natgillin/translations-raw huggingface dataset:
Since the objective of this Regulation, namely to support the fair and equitable sharing of the benefits arising from the utilisation of genetic resources in accordance with the Nagoya Protocol, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and the need to ensure the functioning of the internal market, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Ker cilja te uredbe, in sicer podpiranja poštene in pravične delitve koristi, ki izhajajo iz uporabe genskih virov v skladu z Nagojskim protokolom, države članice ne morejo zadovoljivo doseči, temveč se zaradi njegovega obsega ter potrebe po zagotavljanju delovanja notranjega trga lažje doseže na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
The date of entry into force of this Regulation should be directly correlated to the entry into force of the Nagoya Protocol for the Union in order to ensure equal conditions at Union and global level in activities relating to access and benefit-sharing of genetic resources,
Datum začetka veljavnosti te uredbe bi moral biti neposredno povezan z začetkom veljavnosti Nagojskega protokola za Unijo, da se zagotovijo enaki pogoji na ravni Unije in svetovni ravni pri dejavnostih, povezanih z dostopom do genskih virov in delitvijo koristi –
This Regulation establishes rules governing compliance with access and benefit-sharing for genetic resources and traditional knowledge associated with genetic resources in accordance with the provisions of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (the ‘Nagoya Protocol’).
Ta uredba določa pravila, ki urejajo izpolnjevanje obveznosti pri dostopu do genskih virov in tradicionalnega znanja v zvezi z njimi ter delitvi koristi v skladu z določbami Nagojskega protokola o dostopu do genskih virov ter pošteni in pravični delitvi koristi, ki izhajajo iz njihove uporabe, h Konvenciji o biološki raznovrstnosti (v nadaljnjem besedilu: Nagojski protokol).
The effective implementation of this Regulation will also contribute to the conservation of biological diversity and the sustainable use of its components, in accordance with the provisions of the Convention on Biological Diversity (the ‘Convention’).
Učinkovito izvajanje te uredbe bo prispevalo tudi k ohranjanju biotske raznovrstnosti in trajnostni rabi njenih sestavnih delov v skladu z določbami Konvencije o biološki raznovrstnosti (v nadaljnjem besedilu: Konvencija).
This Regulation applies to genetic resources over which States exercise sovereign rights and to traditional knowledge associated with genetic resources that are accessed after the entry into force of the Nagoya Protocol for the Union.
Ta uredba se uporablja za genske vire, nad katerimi imajo države suverene pravice, in tradicionalno znanje v zvezi z genskimi viri, do katerih se dostopa po začetku veljavnosti Nagojskega protokola za Unijo.
It also applies to the benefits arising from the utilisation of such genetic resources and traditional knowledge associated with genetic resources.
Uporablja se tudi za koristi, ki izhajajo iz uporabe takih genskih virov in tradicionalnega znanja v zvezi z genskimi viri.
This Regulation does not apply to genetic resources for which access and benefit-sharing is governed by specialised international instruments that are consistent with, and do not run counter to the objectives of the Convention and the Nagoya Protocol.
Ta uredba se ne uporablja za genske vire, dostop do katerih in katerih delitev koristi urejajo posebni mednarodni instrumenti, ki so skladni s cilji Konvencije in Nagojskega protokola in niso v nasprotju z njimi.
This Regulation is without prejudice to Member States’ rules on access to genetic resources over which they exercise sovereign rights within the scope of Article 15 of the Convention, and to Member States’ provisions on Article 8(j) of the Convention concerning traditional knowledge associated with genetic resources.
Ta uredba ne posega v pravila držav članic o dostopu do genskih virov, nad katerimi imajo suverene pravice v skladu s členom 15 Konvencije, ter v določbe držav članic o členu 8(j) Konvencije glede tradicionalnega znanja v zvezi z genskimi viri.
This Regulation applies to genetic resources and traditional knowledge associated with genetic resources to which access and benefit-sharing legislation or regulatory requirements of a Party to the Nagoya Protocol are applicable.
Ta uredba se uporablja za genske vire in tradicionalno znanje v zvezi z njimi, za katere se uporabljajo zakonodaja in regulativne zahteve pogodbenice Nagojskega protokola, ki veljajo za dostop do genskih virov in delitev koristi.
Nothing in this Regulation shall oblige a Member State to supply information the disclosure of which it considers contrary to the essential interests of its security.
