natgillin/translations-raw huggingface dataset:
Storage, print and use of labels on the packaging of active substances shall be controlled.
Skladiščenje, tiskanje in uporaba oznak na embalaži zdravilnih učinkovin se nadzirajo.
Labels shall contain the information necessary to assure the quality of the active substance.
Oznake vsebujejo informacije, ki so potrebne za zagotovitev kakovosti zdravilne učinkovine.
An active substance shall only be placed on the market after it has been released for sale by the quality unit.
Zdravilna učinkovina se da v promet šele po tem, ko enota za kakovost odobri prodajo.
Laboratory controls
Laboratorijski nadzor
The manufacturer shall establish specifications for the quality and purity of the active substances he manufactures and for the raw materials, active substance starting materials and active substance intermediates used in that process.
Proizvajalec določi specifikacije za kakovost in čistost zdravilne učinkovine, ki jo proizvaja, in za surovine, vhodne snovi zdravilne učinkovine in intermediate zdravilne učinkovine, ki se uporabljajo v tem postopku.
Laboratory tests shall be conducted to verify compliance with the specifications referred to in paragraph 1.
Izvedejo se laboratorijski testi, da se preveri skladnost s specifikacijami iz odstavka 1.
The manufacturer shall issue certificates of analysis for each batch of active substance upon the request of:
Proizvajalec izda certifikate o analizi za vsako serijo zdravilne učinkovine na zahtevo:
the competent authorities of a Member State;
pristojnih organov posamezne države članice;
manufacturers of active substances supplied directly or indirectly with the active substance for the purpose of further processing, packing, repacking, labelling or relabelling the active substance;
proizvajalcev zdravilnih učinkovin, dobavljenih neposredno ali posredno z zdravilno učinkovino za namen nadaljnje obdelave, pakiranja, prepakiranja, označevanja ali ponovnega označevanja zdravilne učinkovine;
distributors and brokers of active substances;
distributerjev in posrednikov zdravilnih učinkovin;
manufacturers of medicinal products supplied directly or indirectly with the active substance.
proizvajalcev zdravil, dobavljenih neposredno ali posredno z zdravilno učinkovino.
The manufacturer shall monitor the stability of the active substance through stability studies.
Proizvajalec spremlja stabilnost zdravilne učinkovine preko študij stabilnosti.
Dates for the expiry or retest of active substances shall be set on the basis of an evaluation of data derived from the stability studies.
Datumi izteka roka uporabnosti ali ponovnega preskušanja zdravilnih učinkovin se določijo na podlagi ocene podatkov iz študij stabilnosti.
Appropriately identified samples of the active substance shall be retained in accordance with a sampling plan established on the basis of the shelf-life of the active substance.
Ustrezno identificirani vzorci zdravilnih učinkovin se hranijo v skladu z načrtom vzorčenja, določenim na podlagi roka uporabnosti zdravilne učinkovine.
Validation
Validacija
The manufacturer shall set up and implement a validation policy for those processes and procedures that are critical to ensure that the active substance meets the quality and purity specifications established in accordance with Article 12(1).
Proizvajalec vzpostavi in izvaja politiko validiranja za tiste postopke, ki so ključnega pomena za zagotovitev, da zdravilna učinkovina ustreza specifikacijam za kakovost in čistost, določenim v skladu s členom 12(1).
Change control
Nadziranje sprememb
The manufacturer shall evaluate the potential impact on the quality of the active substance of any changes to the manufacturing process that may affect the production and control of the active substance before implementing those changes.
Proizvajalec oceni morebiten vpliv vseh sprememb proizvodnega postopka, ki lahko vplivajo na proizvodnjo in nadzor zdravilne učinkovine, na kakovost zdravilne učinkovine, preden začne uvajati te spremembe.
Changes to the manufacturing process that negatively affect the quality of the active substance shall be not be implemented.
