natgillin/translations-raw huggingface dataset:
This Regulation should therefore be read in conjunction with Directive (EU) 2017/2103 of the European Parliament and of the Council [5] because both acts are designed to replace the mechanism established by Decision 2005/387/JHA.
To uredbo bi bilo zato treba brati v povezavi z Direktivo (EU) 2017/2103 Evropskega parlamenta in Sveta [5], saj naj bi oba akta nadomestila mehanizem, vzpostavljen s Sklepom 2005/387/PNZ.
A small number of new psychoactive substances can have commercial and industrial uses and can be used for scientific research and development.
Manjše število novih psihoaktivnih snovi se lahko uporablja za komercialne in industrijske namene ter za znanstvene raziskave in razvoj.
Provisions concerning information exchange on, and the early warning system and risk assessment procedure for, new psychoactive substances should be included in Regulation (EC) No 1920/2006 of the European Parliament and of the Council [6].
V Uredbo (ES) št. 1920/2006 Evropskega parlamenta in Sveta [6] bi bilo treba vključiti določbe glede izmenjave informacij o novih psihoaktivnih snoveh in sistema za zgodnje opozarjanje na te snovi ter postopka ocene tveganja zanje.
Provisions concerning the early warning of new psychoactive substances should, in particular, be strengthened and the procedures for drawing up an initial report and organising the risk assessment should be made more efficient.
Zlasti bi bilo treba okrepiti določbe glede zgodnjega opozarjanja na nove psihoaktivne snovi ter povečati učinkovitost postopkov za pripravo začetnega poročila in za organizacijo postopka ocene tveganja.
Substantially shortened deadlines for all stages of those procedures should be set.
Določiti bi bilo treba znatno krajše roke za vse faze teh postopkov.
Any Union action on new psychoactive substances should be based on scientific evidence and be subject to a specific procedure.
Vsi ukrepi Unije v zvezi z novimi psihoaktivnimi snovmi bi morali temeljiti na znanstvenih dokazih, zanje pa bi bilo treba uporabljati poseben postopek.
An initial report should be drawn up on a new psychoactive substance where information provided by the Member States on that new psychoactive substance gives rise to concerns that it might pose health or social risks at Union level.
Kadar informacije držav članic o novi psihoaktivni snovi vzbujajo skrb, da bi lahko predstavljala zdravstvena ali socialna tveganja na ravni Unije, bi bilo treba o tej snovi pripraviti začetno poročilo.
The initial report should allow the Commission to make an informed decision regarding the launch of the risk assessment procedure.
Začetno poročilo bi moralo Komisiji omogočiti sprejetje informirane odločitve v zvezi z začetkom postopka ocene tveganja.
The risk assessment procedure at Union level should be undertaken rapidly.
Postopek ocene tveganja na ravni Unije bi bilo treba izvesti hitro.
Following the risk assessment procedure, the Commission should determine whether the new psychoactive substance in question should be included in the definition of ‘drug’ in accordance with the procedure provided for in Council Framework Decision 2004/757/JHA [7].
Komisija bi morala po izvedbi postopka ocene tveganja določiti, ali bi bilo treba zadevne nove psihoaktivne snovi vključiti v opredelitev pojma „prepovedana droga“ v skladu s postopkom iz Okvirnega sklepa Sveta 2004/757/PNZ [7].
With a view to ensuring the continuous functioning of the mechanism for information exchange and of the reporting and risk assessment procedures set out in Decision 2005/387/JHA and in this Regulation, this Regulation should apply from the same date as the deadline for transposition of Directive (EU) 2017/2103, which is also the date on which Decision 2005/387/JHA is to be repealed.
Da bi zagotovili neprekinjeno delovanje mehanizma za izmenjavo informacij ter postopkov poročanja in ocene tveganja, kot je določeno v Sklepu 2005/387/PNZ in v tej uredbi, bi se morala ta uredba uporabljati od datuma, ki je določen kot rok za prenos Direktive (EU) 2017/2103 in ki je hkrati datum, na katerega se razveljavi Sklep Sveta 2005/387/PNZ.
In principle, no risk assessment should be carried out on a new psychoactive substance if it is subject to an assessment under international law.
Načeloma ne bi smeli izvajati ocene tveganja v zvezi z novo psihoaktivno snovjo, če je snov predmet ocene na podlagi mednarodnega prava.
No risk assessment should be carried out on a new psychoactive substance if it is an active substance in a medicinal product for human use or in a veterinary medicinal product.