Nič iz te uredbe ne zavezuje države članice k dajanju informacij, katerih razkritje bi bilo po njenem mnenju v nasprotju z njenimi bistvenimi varnostnimi interesi.
For the purposes of this Regulation, the definitions of the Convention and the Nagoya Protocol as well as the following definitions apply:
V tej uredbi se uporabljajo opredelitve pojmov iz Konvencije in Nagojskega protokola ter naslednje opredelitve pojmov:
‘genetic material’ means any material of plant, animal, microbial or other origin containing functional units of heredity;
„genski material“ pomeni vsak material rastlinskega, živalskega, mikrobskega ali drugega izvora, ki vsebuje funkcionalne enote dednosti;
‘genetic resources’ means genetic material of actual or potential value;
„genski viri“ pomeni genski material z dejansko ali potencialno vrednostjo;
‘access’ means the acquisition of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol;
„dostop“ pomeni pridobitev genskih virov ali tradicionalnega znanja v zvezi z genskimi viri v pogodbenici Nagojskega protokola;
‘user’ means a natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources;
„uporabnik“ pomeni fizično ali pravno osebo, ki uporablja genske vire ali tradicionalno znanje v zvezi z genskimi viri;
‘utilisation of genetic resources’ means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention;
„uporaba genskih virov“ pomeni raziskovanje in razvijanje genske in/ali biokemijske sestave genskih virov, tudi z uporabo biotehnologije, kakor je opredeljena v členu 2 Konvencije;
‘mutually agreed terms’ means the contractual arrangements concluded between a provider of genetic resources, or of traditional knowledge associated with genetic resources, and a user, that set out specific conditions for the fair and equitable sharing of benefits arising from the utilisation of genetic resources or of traditional knowledge associated with genetic resources, and that may also include further conditions and terms for such utilisation as well as subsequent applications and commercialisation;
„medsebojno dogovorjeni pogoji“ pomeni pogodbeni dogovor, sklenjen med ponudnikom genskih virov ali tradicionalnega znanja v zvezi z genskimi viri in uporabnikom, ki določa posebne pogoje za pošteno in pravično delitev koristi, ki izhajajo iz uporabe genskih virov ali tradicionalnega znanja v zvezi z njimi, in lahko vključuje tudi dodatne pogoje za tako uporabo ter poznejšo rabo ali trženje;
‘traditional knowledge associated with genetic resources’ means traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources;
„tradicionalno znanje v zvezi z genskimi viri“ pomeni tradicionalno znanje avtohtone ali lokalne skupnosti, ki je pomembno za uporabo genskih virov ter je kot tako opisano v medsebojno dogovorjenih pogojih, ki veljajo za uporabo genskih virov;
‘illegally accessed genetic resources’ means genetic resources and traditional knowledge associated with genetic resources which were not accessed in accordance with the national access and benefit-sharing legislation or regulatory requirements of the provider country that is a Party to the Nagoya Protocol requiring prior informed consent;
„nezakonito pridobljeni genski viri“ pomeni genske vire in tradicionalno znanje v zvezi z genskimi viri, ki niso bili pridobljeni v skladu z nacionalno zakonodajo ali regulativnimi zahtevami o dostopu in delitvi koristi države ponudnice, ki je pogodbenica Nagojskega protokola, po kateri je potrebna predhodna privolitev;
‘collection’ means a set of collected samples of genetic resources and related information that is accumulated and stored, whether held by public or private entities;
„zbirka“ pomeni nabor zbranih vzorcev genskih virov in informacij o njih, ki so zbrani in shranjeni, ne glede na to, ali so v lasti javnih subjektov ali zasebnikov;
‘association of users’ means an organisation, established in accordance with the requirements of the Member State in which it is located, that represents the interests of users and that is involved in developing and overseeing the best practices referred to in Article 8 of this Regulation;
„združenje uporabnikov“ pomeni organizacijo, ki je ustanovljena v skladu z zahtevami države članice, v kateri se nahaja, in predstavlja interese uporabnikov ter razvija in nadzira najboljše prakse iz člena 8 te uredbe;
‘internationally recognised certificate of compliance’ means a permit or its equivalent issued at the time of access as evidence that the genetic resource it covers has been accessed in accordance with the decision to grant prior informed consent, and that mutually agreed terms have been established for the user and the utilisation specified therein by a competent authority in accordance with Article 6(3)(e) and Article 13(2) of the Nagoya Protocol, that is made available to the Access and Benefit-sharing Clearing House established under Article 14(1) of that Protocol.
