natgillin/translations-raw huggingface dataset:
the name and address of the tissue establishment to receive the cells/tissues;
ime in naslov tkivne ustanove, ki prejme celice/tkiva;
the donor identification.
identifikacija darovalca.
The date and time of procurement may be included, where possible.
Če je mogoče, se lahko vključi datum in čas pridobitve.
All the records must be clear and readable, protected from unauthorised amendment and retained and readily retrieved in this condition throughout their specified retention period in compliance with data protection legislation.
Vsi zapisi morajo biti jasni in razločni, zaščiteni pred nepooblaščenimi spremembami ter shranjeni in nespremenjeni takoj na voljo celotno obdobje, določeno za njihovo shranjevanje v skladu z zakonodajo o varstvu podatkov.
Donor records required for full traceability must be kept for a minimum of 30 years after clinical use, or the expiry date, in an appropriate archive acceptable to the competent authority.
Karton o darovalcu, zahtevan za polno sledljivost, se hrani najmanj 30 let po klinični uporabi ali do roka uporabnosti v ustreznem arhivu, sprejemljivem za pristojni organ.
Following procurement, all recovered tissues and cells must be packaged in a manner which minimises the risk of contamination and must be stored at temperatures that preserve the required characteristics and biological function of the cells/tissues.
Po pridobivanju so vsa pridobljena tkiva in celice zapakirani tako, da se čim bolj zmanjša tveganje za okužbo ter so shranjeni pri temperaturah, pri katerih se ohranijo zahtevane lastnosti in biološko delovanje celic/tkiv.
The packaging must also prevent contamination of those responsible for packaging and transportation of the tissues and cells.
Embalaža mora preprečiti tudi okužbo oseb, odgovornih za pakiranje ter prevoz tkiv in celic.
The packaged cells/tissues must be shipped in a container which is suitable for the transport of biological materials and which maintains the safety and quality of the contained tissue or cells.
Zapakirane celice/tkiva so odpremljeni v embalaži, ki je ustrezna za prevoz bioloških materialov in ki ohranja varnost ter kakovost tkiv in celic v njej.
Any accompanying tissue or blood samples for testing must be accurately labelled to ensure identification with the donor, and must include a record of the time and place the specimen was taken.
Morebitni spremljevalni vzorci tkiva ali krvi za testiranje morajo biti točno označeni, da se zagotovi identifikacija z darovalcem, in morajo vključevati zapis časa in kraja odvzema vzorca.
Labelling of the procured tissues/cells
Označevanje pridobljenega tkiva/celic
At the time of procurement, every package containing tissues and cells must be labelled.
V času pridobitve je treba označiti vsak paket s tkivom in celicami.
The primary tissue/cell container must indicate the donation identification or code and the type of tissues and cells.
Na osnovni embalaži tkiva/celic so vsaj naslednje informacije: identifikacija ali koda darovanja in vrsta tkiv in celic.
Where the size of the package permits, the following information must also be provided:
Če je paket dovolj velik, je treba zagotoviti še naslednje informacije:
date (and time where possible) of donation;
datum (in kjer je možno čas) darovanja;
hazard warnings;
opozorila za nevarnost;
nature of any additives (if used);
narava dodatkov (če so bili uporabljeni);
in the case of autologous donations, the label must state ‘for autologous use only’;
v primeru avtolognih darovanj mora biti na oznaki navedeno „samo za avtologno uporabo“;
in the case of directed donations, the label must identify the intended recipient.
v primeru določenih darovanj je na oznaki identificiran predvideni prejemnik;
If any of the information under points (a) to (e) above cannot be included on the primary package label, it must be provided on a separate sheet accompanying the primary package.
Če katere od informacij iz točk od (a) do (e) ni mogoče vključiti na etiketo primarne embalaže, jih je treba zapisati na ločen papir, ki se priloži primarni embalaži.