Spremembe proizvodnega postopka, ki negativno vplivajo na kakovost zdravilne učinkovine, se ne uvedejo.
The manufacturer of an active substance shall notify without delay the manufacturers of medicinal products which he supplies with the active substance of any changes to the manufacturing process that may impact the quality of the active substance.
Proizvajalec zdravilne učinkovine nemudoma obvesti proizvajalce zdravil, ki jih oskrbuje z zdravilno učinkovino, o vseh spremembah proizvodnega postopka, ki lahko vplivajo na kakovost zdravilne učinkovine.
Rejection and returns
Zavrnitev in vračila
Batches of active substances and active substance intermediates failing to conform to the specifications established in accordance with Article 12(1) shall be rejected, labelled as such and quarantined.
Serije zdravilnih učinkovin in intermediati zdravilnih učinkovin, ki ne ustrezajo specifikacijam, določenim v skladu s členom 12(1), se zavrnejo, označijo kot zavrnjeni in dajo v karanteno.
The manufacturer who reprocesses or reworks rejected batches of an active substance that do not conform to specifications, or recovers raw materials and solvents for re-use in the manufacturing process, shall follow the procedures established in accordance with Article 7(1) and shall perform appropriate controls to ensure that:
Proizvajalec, ki obdeluje ali predeluje zavrnjene serije zdravilne učinkovine, ki niso v skladu s specifikacijami, ali predeluje surovine in topila za ponovno uporabo v proizvodnem postopku, se ravna po postopkih, določenih v skladu s členom 7(1), in izvaja ustrezne kontrole za zagotovitev, da:
the reprocessed or reworked active substance meets the quality specifications established in accordance with Article 12(1);
ponovno obdelana ali predelana zdravilna učinkovina ustreza specifikacijam kakovosti, določenim v skladu s členom 12(1);
the recovered raw materials and solvents are suitable for their intended use in the manufacturing process.
so predelane surovine in topila primerni za predvideno uporabo v proizvodnem postopku.
Returned active substances shall be identified as such and quarantined.
Vrnjene zdravilne učinkovine se označijo kot take in dajo v karanteno.
Complaints and recalls
Pritožbe in odpoklici izdelkov
The manufacturer shall record and investigate all quality related complaints.
Proizvajalec evidentira in razišče vse pritožbe, ki so povezane s kakovostjo.
The manufacturer shall establish procedures for the recall of active substances from the market.
Proizvajalec določi postopke za odpoklic zdravilnih učinkovin iz prometa.
In the event of the recalled active substance posing a serious threat to public health, the manufacturer shall inform the competent authorities without delay.
Kadar odpoklicana zdravilna učinkovina predstavlja resno nevarnost za javno zdravje, proizvajalec nemudoma obvesti pristojne organe.
Contract manufacturing
Pogodbena proizvodnja
A manufacturing operation or an operation linked thereto which is to be carried out on behalf of the manufacturer of the active substance by another party (‘the contract manufacturer’) shall be the subject of a written contract.
Dejavnost proizvodnje ali z njo povezana dejavnost, ki jo v imenu proizvajalca zdravilne učinkovine izvaja druga stranka (v nadaljnjem besedilu: pogodbeni proizvajalec), je predmet pisne pogodbe.
The contract shall clearly define the responsibilities of the contract manufacturer with regards to good manufacturing practice.
V pogodbi se jasno opredelijo odgovornosti pogodbenega proizvajalca v zvezi z dobro proizvodno prakso.
The manufacturer of the active substance shall control that operations carried out by a contract manufacturer comply with good manufacturing practice.
Proizvajalec zdravilne učinkovine nadzira, da so dejavnosti, ki jih izvaja pogodbeni proizvajalec, v skladu z dobro proizvodno prakso.
A manufacturing operation or an operation linked thereto which has been entrusted to a contract manufacturer shall not be subcontracted to a third party without the written consent of the manufacturer of the active substance.