V zvezi z novo psihoaktivno snovjo ne bi smeli izvajati ocene tveganja, če je snov zdravilna učinkovina v zdravilu za uporabo v humani medicini ali zdravilu za uporabo v veterinarski medicini.
Regulation (EC) No 1920/2006 should therefore be amended accordingly,
Uredbo (ES) št. 1920/2006 bi bilo zato treba ustrezno spremeniti –
Amendments to Regulation (EC) No 1920/2006
Spremembe uredbe (ES) št. 1920/2006
Regulation (EC) No 1920/2006 is amended as follows:
Uredba (ES) št. 1920/2006 se spremeni:
in Article 2, the following point is added:
v členu 2 se doda naslednja točka:
Exchange of information on, early warning system for, and risk assessment of, new psychoactive substances
izmenjava informacij o novih psihoaktivnih snoveh, sistem zgodnjega opozarjanja na te snovi in ocena tveganja zanje
collecting, collating, analysing and assessing the available information from the national focal points referred to in Article 5 and the Europol national units on new psychoactive substances as defined in point 4 of Article 1 of Council Framework Decision 2004/757/JHA and communicating that information to the national focal points and the Europol national units as well as to the Commission without undue delay;
zbiranje, primerjanje, analiziranje in ocenjevanje razpoložljivih informacij iz nacionalnih kontaktnih točk iz člena 5 in nacionalnih enot Europola za nove psihoaktivne snovi, kot je opredeljeno v točki 4 člena 1 Okvirnega sklepa Sveta 2004/757/PNZ, in sporočanje teh informacij brez nepotrebnega odlašanja nacionalnim kontaktnim točkam in nacionalnim enotam Europola ter Komisiji;
drawing up the initial report or combined initial report in accordance with Article 5b;
priprava začetnega poročila ali skupnega začetnega poročila v skladu s členom 5b;
organising the risk assessment procedure in accordance with Articles 5c and 5d;
organizacija postopka ocene tveganja v skladu s členoma 5c in 5d;
monitoring, in cooperation with Europol and with the support of the national focal points referred to in Article 5 and the Europol national units, all new psychoactive substances that have been reported by Member States.
spremljanje vseh novih psihoaktivnih snovi, o katerih so poročale države članice, v sodelovanju z Europolom in ob podpori nacionalnih kontaktnih točk iz člena 5 in nacionalnih enot Europola.
in Article 5(2), the second subparagraph is deleted;
v členu 5(2) se črta drugi pododstavek;
‘Article 5a
„Člen 5a
Information exchange on, and early warning system for, new psychoactive substances
Izmenjava informacij o novih psihoaktivnih snoveh in sistem zgodnjega opozarjanja na te snovi
Each Member State shall ensure that its national focal point, as referred to in Article 5, and its Europol national unit provide the Centre and Europol, taking into account their respective mandates, with the available information on new psychoactive substances in a timely manner and without undue delay.
Vsaka država članica zagotavlja, da njena nacionalna kontaktna točka iz člena 5 in njena nacionalna enota Europola Centru in Europolu pravočasno in brez nepotrebnega odlašanja zagotovita razpoložljive informacije o novih psihoaktivnih snoveh.
The information shall be related to the detection and identification, use and patterns of use, manufacture, extraction, distribution and distribution methods, trafficking, and commercial, medical and scientific use of, and potential and identified risks posed by, those substances.
Informacije so povezane z odkrivanjem in identifikacijo, uporabo in vzorci uporabe, proizvodnjo, ekstrakcijo, distribucijo in distribucijskimi metodami, prometom, komercialno, medicinsko in znanstveno uporabo teh snovi ter z morebitnimi in opredeljenimi tveganji, ki jih te snovi predstavljajo.
The Centre, in cooperation with Europol, shall collect, collate, analyse and assess the information and communicate it in a timely manner to the national focal points and the Europol national units as well as to the Commission with a view to providing them with any information required for the purposes of early warning and for the purposes of allowing the Centre to draw up the initial report or the combined initial report pursuant to Article 5b.
Center v sodelovanju z Europolom zbira, primerja, analizira in ocenjuje informacije ter jih pravočasno sporoča nacionalnim kontaktnim točkam in nacionalnim enotam Europola ter Komisiji, da se jim zagotovijo vse informacije, ki so potrebne za zgodnje opozarjanje, in Centru omogoči pripravo začetnega poročila ali skupnega začetnega poročila v skladu s členom 5b.
