natgillin/translations-raw huggingface dataset:
To that end, Article 4(2) of that Directive provides that the user is to assess the risks that the specific type of contained use may pose, using as a minimum the elements of assessment and the procedure set out in Sections A and B of Annex III to that Directive.
V ta namen člen 4(2) navedene direktive določa, da mora uporabnik oceniti tveganja, ki jih lahko predstavlja določena vrsta uporabe v zaprtem sistemu, in pri tem uporabiti vsaj tiste elemente ocene in postopka, ki so določeni v oddelkih A in B Priloge III k navedeni direktivi.
The development of vaccines and therapies against the virus is of major public interest and we are collectively called to make safe and efficacious medicinal products available to our citizens as soon as possible.
Razvoj cepiv in zdravljenj proti virusu je pomemben javni interes in skupaj moramo državljanom čim prej zagotoviti varna in učinkovita zdravila.
A common approach for all the Union Member States is deemed necessary as threats to health arising from the COVID-19 pandemic have, by their nature, transnational implications.
Skupen pristop za vse države članice Unije je nujno potreben, saj so nevarnosti za zdravje zaradi pandemije COVID-19 po svoji naravi nadnacionalne.
The environmental risks of all medicinal products are assessed as part of the marketing authorisation procedures, including for medicinal products that contain or consist of genetically modified organisms ("GMOs").
Okoljska tveganja pri vseh zdravilih se ocenjujejo kot del postopkov za pridobitev dovoljenja za promet, vključno z zdravili, ki vsebujejo gensko spremenjene organizme (GSO) ali so iz njih sestavljena.
Some of the vaccines under development are based on genetically modified viruses and may fall within the definition of GMO.
Nekatera cepiva v razvoju temeljijo na gensko spremenjenih virusih in lahko spadajo v opredelitev pojma „GSO".
Some of the vaccines in development contain attenuated viruses or live vectors, which may fall within the definition of GMO.
Nekatera cepiva v razvoju vsebujejo oslabljene viruse ali žive vektorje, ki lahko spadajo v opredelitev GSO.
The Coronavirus outbreak has created an unprecedented public health emergency.
Izbruh koronavirusa je povzročil izredne razmere v javnem zdravju, kakršnih še ni bilo.
(11)The COVID-19 pandemic has created an unprecedented public health emergency that has claimed the life of thousands of people, affecting in particular the elderly and those with pre-existing health conditions.
(11)Zaradi pandemije COVID-19, ki je povzročila izredne razmere v javnem zdravju brez primere, je umrlo na tisoče ljudi, zlasti starejših in oseb s predhodnimi bolezenskimi stanji.
The purpose of the authorisation is to protect the rights, safety and well-being of persons taking part in clinical trials, and to ensure the reliability and robustness of the data generated by the clinical trial.
Namen dovoljenja je zaščititi pravice, varnost in dobrobit oseb, ki sodelujejo v kliničnih preskušanjih, ter zagotoviti zanesljivost in trdnost podatkov, pridobljenih s kliničnim preskušanjem.
The notification is to include an environmental risk assessment performed in accordance with Annex II to Directive 2001/18/EC and a technical dossier supplying the information specified in Annex III to that Directive.
Prijava mora vključevati oceno tveganja za okolje, izvedeno v skladu s Prilogo II k Direktivi 2001/18/ES, in tehnično dokumentacijo z informacijami iz Priloge III k navedeni direktivi.
In so far as the proposed Regulation will allow Member States to facilitate the development and/or availability of high quality and safe medicinal products for human use in response to the situation of public health emergency created by the COVID-19 pandemic, the adoption thereof should be based on Article 168(4)(c) TFEU.
Ker bo predlagana uredba državam članicam omogočila, da spodbudijo razvoj in/ali razpoložljivost visokokakovostnih in varnih zdravil za uporabo v humani medicini v odziv na izredne razmere v javnem zdravju, ki jih je povzročila pandemija COVID-19, bi moralo njeno sprejetje temeljiti na členu 168(4)(c) PDEU.
