natgillin/translations-raw huggingface dataset:
METHOD FOR CALCULATING THE CRUDE OIL EQUIVALENT OF INLAND CONSUMPTION
METODA ZA IZRAČUN DOMAČE PORABE V EKVIVALENTU SUROVE NAFTE
For the purpose of Article 3, the crude oil equivalent of inland consumption must be calculated using the following method:
Za namene člena 3 se domača poraba v ekvivalentu surove nafte izračuna po naslednji metodi:
Inland consumption is the sum of the aggregate ‘observed gross inland deliveries’, as defined in Section 3.2.1 of Annex C to Regulation (EC) No 1099/2008, of the following products only: motor gasoline, aviation gasoline, gasoline-type jet fuel (naphtha-type jet fuel or JP4), kerosene-type jet fuel, other kerosene, gas/diesel oil (distillate fuel oil) and fuel oil (high sulphur content and low sulphur content) as defined in Section 4 of Annex B to Regulation (EC) No 1099/2008.
Domača poraba je vsota skupne „zabeležene bruto notranje dobave“, kakor je opredeljena v oddelku 3.2.1 Priloge C k Uredbi (ES) št. 1099/2008, le naslednjih derivatov: motornega bencina, letalskega bencina, bencinskega reaktivnega goriva (petrolejskega reaktivnega goriva ali JP4), reaktivnega letalskega goriva, drugih kerozinov, plinskega olja/dizelskega goriva (destiliranega pogonskega goriva), kurilnega olja (z visoko in nizko vsebnostjo žvepla), kot so opredeljeni v oddelku 4 Priloge B k Uredbi št. 1099/2008.
The crude oil equivalent of inland consumption is calculated by multiplying by a factor of 1,2.
Izračun domače porabe v ekvivalentu surove nafte se pomnoži s faktorjem 1,2.
METHODS FOR CALCULATING THE LEVEL OF STOCKS HELD
METODE ZA IZRAČUN VZDRŽEVANE RAVNI ZALOG
The following methods must be used to calculate stock levels:
Za izračun ravni zalog se uporabljajo naslednje metode:
Without prejudice to the case addressed in Article 4(3), no quantity may be counted as stock more than once.
Ne glede na primer iz člena 4(3) se nobena količina ne sme večkrat upoštevati kot zaloga.
Crude oil stocks are reduced by 4 %, which corresponds to the average naphtha yield.
Zaloge surove nafte se zmanjšajo za 4 %, kar ustreza povprečnemu donosu primarnega bencina.
Stocks of naphtha and petroleum products for international marine bunkers are not included.
Zaloge primarnega bencina in naftnih derivatov za mednarodna pomorska skladišča se ne upoštevajo.
Other petroleum products are included in the stock count using one of the two methods set out below.
Drugi naftni derivati se knjižijo v zaloge po eni od naslednjih metod.
Member States must continue to use the method they have chosen throughout the whole calendar year in question.
Države članice morajo izbrano metodo uporabljati celo zadevno koledarsko leto.
include all other stocks of the petroleum products identified in the first paragraph of Section 3.1 of Annex C to Regulation (EC) No 1099/2008 and calculate the crude oil equivalent by multiplying the quantities by a factor of 1,065; or
bodisi vključijo vse druge zaloge naftnih derivatov, opredeljenih v prvem odstavku oddelka 3.1 Priloge C k Uredbi št. 1099/2008, in izračunajo ekvivalent surove nafte tako, da količine pomnožijo s faktorjem 1,065, ali
include stocks of only the following products: motor gasoline, aviation gasoline, gasoline-type jet fuel (naphtha-type jet fuel or JP4), kerosene-type jet fuel, other kerosene, gas/diesel oil (distillate fuel oil) and fuel oil (high sulphur content and low sulphur content) and calculate the crude oil equivalent by multiplying the quantities by a factor of 1,2.
bodisi vključijo samo naslednje derivate: motorni bencin, letalski bencin, bencinsko reaktivno gorivo (petrolejsko reaktivno gorivo ali JP4), reaktivno letalsko gorivo, druge kerozine, plinsko olje/dizelsko gorivo (destilirano pogonsko gorivo), kurilno olje (z visoko in nizko vsebnostjo žvepla), in določijo ekvivalent surove nafte tako, da količine pomnožijo s faktorjem 1,2.
