natgillin/translations-raw huggingface dataset:
Če se zaradi znanstvenega napredka pojavi potreba po kakršnih koli spremembah, bi jih bilo treba sprejeti s postopkom soodločanja, ki v celoti vključuje Evropski parlament.
Should any changes be necessary due to scientific progress, they should be adopted in codecision, fully involving the European Parliament.
ČLEN 25
ARTICLE 25
Komisija v tem poročilu tudi oceni vpliv tehničnega napredka na uporabo te uredbe in, če je to potrebno, predloži zakonodajni predlog za revizijo njenega obsega za vključitev novih oblik zdravljenja, ki niso niti gensko zdravljenje niti celično zdravljenje niti gensko inženirstvo.
In that report, the Commission shall also assess the impact of technical progress on the application of this Regulation and, if necessary, submit a legislative proposal for a review of its scope to include novel therapies which are neither gene therapy, nor cell therapy nor tissue engineering.
Znanstveni napredek lahko omogoči dodatne nove oblike zdravljenja, ki niso niti gensko zdravljenje niti celično zdravljenje niti gensko inženirstvo.
Scientific advances may make additional novel therapies possible which are neither gene therapy, nor cell therapy nor tissue engineering.
Njihova vključitev v prihodnosti, ki bi omogočila izdajanje dovoljenj za iz njih izhajajoča zdravila na evropski ravni, bi bila v interesu pacientov.
It would be in the interest of patients for these to be included at some future date in order to allow European authorisation of the resulting products.
ČLEN 25 A (novo)
ARTICLE 25 A (new)
Komisija najkasneje do konca leta 2007 predloži zakonodajni predlog, s katerim se zagotovi, da bo ustrezna zakonodaja Skupnosti zajemala tudi izdelke, ki se uporabljajo v kozmetične namene in ki vsebujejo človeške ali živalske celice ali tkiva.
The Commission shall by no later than the end of 2007 submit a legislative proposal in order to ensure that products used for cosmetic purposes which contain human or animal cells or tissues are also covered by adequate Community legislation.
Pravo Skupnosti zaenkrat ne ureja izdelkov, ki se uporabljajo v kozmetične namene in ki vsebujejo človeške ali živalske celice ali tkiva, čeprav se že pojavljajo na trgu.
Until now products used for cosmetic purposes containing human or animal cells or tissues, although already being placed on the market, are not regulated under Community law.
To ureditveno vrzel je treba zapolniti.
This regulation gap needs to be closed.
ČLEN 26, ODSTAVEK 2, PODODSTAVEK 1
ARTICLE 26, PARAGRAPH 2, SUBPARAGRAPH 1
Pri sklicevanju na ta odstavek se uporabljata člena 5 in 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Pri sklicevanju na ta odstavek in brez poseganja v člen 26 a se uporabljata člena 5 in 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.
Where reference is made to this paragraph, and without prejudice to Article 26a, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Ta predlog spremembe je posledica uvedbe novega člena 26a spodaj.
This is a consequential amendment to the introduction of the new Article 26(a) below.
ČLEN 26 A (novo)
ARTICLE 26 A (new)
Brez poseganja v že sprejete izvedbene ukrepe, je treba najkasneje 1. aprila 2008 uporabo določb iz te uredbe, ki zahtevajo sprejetje tehničnih pravil, sprememb in sklepov, prekiniti.
Without prejudice to the implementing measures already adopted, on 1 April 2008 at the latest, the application of the provisions of this Regulation requiring the adoption of technical rules, amendments and decisions shall be suspended.
Na predlog Komisije Evropski parlament in Svet lahko obnovita zadevne določbe v skladu s postopkom iz člena 251 Pogodbe, in v ta namen določbe ponovno ocenita pred iztekom zgoraj navedenega roka.
Acting on a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, they shall review them prior to the expiry of the date referred to above.
Prvi odstavek se uporablja do takrat, ko je nadomeščen z novim sporazumom o komitologiji.
The first paragraph shall apply until such time as it is superseded by a new agreement on comitology.
Ta predlog spremembe se predhodno vloži vse do sprejema novega komitološkega postopka, ki bo zagotovil Parlamentu več kontrole.
This amendment is preliminary tabled until the new comitology procedure is adopted which ensures more control by the Parliament.
Priloga, točka 1 a (Uredba (ES) št. 726/2004)
Annex, point 1 a (Regulation (EC) No 726/2004)
Zdravila za napredno zdravljenje, kot so opredeljena v Uredbi (ES) št. […/Evropskega parlamenta in Sveta (Uredba o zdravilih za napredno zdravljenje)*]
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)*].