Article 5b
Člen 5b
Initial report
Začetno poročilo
Where the Centre, the Commission or a majority of the Member States considers that information shared on a new psychoactive substance collected pursuant to Article 5a in one or more Member States gives rise to concerns that the new psychoactive substance may pose health or social risks at Union level, the Centre shall draw up an initial report on the new psychoactive substance.
Kadar Center, Komisija ali večina držav članic meni, da izmenjane informacije o novi psihoaktivni snovi, ki so bile zbrane na podlagi člena 5a v eni ali več državah članicah, vzbujajo skrb, da bi lahko nova psihoaktivna snov predstavljala zdravstvena ali socialna tveganja na ravni Unije, Center pripravi začetno poročilo o novi psihoaktivni snovi.
For the purpose of this paragraph, Member States shall inform the Commission and other Member States of their wish that an initial report be drawn up.
Za namene tega odstavka države članice obvestijo Komisijo in druge države članice o svoji želji, da se pripravi začetno poročilo.
Where the majority of Member States is reached, the Commission shall instruct the Centre accordingly and shall inform the Member States thereof.
Kadar je dosežena večina držav članic, Komisija pošlje ustrezna navodila Centru in o tem obvesti države članice.
The initial report shall contain a first indication of:
Začetno poročilo vsebuje prve informacije o:
the nature, number and scale of incidents showing health and social problems in which the new psychoactive substance may potentially be involved, and the patterns of use of the new psychoactive substance;
vrsti, številu in obsegu incidentov, iz katerih so razvidni zdravstveni in socialni problemi, ki bi jih potencialno lahko povzročila nova psihoaktivna snov, ter o vzorcih uporabe nove psihoaktivne snovi;
the chemical and physical description of the new psychoactive substance and the methods and precursors used for its manufacture or extraction;
kemijskem in fizikalnem opisu nove psihoaktivne snovi ter metodah in predhodnih sestavinah, ki se uporabljajo za njeno izdelavo ali ekstrakcijo;
the pharmacological and toxicological description of the new psychoactive substance;
farmakološkem in toksikološkem opisu nove psihoaktivne snovi;
the involvement of criminal groups in the manufacture or distribution of the new psychoactive substance.
vpletenosti kriminalnih združb v proizvodnjo ali distribucijo nove psihoaktivne snovi.
The initial report shall also contain:
Začetno poročilo vsebuje tudi:
information on the human and veterinary medical use of the new psychoactive substance, including as an active substance in a medicinal product for human use or in a veterinary medicinal product;
informacije o uporabi nove psihoaktivne snovi v humani in veterinarski medicini, med drugim tudi kot zdravilne učinkovine v zdravilu za uporabo v humani medicini ali zdravilu za uporabo v veterinarski medicini;
information on the commercial and industrial use of the new psychoactive substance, the extent of such use, as well as its use for scientific research and development purposes;
informacije o komercialni in industrijski uporabi nove psihoaktivne snovi, obsegu take uporabe ter njeni uporabi za namene znanstvenih raziskav in razvoja;
information on whether the new psychoactive substance is subject to any restrictive measures in the Member States;
informacije o tem, ali za novo psihoaktivno snov veljajo kakršni koli omejevalni ukrepi v državah članicah;
information on whether the new psychoactive substance is currently or has been under assessment within the system established by the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, and the 1971 Convention on Psychotropic Substances (‘United Nations system’);
informacije o tem, ali se nova psihoaktivna snov trenutno ocenjuje ali se je ocenjevala v okviru sistema iz Enotne konvencije o mamilih iz leta 1961, kakor je bila spremenjena s Protokolom iz leta 1972, in Konvencije o psihotropnih substancah iz leta 1971 (v nadaljnjem besedilu: sistem Združenih narodov);
other relevant information, where available.
druge pomembne informacije, kadar so na voljo.
For the purpose of the initial report, the Centre shall use information which is at its disposal.
Center za začetno poročilo uporabi informacije, ki so mu na voljo.
Where the Centre considers it necessary, it shall request the national focal points referred to in Article 5 to provide additional information on the new psychoactive substance.
Center po potrebi zahteva, da nacionalne kontaktne točke iz člena 5 zagotovijo dodatne informacije o novi psihoaktivni snovi.
The national focal points shall provide that information within two weeks of receipt of the request.
Nacionalne kontaktne točke zagotovijo navedene informacije v roku dveh tednov od prejema zahteve.