Labelling of the shipping container
Označevanje embalaže za odpremo
When tissues/cells are shipped by an intermediary, every shipping container must be labelled at least with:
Kadar so tkiva/celice odpremljene prek posrednika, mora biti vsaka embalaža za odpremo označena vsaj z naslednjim:
TISSUES AND CELLS and HANDLE WITH CARE;
TKIVA IN CELICE ter RAVNATI PREVIDNO;
the identification of the establishment from which the package is being transported (address and phone number) and a contact person in the event of problems;
identifikacija ustanove, iz katere je paket pripeljan (naslov in telefonska številka) ter kontaktna oseba v primeru težav;
the identification of the tissue establishment of destination (address and phone number) and the person to be contacted to take delivery of the container;
identifikacija namembne tkivne ustanove (naslov in telefonska številka) ter kontaktna oseba, ki prevzame dobavljeno pošiljko;
the date and time of the start of transportation;
datum in začetek prevoza;
specifications concerning conditions of transport relevant to the quality and safety of the tissues and cells;
specifikacije pogojev prevoza, ki so pomembni za kakovost ter varnost tkiv in celic;
in the case of all cellular products, the following indication: DO NOT IRRADIATE;
v primeru vseh izdelkov iz celic se doda naslednje: PREPOVEDANO OBSEVANJE; in
when a product is known to be positive for a relevant infectious disease marker, the following indication: BIOLOGICAL HAZARD;
ko je znano, da je izdelek pozitiven na označevalce ustreznih nalezljivih bolezni, se doda napis BIOLOŠKO TVEGANJE;
in the case of autologous donors, the following indication: ‘FOR AUTOLOGOUS USE ONLY’;
v primeru avtolognih darovalcev se doda naslednje: „samo za avtologno uporabo“;
specifications concerning storage conditions (such as DO NOT FREEZE).
specifikacije pogojev shranjevanja (kot je PREPOVEDANO ZAMRZOVANJE).
Reception of the tissue/cells at the tissue establishment
Sprejem tkiva/celic v tkivni ustanovi
When the retrieved tissues/cells arrive at the tissue establishment, there must be documented verification that the consignment, including the transport conditions, packaging, labelling and associated documentation and samples, meet the requirements of this Annex and the specifications of the receiving establishment.
Ko odvzeta tkiva/celice prispejo v tkivno ustanovo, poteka dokumentirano preverjanje, ali pošiljka, vključno s pogoji prevoza, pakiranjem, označevanjem ter podobno dokumentacijo in vzorci, izpolnjujejo zahteve iz tega dokumenta in specifikacije ustanove prejemnice.
Each establishment must ensure that the tissue and cells received are quarantined until they, along with the associated documentation, have been inspected or otherwise verified as conforming to requirements.
Vsaka ustanova zagotovi, da so prejeta tkiva in celice v karanteni, dokler ta tkiva in celice in z njimi povezana dokumentacija niso pregledani ali drugače potrjeni v skladu z zahtevami.
The review of relevant donor/procurement information and thus acceptance of the donation needs to be carried out by specified/authorised persons.
Pregled ustreznih informacij o darovalcu/pridobivanju in sprejem darovanja morajo opraviti določene/pooblaščene osebe.
Each tissue establishment must have a documented policy and specifications against which each consignment of tissues and cells, including samples, are verified.
Vsaka tkivna ustanova ima dokumentirano politiko in specifikacije, s katerimi se preveri vsaka pošiljka tkiv in celic, vključno z vzorci.
These must include the technical requirements and other criteria considered by the tissue establishment to be essential for the maintenance of acceptable quality.
To vključuje te tehnične zahteve in druga merila, za katere tkivna ustanova meni, da so bistvena za ohranjanje sprejemljive kakovosti.
The tissue establishment must have documented procedures for the management and segregation of non-conforming consignments, or those with incomplete test results, to ensure that there is no risk of contamination of other tissues and cells being processed, preserved or stored.
Tkivna ustanova ima dokumentirane postopke za upravljanje in ločevanje neskladnih pošiljk ali pošiljk z nepopolnimi rezultati testov za zagotovitev, da ni nobenega tveganja za okužbo drugih tkiv in celic, ki se predelujejo, konzervirajo ali hranijo.