Dejavnost proizvodnje ali z njo povezana dejavnost, ki je bila zaupana pogodbenemu proizvajalcu, se ne odda v podizvajanje tretji osebi brez predhodnega pisnega soglasja proizvajalca zdravilne učinkovine.
Repackaging
Ponovno pakiranje
Where the active substance is repackaged by a manufacturer in a container which differs from the original container with regard to its volume, or the material it is made of, or its opaqueness to light, he shall conduct stability studies on the active substance and assign an expiration or retest date for it on the basis of those studies.
Kadar proizvajalec prepakira zdravilno učinkovino v zabojnik, ki se razlikuje od prvotnega zabojnika po prostornini ali materialu, iz katerega je narejen, ali njegovi neprepustnosti za svetlobo, opravi študije stabilnosti zdravilne učinkovine in na podlagi teh študij določi datum izteka roka uporabnosti ali datum ponovnega preskušanja.
It shall apply from 25 May 2015.
Uporabljati se začne 25. maja 2015.
Commission Regulation (EU) No 1253/2014
Uredba Komisije (EU) št. 1253/2014
implementing Directive 2009/125/EC of the European Parliament and of the Council with regard to ecodesign requirements for ventilation units
o izvajanju Direktive 2009/125/ES Evropskega parlamenta in Sveta glede zahtev za okoljsko primerno zasnovo prezračevalnih enot
Having regard to Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products [1], and in particular Article 15(1) thereof,
ob upoštevanju Direktive 2009/125/ES Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o vzpostavitvi okvira za določanje zahtev za okoljsko primerno zasnovo izdelkov, povezanih z energijo [1], in zlasti člena 15(1) Direktive,
Under Directive 2009/125/EC energy-related products representing significant volumes of sales and trade, having significant environmental impact within the Union and presenting significant potential for improvement in terms of their environmental impact, without entailing excessive costs, are to be covered by an implementing measure or a self-regulation measure regarding ecodesign requirements.
V skladu z Direktivo 2009/125/ES se izdelki, povezani z energijo, ki predstavljajo pomemben obseg prodaje in trgovanja, imajo pomemben vpliv na okolje v Uniji in pomenijo veliko možnost za izboljšanje vpliva na okolje brez pretiranih stroškov, zajamejo v izvedbene ali samoregulacijske ukrepe v zvezi z zahtevami za okoljsko primerno zasnovo.
The Commission has assessed the technical, environmental and economic aspects of ventilation units.
Komisija je ocenila tehnične, okoljske in gospodarske vidike prezračevalnih enot.
The assessment showed that ventilation units are placed on the Union market in large quantities.
Ocena je pokazala, da se prezračevalne enote dajejo na trg Unije v velikih količinah.
The energy consumption in the use phase is the most significant environmental aspect of ventilation units, presenting significant potential for cost-effective energy savings and greenhouse gas emission reduction.
Poraba energije v času uporabe je najpomembnejši okoljski vidik prezračevalnih enot in predstavlja veliko priložnost za stroškovno učinkovite prihranke energije in zmanjšanje emisij toplogrednih plinov.
Fans are an important part of ventilation units.
Ventilatorji so pomemben del prezračevalnih enot.
Generic minimum energy efficiency requirements for fans have been established in Commission Regulation (EU) No 327/2011 [2].
Splošne minimalne zahteve za energijsko učinkovitost ventilatorjev so določene v Uredbi Komisije (EU) št. 327/2011 [2].
The power consumption of the ventilation functions of fans which are part of ventilation units is covered by the minimum energy performance requirements of that Regulation, but many ventilation units use fans not covered by it.
Minimalne zahteve za energijsko učinkovitost navedene uredbe zajemajo porabo energije prezračevalnih funkcij ventilatorjev, ki so del prezračevalnih enot, mnoge prezračevalne enote pa uporabljajo ventilatorje, ki jih navedena uredba ne zajema.