„mednarodno priznano potrdilo o skladnosti“ pomeni dovoljenje ali enakovreden dokument, ki ga ob dostopu kot dokazilo, da je bil dostop do genskega vira, za katere je bilo izdano, skladen z odločitvijo o podelitvi predhodne privolitve ter da so bili določeni medsebojno dogovorjeni pogoji za uporabnika in uporabo iz potrdila, izda pristojni organ v skladu s členom 6(3)(e) in členom 13(2) Nagojskega protokola ter je na voljo posredovalnici informacij o dostopu in delitvi koristi, ustanovljeni na podlagi člena 14(1) navedenega protokola.
USER COMPLIANCE
IZPOLNJEVANJE OBVEZNOSTI UPORABNIKOV
Obligations of users
Obveznosti uporabnikov
Users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements, and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.
Uporabniki s primerno skrbnostjo preverijo, ali je bil dostop do genskih virov, ki jih uporabljajo, in uporabljenega tradicionalnega znanja v zvezi z genskimi viri v skladu z veljavno zakonodajo ali regulativnimi zahtevami o dostopu in delitvi koristi, ter da se koristi pošteno in pravično delijo na podlagi medsebojno dogovorjenih pogojev v skladu z veljavno zakonodajo in regulativnimi zahtevami.
Genetic resources and traditional knowledge associated with genetic resources shall only be transferred and utilised in accordance with mutually agreed terms if they are required by applicable legislation or regulatory requirements.
Genski viri in tradicionalno znanje v zvezi z genskimi viri se posredujejo in uporabijo v skladu z medsebojno dogovorjenimi pogoji le, če so ti potrebni v skladu z veljavno zakonodajo ali regulativnimi zahtevami.
For the purposes of paragraph 1, users shall seek, keep and transfer to subsequent users:
Za namene odstavka 1 uporabniki pridobijo, imajo in na naslednje uporabnike prenesejo:
the internationally-recognised certificate of compliance, as well as information on the content of the mutually agreed terms relevant for subsequent users; or
mednarodno priznano potrdilo o skladnosti ter informacije o vsebini medsebojno dogovorjenih pogojev, ki so pomembne za naslednje uporabnike, ali
where no internationally-recognised certificate of compliance is available, information and relevant documents on:
kadar mednarodno priznano potrdila o skladnosti ni na voljo, informacije in ustrezno dokumentacijo o:
the date and place of access of genetic resources or of traditional knowledge associated with genetic resources;
datumu in kraju dostopa do genskih virov ali tradicionalnega znanja v zvezi z genskimi viri;
the description of the genetic resources or of traditional knowledge associated with genetic resources utilised;
opisu uporabljenih genskih virov ali tradicionalnega znanja v zvezi z genskimi viri;
the source from which the genetic resources or traditional knowledge associated with genetic resources were directly obtained, as well as subsequent users of genetic resources or traditional knowledge associated with genetic resources;
viru, od katerega so bili neposredno pridobljeni genski viri ali tradicionalno znanje v zvezi z genskimi viri, ter naslednjih uporabnikih genskih virov ali tradicionalnega znanja v zvezi z genskimi viri;
the presence or absence of rights and obligations relating to access and benefit-sharing including rights and obligations regarding subsequent applications and commercialisation;
o tem, ali obstajajo pravice in obveznosti v zvezi z dostopom in delitvijo koristi, vključno s pravicami in obveznostmi glede nadaljnje rabe in trženja;
access permits, where applicable;
dovoljenjih za dostop, kadar je potrebno;
mutually agreed terms, including benefit-sharing arrangements, where applicable.
medsebojno dogovorjenih pogojih in dogovoru o delitvi koristi, kadar je potrebno.
Users acquiring Plant Genetic Resources for Food and Agriculture (PGRFA) in a country that is a Party to the Nagoya Protocol which has determined that PGRFA under its management and control and in the public domain, not contained in Annex I to the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), will also be subject to the terms and conditions of the standard material transfer agreement for the purposes set out under the ITPGRFA, shall be considered to have exercised due diligence in accordance with paragraph 3 of this Article.