Compliance with ethical requirements and good clinical practice in the conduct of clinical trials will continue to be mandatory as well as compliance with good manufacturing practice in the manufacture or importation of investigational medicinal products containing or consisting of GMOs.
Še naprej se bodo zahtevali izpolnjevanje etičnih zahtev in skladnost z dobro klinično prakso pri izvajanju kliničnih preskušanj ter skladnost z dobro proizvodno prakso pri proizvodnji ali uvozu zdravil v preskušanju, ki vsebujejo GSO ali so iz njih sestavljena.
(c)where such medicinal products are made available by a Member State pursuant to Article 83(1) of Regulation (EC) No 726/2004.
(c)kadar država članica taka zdravila da na voljo v skladu s členom 83(1) Uredbe (ES) št. 726/2004.
In addition, the proposal also aims at clarifying certain aspects of the application of provisions of the pharmaceutical acquis that allow the national competent authorities to authorise the supply and administration of medicinal products that do not have a marketing authorisation to situations of urgency and/or emergency, such as the COVID-19 pandemic.
Poleg tega je namen predloga tudi pojasniti nekatere vidike uporabe določb pravnega reda na farmacevtskem področju, ki pristojnim nacionalnim organom omogočajo, da dovolijo dobavo in dajanje zdravil, ki nimajo dovoljenja za promet, v nujnih in/ali izrednih razmerah, kot je pandemija COVID-19.
On the basis of the available evidence, it is concluded that it is unlikely that the concerns arising from the lack of tools in the Union legislation to address the specific characteristics of clinical trials with investigational medicinal products for human use that contain or consist of GMOs in the current situation of public health emergency created by COVID-19 will be resolved unless this situation is addressed at Union level.
Na podlagi razpoložljivih dokazov je bilo ugotovljeno, da ni verjetno, da bodo pomisleki, ki izhajajo iz pomanjkanja orodij v zakonodaji Unije za obravnavanje posebnih značilnosti kliničnih preskušanj zdravil za uporabo v humani medicini v preskušanju, ki vsebujejo GSO ali so iz njih sestavljena, v trenutnih izrednih razmerah v javnem zdravju, ki jih je povzročil COVID-19, razrešeni, razen če se razmere obravnavajo na ravni Unije.
It is necessary to adapt the regulatory framework on GMOs so that the conduct of clinical trials with these vaccines can start within the shortest possible timelines while ensuring the rights, safety, dignity and well-being of those individuals that take part in a clinical trial, as well as the reliability and robustness of the data generated and adequate protection of the environment and of human health via the environment.
Regulativni okvir o GSO je treba prilagoditi, da se lahko izvajanje kliničnih preskušanj teh cepiv začne čim prej, hkrati pa zagotovijo pravice, varnost, dostojanstvo in dobrobit tistih posameznikov, ki sodelujejo v kliničnem preskušanju, ter zanesljivost in trdnost pridobljenih podatkov in ustrezno varovanje okolja in zdravja ljudi prek okolja.
(14)To achieve the objective of making available safe and efficacious medicinal products to treat or prevent COVID-19, a range of measures have been taken at Union level by the European Medicines Agency (EMA) and by the network of national competent authorities to facilitate, support and speed up the development and marketing authorisation of treatments and vaccines.
(14)Za dosego tega cilja, tj. dati na voljo varna in učinkovita zdravila za zdravljenje ali preprečevanje COVID-19, sta Evropska agencija za zdravila (EMA) in mreža nacionalnih pristojnih organov na ravni Unije sprejeli vrsto ukrepov za spodbujanje, podpiranje in pospešitev razvoja zdravil in cepiv ter izdajanja dovoljenj za promet.