The calculation may include quantities held:
Za izračun zalog se lahko upoštevajo količine, shranjene v:
in refinery tanks,
cisternah v rafinerijah,
in bulk terminals,
tovornih terminalih,
in pipeline tankage,
cisternah ob cevovodih,
in barges,
baržah,
in intercoastal tankers,
obalnih tankerjih,
in oil tankers in port,
tankerjih v pristaniščih,
in inland ship bunkers,
prostorih za zaloge na ladjah v notranji plovbi,
in storage tank bottoms,
na dnu cistern,
as working stocks,
v obliki obratnih zalog,
by large consumers as required by law or otherwise controlled by governments.
pri velikih potrošnikih v skladu s predpisanimi obveznostmi in drugimi usmeritvami javnih organov.
However, those quantities except for any held in refinery tanks, in pipeline tankage or in bulk terminals, may not be included when calculating levels of specific stocks where such stocks are calculated separately from emergency stocks.
Vendar se teh količin, razen tistih, ki so shranjene v rezervoarjih rafinerij ali cevovodih ali tovornih terminalih, ne sme upoštevati pri izračunu ravni posebnih zalog, kadar se te ravni izračunavajo ločeno od varnostnih zalog.
The calculation may never include:
Pri izračunu zalog se nikoli ne upoštevajo:
crude oil not yet produced;
še ne proizvedena surova nafta;
quantities held:
količine, shranjene v:
in pipelines,
naftovodih,
in rail tank cars,
vagonih cisternah,
in seagoing ships’ bunkers,
prostorih za zaloge na morskih ladjah,
in service stations and retail stores,
bencinskih črpalkah in prodajalnah,
by other consumers,
pri drugih potrošnikih,
in tankers at sea,
v tankerjih na morju,
as military stocks.
v obliki vojaških zalog.
When calculating their stocks, Member States must reduce the quantities of stocks calculated as set out above by 10 %.
Države članice pri izračunu svojih zalog za 10 % znižajo količine, izračunane v skladu z navedenim.
That reduction applies to all quantities included in a given calculation.
To znižanje se uporabi za vse količine, ki se upoštevajo pri določenem izračunu.
However, no 10 % reduction is to be applied when calculating the level of specific stocks or the levels of the different categories of specific stocks where those stocks or categories are considered separately from the emergency stocks, particularly with a view to verifying compliance with the minimum levels laid down by Article 9.
Vendar pa se 10 % znižanje ne uporabi pri izračunu ravni posebnih zalog in njihovih različnih kategorij, kadar se te posebne zaloge ali kategorije obravnavajo ločeno od varnostnih zalog, zlasti za namene preverjanja, ali je dosežena minimalna raven iz člena 9.
Rules for the preparation and submission to the Commission of statistical summaries of stocks to be held pursuant to Article 3
Pravila glede priprave in predložitve Komisiji statističnih poročil o zalogah iz člena 3
Each Member State must draw up and submit to the Commission, on a monthly basis, a definitive statistical summary of the level of stocks actually held on the last day of the calendar month, calculated either on the basis of the number of days of net oil imports or on the basis of the number of days of inland oil consumption, in accordance with Article 3.
Države članice vsak mesec pripravijo in Komisiji predložijo dokončno statistično poročilo o dejanski ravni zalog na zadnji dan koledarskega meseca, ki se izračuna na podlagi števila dni neto uvoza nafte ali na podlagi števila dni domače porabe nafte v skladu z merilom, ki ga je treba upoštevati pri uporabi člena 3.
The statistical summary must provide precise details of why the calculation is based on the number of days of imports or, conversely, on the number of days of consumption and must specify which of the calculation methods set out in Annex III was used.
V poročilu natančno navedejo, zakaj je osnova za izračun število dni uvoza ali, nasprotno, število dni porabe, in opredelijo, katera metoda iz Priloge III je bila uporabljena pri izračunu zalog.
If some of the stocks included when calculating the level of stocks held pursuant to Article 3 are held outside national territory, each summary shall give details of the stocks held by the various Member States and CSEs concerned on the last day of the period to which it relates.
Če se nekatere zaloge, ki se upoštevajo pri izračunu ravni v skladu s členom 3, hranijo izven nacionalnega ozemlja, se v vsakem poročilu natančno navedejo zaloge, ki jih vzdržujejo različne države članice in zadevni osrednji organi za vzdrževanje zalog, na zadnji dan obdobja, na katerega se nanaša.
In its summary, each Member State must also indicate, in each case, whether the stocks are being held pursuant to a delegation request made by one or more economic operators or whether they are being held at its request or at the request of its CSE.