The Centre shall, without undue delay, request the European Medicines Agency to provide information on whether, at Union or national level, the new psychoactive substance is an active substance in:
Center brez nepotrebnega odlašanja zahteva, da Evropska agencija za zdravila zagotovi informacije o tem, ali je nova psihoaktivna snov na ravni Unije ali nacionalni ravni zdravilna učinkovina v:
a medicinal product for human use or in a veterinary medicinal product that has obtained a marketing authorisation in accordance with Directive 2001/83/EC of the European Parliament and of the Council, Directive 2001/82/EC of the European Parliament and of the Council or Regulation (EC) No 726/2004 of the European Parliament and of the Council;
zdravilu za uporabo v humani medicini ali zdravilu za uporabo v veterinarski medicini, za katero je bilo pridobljeno dovoljenje za promet v skladu z Direktivo 2001/83/ES Evropskega parlamenta in Sveta, Direktivo 2001/82/ES Evropskega parlamenta in Sveta ali Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta;
a medicinal product for human use or in a veterinary medicinal product that is the subject of an application for a marketing authorisation;
zdravilu za uporabo v humani medicini ali zdravilu za uporabo v veterinarski medicini, za katero je bila vložena vloga za pridobitev dovoljenja za promet;
a medicinal product for human use or in a veterinary medicinal product whose marketing authorisation has been suspended by the competent authority;
zdravilu za uporabo v humani medicini ali zdravilu za uporabo v veterinarski medicini, za katero je pristojni organ začasno preklical dovoljenje za promet;
an unauthorised medicinal product for human use in accordance with Article 5 of Directive 2001/83/EC or in a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national law in accordance with point (c) of Article 10(1) of Directive 2001/82/EC;
zdravilu za uporabo v humani medicini, za katero ni bilo izdano dovoljenje za promet, v skladu s členom 5 Direktive 2001/83/ES ali v zdravilu za uporabo v veterinarski medicini, ki ga za vsak primer posebej pripravi oseba, ki je za tako dejavnost pooblaščena na podlagi nacionalnega prava v skladu s točko (c) člena 10(1) Direktive 2001/82/ES;
an investigational medicinal product as defined in point (d) of Article 2 of Directive 2001/20/EC of the European Parliament and of the Council.
zdravilu v preskušanju, kakor je opredeljeno v točki (d) člena 2 Direktive 2001/20/ES Evropskega parlamenta in Sveta.
Where the information relates to marketing authorisations granted by Member States, the Member States concerned shall provide the European Medicines Agency with such information upon its request.
Kadar se informacije nanašajo na dovoljenja za promet, ki jih izdajo države članice, zadevne države članice te informacije na njeno zahtevo posredujejo Evropski agenciji za zdravila.
The Centre shall, without undue delay, request Europol to provide information on the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance, and in any use of the new psychoactive substance.
Center brez nepotrebnega odlašanja zahteva, da Europol zagotovi informacije o vpletenosti kriminalnih združb v proizvodnjo, distribucijo in distribucijske metode ter v kakršno koli uporabo nove psihoaktivne snovi in promet s to snovjo.
The Centre shall, without undue delay, request the European Chemicals Agency, the European Centre for Disease Prevention and Control and the European Food Safety Authority to provide the information and data at their disposal on the new psychoactive substance.
Center brez nepotrebnega odlašanja zahteva, da Evropska agencija za kemikalije, Evropski center za preprečevanje in obvladovanje bolezni ter Evropska agencija za varnost hrane zagotovijo razpoložljive informacije in podatke o novi psihoaktivni snovi.
The details of the cooperation between the Centre and the bodies and agencies referred to in paragraphs 5, 6 and 7 of this Article shall be governed by working arrangements.
Podrobnosti sodelovanja med Centrom ter organi in agencijami iz odstavkov 5, 6 in 7 tega člena so urejene z delovnimi dogovori.
Such working arrangements shall be concluded in accordance with the second paragraph of Article 20.
Taki delovni dogovori se sklenejo v skladu z drugim odstavkom člena 20.
The Centre shall respect the conditions on use of the information, which are communicated to the Centre, including conditions on access to documents, information and data security and protection of confidential data, including sensitive data and confidential business information.
Center spoštuje pogoje glede uporabe informacij, ki so sporočene Centru, vključno s pogoji o dostopu do dokumentov, varnosti informacij in podatkov ter varstvu zaupnih podatkov, vključno z občutljivimi podatki in zaupnimi poslovnimi informacijami.
The Centre shall submit the initial report to the Commission and the Member States within five weeks of making the requests for information referred to in paragraphs 5, 6 and 7.
Center predloži začetno poročilo Komisiji in državam članicam v petih tednih od vložitve zahtev za informacije iz odstavkov 5, 6 in 7.