The data that must be registered at the tissue establishment (except for donors of reproductive cells intended for partner donation) include:
Podatki, ki morajo biti registrirani v tkivni ustanovi (razen za darovalce reproduktivnih celic, namenjenih za darovanje med partnerjema), vključujejo:
consent/authorisation; including the purpose(s) for which the tissues and cells may be used (i.e. therapeutic or research, or both therapeutic use and research) and any specific instructions for disposal if the tissue or cells are not used for the purpose for which consent was obtained;
soglasje/dovoljenje; vključno z namenom(-i), za katerega/katere se lahko uporabljajo tkiva in celice (tj. terapevtska raba ali raziskave ali tako terapevtska raba kot raziskave), ter vsemi posebnimi navodili za odstranitev, če tkivo ali celice niso uporabljene v namen, za katerega je bilo pridobljeno soglasje;
all required records relating to the procurement and the taking of the donor history, as described in the donor documentation section;
vse zahtevane zapise, povezane s pridobivanjem in podatki o darovalčevi preteklosti, kot je opisano v delu glede dokumentacije o darovalcu;
results of physical examination, of laboratory tests and of other tests (such as the autopsy report, if used in accordance with point 1.2.2.);
rezultate fizikalnega pregleda, laboratorijskih in drugih testov (kot je poročilo o obdukciji, če se uporabi v skladu z oddelkom 1.2.2);
for allogeneic donors, a properly documented review of the complete donor evaluation against the selection criteria by an authorised and trained person;
ustrezno dokumentiran pregled celotne ocene darovalca v skladu z merili za izbiro s strani pooblaščene in usposobljene osebe, za alogenske darovalce;
in the case of cell cultures intended for autologous use, documentation of the possibility of medicinal allergies (such as to antibiotics) of the recipient.
v primeru celičnih kultur, namenjenih za avtologno rabo, je treba dokumentirati tudi možnost alergij na zdravila (kot so antibiotiki) prejemnika.
In the case of reproductive cells intended for partner donation, the data to be registered at the tissue establishment include:
V primeru reproduktivnih celic, namenjenih za darovanje med partnerjema, podatki, ki morajo biti zabeleženi v tkivni ustanovi, vključujejo:
consent; including the purpose(s) for which the tissues and cells may be used (such as reproductive only and/or for research) and any specific instructions for disposal if the tissue or cells are not used for the purpose for which consent was obtained;
soglasje; vključno z namenom(-i), za katerega/katere se lahko uporablja tkivo in celice (npr. samo reproduktivna raba in/ali raziskave), ter vsemi posebnimi navodili za odstranitev tkiva ali celic, ki niso uporabljeni v namen, za katerega je bilo pridobljeno soglasje;
donor identification and characteristics: type of donor, age, sex, presence of risk factors and, in the case of a deceased donor, the cause of death;
identifikacijo in značilnosti darovalca: vrsto darovalca, starost, spol, prisotnost dejavnikov tveganja in v primeru umrlega darovalca vzrok smrti;
partner identification;
identifikacijo partnerja;
place of procurement;
kraj pridobivanja;
tissues and cells obtained and relevant characteristics.
pridobljena tkiva in celice ter ustrezne značilnosti.
Council Directive 2006/18/EC
Direktiva Sveta 2006/18/ES
amending Directive 77/388/EEC with regard to reduced rates of value added tax
o spremembah Direktive 77/388/EGS v zvezi z uporabo nižjih stopenj davka na dodano vrednost
The possibility of applying a reduced rate of value added tax should be granted in respect of supplies of district heating as for supplies of natural gas and electricity, for which the possibility of applying a reduced rate is already allowed in Sixth Council Directive 77/388/EEC of 17 May 1977 on the harmonisation of the laws of the Member States relating to turnover taxes — Common system of value added tax: uniform basis of assessment [3].
Za dobave daljinskega ogrevanja bi bilo treba zagotoviti možnost uporabe nižje stopnje davka na dodano vrednost, enako kot za dobave zemeljskega plina in električne energije, za katere je možnost uporabe nižje stopnje predvidena že v Šesti direktivi Sveta 77/388/EGS z dne 17. maja 1977 o usklajevanju zakonodaje držav članic o prometnih davkih – Skupni sistem davka na dodano vrednost: enotna osnova za odmero [3].
To achieve a better understanding of the impact of reduced rates, it is necessary for the Commission to prepare an assessment report on the impact of reduced rates applied to locally supplied services, notably in terms of job creation, economic growth and the proper functioning of the internal market.
Za boljše vrednotenje vpliva nižjih stopenj je potrebno poročilo Komisije, v katerem se oceni vpliv uporabe nižjih stopenj za storitve, ki se opravljajo na lokalni ravni, predvsem v zvezi z ustvarjanjem delovnih mest, gospodarsko rastjo ter pravilnim delovanjem notranjega trga.
The experiment of reduced rates for labour-intensive services should therefore be extended until 31 December 2010 and it should also be made possible for all Member States to take part in it under the same conditions.
Zato bi bilo treba uporabo nižjih stopenj, ki so bile poskusno uvedene za delovno intenzivne storitve, podaljšati do 31. decembra 2010 in tudi zagotoviti možnost sodelovanja vseh držav članic pod istimi pogoji.