Poleg tega država članica v poročilu v vsakem primeru navede, ali gre za zaloge, prenesene na zahtevo enega ali več gospodarskih subjektov, ali za zaloge, vzdrževane na njeno zahtevo ali zahtevo njenega osrednjega organa za vzdrževanje zalog.
For any stocks held by a Member State within its territory on behalf of other Member States or CSEs, that Member State must draw up and submit to the Commission a summary showing the stocks existing on the last day of each calendar month, broken down by product category.
Država članica za zaloge, ki se hranijo na njenem ozemlju za druge države članice ali osrednje organe za vzdrževanje zalog, pripravi in Komisiji predloži poročilo o obstoječih zalogah po kategorijah proizvodov na zadnji dan koledarskega meseca.
In that summary, the Member State must also indicate, in particular, the Member State or CSE concerned and the quantities involved in each case.
V tem poročilu država članica v vsakem primeru navede ime države članice ali zadevnega osrednjega organa za vzdrževanje zalog in količine.
The statistical summaries referred to in this Annex must be submitted to the Commission within 55 days of the end of the month to which they relate.
Statistična poročila iz te priloge se sporočijo Komisiji v 55 dneh po mesecu, na katerega se nanaša poročilo.
Those same summaries must also be submitted within 2 months of a request by the Commission.
Poleg tega je treba ista poročila na zahtevo služb Komisije predložiti v dveh mesecih po zahtevi.
Such requests may be made no later than 5 years after the date to which the data relate.
Take zahteve se lahko podajo v roku petih let od datuma, na katerega se nanašajo podatki.
LPG
UNP,
By derogation from the first subparagraph, Member States that are not members of the IEA by 31 December 2012 and cover their inland consumption of petroleum products fully by imports shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 3(1) of this Directive by 31 December 2014.
Z odstopanjem od prvega pododstavka države članice, ki do 31. decembra 2012 niso postale članice Mednarodne agencije za energijo in pokrivajo svojo domačo porabo naftnih derivatov v celoti z uvozom, uveljavijo zakone in druge predpise, potrebne za skladnost s členom 3(1) te direktive najpozneje do 31. decembra 2014.
Until those Member States have brought into force such measures, they shall maintain oil stocks corresponding to 81 days of average daily net imports.
Dokler te države članice ne uveljavijo takih ukrepov, ohranijo naftne rezerve za 81 dni povprečnega dnevnega neto uvoza.
Member States shall also send the Commission a copy of the register within 15 days of a request by the Commission. In this copy, sensitive data relating to the location of stocks may be withheld.
Države članice pošljejo Komisiji izvod registra v 15 dneh po prejemu zahteve s strani Komisije.
Commission Directive 2009/120/EC
Direktiva Komisije 2009/120/ES
amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products
o spremembi Direktive 2001/83/ES Evropskega parlamenta in Sveta o zakoniku Skupnosti o zdravilih za uporabo v humani medicini v zvezi z zdravili za napredno zdravljenje
Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [1], and in particular Article 120 thereof,
ob upoštevanju Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [1] in zlasti člena 120 Direktive,
Medicinal products for human use may only be placed on the market if a marketing authorisation has been delivered by a competent authority on the basis of an application dossier containing the results of tests and trials carried out on the products concerned.
Zdravila za uporabo v humani medicini se lahko dajo v promet le, če pristojni organ izda dovoljenje za promet z zdravilom na podlagi vloge za pridobitev dovoljenja, ki vsebuje rezultate preskusov in preskušanj, izvedenih na zadevnih izdelkih.
Annex I to Directive 2001/83/EC lays down detailed scientific and technical requirements regarding the testing of medicinal products for human use against which the quality, safety and efficacy of the medicinal product should be assessed.
V Prilogi I k Direktivi 2001/83/ES so navedene podrobne znanstvene in tehnične zahteve v zvezi s preskušanjem zdravil za uporabo v humani medicini, na podlagi katerih je treba oceniti kakovost, varnost in učinkovitost zdravila.
Those detailed scientific and technical requirements should be regularly adapted to take account of scientific and technical progress.
Navedene podrobne znanstvene in tehnične zahteve je treba redno prilagajati, da se upošteva znanstveni in tehnični napredek.
Due to scientific and technical progress in the field of advanced therapies, as reflected in Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 [2], it is appropriate to adapt Annex I. The definitions and detailed scientific and technical requirements for gene therapy medicinal products and somatic cell therapy medicinal products should be updated.