Zdravila za napredno zdravljenje, kot so opredeljena v Uredbi (ES) št. […/Evropskega parlamenta in Sveta (Uredba o zdravilih za napredno zdravljenje)*], razen zdravil za napredno zdravljenje za avtologno ali namensko uporabo, ki se proizvajajo in so naprodaj izključno v eni državi članici in za katera je ta država članica, v skladu z merili iz te uredbe, kot alternativo predvidela postopek pridobitve nacionalnega dovoljenja za promet za obdobje petih let po izdaji dovoljenja za promet na nacionalni ravni.
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)*] , except for advanced therapy medicinal products for autologous or intended use which are exclusively manufactured and distributed in one Member State and for which that Member State has envisaged the national marketing authorisation procedure in accordance with the criteria of this Regulation as an alternative, for a period of five years subsequent to the granting of the marketing authorisation at national level.
Po tem obdobju je potrebna vloga za posamezno podaljšanje v okviru centraliziranega postopka, ki ima za posledico, da nacionalno dovoljenje za promet po podaljšanju postane centralizirano dovoljenje za promet .
Afterwards an application for a single renewal within the centralised procedure shall be necessary, with the effect that, after the renewal, the national marketing authorisation will become a centralised marketing authorisation .
Ta direktiva in vse v njej navedene uredbe ne vplivajo na uporabo nacionalne zakonodaje, ki prepoveduje ali omejuje uporabo kakršne koli posebne vrste človeških ali živalskih celic ali prodajo, dobavo ali uporabo zdravil, ki vsebujejo te celice ali jih te celice sestavljajo ali so izdelane na njihovi podlagi.
This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells .
Države članice Komisijo obvestijo o zadevni nacionalni zakonodaji.“
The Member States shall communicate the national legislation concerned to the Commission .”
Na podlagi člena 30 Pogodbe o ustanovitvi Evropske skupnosti t a direktiva in vse v njej navedene uredbe ne vplivajo na uporabo nacionalne zakonodaje, ki prepoveduje ali omejuje uporabo kakršne koli posebne vrste človeških ali živalskih celic ali prodajo, dobavo ali uporabo zdravil, ki vsebujejo te celice ali jih te celice sestavljajo ali so izdelane na njihovi podlagi.“
This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells , by virtue of the Article 30 of the Treaty establishing the European Community .”
Ker ta uredba predstavlja tudi delno usklajevalni ukrep, bi bilo treba pojasniti, da imajo države članice pri vprašanju dostopa določenih zdravil na njihov trg pravico do sklicevanja na člen 30 Pogodbe ES.
As this regulation is a partially harmonizing measure, it should be made clear that Member States has the right to refer to the Article 30 of the TEC when it comes to the access of certain medicinal products to their market.
Obveznost obveščanja Komisije o zadevni nacionalni zakonodaji je z ozirom na odstavek 4 člena 95 Pogodbe ES primerna samo, če gre za popolnoma usklajevalni ukrep Skupnosti.
With regard to the Article 95, paragraph 4 of the TEC, the obligation to communicate the national legislation concerned to the Commission is only appropriate if the community measure is a fully harmonizing one.
ČLEN 28 A (novo)
ARTICLE 28 A (new)
Člen 2, odstavek 1 (Direktiva 2004/23/ES)
Article 2, paragraph 1 (Directive 2004/23/EC)
Sprememba Direktive 2004/23/ES
Amendment to Directive 2004/23/EC
V členu 2(1) Direktive 2004/23/ES se drugi pododstavek nadomesti z:
In Article 2(1) of Directive 2004/23/EC, the second subparagraph shall be replaced by the following:
„Če take industrijske izdelke obravnava druga zakonodaja Skupnosti, se ta direktiva uporablja le za darovanje, pridobivanje in testiranje.
"Where such manufactured products are covered by other Community legislation, this Directive shall apply only to donation, procurement and testing.
Vendar določbe o darovanju, pridobivanju in testiranju iz te direktive ne posegajo v bolj natančne določbe, ki jih vsebuje druga zakonodaja Skupnosti.“
However, the donation, procurement and testing provisions of this Directive shall be without prejudice to more specific provisions contained in other Community legislation."
V skladu z obstoječo zakonodajo mora biti darovanje, pridobivanje in testiranje človeških tkiv in celic usklajeno z visokimi standardi kakovosti in varnosti, da bi zagotovili visoko stopnjo varovanja zdravja v Skupnosti.