It is therefore necessary to introduce implementing measures for ventilation units.
Zaradi tega je pomembno, da se uvedejo izvedbeni ukrepi za prezračevalne enote.
A distinction should be made between measures applying to residential ventilation units and those applying to non-residential ventilation units on the basis of their individual air flow rate because two different sets of measurement standards are used in practice.
Razlikovati bi bilo treba med ukrepi, ki veljajo za stanovanjske prezračevalne enote, in tistimi, ki veljajo za nestanovanjske prezračevalne enote, in sicer na podlagi posameznih stopenj pretoka zraka, saj se v praksi uporabljata dva različna sklopa merilnih standardov.
Small ventilation units with an electric power input of less than 30 W per air stream should be exempted from the requirements of this Regulation, except for information requirements.
Majhne prezračevalne enote z električno vhodno močjo, manjšo od 30 W na tok zraka, bi bilo treba izvzeti iz zahtev te uredbe, razen iz zahtev za navajanje podatkov.
Those units are designed for many different applications, predominantly working intermittently and with supplementary functions only, for example in bathrooms.
Te enote so zasnovane za različne vrste uporabe in večinoma delujejo prekinjeno, saj je njihova funkcija le dopolnilna, kot na primer v kopalnicah.
Including those would represent a considerable administrative burden in terms of market surveillance because of large sales numbers, while contributing only to a small share of the energy saving potential.
Vključitev teh enot bi povzročila precejšnjo upravno obremenitev na področju tržnega nadzora zaradi velikega števila prodanih izdelkov, k prihranku energije pa bi prispevala le malo.
However, considering that they offer similar functionalities to other ventilation units, their possible inclusion should similarly be addressed in the review of this Regulation.
Toda z upoštevanjem, da so njihove funkcije podobne drugim prezračevalnim enotam, bi bilo treba njihovo možno vključitev prav tako obravnavati pri pregledu te uredbe.
Furthermore, ventilation units specifically designed to operate exclusively for emergency purposes or in exceptional or hazardous environments should also be exempted, as they are used rarely and for a short time.
Poleg tega bi bilo treba izvzeti tudi prezračevalne enote, posebej zasnovane za uporabo v nujnih primerih ali izjemnih ali nevarnih okoljih, saj se uporabljajo redko in kratek čas.
The exemptions also clarify that multifunctional units which predominantly heat or cool and kitchen range hoods are excluded.
Izjeme tudi pojasnjujejo, da so večfunkcijske enote, ki predvsem ogrevajo ali hladijo, in kuhinjske nape izvzete.
The Commission has carried out preparatory studies to analyse the technical, environmental and economic aspects of residential and non-residential ventilation units.
Komisija je izvedla pripravljalne študije za analizo tehničnih, okoljskih in gospodarskih vidikov stanovanjskih in nestanovanjskih prezračevalnih enot.
The studies have been developed together with stakeholders and interested parties from the Union and third countries, and the results have been made publicly available.
Študije so bile pripravljene skupaj z deležniki in zainteresiranimi stranmi iz Unije in tretjih držav, rezultati pa so na voljo javnosti.
The environmental parameter of the products covered which has been identified as the most significant for the purposes of this Regulation is energy consumption in the use phase.
Ugotovljeno je bilo, da je za namene te uredbe najpomembnejši okoljski parameter analiziranih izdelkov poraba energije v času uporabe.
In aggregate, using a primary energy conversion coefficient of 2,5 for electricity, the energy balance is 1872 PJ primary energy of annual saving in 2010.
Pripravljalne študije kažejo, da zahteve v zvezi z drugimi parametri za okoljsko primerno zasnovo iz dela 1 Priloge I k Direktivi 2009/125/ES niso potrebne, saj je pri prezračevalnih enotah daleč najpomembnejši okoljski parameter poraba energije v času uporabe.
