natgillin/translations-raw huggingface dataset:
– ob upoštevanju sklepov o zahodnem Balkanu, ki jih je sprejel Svet za splošne zadeve 16. in 17. oktobra 2006,
– having regard to the conclusions on the Western Balkans of the General Affairs Council of 16 and 17 October 2006,
A. ker so se predstavniki dveh entitet sporazumeli, da bi predlagana reforma policije predvidevala prenos vseh proračunskih pristojnosti na državno raven, odstranitev vsakega političnega vmešavanja v delovanje policije ter razmejitev teritorialnih enot po izključno tehničnih in funkcionalnih mejah,
A. whereas the representatives of the two entities had agreed that the proposed police force reform would envisage the transfer to state level of all budgetary competencies, the elimination of all political interference in the operation of such forces and the delimitation of territorial units along purely functional lines,
B. ker je sporazum predvidel ustanovitev direktorata za izvajanje prestrukturiranja policije, v katerem bi bili predstavniki vseh ravni oblasti (države, entitet in kantonov), njegova naloga pa bi bila podati predlog za izvršitev reforme, vključno z razmejitvijo novih ozemeljskih enot,
B. whereas the agreement foresaw the setting up of a directorate for the implementation of police force restructuring, with representatives from all levels of authority (state, entity and cantons), whose task would be to submit a proposal for the implementation of the reform, including the demarcation of the new territorial units,
C. ker bi moral direktorat predložiti svoj predlog do 30. septembra 2006, vendar se tega roka ni držal, ker so predstavniki Republike Srbske zavrnili nadaljnje sodelovanje pri tej zadevi,
C. whereas the directorate should have submitted its proposals by 30 September 2006, a deadline which it failed to respect, given that the representatives of the Republika Srpska refused to cooperate further on this issue,
D. ker je vodstvo Republike Srbske med kampanjo večkrat podalo izjave, v katerih je podvomilo v predlagano reformo policije in v sporazum, ki so ga stranke dosegle oktobra lani,
D. whereas during the campaign the Republika Srpska leadership repeatedly issued statements which questioned the proposed police reform and the agreement reached by the parties in October last year,
E. ker sta parlamentu Bosne in Hercegovine manjkala samo dva glasova, da bi dosegel potrebno kvalificirano večino za sprejetje predlogov ustavnih sprememb, o katerih so se sporazumele najpomembnejše politične stranke,
E. whereas the Parliament of Bosnia and Herzegovina failed by only two votes to reach the qualified majority required for the adoption of the constitutional amendments agreed by the main political parties,
F. ker je bil glavni nasprotnik glasovanja "proti" izvoljen za predsednika Bosne in Hercegovine,
F. whereas the main opponent of the 'no' vote was elected President of Bosnia and Herzegovina,
G. ker so predstavniki Republike Srbske med predvolilno kampanjo pozivali k referendumu o neodvisnosti, če bi se pogajanja o prihodnjem statusu Kosova zaključila s pravno in ozemeljsko ločitvijo od Srbije,
G. whereas during the election campaign representatives of the Republika Srpska called for an independence referendum, should the negotiations on the future status of Kosovo result in a legal and territorial separation from Serbia,
H. ker bi lahko odločitev o prenehanju delovanja urada visokega predstavnika vplivala na hitrost upravnih in ustavnih reform, ki so nujen predpogoj za evropsko povezovanje države,
H. whereas the decision to close down the Office of the High Representative could have an impact on the pace of the administrative and constitutional reforms, which are an essential prerequisite for the country's European integration process,
I. ker je predvolilna kampanja potrdila vztrajanje močnih etničnih delitev v Bosni in Hercegovini ter potrebo države po bolj celovitem, sodobnem vzgojno-izobraževalnem sistemu, ki ne bo segregacijski,
I. whereas the election campaign confirmed the persistence of strong ethnic divisions within Bosnia and Herzegovina and the need for a more integrated, non-segregationist, modern education system in the country,
a) pozdravlja poziv Sveta, naj se hitro oblikujejo nove vlade, da se lahko zakonodajne dejavnosti kmalu spet začnejo;
(a) welcomes the Council's call for the new governments to be formed quickly, so as to allow the rapid resumption of legislative activity;