According to the existing legislation, the donation, procurement and testing of human tissues and cells should comply with high standards of quality and safety in order to ensure a high level of health protection in the Community.
Poleg tega je treba zagotoviti, da se človeško telo in njegovi deli ne tržijo.
Moreover, it also has to be ensured that the human body or its parts as such are not commercialised.
Zato imajo države članice za namene te uredbe nujno obveznost, da zagotovijo prostovoljno in neplačano darovanje ter neprofitno pridobivanje tkiv ali celic.
Therefore, for the purposes of this Regulation, Member States shall have an imperative obligation to ensure voluntary and unpaid donation and to guarantee that the procurement of tissues or cells is carried out on a non-profit basis.
V nasprotnem primeru bi to lahko bolnikom onemogočilo dostop do teh pomembnih novih zdravil.
Otherwise, it could deprive patients from these important new medicinal products.
PRILOGA II, TOČKA 2.2
ANNEX II, POINT 2.2.
PRILOGA IV, TOČKA (A), TOČKA (III)
ANNEX IV, POINT (A), POINT (III)
o biotehnologiji: obeti in izzivi za kmetijstvo v Evropi
on Biotechnology: Prospects and Challenges for Agriculture in Europe
MANJŠINSKO MNENJE........................................................................................................17
MINORITY OPINION.............................................................................................................18
MNENJE Odbora za mednarodno trgovino ........................................................18
OPINION of the Committee on International Trade ......................................19
– ob upoštevanju sporočila Komisije o znanostih o življenju in biotehnologiji – strategija za Evropo
– having regard to the Commission Communication on Life Sciences and Biotechnology – a Strategy for Europe
UL C 55, 2.3.2002, str.
OJ C 55, 2.3.2002, p.
– ob upoštevanju Sklepa Sveta št. 2004/869/ES z dne 24. februarja 2004 o sklenitvi, v imenu Evropske skupnosti, mednarodne pogodbe o rastlinskih genskih virih za prehrano in kmetijstvo
- having regard to Council Decision No 2004/869/EC of 24 February 2004 concerning the conclusion, on behalf of the European Community, of the International Treaty on Plant Genetic Resources for Food and Agriculture
UL L 378, 23.12.2004, str.
OJ L 378, 23.12.2004, p.
– ob upoštevanju Direktive Sveta 98/95/ES z dne 14. decembra 1998 o spremembi direktiv 66/400/EGS, 66/401/EGS, 66/402/EGS, 66/403/EGS, 69/208/EGS, 70/457/EGS in 70/458/EGS, s katero je bila uvedena pravna podlaga, ki omogoča gensko raznolikost,
- having regard to Council Directive 98/95/EC of 14 December 1998, amending Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 70/458/EEC, which introduced a legal basis enabling genetic variability,
– ob upoštevanju kartagenskega protokola o biološki varnosti h konvenciji o biološki raznovrstnosti z dne 29. januarja 2000
– having regard to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity of 29 January 2000
UL L 201, 31.7.2002, str.
OJ L 201, 31.7.2002, p.
50. , ki jo je Evropska skupnost podpisala maja 2000,
50. , signed by the European Community on 24 May 2000,
– ob upoštevanju predloga Sklepa Evropskega parlamenta in Sveta o sedmem okvirnem programu Evropske skupnosti za raziskave, tehnološki razvoj in predstavitvene dejavnosti (2007 do 2013) ( KOM(2005)0119 ),
– having regard to the Proposal for a decision of the European Parliament and of the Council concerning the seventh framework programme of the European Community for research, technological development and demonstration activities (2007 to 2013) ( COM(2005)0119 ),
– ob upoštevanju Direktive 2001/18/ES Evropskega parlamenta in Sveta z dne 12. marca 2001 o namernem sproščanju gensko spremenjenih organizmov v okolje in razveljavitvi Direktive Sveta 90/220/EGS
– having regard to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
UL L 106, 17.4.2001, str.
OJ L 106, 17.4.2001, p.
Direktiva, kakor je bila nazadnje spremenjena z odločbo 2002/623/ES (UL L 200, 30.7.2002, str.
Directive as last amended by Decision 2002/623/EC (OJ L 200, 30.7.2002, p.
