further additional biological testing for donors originating from high-incidence areas of specific diseases or whose sexual partners or parents originate from high-incidence areas, Member States will refer to existing international scientific evidence.
Še zlasti v zvezi z nadaljnjimi dodatnimi biološkimi testiranji darovalcev, ki izvirajo z območij z visoko pojavnostjo določenih bolezni, ali katerih spolni partnerji ali starši izvirajo z območij z visoko pojavnostjo, se države članice sklicujejo na obstoječe mednarodne znanstvene dokaze.
The Directive is consistent with the fundamental principles set out in the European Charter of Fundamental Rights.
Direktiva je v skladu s temeljnimi načeli, navedenimi v Evropski listini o temeljnih pravicah.
The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2004/23/EC,
Ukrepi iz te direktive so v skladu z mnenjem Odbora, ustanovljenega z Direktivo 2004/23/ES –
For the purposes of this Directive, the following definitions apply:
V tej direktivi se uporabljajo naslednje opredelitve:
‘reproductive cells’ means all tissues and cells intended to be used for the purpose of assisted reproduction;
„reproduktivne celice“ pomenijo vsa tkiva in celice za uporabo v asistirani reprodukciji;
‘partner donation’ means the donation of reproductive cells between a man and a woman who declare that they have an intimate physical relationship;
„darovanje med partnerjema“ pomeni darovanje reproduktivnih celic med moškim in žensko, ki izjavita, da imata intimen fizičen odnos;
‘direct use’ means any procedure where cells are donated and used without any banking;
„neposredna uporaba“ pomeni vsak postopek, kjer so celice darovane in uporabljene brez kakršnega koli shranjevanja;
‘quality system’ means the organisational structure, defined responsibilities, procedures, processes, and resources for implementing quality management and includes all activities which contribute to quality, directly or indirectly;
„sistem kakovosti“ pomeni organizacijsko strukturo, določene odgovornosti, postopke, procese in sredstva za izvajanje upravljanja kakovosti ter vključuje vse dejavnosti, ki neposredno in posredno prispevajo h kakovosti;
‘standard operating procedures’ (SOPs) means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product;
„standardni operativni postopki (SOP)“ pomenijo pisna navodila, ki opisujejo korake posebnega procesa, vključno z materiali in metodami, ki se uporabljajo, ter pričakovanim končnim izdelkom;
‘validation’ (or ‘qualification’ in the case of equipment or environments) means establishing documented evidence that provides a high degree of assurance that a specific process, SOP, piece of equipment or environment will consistently produce a product meeting its predetermined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use;
„validacija“ (ali „kvalifikacija“ v primeru opreme ali okolja) pomeni priprava dokumentiranega dokaza, ki z visoko stopnjo zagotavlja, da bodo specifični proces, SOP, kos opreme ali okolje vedno proizvajali izdelek, ki ustreza svojim vnaprej določenim specifikacijam in kakovostnim lastnostim; postopek se validira z namenom ovrednotenja delovanja sistema glede njegove učinkovitosti za predvideno uporabo;
‘traceability’ means the ability to locate and identify the tissue/cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storing the tissue/cells, and the ability to identify the recipient(s) at the medical facility/facilities applying the tissue/cells to the recipient(s); traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues/cells;
„sledljivost“ pomeni zmožnost ugotavljanja položaja in identifikacije tkiva/celice na vsakem koraku od njegovega/njenega pridobivanja, med predelavo, testiranjem in shranjevanjem, vse do razdeljevanja prejemniku ali odstranitvijo, ki vključuje zmožnost identifikacije darovalca in tkivne ustanove, ali proizvodnega obrata, ki prejme, predela ali shrani tkivo/celice, ter zmožnost identifikacije prejemnika(-ov) v zdravstveni(-h) ustanovi(-ah), ki tkivo/celice presadijo na prejemnika(-e); sledljivost pomeni tudi zmožnostjo ugotavljanja položaja in identifikacije vseh ustreznih podatkov, povezanih z izdelki in materiali, ki pridejo v stik s temi tkivi/celicami;
‘procurement organisation’ means a health care establishment or a unit of a hospital or another body that undertakes the procurement of human tissues and cells and that may not be accredited, designated, authorised or licensed as a tissue establishment.
„organizacija za pridobivanje“ pomeni zdravstveno ustanovo ali enoto bolnišnice ali drugo telo, ki izvaja dejavnosti pridobivanja človeških tkiv in celic in ni potrebno, da ima akreditacijo, imenovanje, odobritev ali dovoljenje za tkivno ustanovo.
Requirements for the procurement of human tissues and cells
Zahteve za pridobivanje človeških tkiv in celic
With the exception of partner donation of reproductive cells for direct use, Member States shall ensure that the procurement of human tissues and cells is accredited, designated, authorised or licensed only when the requirements in paragraphs 2 to 12 are met.