b) poziva Svet, naj preko dobrih uslug posebnega predstavnika EU ponovno začne pogovore o zelo potrebni ustavni reformi Bosne in Hercegovine;
(b) invites the Council, through the good offices of the EU Special Representative, to relaunch the talks on much-needed constitutional reform in Bosnia and Herzegovina;
c) poziva Svet, naj izvaja pritisk na vlado Republike Srbske, da se ta ponovno obveže za delo direktorata za izvajanje reforme policije, in naj vse stranke spomni, da je prestrukturiranje policije ključni predpogoj za sklenitev stabilizacijsko-pridružitvenega sporazuma;
(c) urges the Council to exert pressure on the Government of the Republika Srpska to recommit to the work of the directorate for police reform implementation and to remind all parties that police force restructuring is a key prerequisite for the conclusion of the Stabilisation and Association Agreement;
Predlog priporočila Evropskega parlamenta Svetu o Bosni in Hercegovini
Proposal for a European Parliament recommendation to the Council on Bosnia–Herzegovina
o predlogu Uredbe Evropskega parlamenta in Sveta o zdravilih za napredno zdravljenje ter o spremembi Direktive 2001/83/ES in Uredbe (ES) št. 726/2004
on the proposal for a regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
Hiltrud Breyer , Odbor za pravne zadeve
Hiltrud Breyer , Committee on Legal Affairs
PE 371.745v01-00
PE 380.740v02-00
MNENJE Odbora za industrijo, raziskave in energetiko .............................39
OPINION of the Committee on Industry, Research and Energy ...............42
MNENJE Odbora za pravne zadeve (*).....................................................................61
OPINION of the Committee on Legal Affairs (*) ................................................66
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2005)0567 )
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2005)0567 )
– ob upoštevanju členov 251(2) in 95 Pogodbe ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C6‑0401/2005 ),
– having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6‑0401/2005 ),
– ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane in mnenj Odbora za industrijo, raziskave in energetiko ter Odbora za pravne zadeve ( A6‑0031/2007 ),
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on Legal Affairs ( A6‑0031/2007 ),
(2) V kolikor imajo ti izdelki za napredno zdravljenje lastnosti za zdravljenje ali preprečevanje bolezni ljudi ali za uporabo pri ljudeh ali dajanje ljudem za ponovno vzpostavitev, izboljšanje ali spreminjanje fizioloških funkcij prek farmakološkega, imunološkega ali presnovnega delovanja, se štejejo za biološka zdravila v smislu člena 1(2) in Priloge I k Direktivi 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini.
(2) Insofar as these advanced therapy products are presented as having properties for treating or preventing diseases in human beings, or that they may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, they are biological medicinal products within the meaning of Article 1(2) and Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
Zato mora biti osnovni cilj kakršnih koli predpisov, ki urejajo njihovo izdelavo, promet in uporabo, varovanje javnega zdravja.
Thus, the essential aim of any rules governing their production, distribution and use must be to safeguard public health.
(2) V kolikor imajo ti izdelki za napredno zdravljenje lastnosti za zdravljenje ali preprečevanje bolezni ljudi ali za uporabo pri ljudeh ali dajanje ljudem za ponovno vzpostavitev, izboljšanje ali spreminjanje fizioloških funkcij prek predvsem farmakološkega, imunološkega ali presnovnega delovanja, se štejejo za biološka zdravila v smislu člena 1(2) in Priloge I k Direktivi 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini.
(2) Insofar as these advanced therapy products are presented as having properties for treating or preventing diseases in human beings, or that they may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting principally a pharmacological, immunological or metabolic action, they are biological medicinal products within the meaning of Article 1(2) and Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
Direktive o medicinskih pripomočkih predvidevajo ureditveni okvir, ki se z lahkoto prilagodi nadzoru pripomočkov, ki vsebujejo ali so narejeni iz izdelkov tkivnega inženirstva.
The Medical Devices Directives (MDD) provide a regulatory framework which is readily adapted to the control of devices containing or made of tissue engineered products.