Where the Centre collects information on several new psychoactive substances that it considers to be of similar chemical structure, it shall submit to the Commission and to the Member States individual initial reports, or combined initial reports dealing with several new psychoactive substances, provided that the characteristics of each new psychoactive substance are clearly identified, within six weeks of making the requests for information referred to in paragraphs 5, 6 and 7.
Kadar Center zbere informacije o več novih psihoaktivnih snoveh, za katere oceni, da imajo podobno kemijsko sestavo, v šestih tednih od vložitve zahtev za informacije iz odstavkov 5, 6 in 7 Komisiji in državam članicam predloži posamezna začetna poročila ali skupna začetna poročila o več novih psihoaktivnih snoveh, pod pogojem, da so značilnosti vsake nove psihoaktivne snovi jasno opredeljene.
Article 5c
Člen 5c
Risk assessment procedure and report
Postopek ocene tveganja in poročilo o oceni tveganja
Within two weeks of receipt of an initial report as referred to in Article 5b(10), the Commission may request the Centre to assess the potential risks posed by the new psychoactive substance and to draw up a risk assessment report, where there are indications in the initial report to believe that the substance may pose severe public health risks and, where applicable, severe social risks.
Komisija lahko v dveh tednih od prejema začetnega poročila iz člena 5b(10) zahteva, da Center oceni morebitna tveganja, ki jih predstavlja nova psihoaktivna snov, in pripravi poročilo o oceni tveganja, kadar je iz začetnega poročila razvidno, da bi ta snov lahko predstavljala resna tveganja za javno zdravje ali, v nekaterih primerih, resna socialna tveganja.
The risk assessment shall be carried out by the Scientific Committee.
Oceno tveganja izvede znanstveni odbor.
Within two weeks of receipt of a combined initial report as referred to in Article 5b(11), the Commission may request the Centre to assess the potential risks posed by several new psychoactive substances with a similar chemical structure and to draw up a combined risk assessment report, where there are indications in the combined initial report to believe that the substances may pose severe public health risks and, where applicable, severe social risks.
Komisija lahko v dveh tednih od prejema skupnega začetnega poročila iz člena 5b(11) zahteva, da Center oceni morebitna tveganja, ki jih predstavlja več novih psihoaktivnih snovi s podobno kemijsko strukturo, in pripravi skupno poročilo o oceni tveganja, kadar je iz skupnega začetnega poročila razvidno, da bi te snovi lahko predstavljale resna tveganja za javno zdravje ali, v nekaterih primerih, resna socialna tveganja.
The combined risk assessment shall be carried out by the Scientific Committee.
Skupno oceno tveganja izvede znanstveni odbor.
The risk assessment report or combined risk assessment report shall contain:
Poročilo o oceni tveganja oziroma skupno poročilo o oceni tveganja vsebuje:
available information on the chemical and physical properties of the new psychoactive substance and the methods and the precursors used for its manufacture or extraction;
razpoložljive informacije o kemijskih in fizikalnih lastnostih nove psihoaktivne snovi ter metodah in predhodnih sestavinah, ki se uporabljajo za njeno proizvodnjo ali ekstrakcijo;
available information on the pharmacological and toxicological properties of the new psychoactive substance;
razpoložljive informacije o farmakoloških in toksikoloških lastnostih nove psihoaktivne snovi;
an analysis of the health risks associated with the new psychoactive substance, in particular with respect to its acute and chronic toxicity, abuse liability, dependence-producing potential, and physical, mental and behavioural effects;
analizo zdravstvenih tveganj, ki so povezana z novo psihoaktivno snovjo, zlasti glede njene akutne in kronične toksičnosti, možnosti zlorabe in potenciala za zasvojenost ter učinkov na telo, duševnost in vedenje;
an analysis of the social risks associated with the new psychoactive substance – in particular its impact on social functioning, public order and criminal activities, and the involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking of the new psychoactive substance;
analizo socialnih tveganj, ki so povezana z novo psihoaktivno snovjo - zlasti njenega vpliva na socialno vedenje, javni red in kriminalne dejavnosti ter vpletenosti kriminalnih združb v proizvodnjo, distribucijo in distribucijske metode nove psihoaktivne snovi ter promet s to snovjo;
available information on the extent and patterns of use of the new psychoactive substance, its availability and potential for diffusion within the Union;
razpoložljive informacije o razširjenosti in vzorcih uporabe nove psihoaktivne snovi, njeni dostopnosti in možnosti širjenja v Uniji;