Kot je navedeno v Uredbi (ES) št. 1394/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o zdravilih za napredno zdravljenje ter o spremembi Direktive 2001/83/ES in Uredbe (ES) št. 726/2004 [2], je primerno Prilogo I zaradi znanstvenega in tehničnega napredka na področju naprednega zdravljenja prilagoditi. Posodobiti je treba opredelitve ter podrobne znanstvene in tehnične zahteve za zdravila za gensko zdravljenje ter zdravila za somatsko celično zdravljenje.
Moreover, detailed scientific and technical requirements should be established for tissue engineered products, as well as for advanced therapy medicinal product containing devices and combined advanced therapy medicinal products.
Poleg tega je treba določiti podrobne znanstvene in tehnične zahteve za izdelke tkivnega inženirstva, zdravila za napredno zdravljenje, ki vključujejo pripomočke ter kombinirana zdravila za napredno zdravljenje.
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use,
Ukrepi, predvideni s to direktivo, so v skladu z mnenjem Stalnega odbora za zdravila za uporabo v humani medicini –
Part IV of Annex I to Directive 2001/83/EC is replaced by the text set out in the Annex to this Directive.
Del IV Priloge I k Direktivi 2001/83/ES se nadomesti z besedilom iz Priloge k tej direktivi.
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Države članice sporočijo Komisiji besedilo temeljnih določb nacionalne zakonodaje, sprejetih na področju, ki ga ureja ta direktiva.
ADVANCED THERAPY MEDICINAL PRODUCTS
ZDRAVILA ZA NAPREDNO ZDRAVLJENJE
Marketing authorisation applications for advanced therapy medicinal products, as defined in point (a) of Article 2(1) of Regulation (EC) No 1394/2007, shall follow the format requirements (Modules 1, 2, 3, 4 and 5) described in Part I of this Annex.
Vloge za pridobitev dovoljenja za promet z zdravili za napredno zdravljenje, kot so opredeljene v členu 2(1)(a) Uredbe (ES) št. 1394/2007, upoštevajo zahteve v zvezi s strukturo (moduli 1, 2, 3, 4 in 5) iz dela I te priloge.
The technical requirements for Modules 3, 4 and 5 for biological medicinal products, as described in Part I of this Annex, shall apply.
Za biološka zdravila se uporabljajo tehnične zahteve za module 3, 4 in 5, kot je navedeno v delu I te priloge.
The specific requirements for advanced therapy medicinal products described in sections 3, 4 and 5 of this part explain how the requirements in Part I apply to advanced therapy medicinal products.
Posebne zahteve za zdravila za napredno zdravljenje, ki so navedene v oddelkih 3, 4 in 5 tega dela, pojasnjujejo način uporabe zahtev iz dela I za zdravila za napredno zdravljenje.
In addition, where appropriate and taking into account the specificities of advanced therapy medicinal products, additional requirements have been set.
Kadar je ustrezno, se ob upoštevanju posebnosti zdravil za napredno zdravljenje poleg tega določijo tudi dodatne zahteve.
Due to the specific nature of advanced therapy medicinal products, a risk-based approach may be applied to determine the extent of quality, non-clinical and clinical data to be included in the marketing authorisation application, in accordance with the scientific guidelines relating to the quality, safety and efficacy of medicinal products referred to in point 4 of the “Introduction and general principles”.
Zaradi posebnih lastnosti zdravil za napredno zdravljenje se lahko uporablja pristop, ki temelji na analizi tveganja, da se določijo kakovost ter neklinični in klinični podatki, ki jih je treba v skladu z znanstvenimi smernicami o kakovosti, varnosti in učinkovitosti zdravil iz točke 4 poglavja ‚Uvod in splošna načela‘ vključiti v vlogo za pridobitev dovoljenja za promet z zdravilom.
The risk analysis may cover the entire development.
Analiza tveganja lahko zajame razvoj v celoti.
Risk factors that may be considered include: the origin of the cells (autologous, allogeneic, xenogeneic), the ability to proliferate and/or differentiate and to initiate an immune response, the level of cell manipulation, the combination of cells with bioactive molecules or structural materials, the nature of the gene therapy medicinal products, the extent of replication competence of viruses or micro-organisms used in vivo, the level of integration of nucleic acids sequences or genes into the genome, the long time functionality, the risk of oncogenicity and the mode of administration or use.