Če izdelek tkivnega inženirstva spada pod opredelitev medicinskega pripomočka iz člena 1 direktiv o medicinskih pripomočkih (in torej način njegovega delovanja ni predvsem farmakološki, imunološki ali presnovni), bi ga morale urejati direktive o medicinskih pripomočkih, čeprav bodo morda potrebne dodatne posebne zahteve.
If a tissue engineered product falls within the definition of ‘medical device’ in Article 1 of the MDD (and therefore does not have a mode of action which is primarily pharmacological, immunological or metabolic), it should be regulated under the MDD although additional specific requirements may be necessary.
(5) Zdravila za napredno zdravljenje je treba urejati v obsegu , v katerem so dana na trg v državah članicah in v katerem so izdelana industrijsko ali pripravljena z uporabo metode, ki vključuje industrijski postopek , v smislu člena 2(1) Direktive 2001/83/ES.
(5) Advanced therapy medicinal products should be regulated in so far as they are intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process, within the meaning of Article 2(1) of Directive 2001/83/EC.
Zdravila za napredno zdravljenje, ki so v isti bolnišnici v celoti pripravljena in uporabljena za posameznega bolnika v skladu z receptom , je zato treba izključiti iz obsega te uredbe.
Advanced therapy medicinal products which are both prepared in full and used in a hospital, in accordance with a medical prescription for an individual patient, should thus be excluded from the scope of the present Regulation.
(5) Ta uredba je lex specialis, saj vsebuje dodatne določbe k tistim iz Direktive 2001/83/ES.
(5) This Regulation is a lex specialis, which introduces additional provisions to those laid down in Directive 2001/83/EC .
Direktiva bi morala urejati zdravila za napredno zdravljenje , ki so dana na trg v državah članicah in izdelana industrijsko ali pripravljena z uporabo metode, ki vključuje industrijski postopek, v skladu s splošnim obsegom farmacevtske zakonodaje Skupnosti, določene v naslovu II Direktive 2001/83/ES.
The scope of this Regulation should be to regulate advanced therapy medicinal products which are intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process, in accordance with the general scope of the Community pharmaceutical legislation laid down in Title II of Directive 2001/83/EC .
Zdravila za napredno zdravljenje, ki so v isti bolnišnici v celoti pripravljena na neprofitni osnovi in za posamezen primer v skladu s posebnim, nestandardiziranim in nepatentiranim postopkom in uporabljena za posameznega bolnika, zaradi upoštevanja posameznega recepta , ob izključni poklicni odgovornosti zdravnika ali za klinično raziskavo je zato treba izključiti iz obsega te uredbe.
Advanced therapy medicinal products which are prepared in full in a hospital in a non-profit manner and on a one-off basis according to a specific, non-standardised and non-patented process , and used in a hospital , in order to comply with an individual medical prescription for an individual patient under the exclusive professional responsibility of a medical practitioner or for clinical research , should thus be excluded from the scope of this Regulation.
Če bolnišnice ali druge institucije pripravijo izdelke z uporabo uveljavljenih postopkov za rutinsko zdravljenje bolnikov, morajo ravnati v skladu z določbami te uredbe.
Where hospitals or other institutions prepare products using an established process to create treatments for patients on a routine basis, they should have to comply with the provisions of this Regulation.
Če pa bolnišnice proizvajajo zdravila za napredno zdravljenje v raziskovalne namene ali le izjemno in za enkratno uporabo, jim ni treba izpolnjevati centraliziranega postopka za pridobitev dovoljenja.
However, when hospitals produce ATMP for research purposes or on an exceptional, one-off basis, they should not have to comply with the centralised authorisation procedure.
(6) Uredba o zdravilih za napredno zdravljenje na ravni Skupnosti ne sme vplivati na odločitve držav članic o dovoljenju uporabe kakršne koli posebne vrste človeških celic , kot so embrionalne matične celice ali živalske celice .
(6) The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type of human cells , such as embryonic stem cells, or animal cells .
Ravno tako ne sme vplivati na uporabo nacionalne zakonodaje, ki prepoveduje ali omejuje prodajo, dobavo ali uporabo zdravil, ki vsebujejo te celice ali jih te celice sestavljajo ali so izdelane na njihovi podlagi.
It should also not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products containing, consisting of or derived from these cells.