– ob upoštevanju Uredbe (ES) št. 1829/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o gensko spremenjenih živilih in krmi
– having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed
1. in Uredbe (ES) št. 1830/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o sledljivosti in označevanju gensko spremenjenih organizmov ter sledljivosti živil in krme, proizvedenih iz gensko spremenjenih organizmov, ter o spremembi Direktive 2001/18/ES
1. and to Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC
– ob upoštevanju sporočila Komisije Svetu in Evropskemu parlamentu v zvezi s poročilom o izvajanju nacionalnih ukrepov na področju soobstoja gensko spremenjenih pridelkov s konvencionalnim in ekološkim kmetijstvom ( KOM(2006)0104 ),
– having regard to the Communication from the Commission to the Council and the European Parliament on the report on the implementation of national measures on the coexistence of genetically modified crops with conventional and organic farming ( COM(2006)0104 ),
– ob upoštevanju svoje resolucije z dne 15. marca 2001 o prihodnosti biotehnološke industrije
– having regard to its resolution of 15 March 2001 on the Future of the Biotechnology Industry
– ob upoštevanju svoje resolucije z dne 21. novembra 2002 o sporočilu Komisije o znanostih o življenju in biotehnologiji – strategija za Evropo
– having regard to its resolution of 21 November 2002 on the Commission Communication on Life Sciences and Biotechnology – a Strategy for Europe
– ob upoštevanju resolucije z dne 18. decembra 2003 o soobstoju gensko spremenjenih pridelkov ter konvencionalnih in ekoloških pridelkov
– having regard to its resolution of 18 December 2003 on coexistence between genetically modified crops and conventional and organic crops
UL C 91 E, 15.4.2004, str.
OJ C 91 E, 15.4.2004, p.680. ,
– ob upoštevanju člena 45 svojega poslovnika,
– having regard to Rule 45 of the Rules of Procedure,
– ob upoštevanju poročila Odbora za kmetijstvo in razvoj podeželja ter mnenj Odbora za mednarodno trgovino in Odbora za industrijo, raziskave in energetiko ( A6‑0032/2007 ),
– having regard to the report of the Committee on Agriculture and Rural Development and the opinions of the Committee on International Trade and the Committee on Industry, Research and Energy ( A6‑0032/2007 ),
A. ker sektor biotehnologije zajema številna področja raziskav, ki zadevajo kmetijstvo, okolje in hrano, ker biotehnologija poleg gensko spremenjenih organizmov zadeva tudi veliko drugih področij, med drugim tista v zvezi z uporabo biomase (iz kmetijskih, gozdarskih in organskih odpadkov), biomolekul in genomov mikrobov, ki bi se morala v prihodnjih letih razviti kot del celovitega pristopa k trajnostnemu razvoju, z gospodarskimi, družbenimi, okoljskimi in zdravstvenimi posledicami v Evropi in po svetu,
A. whereas (the biotechnology sector includes several fields of research concerning agriculture, the environment and food; whereas biotechnology also concern many fields other than GMOs, including those concerning the use of biomass (from agriculture, forestry and organic waste), biomolecules and microbial genomes which should in the coming years develop as part of a global approach to sustainable development, with economic, social, environmental and health implications in Europe and globally,
B. ker si lizbonska in göteborška strategija prizadevata, da bi Evropo usmerili k trajnostnemu razvoju, temelječemu na dinamični rasti, ki zagotavlja več delovnih mest, večjo družbeno kohezijo in več spoštovanja do okolja do leta 2010, in ker bi k temu lahko največ prispeval sodoben kmetijski sektor s tržno naravnano proizvodnjo; inovacije, raziskave in razvojne dejavnosti v različnih sektorjih biotehnologije bi lahko prispevale k temu cilju trajnostnega razvoja,
B. whereas the Lisbon and Gothenburg Strategies both aim to steer Europe towards sustainable development based on dynamic growth that ensures more jobs, increased social cohesion and greater respect for the environment by 2010 and a modern agricultural sector with market-oriented production could serve as a major contributor to achieving this; innovation, research and development activities in various sectors of biotechnology could contribute towards that sustainable development objective,
C. ker mehanizem za odkrivanje nedovoljenih transgenikov in zaščito pred njimi ne obstaja in lahko pride do kontaminacije prehranjevalne verige z nedovoljenimi transgeniki, ki še niso bili odkriti, ker še ne obstajajo analitske metode za njihovo odkrivanje,
C. whereas no mechanism has been set up to detect and protect against unauthorised transgenics, and the food chain may be contaminated with such unauthorised transgenics which have not yet been detected because the analytical methods necessary to detect them are not yet available,