Accordingly, Member States wishing to avail themselves, for the first time, of the option provided for in Article 28(6) of Directive 77/388/EEC and those wishing to amend the list of services to which they have applied the said provision in the past should submit a request to the Commission, together with the relevant particulars for the purpose of assessment.
Države članice, ki želijo prvič koristiti možnost, predvideno v členu 28(6) Direktive 77/388/EGS, in države članice, ki želijo seznam storitev, za katere so to določbo uporabile v preteklosti, spremeniti, bi torej morale Komisiji predložiti prošnjo in ji sporočiti ustrezne podatke za oceno.
Such prior assessment by the Commission does not appear necessary where Member States have previously benefited from an authorisation and submitted a report on the matter to the Commission.
Takšna predhodna ocena Komisije se ne zdi potrebna, če so države članice ukrep izkoristile v preteklosti in Komisiji predložile zadevno poročilo.
To ensure legal continuity, this Directive should be applicable as from 1 January 2006.
Za zagotovitev pravne kontinuitete bi bilo treba to direktivo začeti uporabljati s 1. januarjem 2006.
Implementation of this Directive in no way implies change in the legislative provisions of Member States,
Izvajanje te direktive na noben način ne spreminja zakonodaje držav članic –
Directive 77/388/EEC is hereby amended as follows:
Direktiva 77/388/EGS se spremeni, kakor sledi:
Article 12 shall be amended as follows:
člen 12 se spremeni, kakor sledi:
paragraph 3(b) shall be replaced by the following:
točka (b) odstavka 3 se nadomesti z naslednjim besedilom:
Member States may apply a reduced rate to supplies of natural gas, electricity and district heating provided that no risk of distortion of competition exists.
Države članice lahko uporabljajo nižjo stopnjo za dobave zemeljskega plina, električne energije in daljinskega ogrevanja, če ni nevarnosti izkrivljanja konkurence.
A Member State intending to apply such a rate must inform the Commission before doing so.
Država članica, ki namerava uporabljati takšno stopnjo, mora pred tem obvestiti Komisijo.
The Commission shall give a decision on the existence of a risk of distortion of competition.
Komisija odloči o obstoju nevarnosti izkrivljanja konkurence.
If the Commission has not taken that decision within three months of the receipt of the information a risk of distortion of competition is deemed not to exist.’;
Če Komisija te odločitve ne sprejme v treh mesecih od prejema informacije, se šteje, da nevarnost izkrivljanja konkurence ne obstaja.“;
in paragraph 4, the following subparagraph shall be inserted:
v odstavku 4 se vstavi naslednji pododstavek:
‘By 30 June 2007 at the latest the Commission shall present to the European Parliament and the Council an overall assessment report on the impact of reduced rates applying to locally supplied services, including restaurant services, notably in terms of job creation, economic growth and the proper functioning of the internal market, based on a study carried out by an independent economic think-tank.’;
„Komisija predloži Evropskemu parlamentu in Svetu, najpozneje do 30. junija 2007 in na podlagi raziskave, ki jo izvede neodvisna skupina za gospodarska vprašanja, poročilo splošni oceni vpliva uporabe nižjih stopenj za storitve, ki se opravljajo na lokalni ravni, vključno z restavracijskimi storitvami, predvsem v zvezi z ustvarjanjem delovnih mest, gospodarsko rastjo ter pravilnim delovanjem notranjega trga.“;
Article 28(6) shall be amended as follows:
odstavek 6 člena 28 se spremeni, kakor sledi:
the first subparagraph shall be replaced by the following:
prvi pododstavek se nadomesti z naslednjim:
‘The Council, acting unanimously on a proposal from the Commission, may authorise any Member State to apply until 31 December 2010 at the latest the reduced rates provided for in the third subparagraph of Article 12(3)(a) to services listed in a maximum of two of the categories set out in Annex K. In exceptional cases, a Member State may be authorised to apply the reduced rates to services belonging to three of the aforementioned categories.’;
„Svet, na predlog Komisije in s soglasnim odločanjem, lahko dovoli, da katera koli država članica najpozneje do 31. decembra 2010 uvede nižje stopnje iz tretjega pododstavka člena 12(3)(a) za storitve, naštete v največ dveh kategorijah iz Priloge K. V izjemnih primerih se lahko državi članici dovoli, da uporablja nižjo stopnjo za tri zgoraj navedene kategorije.“;
‘Any Member State wishing to apply for the first time after 31 December 2005 a reduced rate to one or more of the services mentioned in the first subparagraph pursuant to this provision shall inform the Commission before 31 March 2006.