Without specific measures, the aggregate saving is projected to grow to 2829 PJ in 2025.
Zahteve za okoljsko primerno zasnovo bi bilo treba uvajati postopoma, tako da bodo imeli proizvajalci na voljo dovolj časa za ponovno zasnovo izdelkov, ki so predmet te uredbe.
The preparatory studies show that the energy consumption of products subject to this Regulation can be significantly reduced.
Časovno obdobje bi moralo biti takšno, da bi se upoštevale stroškovne posledice za končne uporabnike in proizvajalce, zlasti za mala in srednje velika podjetja, hkrati pa bi se zagotovilo izboljšanje okoljske učinkovitosti prezračevalnih enot brez nepotrebnih zamud.
The combined effect of the ecodesign requirements set out in this Regulation and in Commission Delegated Regulation (EU) No 1254/2014 [3] is expected to result in an aggregate increase in savings by 1300 PJ (45 %) to a level of 4130 PJ in 2025.
Parametre izdelkov bi bilo treba izmeriti in izračunati z zanesljivimi, točnimi in ponovljivimi metodami, ki upoštevajo najsodobnejše priznane merilne in računske metode ter harmonizirane standarde, če so na voljo, ki jih sprejmejo evropske organizacije za standardizacijo na zahtevo Komisije, v skladu s postopki iz Uredbe (EU) št. 1025/2012 Evropskega parlamenta in Sveta [4].
The preparatory studies show that requirements regarding the other ecodesign parameters referred to in Part 1 of Annex I to Directive 2009/125/EC are not necessary for ventilation units as energy consumption in the use phase is by far the most important environmental parameter.
Ciljne vrednosti za trenutno razpoložljive vrste prezračevalnih enot z visoko energijsko učinkovitostjo bi bilo treba določiti v izvedbenem ukrepu na podlagi informacij, zbranih med pripravo ukrepa, tako da proizvajalci lahko sledijo oceni ter vrednotijo alternativne zasnove in doseženo okoljsko učinkovitost izdelka glede na ciljne vrednosti.
The ecodesign requirements should be introduced gradually in order to provide a sufficient timeframe for manufacturers to re-design products subject to this Regulation.
To bo pripomoglo k zagotavljanju široke razpoložljivosti in preprostega dostopa do informacij, in sicer zlasti malim, srednje velikim in zelo majhnim podjetjem, kar dodatno olajšuje integracijo najboljših razvojnih tehnologij in razvoj učinkovitejših izdelkov za zmanjšanje porabe energije.
The timing should take into account the impact on costs for end-users and manufacturers, in particular small and medium-sized enterprises, while ensuring that the environmental performance of ventilation units is improved without unnecessary delay.
Opravljeno je bilo posvetovanje s Posvetovalnim forumom iz člena 18 Direktive 2009/125/ES.
Product parameters should be measured and calculated using reliable, accurate and reproducible methods which take into account recognised state-of-the-art measurement and calculation methods, including, where available, harmonised standards adopted by the European standardisation bodies following a request by the Commission, in accordance with the procedures laid down in Regulation (EU) No 1025/2012 of the European Parliament and of the Council [4].
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem odbora, ustanovljenega na podlagi člena 19(1) Direktive 2009/125/ES –
Benchmarks for currently available ventilation unit types with high energy efficiency should be identified in the implementing measure on the basis of information gathered during the preparation of the measure, in order that manufacturers can make use of this assessment to evaluate alternative design solutions and the achieved environmental performance of the product against benchmarks.
SPREJELA NASLEDNJO UREDBO:
This will help to ensure a wide availability and easy accessibility of information, in particular for small and medium-sized enterprises and very small firms, which will further facilitate the integration of best design technologies and facilitate the development of more efficient products for reducing energy consumption.
Člen 1
The Consultation Forum referred to in Article 18 of Directive 2009/125/EC has been consulted.