D. ker razvoj in uporaba kmetijske biotehnologije ponujata priložnost za razvoj gospodarsko in okoljsko trajnostnega kmetijstva in proizvodnje hrane,
D . whereas the development and use of agricultural biotechnology offers an opportunity to develop both economically and environmentally sustainable farming and food production,
E. ker lahko razvoj biotehnologij, pod pogojem, da te zadovoljujejo potrebe, ki so v splošnem interesu, prinese veliko koristi kmetijstvu, kot so večji pridelek, boljša kakovost proizvodov, manjša uporaba kemičnih gnojil, herbicidov, pesticidov in fosilnih goriv ter manjša erozija tal in manjše onesnaževanje,
E. whereas developments in biotechnologies, provided these meet a need in the general interest, have the potential to yield many benefits for agriculture, such as increased yields, better product quality, reduced use of chemical fertilisers, herbicides, pesticides and fossil fuels and reduced soil erosion and pollution,
F. ker lahko napredek na področju biotehnologije ustvari nove možnosti za kmetijstvo in gozdarstvo ter v širšem smislu prispeva k boljši uporabi vseh vrst biomase iz obnovljivih virov; ker te inovacije zadevajo področja „zelene“ kemije, hrane in zdravja,
F. whereas advances made in biotechnology have the potential to create new openings for agriculture and sylviculture and, more broadly, to contribute to a better use of all biomass from renewable sources; and whereas these innovations concern the fields of green chemistry, food and health,
G. ker narašča povpraševanje po bolj zdravi, varnejši in kakovostnejši hrani, ob hkratnem upoštevanju dobrega počutja živali in ohranjanja podeželja,
G. whereas there is a growing demand for healthier, safer and higher-quality food, at the same time taking account of animal welfare and rural conservation,
H. ker se je pri vmesnem pregledu pokazalo, da je bil dosežen napredek pri doseganju ciljev, opredeljenih v sporočilu Komisije z naslovom „Znanosti o življenju in biotehnologija – strategija za Evropo“, in sicer v zvezi z vzpostavitvijo regulativnih načel ter s spodbujanjem trdne javne raziskovalne baze za znanosti o življenju in uporabe v zdravstvenem varstvu; ker napredek pri doseganju posebnih ciljev v zvezi z uporabo kmetijske biotehnologije zaostaja za temi dosežki in zaenkrat ni preveč očiten,
H. whereas the mid-term review shows that progress has been made towards achieving the goals set out in “Life Sciences and Biotechnology — A strategy for Europe” with respect to establishing regulatory principles and promoting a strong public life sciences research base and healthcare applications; whereas progress towards the specific goals established for the agricultural biotechnology applications is lagging behind these achievements and so far is not very tangible,
I. ker si države članice različno razlagajo zakonodajo Skupnosti in ker zato njeno izvajanje ni usklajeno po vseh državah članicah; ker obstaja jasna potreba po razvoju skupnega pristopa, zlasti v zvezi s soobstojem gensko spremenjenih pridelkov ter konvencionalnih in ekoloških pridelkov, ki kmetom in potrošnikom omogoča izbiro,
I.whereas Community legislation is interpreted differently by Member States and its implementation is therefore not consistent across all Member States; whereas there is a clear need to develop a common approach, particularly with regard to the coexistence of genetically modified crops and conventional and organic crops which provides the basis for choice for both farmers and consumers,
J. ker bi sodobna biotehnologija lahko olajšala spopadanje z izzivi, ki jih prinašajo revščina, rast prebivalstva in spreminjajoče se okoljske razmere v državah v razvoju,
J. whereas modern biotechnology could help to respond to the challenges brought about by poverty, population growth and changing environmental conditions in the developing world,
K. ker uporaba novih tehnologij, npr. pri novih pridelkih v medicinske ali druge neprehranske namene, ponuja nove proizvodne priložnosti, zlasti v sektorjih, kjer konvencionalna proizvodnja ni več donosna,
K. whereas the use of new technologies, for example in new crops for medicinal or other non-food purposes, offers new production opportunities, particularly in sectors where conventional production has ceased to be economically profitable,
L. ker morajo gensko spremenjeni proizvodi za uporabo v kmetijstvu opraviti zelo strogo ocenjevanje in je sedanji postopek odobritve počasen in birokratski, kar prispeva k zaostajanju EU za njenimi svetovnimi konkurenti,
L. whereas GM products for use in agriculture necessarily have to pass very stringent assessments and the present authorisation process is slow and bureaucratic, contributing to the EU lagging behind its global competitors,