„Vsaka država članica, ki želi prvič po 31. decembru 2005 v skladu s to določbo uporabiti nižjo stopnjo za eno ali več storitev iz prvega pododstavka, to sporoči Komisiji do 31. marca 2006.
It shall communicate to it before that date all relevant particulars concerning the new measures it wishes to introduce, and in particular the following:
Do tega datuma ji pošlje vse podatke, potrebne za oceno novih ukrepov, ki jih želi uvesti, še zlasti pa naslednje:
scope of the measure and detailed description of the services concerned;
področje uporabe ukrepa in podroben opis zadevnih storitev;
particulars showing that the conditions laid down in the second and third subparagraphs have been met;
podatke, iz katerih je razvidno, da so bili pogoji iz drugega in tretjega pododstavka izpolnjeni;
particulars showing the budgetary cost of the measure envisaged.’
podatke v zvezi s proračunskimi stroški predvidenega ukrepa.“.
It shall be applicable as from 1 January 2006.
Uporablja se od 1. januarja 2006.
OJ C 89 E, 14.4.2004, p. 138.
UL C 89 E, 14.4.2004, str. 138.
OJ C 32, 5.2.2004, p. 113.
UL C 32, 5.2.2004, str. 113.
Commission Directive 2006/19/EC
Direktiva Komisije 2006/19/ES
amending Council Directive 91/414/EEC to include 1-methylcyclopropene as active substance
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve 1-metilciklopropena med aktivne snovi
In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 28 February 2002 an application from Rohm and Haas France S.A. for the inclusion of the active substance 1-methylcyclopropene in Annex I to Directive 91/414/EEC.
Nizozemska je 28. februarja 2002 v skladu s členom 6(2) Direktive 91/414/EGS prejela zahtevek Rohm and Haas France S.A. za vključitev aktivne snovi 1-metilciklopropena v Prilogo I k Direktivi 91/414/EGS.
Commission Decision 2003/35/EC [2] confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
Z Odločbo Komisije 2003/35/ES [2] je bilo potrjeno, da je dokumentacija „popolna“, tj., da zanjo načeloma velja, da izpolnjuje zahteve po podatkih in informacijah iz prilog II in III k Direktivi 91/414/EGS.
For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant.
Za navedeno aktivno snov so bili ocenjeni vplivi na zdravje ljudi in okolje v skladu z določbami člena 6(2) in (4) Direktive 91/414/EGS za uporabe, ki so jih predlagali vlagatelji.
The designated rapporteur Member States submitted a draft assessment report concerning the substance to the European Food Safety Authority (EFSA) on 22 March 2003.
Imenovane države članice poročevalke so dne 22. marca 2003 Evropski agenciji za varnost hrane (EFSA) predložile osnutek poročila o oceni, ki se nanaša na aktivno snov.
The assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 14 January 2005 in the format of the EFSA Scientific Report for 1-methylcyclopropene [3].
Poročilo o oceni so v okviru delovne skupine za ovrednotenje pregledali strokovnjaki držav članic in EFSA in ga 14. januarja 2005 predstavili Komisiji v obliki znanstvenega poročila EFSA o 1-metilciklopropenu [3].
This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 23 September 2005 in the format of the Commission review report for 1-methylcyclopropene.
To poročilo so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali in ga dokončno oblikovale 23. septembra 2005 v obliki poročila Komisije o pregledu glede 1-metilciklopropena.
The review of 1-methylcyclopropene did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority which has taken over the role of that Committee.
Pregled 1-metilciklopropena ni pokazal nobenih odprtih vprašanj ali razlogov za zaskrbljenost, ki bi zahtevali posvetovanje z Znanstvenim odborom za rastline ali Evropsko agencijo za varnost hrane, ki je prevzela vlogo navedenega odbora.
It has appeared from the various examinations made that plant protection products containing the active substance concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report.
Različne opravljene preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo zadevno aktivno snov, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) in člena 5(3) Direktive 91/414/EGS, zlasti glede uporab, ki so bile preučene in podrobno navedene v poročilih Komisije o pregledu.
It is therefore appropriate to include 1-methylcyclopropene in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
Zato je primerno, da se 1-metilciklopropen vključi v Prilogo I k navedeni direktivi, da se lahko v vseh državah članicah zagotovi izdaja registracije fitofarmacevtskih sredstev, ki vsebujejo to aktivno snov, v skladu z določbami navedene direktive.