Dejavniki tveganja, ki se lahko upoštevajo, vključujejo: izvor celic (avtologne, alogenske, ksenogenske), sposobnost za razmnoževanje in/ali razlikovanje ter sprožitev imunskega odziva, stopnjo manipulacije celic, kombinacijo celic in bioaktivnih molekul ali strukturnih materialov, lastnost zdravil za gensko zdravljenje, obseg sposobnosti uporabljenih virusov in mikroorganizmov za razmnoževanje in vivo, stopnjo vključevanja verig nukleinskih kislin ali genov v genom, dolgotrajno funkcionalnost, tveganje za rakotvornost in način dajanja ali uporabe.
Relevant available non-clinical and clinical data or experience with other, related advanced therapy medicinal products may also be considered in the risk analysis.
V analizi tveganja se lahko upoštevajo tudi ustrezni dostopni neklinični in klinični podatki ali izkušnje z drugimi sorodnimi zdravili za napredno zdravljenje.
Any deviation from the requirements of this Annex shall be scientifically justified in Module 2 of the application dossier.
Vsako odstopanje od zahtev iz te priloge se znanstveno utemelji v modulu 2 vloge za pridobitev dovoljenja za promet z zdravilom.
The risk analysis described above, when applied, shall also be included and described in Module 2.
Kadar se uporabi navedena analiza tveganja, se prav tako vključi in opiše v modulu 2.
In this case, the methodology followed, the nature of the identified risks and the implications of the risk based approach for the development and evaluation program shall be discussed and any deviations from the requirements of this Annex resulting from the risk analysis shall be described.
V tem primeru se obravnavajo uporabljena metodologija, ugotovljena tveganja in posledice pristopa, ki temelji na oceni tveganja, za razvoj in ovrednotenje programa ter opišejo vsa odstopanja od zahtev iz te priloge zaradi analize tveganja.
For the purposes of this Annex, in addition to the definitions laid down in Regulation (EC) No 1394/2007, the definitions set out in sections 2.1 and 2.2 shall apply.
V tej prilogi se poleg opredelitev iz Uredbe (ES) št. 1394/2007 uporabljajo tudi opredelitve iz oddelkov 2.1 in 2.2.
Gene therapy medicinal product
Zdravilo za gensko zdravljenje
Gene therapy medicinal product means a biological medicinal product which has the following characteristics:
Zdravilo za gensko zdravljenje pomeni biološko zdravilo z naslednjimi lastnostmi:
it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence;
vsebuje zdravilno učinkovino, ki vsebuje ali je sestavljena iz rekombinantne nukleinske kisline, ki se uporablja pri ljudeh ali daje ljudem za urejanje, popravljanje, nadomestitev, dodajanje ali odstranitev genskega zaporedja;
its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.
njegov zdravilen, preprečevalen ali diagnostičen učinek zadeva neposredno zaporedje rekombinantne nukleinske kisline, ki ga vsebuje, ali proizvod izražanja genov tega zaporedja.
Gene therapy medicinal products shall not include vaccines against infectious diseases.
Zdravila za gensko zdravljenje ne vključujejo cepiv proti nalezljivim boleznim.
Somatic cell therapy medicinal product
Zdravilo za somatsko celično zdravljenje
Somatic cell therapy medicinal product means a biological medicinal product which has the following characteristics:
Zdravilo za somatsko celično zdravljenje pomeni biološko zdravilo z naslednjimi lastnostmi:
contains or consists of cells or tissues that have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or of cells or tissues that are not intended to be used for the same essential function(s) in the recipient and the donor;
vsebuje ali je sestavljeno iz celic ali tkiv, ki so bila podvržena bistveni manipulaciji, s čimer so se spremenile njihove biološke značilnosti, fiziološke funkcije ali strukturne lastnosti, pomembne za predvideno klinično uporabo, ali iz celic ali tkiv, ki niso predvidena za uporabo za enake bistvene funkcije v prejemniku in darovalcu;
is presented as having properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.
ima lastnosti za ljudi ali se uporablja pri ljudeh ali se daje ljudem za zdravljenje, preprečevanje ali diagnosticiranje bolezni s farmakološkim, imunološkim ali presnovnim delovanjem celic ali tkiv.
For the purposes of point (a), the manipulations listed in Annex I to Regulation (EC) No 1394/2007, in particular, shall not be considered as substantial manipulations.
Za namene točke (a) se kot bistvene manipulacije ne štejejo zlasti manipulacije iz Priloge I k Uredbi (ES) št. 1394/2007.
SPECIFIC REQUIREMENTS REGARDING MODULE 3
POSEBNE ZAHTEVE V ZVEZI Z MODULOM 3
Specific requirements for all advanced therapy medicinal products
Posebne zahteve za vsa zdravila za napredno zdravljenje