(6) Veljavna zakonodaja o uporabi določenih vrst celic, kot so embrionalne matične celice, se v državah članicah zelo razlikuje.
(6) Legislation in force in Member States concerning the use of certain types of cells, such as embryonic stem cells, varies considerably.
Uredba o zdravilih za napredno zdravljenje na ravni Skupnosti ne sme vplivati na odločitve držav članic o dovoljenju uporabe kakršne koli posebne vrste celic.
The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type of cells.
Poleg tega je nemogoče oceniti, kdaj, če sploh kdaj, bodo raziskave teh celic dosegle stopnjo, na kateri bi se lahko na trgu pojavili komercialni izdelki, narejeni iz teh celic.
Moreover, it is impossible to assess when, if ever, research on these cells will reach the stage at which commercial products made from these cells could be placed on the market.
Zaradi spoštovanja osnovnih načel in pravilnega delovanja notranjega trga ter za zagotovitev pravne varnosti, mora ta uredba veljati le za izdelke, narejene iz celic, s katerimi bo mogoče trgovati v bližnji prihodnosti in ki ne sprožajo večjih polemik.
In order to respect the basic principles and the proper functioning of the internal market and to ensure legal certainty, this Regulation should apply only to products made of cells, for which marketing is feasible in the near future and which do not raise major controversies.
Predlog spremembe odbora JURI, ki v skladu s členom 47 vključen v poročilo brez glasovanja.
JURI amendment, which was incorporated in the report without vote following Rule 47.
Primer SES C-376/98).
ECJ Case C-376/98).
Zato je treba iz področja uporabe te uredbe izključiti izdelke, ki uporabljajo sporne materiale in pri katerih države članice med seboj ne nameravajo poenotiti različnih zakonodajnih določb.
It is therefore necessary to exclude from the scope of this regulation products using materials which are controversial and for which differing Member States legislative provisions are intended to remain.
V vsakem primeru pa verjetnost, da bodo izdelki, ki uporabljajo te materiale, v predvidljivi prihodnosti pripravljeni za prodajo, ni ravno velika.
In any case, products using these materials are unlikely to be ready to be placed on the market in the foreseeable future.
(9) Vrednotenje zdravil za napredno zdravljenje pogosto zahteva zelo posebno strokovno znanje, ki presega okvire tradicionalnega farmacevtskega področja in zajema mejna področja z drugimi sektorji, kot so biotehnologija in medicinski pripomočki.
(9) The evaluation of advanced therapy medicinal products often requires very specific expertise, which goes beyond the traditional pharmaceutical field and covers areas on the borderline to other sectors such as biotechnology and medical devices.
Zato je primerno znotraj Agencije ustanoviti Odbor za napredno zdravljenje, s katerim bi se Odbor za zdravila za uporabo v humani medicini posvetoval glede ocene podatkov o zdravilih za napredno zdravljenje, preden bi izdal končno znanstveno mnenje .
For this reason, it is appropriate to create, within the Agency, a Committee for Advanced Therapies, which the Committee for Medicinal Products for Human Use of the Agency should consult on the assessment of data related to advanced therapy medicinal products, before issuing its final scientific opinion.
Poleg tega se je mogoče z Odborom za napredno zdravljenje posvetovati za vrednotenje katerega koli drugega zdravila, ki zahteva posebno strokovno znanje v okviru njegovih pristojnosti.
In addition, the Committee for Advanced Therapies may be consulted for the evaluation of any other medicinal product which requires specific expertise falling within its area of competence.
Zato je primerno znotraj Agencije ustanoviti Odbor za napredno zdravljenje, ki bo odgovoren za pripravo osnutka mnenja o kakovosti, varnosti in učinkovitosti vsakega zdravila za napredno zdravljenje, da ga končno odobri Odbor za zdravila za uporabo v humani medicini .
For this reason, it is appropriate to create, within the Agency, a Committee for Advanced Therapies, which should be responsible for preparing a draft opinion on the quality, safety and efficacy of each advanced therapy medicinal product for final approval by the Committee for Medicinal Products for Human Use of the Agency.
Poleg tega se je treba z Odborom za napredno zdravljenje posvetovati za vrednotenje katerega koli drugega zdravila, ki zahteva posebno strokovno znanje v okviru njegovih pristojnosti.