Šteje se, da so skrbno ravnanje v skladu z odstavkom 3 tega člena izvedli tudi uporabniki, ki pridobijo rastlinske genske vire za prehrano in kmetijstvo v državi, ki je pogodbenica Nagojskega protokola in je določila, da bodo za rastlinske genske vire pod njenim upravljanjem in nadzorom, ki so v javni rabi, a niso vključeni v Prilogo I k Mednarodni pogodbi o rastlinskih genskih virih za prehrano in kmetijstvo (MPRGV), za namene, določene v MPRGV, veljali tudi pogoji tipskega sporazuma o prenosu materiala.
When the information in their possession is insufficient or uncertainties about the legality of access and utilisation persist, users shall obtain an access permit or its equivalent and establish mutually agreed terms, or discontinue utilisation.
Če uporabniki nimajo zadostnih informacij ali če obstajajo nejasnosti glede zakonitosti njihovega dostopa ali uporabe, uporabniki pridobijo dovoljenje za dostop ali enakovreden dokument ter določijo medsebojno dogovorjene pogoje, ali pa prenehajo uporabo.
Users shall keep the information relevant to access and benefit-sharing for 20 years after the end of the period of utilisation.
Uporabniki hranijo informacije, ki se nanašajo na dostop in delitev koristi, dvajset let po koncu obdobja uporabe.
Users obtaining a genetic resource from a collection included in the register of collections within the Union referred to in Article 5(1) shall be considered to have exercised due diligence as regards the seeking of information listed in paragraph 3 of this Article.
Šteje se, da so uporabniki, ki pridobijo genski vir iz zbirke, ki je vključena v register zbirk v Uniji iz člena 5(1), s primerno skrbnostjo pridobivali informacije iz odstavka 3 tega člena.
Users acquiring a genetic resource that is determined to be, or is determined as likely to be, the causing pathogen of a present or imminent public health emergency of international concern, within the meaning of the International Health Regulations (2005), or of a serious cross-border threat to health as defined in the Decision No 1082/2013/EU of the European Parliament and of the Council [9], for the purpose of public health emergency preparedness in not yet affected countries and response in affected countries, shall fulfil the obligations listed in paragraph 3 or 5 of this Article at the latest:(a) one month after the imminent or present threat to public health is terminated; or
Uporabniki, ki zaradi pripravljenosti na izredne razmere na področju javnega zdravja v državah, ki še niso prizadete, oziroma ukrepanja v prizadetih državah pridobijo genski vir, za katerega je ugotovljeno, da je dejanski povzročitelj - oziroma je ugotovljeno, da je verjetni povzročitelj - trenutnih ali grozečih izrednih razmer mednarodnih razsežnosti na področju javnega zdravja v smislu Mednarodnega zdravstvenega pravilnika (2005) ali resne čezmejne nevarnosti za zdravje, kot je opredeljena v Sklepu št. 1082/2013/EU Evropskega parlamenta in Sveta [9], izpolnijo obveznosti iz odstavka 3 ali 5 tega člena najpozneje:(a) en mesec po koncu grozeče oziroma dejanske nevarnosti za zdravje, ali
three months after commencement of utilisation of the genetic resource;
tri mesece po začetku uporabe genskega vira,
whichever is the earlier.
karkoli je prej.
Should the obligations listed in paragraph 3 or 5 of this Article not be fulfilled by the deadlines laid down in points (a) and (b) of the first subparagraph of this paragraph, utilisation shall be discontinued.
Če se obveznost iz odstavka 3 ali 5 tega člena ne izpolni v roku, določenem v točkah (a) in (b) prvega pododstavka tega odstavka, se uporaba preneha.
In the event of a request for market approval or the placing on the market of products deriving from utilisation of a genetic resource as referred to in the first subparagraph, the obligations listed in paragraph 3 or 5 shall apply entirely and without delay.
V primeru, da je vložena vloga za tržno dovoljenje ali je proizvod, izdelan z uporabo takega genskega vira iz prvega pododstavka, dan na trg, se začnejo obveznosti iz odstavka 3 ali 5 uporabljati v celoti in nemudoma.