Z izjemo darovanja reproduktivnih celic med partnerjema za neposredno uporabo države članice zagotovijo, da je pridobivanje človeških tkiv in celic akreditirano, imenovano, ima odobritev ali dovoljenje samo kadar so izpolnjene zahteve iz odstavkov 2 do 12.
Procurement of human tissues and cells shall be carried out by persons who have successfully completed a training programme specified by a clinical team specialising in the tissues and cells to be procured or a tissue establishment authorised for procurement.
Pridobivanje človeških tkiv in celic opravljajo osebe, ki so uspešno zaključile program usposabljanja, ki ga določi klinična skupina, specializirana za tkiva in celice, ki jih je treba pridobiti, ali tkivna ustanova, ki ima odobritev za pridobivanje.
The tissue establishment or procurement organisation shall have written agreements with the staff or clinical teams responsible for donor selection, unless they are employed by the same organisation or establishment, specifying the procedures to be followed to assure compliance with the selection criteria for donors set out in Annex I.
Tkivna ustanova ali organizacija za pridobivanje ima z osebjem ali kliničnimi skupinami, odgovornimi za izbor darovalcev, razen če so zaposleni pri isti organizaciji ali ustanovi, sklenjene pisne sporazume, v katerih so določeni postopki, ki jih je treba upoštevati za zagotovitev skladnosti z merili za izbor darovalcev iz Priloge I.
The tissue establishment or procurement organisation shall have written agreements with the staff or clinical teams responsible for tissue/cell procurement, unless they are employed by the same establishment or organisation, specifying the type(s) of tissues and/or cells and/or test samples to be procured and the protocols to be followed.
Tkivna ustanova ali organizacija za pridobivanje ima z osebjem ali kliničnimi skupinami, odgovornimi za pridobivanje tkiv/celic, razen če so zaposleni v isti ustanovi ali organizaciji, sklenjene pisne sporazume, v katerih je/so določena(-e) vrsta(-e) tkiv in/ali celic in/ali vzorcev za testiranje, ki jih je treba priskrbeti, ter protokoli, ki jih je treba upoštevati.
There shall be standard operating procedures (SOPs) for the verification of:
Standardni operativni postopki (SOP) se uporabljajo za preverjanje:
donor identity;
identitete darovalca;
the details of donor or donor family consent or authorisation;
podrobnosti o privolitvi ali odobritvi darovalca ali darovalčeve družine;
the assessment of the selection criteria for donors as detailed in Article 3;
ocenjevanje meril za izbor darovalcev, kot je opredeljeno v členu 3;
the assessment of the laboratory tests required for donors as detailed in Article 4.
ocenjevanje potrebnega laboratorijskega testiranja darovalcev, kot je opredeljeno v členu 4.
There shall also be SOPs describing the procedures for procurement, packaging, labelling and transportation of the tissues and cells to the point of arrival at the tissue establishment or, in the case of direct distribution of tissues and cells, to the clinical team responsible for their application or, in the case of tissue/cell samples, to the laboratory for testing, in accordance with Article 5 of this Directive.
Obstajajo tudi SOP, ki opisujejo postopke za pridobivanje, pakiranje, označevanje ter prevoz tkiv in celic do točke prihoda v tkivno ustanovo ali, v primeru neposrednega razdeljevanja tkiv in celic, do klinične skupine, odgovorne za njihovo uporabo ali, v primeru vzorcev tkiv/celic, do laboratorija za testiranje, v skladu s členom 5 te direktive.
Procurement shall take place in appropriate facilities, following procedures that minimise bacterial or other contamination of procured tissues and cells, in accordance with Article 5.
Pridobivanje poteka v ustreznih objektih, v skladu s postopki, ki kar najbolj zmanjšajo možnost za bakterijsko ali drugo okužbo pridobljenih tkiv in celic, v skladu s členom 5.
Procurement materials and equipment shall be managed in accordance with the standards and specifications laid down in Annex IV, section 1.3, and with due regard to relevant national and international regulation, standards and guidelines covering the sterilisation of medicines and medical devices.
Z materiali in opremo za pridobivanje se ravna v skladu s standardi in specifikacijami, določenimi v Prilogi IV, oddelku 1.3 ter ob upoštevanju ustreznih nacionalnih in mednarodnih predpisov, standardov in smernic, ki zajemajo sterilizacijo zdravil in medicinskih pripomočkov.
Qualified, sterile instruments and procurement devices shall be used for tissue and cell procurement.
Za pridobivanja tkiv in celic se uporabljajo kvalificirani sterilni instrumenti in naprave za pridobivanje.