In addition, the Committee for Advanced Therapies should be consulted for the evaluation of any other medicinal product which requires specific expertise falling within its area of competence.
Zaradi zelo posebnih in edinstvenih značilnosti zdravil za napredno zdravljenje se je v okviru Evropske agencije za zdravila (EMEA) ustanovil nov Odbor za napredno zdravljenje, ki ga sestavljajo strokovnjaki s posebno usposobljenostjo ali strokovnim znanjem na tem zelo inovativnem in hitro razvijajočem področju.
Due to a highly specific and unique character of the advanced therapy medicinal products, a new Committee for Advanced Therapies is established within EMEA and composed of experts having specific qualifications or experience in this highly innovative and quickly developing field.
Zato mora biti nova struktura odgovorna za sestavo osnutka mnenja o kakovosti, varnosti in učinkovitosti zdravil, da ga končno odobri Odbor za zdravila za uporabo v humani medicini (CHMP).
Therefore, the new structure should be responsible for drafting an opinion on the quality, safety, and efficacy of products for the final approval by the CHMP.
Poleg tega se je treba z Odborom za napredno zdravljenje posvetovati za vrednotenje drugih zdravil v okviru njegovih pristojnosti.
Furthermore, the committee should be consulted for the evaluation of other products under its competence.
(10) Odbor za napredno zdravljenje naj bi združeval najboljše razpoložljivo strokovno znanje Skupnosti o zdravilih za napredno zdravljenje.
(10) The Committee for Advanced Therapies should gather the best available Community expertise on advanced therapy medicinal products.
Sestava Odbora za napredno zdravljenje naj bi zagotovila primerno pokritost znanstvenih področij, pomembnih za napredno zdravljenje, vključno z genskim zdravljenjem, celičnim zdravljenjem, tkivnim inženirstvom, medicinskimi pripomočki, farmakovigilanco in etiko.
The composition of the Committee for Advanced Therapies should ensure appropriate coverage of the scientific areas relevant to advanced therapies, including gene therapy, cell therapy, tissue-engineering, medical devices, pharmacovigilance and ethics.
Zastopana morajo biti tudi združenja bolnikov in kirurgov z znanstvenimi izkušnjami z zdravili za napredno zdravljenje.
Patient associations and surgeons with scientific experience of advanced therapy medicinal products should also be represented.
Zastopana morajo biti tudi združenja bolnikov in zdravnikov z znanstvenimi izkušnjami z zdravili za napredno zdravljenje.
Patient associations and physicians with scientific experience of advanced therapy medicinal products should also be represented.
Da bi zajeli vsa medicinska področja, na katere se nanaša napredno zdravljenje, mora Odbor za napredno zdravljenje imeti splošnejše medicinsko strokovno znanje.
In order to cover all other medical fields which the advanced therapies may relate to, the Committee for Advanced Therapies should be represented by a more general medical expertise.
(14) Načeloma je dovoljeno človeške celice ali tkiva, ki so v zdravilih za napredno zdravljenje, pridobivati samo s prostovoljnim in brezplačnim darovanjem.
(14) As a matter of principle, human cells or tissues contained in advanced therapy medicinal products should be procured from voluntary and unpaid donation.
Prostovoljno in brezplačno darovanje tkiv in celic je dejavnik, ki lahko prispeva k visokim varnostnim standardom za tkiva in celice, s tem pa k varovanju zdravja ljudi.
Voluntary and unpaid tissue and cell donations are a factor which may contribute to high safety standards for tissues and cells and therefore to the protection of human health.
(14) Pri darovanju človeških tkiv in celic je treba spoštovati evropska načela, kot so anonimnost darovalca in prejemnika, altruizem darovalca ter solidarnost med darovalcem in prejemnikom.
(14) As regards the donation of humancells or tissues, European principles such as the anonymity of both donor and recipient, altruism of the donor and solidarity between donor and recipient should be respected.
Načeloma je človeške celice ali tkiva, ki so v zdravilih za napredno zdravljenje, dovoljeno pridobivati samo s prostovoljnim in brezplačnim darovanjem.
As a matter of principle, human cells or tissues contained in advanced therapy medicinal products should be procured from voluntary and unpaid donation.