In the absence of prior informed consent having been obtained in a timely manner and mutually agreed terms having been established, and until an agreement is reached with the provider country concerned, no exclusive rights of any kind will be claimed by such a user to any developments made via the use of such pathogens.
Če predhodna privolitev ni bila pridobljena pravočasno in niso bili določeni medsebojno dogovorjeni pogoji, tak uporabnik ne bo zahteval nobenih izključnih pravic nad ničemer, kar je razvito prek uporabe takih povzročiteljev, vse dokler ni dosežen dogovor z zadevno državo ponudnico.
Specialised international access and benefit-sharing instruments as mentioned in Article 2 remain unaffected.
To ne vpliva na posebne mednarodne instrumente za dostop in delitev koristi iz člena 2.
Register of collections
Register zbirk
The Commission shall establish and maintain a register of collections within the Union (‘the register’).
Komisija vzpostavi in vodi register zbirk v Uniji (v nadaljnjem besedilu: register).
The Commission shall ensure that the register is internet-based and is easily accessible to users.
Komisija zagotovi, da je register na spletu in enostavno dostopen uporabnikom.
The register shall include the references of the collections of genetic resources, or of parts of those collections, identified as meeting the criteria set out in paragraph 3.
Register vsebuje podatke o zbirkah ali delih zbirk genskih virov, za katere je ugotovljeno, da izpolnjujejo merila iz odstavka 3.
A Member State shall, upon request by a collection holder under its jurisdiction, consider the inclusion of that collection, or a part of it, in the register.
Država članica na zahtevo imetnika zbirke pod njeno jurisdikcijo preuči možnost vključitve te zbirke ali njenega dela, v register.
After verifying that the collection, or a part of it, meets the criteria set out in paragraph 3, the Member State shall notify the Commission without undue delay of the name and contact details of the collection and of its holder, and of the type of collection concerned.
Potem ko država članica preveri, da zbirka ali njen del izpolnjuje merila iz odstavka 3, brez nepotrebnega odlašanja Komisiji sporoči ime in kontaktne podatke zbirke in njenega imetnika ter vrsto zadevne zbirke.
The Commission shall without delay include the information received in the register.
Komisija prejete podatke nemudoma vključi v register.
In order for a collection or a part of a collection to be included in the register, a collection shall demonstrate its capacity to:
Zbirka ali del zbirke je vključena v register, če je dokazana njena zmožnost, da:
apply standardised procedures for exchanging samples of genetic resources and related information with other collections, and for supplying samples of genetic resources and related information to third persons for their utilisation in line with the Convention and the Nagoya Protocol;
uporablja standardizirane postopke za izmenjavo vzorcev genskih virov in informacij v zvezi z njimi z drugimi zbirkami ter za dobavljanje vzorcev genskih virov in informacij v zvezi z njimi tretjim osebam za njihovo uporabo v skladu s Konvencijo in Nagojskim protokolom;
supply genetic resources and related information to third persons for their utilisation only with documentation providing evidence that the genetic resources and the related information were accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and, where relevant, with mutually agreed terms;
dobavlja genske vire in informacije v zvezi z njimi tretjim osebam za njihov uporabo samo z dokumentacijo, ki dokazuje, da je bil dostop do genskih virov in informacij o njih skladen z veljavno zakonodajo ali regulativnimi zahtevami o dostopu in delitvi koristi ter, če je ustrezno, medsebojno dogovorjenimi pogoji;
keep records of all samples of genetic resources and related information supplied to third persons for their utilisation;
vodi evidenco vseh vzorcev genskih virov in informacij o njih, ki so bili dobavljeni tretjim osebam za njihovo uporabo;
establish or use unique identifiers, where possible, for samples of genetic resources supplied to third persons; and
po možnosti določi ali uporabi posebne identifikatorje za vzorce genskih virov, dobavljene tretjim osebam, in
use appropriate tracking and monitoring tools for exchanging samples of genetic resources and related information with other collections.
uporabi ustrezna orodja za sledenje in spremljanje izmenjave vzorcev genskih virov in z njimi povezanih informacij z drugimi zbirkami.
The Member States shall regularly verify that each collection or part of a collection under their jurisdiction included in the register meets the criteria set out in paragraph 3.
Države članice redno preverjajo, da vsaka zbirka ali deli zbirke pod njihovo jurisdikcijo, ki so vključeni v register, izpolnjujejo merila iz odstavka 3.