The Union legislation on GMOs encompasses Directive 2009/41/EC on the contained use of genetically modified microorganisms (the "contained use Directive") and Directive 2001/18/EC on the deliberate release into the environment of GMOs (the "deliberate release Directive").
Zakonodaja Unije o GSO zajema Direktivo 2009/41/ES o uporabi gensko spremenjenih mikroorganizmov v zaprtih sistemih (direktiva o uporabi v zaprtih sistemih) in Direktivo 2001/18/ES o namernem sproščanju gensko spremenjenih organizmov v okolje (direktiva o namernem sproščanju).
1.This Regulation applies as long as COVID-19 is regarded as a pandemic by the World Health Organisation or as long as a Commission decision recognising a situation of public health emergency due to COVID-19 in accordance with Article 12 of Decision No 1082/2013/EU of the European Parliament and of the Council 7 applies.
1.Ta uredba se uporablja, dokler Svetovna zdravstvena organizacija COVID-19 šteje za pandemijo ali dokler se uporablja sklep Komisije o razglasitvi izrednih razmer v javnem zdravju zaradi COVID-19 v skladu s členom 12 Sklepa št. 1082/2013/EU Evropskega parlamenta in Sveta 7 .
(7)Clinical trials necessitate the performance of multiple operations, including, for example, the manufacture, transport and storage of the investigational medicinal products, packaging and labelling, the administration thereof to trial subjects and subsequent monitoring of the subjects and the disposal of waste and unused investigational medicinal products.
(7)Za klinična preskušanja je treba izvesti več postopkov, ki na primer vključujejo proizvodnjo, prevoz in shranjevanje zdravil v preskušanju, njihovo pakiranje in označevanje, njihovo dajanje preizkušancem in posledično spremljanje preizkušancev ter odstranjevanje odpadkov in neuporabljenih zdravil v preskušanju.
(6)Directive 2009/41/EC ensures that the risks to human health and the environment associated with the contained use of genetically modified micro-organisms is assessed on a case-by-case basis.
(6)Direktiva 2009/41/ES zagotavlja, da se tveganja za zdravje ljudi in okolje, povezana z uporabo gensko spremenjenih mikroorganizmov v zaprtih sistemih, ocenijo za vsak primer posebej.
In those exceptional and urgent situations, where there is a lack of a suitable approved medicinal product, the Union legislator has made a choice that the need to protect public health or the health of individual patients and the benefits of the medicinal product must prevail over other considerations, in particular the need to obtain a marketing authorization and consequently, to have available complete information about the risks posed by the medicinal product, therefore including any risks to the environment from medicinal products containing or consisting of GMOs.
V navedenih izrednih in nujnih razmerah, kadar ni ustreznega odobrenega zdravila, je zakonodajalec Unije odločil, da morajo varovanje javnega zdravja ali zdravja posameznih pacientov in koristi zdravila prevladati nad drugimi vidiki, zlasti potrebo po pridobitvi dovoljenja za promet in posledično razpoložljivih popolnih informacijah o tveganjih, ki jih predstavlja zadevno zdravilo, torej vključno z vsemi tveganji za okolje zaradi zdravil, ki vsebujejo GSO ali so iz njih sestavljena.
However, the specific characteristics of the setting of clinical trials in a situation of a public health emergency such as the one created by the COVID-19 pandemic are not foreseen in Directive 2001/18/EC or Directive 2009/41/EC.
Vendar posebne značilnosti kliničnih preskušanj v izrednih razmerah v javnem zdravju, kot jih je povzročila pandemija COVID-19, v Direktivi 2001/18/ES ali Direktivi 2009/41/ES niso predvidene.
(2)Directive 2001/83/EC of the European Parliament and of the Council 2 and Regulation (EC) No 726/2004 of the European Parliament and of the Council 3 require that applications for authorisation to place a medicinal product on the market, in a Member State or in the Union, be accompanied by a dossier containing the results of clinical trials carried out on the product.
(2)Z Direktivo 2001/83/ES Evropskega parlamenta in Sveta 2 ter Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta 3 se zahteva, da se vlogam za pridobitev dovoljenja za dajanje zdravila v promet v državi članici ali v Uniji priloži dokumentacija, ki vsebuje rezultate kliničnih preskušanj zdravila.
(10)This makes it particularly difficult to perform multi-centre clinical trials with investigational medicinal products that contain or consist of GMOs in several Member States.
(10)To še posebej otežuje izvajanje multicentričnih kliničnih preskušanj zdravil v preskušanju, ki vsebujejo GSO ali so iz njih sestavljena, v več državah članicah.
Whereas in some Member States a single request for authorisation concerning the conduct of the clinical trial and the GMO aspects can be submitted to a single competent authority, in other Member States parallel requests need to be submitted to different competent authorities.
V nekaterih državah članicah se lahko predloži ena sama zahteva za dovoljenje, ki se nanaša tako na izvajanje kliničnega preskušanja kot na vidike v zvezi z GSO, in sicer enemu samemu pristojnemu organu, v drugih državah članicah pa je treba predložiti vzporedni zahtevi različnima pristojnima organoma.
Under Article 83(1) of Regulation (EC) No 726/2004, Member States may make a medicinal product for human use available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product.
V skladu s členom 83(1) Uredbe (ES) št. 726/2004 lahko države članice zdravilo za uporabo v humani medicini zaradi sočutja dajo na voljo skupini pacientov s kronično ali resno izčrpavajočo boleznijo ali katerih bolezen velja za ogrožajočo in ki jih ni mogoče zadovoljivo zdraviti z odobrenim zdravilom.
(13)In this situation of public health emergency, it is of major interest for the Union that safe and efficacious medicinal products to treat or prevent COVID-19 can be developed and be made available within the Union as soon as possible.
(13)Zaradi izrednih razmer v javnem zdravju je v velikem interesu Unije, da se lahko v najkrajšem možnem času razvijejo in dajo na voljo v Uniji varna in učinkovita zdravila za zdravljenje ali preprečevanje COVID-19.
In particular, Article 5(1) of Directive 2001/83/EC allows Member States to fulfil special needs, to exclude from the provisions of that Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his or her direct personal responsibility.
Zlasti člen 5(1) Direktive 2001/83/ES državam članicam omogoča, da za zadovoljevanje posebnih potreb iz določb navedene direktive izvzamejo tista zdravila, izdana v odgovor na prostovoljno dobroverno naročilo, ki so pripravljena v skladu s specifikacijami pooblaščenega zdravstvenega delavca in ki jih bodo posamezni pacienti uporabljali na njegovo neposredno osebno odgovornost.
(16)It is of paramount importance that clinical trials with investigational medicinal products against COVID-19 containing or consisting of GMOs can be conducted within the Union, that they can begin as soon as possible, and that they are not delayed due to the complexity of differing national procedures put in place by Member States in implementation of Directives 2001/18/EC and 2009/41/EC.
(16)Bistvenega pomena je, da se klinična preskušanja zdravil v preskušanju proti COVID-19, ki vsebujejo GSO ali so iz njih sestavljena, lahko izvedejo v Uniji, pa tudi, da se lahko začnejo čim prej in da ne prihaja do zamud zaradi zapletenosti različnih nacionalnih postopkov, ki so jih države članice uvedle za izvajanje direktiv 2001/18/ES in 2009/41/ES.
1.Articles 6 to 11 and 13 to 24 of Directive 2001/18/EC and Articles 6 to 13 of Directive 2009/41/EC shall not apply to operations related to the use of medicinal products containing or consisting of GMOs that are intended to treat or prevent COVID-19, including packaging and labelling, storage, transport, destruction, disposal, distribution, supply, administration but excluding the manufacturing of the medicinal product, in any of the following cases:
1.Členi 6 do 11 in 13 do 24 Direktive 2001/18/ES ter členi 6 do 13 Direktive 2009/41/ES se ne uporabljajo za dejavnosti, povezane z uporabo zdravil za zdravljenje ali preprečevanje COVID-19, ki vsebujejo GSO ali so iz njih sestavljena, vključno s pakiranjem in označevanjem, shranjevanjem, prevozom, uničevanjem, odstranjevanjem, distribucijo, dobavo in dajanjem zdravila, vendar z izjemo njegove proizvodnje, v naslednjih primerih:
Directives 2001/18/EC and 2009/41/EC have the objective of ensuring a high level of protection of human health and the environment, through the assessment of the risks from the deliberate release or the contained used of GMOs.
Cilj direktiv 2001/18/ES in 2009/41/ES je zagotoviti visoko raven varovanja zdravja ljudi in okolja z oceno tveganj zaradi namernega sproščanja GSO ali njihove uporabe v zaprtem sistemu.
Those operations may fall within the scope of Directive 2001/18/EC or Directive 2009/41/EC in cases where the investigational medicinal product contains or consists of GMOs.
Navedeni postopki lahko spadajo na področje uporabe Direktive 2001/18/ES ali Direktive 2009/41/ES v primerih, ko zdravilo v preskušanju vsebuje GSO ali je iz njih sestavljeno.
(22)As a general rule, no medicinal product may be placed on the market in the Union or in a Member State unless a marketing authorisation has been granted by the competent authorities under Regulation (EC) No 726/2004 or Directive 2001/83/EC.
(22)Na splošno se lahko zdravilo da v promet v Uniji ali v državi članici samo, če so pristojni organi zanj izdali dovoljenje za promet v skladu z Uredbo (ES) št. 726/2004 ali Direktivo 2001/83/ES.
In addition, national requirements and procedures for the environmental risk assessment and consent by competent authorities for the release of GMOs under Directive 2001/18/EC vary greatly from one Member State to another.
Pri tem se nacionalne zahteve ter postopki za oceno tveganja za okolje in za pridobitev odobritve pristojnih organov za sproščanje GSO v skladu z Direktivo 2001/18/ES v različnih državah članicah zelo razlikujejo.
For this purpose, it is necessary to grant a temporary derogation, for the duration of the COVID-19 pandemic, limited to clinical trials with investigational medicinal products to treat or prevent COVID-19.
V ta namen je treba za čas trajanja pandemije COVID-19 odobriti začasno odstopanje, omejeno na klinična preskušanja zdravil v preskušanju za zdravljenje ali preprečevanje COVID-19.
The proposed Regulation aims to expedite the conduct of clinical trials with medicinal products that contain or consist of GMOs in the current scenario of public health emergency created by the COVID-19 pandemic so as to facilitate the availability of high quality, safe and efficacious medicinal products to treat or prevent COVID-19.
Namen predlagane uredbe je pospešiti izvajanje kliničnih preskušanj zdravil, ki vsebujejo GSO ali so iz njih sestavljena, v razmerah, kot so trenutne izredne razmere v javnem zdravju, ki jih je povzročila pandemija COVID-19, da bi se olajšala razpoložljivost visokokakovostnih, varnih in učinkovitih zdravil za zdravljenje ali preprečevanje COVID-19.
Furthermore, some Member States apply Directive 2001/18/EC, others apply Directive 2009/41/EC and there are Member States that apply either Directive 2009/41/EC or Directive 2001/18/EC depending on the specific circumstances of a clinical trial, so it is not possible to determine a priori the national procedure that is to be followed.
Poleg tega nekatere države članice uporabljajo Direktivo 2001/18/ES, druge Direktivo 2009/41/ES, nekatere pa bodisi Direktivo 2009/41/ES bodisi Direktivo 2001/18/ES, odvisno od okoliščin kliničnega preskušanja, tako da ni mogoče vnaprej določiti nacionalnega postopka, ki se bo uporabljal.
(4)In accordance with Article 9(7) of Directive 2001/20/EC, the authorisation for clinical trials is without prejudice to the application of Directives 2001/18/EC 5 and 2009/41/EC 6 of the European Parliament and of the Council.
(4)V skladu s členom 9(7) Direktive 2001/20/ES dovoljenje za klinična preskušanja ne posega v uporabo Direktive 2001/18/ES Evropskega parlamenta in Sveta 5 ter Direktive 2009/41/ES Evropskega parlamenta in Sveta 6 .
(15)To generate the robust clinical evidence necessary to support applications for marketing authorisation of medicinal products to treat or prevent COVID-19 multi-centre clinical trials involving several Member States will need to be conducted.
(15)Za pridobitev zanesljivih kliničnih dokazov, ki so potrebni v podporo vlogam za pridobitev dovoljenja za promet z zdravili za zdravljenje ali preprečevanje COVID-19, bodo potrebna multicentrična klinična preskušanja, ki vključujejo več držav članic.
(8)Experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, the procedure to achieve compliance with the requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental impact assessment and authorization by the competent authority of a Member State is complex and may take a significant amount of time.
(8)Izkušnje kažejo, da je pri kliničnih preskušanjih zdravil v preskušanju, ki vsebujejo GSO ali so iz njih sestavljena, postopek za zagotovitev skladnosti z zahtevami direktiv 2001/18/ES in 2009/41/ES glede ocene tveganja za okolje ter dovoljenja pristojnega organa države članice zapleten, lahko pa tudi precej dolgotrajen.
(9)The complexity of that procedure increases greatly in the case of multi-centre clinical trials conducted in several Member States, as sponsors of clinical trials need to submit multiple requests for authorisation to multiple competent authorities in different Member States in parallel.
(9)Ta postopek je še veliko bolj zapleten, kadar gre za multicentrična klinična preskušanja, ki se izvajajo v več državah članicah, saj morajo naročniki kliničnih preskušanj hkrati predložiti več zahtev za dovoljenje več pristojnim organom v različnih državah članicah.
It would be incoherent and contrary to the very purpose and "effet utile" of those exemptions, and with the objective of protecting human health in Directive 2001/18/EC, Directive 2009/41/EC and in Union legislation on medicinal products, to consider that it was the legislator's intention to still require an authorization under Directive 2001/18/EC or Directive 2009/41/EC when the legislator, taking into account the objective of protecting human health and the environment has made a choice that in those exceptional and urgent situations the protection of public health or the health of individual patients must prevail and has provided an exemption from the authorization procedure in the Union legislation on medicinal products.
Neskladno in v nasprotju s samim namenom in „effet utile" navedenih izjem ter ciljem varovanja zdravja ljudi iz Direktive 2001/18/ES, Direktive 2009/41/ES in zakonodaje Unije o zdravilih bi bilo meniti, da je namen zakonodajalca še vedno zahtevati dovoljenje na podlagi Direktive 2001/18/ES ali Direktive 2009/41/ES, saj se je zakonodajalec ob upoštevanju cilja varovanja zdravja ljudi in okolja odločil, da mora v navedenih izrednih in nujnih razmerah varovanje javnega zdravja ali zdravja posameznih pacientov prevladati, ter v zakonodaji Unije o zdravilih predvidel izjemo od postopka za pridobitev dovoljenja.
(5)Article 6 of Directive 2001/18/EC provides that a release into the environment of Genetically Modified Organisms (GMOs) for any other purpose than for placing on the market is subject to a notification and to written consent by the competent authority of the Member State within whose territory the release is to take place.
(5)Člen 6 Direktive 2001/18/ES določa, da je sproščanje gensko spremenjenih organizmov (GSO) v okolje za druge namene kot dajanje v promet pogojeno s prijavo in pisno odobritvijo pristojnega organa države članice, na ozemlju katere bo prišlo do sproščanja.