Vsebina in področje uporabe
The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 19(1) of Directive 2009/125/EC,
Ta uredba se uporablja za prezračevalne enote in določa zahteve za okoljsko primerno zasnovo za dajanje enot na trg ali v uporabo.
HAS ADOPTED THIS REGULATION:
Ta uredba se ne uporablja za prezračevalne enote, ki:
Article 1
so enosmerne (odvodne ali dovodne), z električno vhodno močjo, manjšo od 30 W, razen pri zahtevah za navajanje podatkov;
Subject matter and scope
so dvosmerne, s skupno električno vhodno močjo za ventilatorje, manjšo od 30 W na tok zraka, razen pri zahtevah za navajanje podatkov;
This Regulation applies to ventilation units and establishes ecodesign requirements for their placing on the market or putting into service.
so osni ali centrifugalni ventilatorji, opremljeni samo z ohišjem v smislu Uredbe (EU) št. 327/2011;
This Regulation shall not apply to ventilation units which:
so navedene izključno za delovanje v potencialno eksplozivnih atmosferah, opredeljenih v Direktivi Evropskega parlamenta in Sveta 94/9/ES [5];
are unidirectional (exhaust or supply) with an electric power input of less than 30 W, except for information requirements;
so navedene izključno za uporabo v nujnih primerih in za kratek čas delovanja in ki ustrezajo osnovnih zahtevam za gradbena dela z ozirom na varnost v primeru požara, kot je opredeljeno v Uredbi (EU) št. 305/2011 Evropskega parlamenta in Sveta [6];
are bidirectional, with a total electric power input for the fans of less than 30 W per air stream, except for information requirements;
so navedene izključno za delovanje:
are axial or centrifugal fans only equipped with a housing in terms of Regulation (EU) No 327/2011;
pri delovni temperaturi zraka, ki se premika, višji od 100 °C;
are exclusively specified as operating in a potentially explosive atmosphere as defined in Directive 94/9/EC of the European Parliament and of the Council [5];
pri delovni temperaturi okolja motorja, ki poganja ventilator, če je nameščen zunaj toka zraka, ki je višja od 65 °C;
are exclusively specified as operating for emergency use, for short periods of time, and which comply with the basic requirements for construction works with regard to safety in case of fire as set out in Regulation (EU) No 305/2011 of the European Parliament and of the Council [6];
pri temperaturi zraka, ki se premika, ali pri delovni temperaturi okolja motorja, ki poganja ventilator, če je nameščen zunaj toka zraka, ki je nižja od – 40 °C;
are exclusively specified as operating:
pri napajalni napetosti, ki presega 1000 V pri izmeničnem toku ali 1500 V pri enosmernem toku;
where operating temperatures of the air being moved exceed 100 °C;
v strupenih, zelo jedkih ali gorljivih okoljih ali v okoljih z abrazivnimi snovmi;
where the operating ambient temperature for the motor, if located outside the air stream, driving the fan exceeds 65 °C;
vključujejo izmenjevalnik toplote in toplotno črpalko za rekuperacijo toplote ali omogočajo transfer toplote ali ekstrakcijo, in sicer dodatno k sistemu za rekuperacijo toplote, razen transfera toplote za zaščito pred zamrzovanjem ali odmrzovanje;
where the temperature of the air being moved or the operating ambient temperature for the motor, if located outside the air stream, are lower than – 40 °C;
so razvrščene kot kuhinjske nape v Uredbi Komisije (EU) št. 66/2014 [7] o kuhinjskih napravah.
where the supply voltage exceeds 1000 V AC or 1500 V DC;
Člen 2
in toxic, highly corrosive or flammable environments or in environments with abrasive substances;
Opredelitve pojmov
include a heat exchanger and a heat pump for heat recovery or allowing heat transfer or extraction being additional to that of the heat recovery system, except heat transfer for frost protection or defrosting;
V tej uredbi se uporabljajo naslednje opredelitve pojmov: