natgillin/translations-raw huggingface dataset:
Države članice bi morale na pregleden način obvestiti Komisijo o proizvodih, za katere bo dovoljeno trženje, da se proizvajalcem omogoči vpogled v nepristranski seznam dovoljenj.
The Commission should be informed in a transparent manner by the Member States of which products will be allowed to be placed on the market with a view to allowing manufacturers to consult an authoritative list.
Člen 29
ARTICLE 29
Za zdravila za napredno zdravljenje, ki niso izdelki tkivnega inženirstva in ki so bila v času začetka veljavnosti te uredbe v skladu z nacionalno zakonodajo ali zakonodajo Skupnosti legalno na trgu Skupnosti, se predloži vloga za dovoljenje za promet najkasneje pet let po začetku veljavnosti te uredbe .
For advanced therapy medicinal products , other than tissue engineered products, which were legally on the Community market in accordance with national or Community legislation at the time of entry into force of this Regulation , an application for a marketing authorisation shall be filed no later than five years after the entry into force of this Regulation .
Za izdelke tkivnega inženirstva, ki so v času začetka veljavnosti tehničnih zahtev iz člena 8 v skladu z nacionalno zakonodajo ali zakonodajo Skupnosti legalno na trgu Skupnosti, se predloži vloga za dovoljenje za promet najpozneje pet let po začetku veljavnosti tehničnih zahtev iz člena 8.
For tissue engineered products which are legally on the Community market in accordance with national or Community legislation at the time of entry into force of the technical requirements referred to in Article 8, an application for a marketing authorisation shall be filed no later than five years after the entry into force of the technical requirements referred to in Article 8.
Predvideno dveletno prehodno obdobje je prekratko, kajti že samo trajanje kliničnih poskusov bo v mnogih primerih preseglo predlagani čas.
The envisaged Transitional period of two years is too short, since the duration of the clinical trials alone will in many cases exceed the proposed time period.
Poleg tega mora biti prosilec odgovoren samo za datum vložitve vloge in ne za zamude, povzročene s strani agencije/nacionalnih pristojnih organov ali zaradi problemov med fazo ocenjevanja.
Furthermore the applicant should only be responsible for the date of filing the application and not for delays due to the Agency/national competent authorities or problems during the assessment phase.
V nasprotnem primeru bi to bolnikom onemogočilo dostop do novih zdravil.
Otherwhise, it could deprive patients from these important new medicinal products.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
Uporablja se od [ 3 mesece po začetku veljavnosti ]
It shall apply from [3 months after entry into force]
Uporablja se od * , razen v povezavi z izdelki tkivnega inženirstva.
It shall apply from * , except in relation to tissue engineered products.
V povezavi z izdelki tkivnega inženirstva se ta uredba uporablja od datuma, ko začnejo veljati vse zahteve iz členov 4, 5 in 8.
In relation to tissue engineered products, this Regulation shall apply from the date on which all the requirements referred to in Articles 4, 5 and 8 have entered into force.
* 3 mesece od dneva začetka veljavnosti te direktive.
* 3 months after the date of entry into force of this Directive.
To je potrebno zaradi upoštevanja različnih časovnih okvirov, ki so nujni za uporabo uredb in direktiv.
This is necessary to take into account the different timeframes necessary for the application of Regulations and Directives.
Predlog spremembe priznava, da farmacevtskega režima v njegovi sedanji obliki ni mogoče uporabljati v zvezi z izdelki tkivnega inženirstva.
The proposal recognizes that the pharmaceutical regime cannot be applied to TEP as it currently stands.
Zato je pomembno, da se uredba uporablja šele, ko se uporabljajo vse direktive, ki jih ta spreminja.
It is therefore important that the regulation is applicable only when all the directives modified by it are also of application.
Predlog Uredbe Evropskega parlamenta in Sveta o zdravilih za napredno zdravljenje ter o spremembi Direktive 2001/83/ES in Uredbe (ES) št. 726/2004
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
Odbori, zaprošen za mnenje Datum razglasitve na zasedanju
Opinion by Date announced in plenary
Prejšnji pripravljavec(-ka) mnenja
Previous drafts(wo)man
Pred končnim glasovanjem je Pia Elda Locatelli izjavila, da, glede na dejstvo, da so sprejeti predlogi sprememb spremenili njeno začetno stališče o tej temi, ne more več opravljati vloge pripravljavke mnenja.
Prior to taking the final vote, Pia Elda Locatelli stated that given the fact that the amendments adopted had changed her initial position on the subject, she therefore could not continue as draftswoman.
Odbor je nato za pripravljavca mnenja imenoval svojega predsednika, Gilesa Chichestra.
The Committee then appointed its chairman, Giles Chichester, draftsman.
MNENJE Odbora za pravne zadeve (*)
OPINION of the Committee on Legal Affairs (*)
Predlog Komisije skuša urediti prodajo izdelkov, ki temeljijo na genskem zdravljenju, celičnem zdravljenju in tkivnem inženirstvu, na evropskem trgu.
The Commission’s proposal seeks to regulate placing on the European market of products based on gene therapy, cell therapy and tissue engineering.
Ti izdelki so v sodobni medicini čedalje bolj pomembni in lahko potencialno pomagajo velikemu številu bolnikov, vendar se lahko v primeru nepravilne ureditve pojavijo resna, z zdravjem povezana tveganja.
These products are of growing importance for modern medicine and can potentially help a lot of patients, but some serious health risks might occur in case of improper regulation.
Zlasti na področju tkivnega inženirstva ni nobenega usklajenega evropskega pristopa.
Especially in the area of tissue engineering no harmonised European approach exists.
Predlog Komisije na splošno pozdravljajo vse zainteresirane strani, toda javna razprava in razprava v odborih Evropskega parlamenta sta pokazali, da je treba zaradi pravne doslednosti, izključitve spornih interpretacij, usklajenosti z veljavno zakonodajo in zaščite pravic Evropskega parlamenta nekatere točke nujno pojasniti.
In general, the Commission’s proposal is welcome by all stakeholders but the public debate and discussion in Parliament committees has shown that there are some points that urgently need clarification to make the proposal legally consistent, to exclude controversial interpretations, to make the proposal coherent with the current legislation and to safeguard Parliament's rights.
Zato Odbor za pravne zadeve predlaga nekaj predlogov sprememb.
This is why the Committee on Legal Affairs proposes a number of amendments.
Pravice Evropskega parlamenta v postopku komitologije
The rights of the Parliament in the comitology procedure.
Predlog Komisije predvideva prenos vseh pomembnih vprašanj na postopek komitologije.
The Commission’s proposal foresees to delegate almost all important questions to the comitology procedure.
Pri tako pomembnem političnem vprašanju je treba zaščititi pravice Evropskega parlamenta.
In such a highly political issue it is important to safeguard Parliament's rights.
Parlament bi moral imeti pravico do pregleda in blokiranja takšnih sklepov.
The Parliament should have the right to examine and to block such decisions.
Nesprejemljivo je, da se člen 8 tega predloga sklicuje na postopek komitologije, čeprav Komisija Evropskemu parlamentu sploh ni predložila osnutka ustreznih tehničnih zahtev.
It is unacceptable that Art. 8 of this proposal refers to the comitology procedure although the Commission has not even submitted to the Parliament a draft of adequate technical requirements.
Evropske institucije so ravnokar dosegle nov sporazum o postopku komitologije, ki predstavlja korak naprej glede uravnoteženosti njihovih moči.
The European institutions have just reached a new agreement on the comitology procedure which is a step forward in balancing their powers.
Medtem pa predlagani predlog spremembe uvaja postopek, ki krepi vlogo Evropskega parlamenta.
In the meantime, a proposed amendment introduces a procedure strengthening Parliament's role.
Pravna varnost pri vprašanju subsidiarnosti
Legal safety on the issue of subsidiarity.
Obstaja široko soglasje o tem, da Evropska unija ne bi smela usklajevati zakonodaje o uporabi človeških zarodkov in človeških embrionalnih matičnih celic.
There is broad agreement that the European Union should not harmonise the legislation on the use of human embryos and human embryonic stem cells.
Ni namreč izključeno, da predlagana uredba ne predstavlja popolne uskladitve.
It can not be excluded that the proposed Regulation constitutes a complete harmonisation.
Potemtakem bi predlagani člen 28(2) predstavljal tujo sestavino in kršitev prava Skupnosti ne bi bila izključena.
Therefore, the proposed Art. 28(2) would be an alien substance and breach of Community law would not be excluded.
Odbor zato predlaga, da se izključi embrionalne matične celice iz okvira te Uredbe v členu 1.
The Committee therefore proposes to exclude embryonic stem cells from the scope of the Regulation in Article 1.
S tem se želi pojasniti, da na tako občutljivem področju ne more priti do usklajevanja.
It would make clear that there will be no harmonization in these delicate areas.
Poleg tega bi bilo treba v predlogu spremeniti besedilo člena 28(2), s čemer bi poudarili, da lahko države članice na podlagi člena 30 Pogodbe ES še naprej prepovedujejo ali omejujejo uporabo, prodajo in dajanje človeških in živalskih celic na trg, kot tudi uporabo zdravil, ki te celice vsebujejo ali jih te celice sestavljajo ali pa so izdelana na njihovi podlagi.
In addition, the wording of Art. 28(2) of the proposal should be changed to underline that Member States, acting on the basis of Art. 30 TEC can further ban or limit the use, the sale, the placing on the market of human and animal cells as well as the use of medicinal products which contain, consist or are derived from such cells.
Za skladnost predloga z veljavno zakonodajo EU nekatere tehnologije, ki so prepovedane na drugem mestu v evropski zakonodaji, prav tako ne bi smele biti dovoljene v skladu s trenutnim predlogom Komisije.
To make the proposal coherent with the current EU legislation, some technologies that are banned in other European legislation should also not get authorisation under the current Commission’s proposal.
Kljub hitremu napredku na nekaterih področjih v zvezi s človekovimi pravicami in ustavnim pravom ne bi smelo prihajati do nikakršnih kompromisov, ne glede na pristojnost držav članic.
Regardless of the competence of the Member States there should not be any compromises regarding human rights and constitutional law, even if progress in some areas is rapid.
Treba je spoštovati načelo nekomercializacije človeškega telesa.
The principle of the non-commercialization of the human body has to be respected.
Osebna celovitost je zaščitena v skladu z Oviedsko konvencijo in Listino o temeljnih pravicah.
The integrity of the person is protected under the Oviedo Convention and the Charter of Fundamental Rights.
Ustvarjanje človeško-živalskih hibridov ali hibridnih bitij predstavlja kršitev načela osebne celovitosti in načela o nedotakljivosti človekovega dostojanstva.
The production of human-animal hybrids or chimeras constitutes a breach of the principle of the integrity of the person and of the principle of inviolability of human dignity.
Posegi v človeško zarodno linijo so v Oviedski konvenciji izrecno poimenovani kot posegi, ki ogrožajo človekovo dostojanstvo.
Interventions in the human germ line are explicitly named in the Oviedo Convention as endangering human dignity.
Izdelki, ki posegajo v človeško zarodno linijo, so v Direktivi 2001/20/ES izključeni iz kliničnega preskušanja in se jih v skladu z Direktivo 98/44/ES ne da patentirati, kar velja tudi za človeško-živalske hibride, saj je to v nasprotju z javnim redom.
Products which intervene in the human germ line are excluded from clinical trials in Directive 2001/20/EC and are non patentable according to Directive 98/44/EC as are also human-animal hybrids being against ordre public.
Za zagotovitev prostovoljnega in neplačanega darovanja človeških tkiv in celic je treba spremeniti Direktivo 2004/23/ES.
To insure the voluntary and unpaid donation of human tissues and cells the Directive 2004/23/EC must be amended.
Neposredno v zvezi z naprednim zdravljenjem, ki se hitro razvija in za čigar izdelke so vedno bolj potrebna človeška tkiva in celice, načelo nekomercializacije človeškega telesa od držav članic zahteva, da zagotovijo prostovoljno in neplačano darovanje in pridobivanje človeških celic in tkiv.
Straight in connection with advanced therapies which are subject to rapid development and for products of which the human tissue and cells are increasingly needed, the principle of the non-commercialization of the human body requires Member States to ensure the voluntary and unpaid donation and procurement of human cells and tissues.
Zato je treba za namene predlagane uredbe spremeniti Direktivo 2004/23/ES.
Therefore the Directive 2004/23/EC must be amended for the purposes of the suggested Regulation.
Odbor za pravne zadeve poziva Odbor za okolje, javno zdravje in varnost hrane, kot pristojni odbor, da v svoje poročilo vključi naslednje predloge sprememb:
The Committee on Legal Affairs calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:
Predlog Uredba Evropskega parlamenta in Sveta o zdravilih za napredno zdravljenje ter o spremembi Direktive 2001/83/ES in Uredbe (ES) št. 726/2004
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
Predlog Uredba Evropskega parlamenta in Sveta o zdravilih za napredno zdravljenje ter o spremembi Direktive 2001/83/ES , Uredbe (ES) št. 726/2004 in Direktive 2004/23/ES
Proposal for a Regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC , Regulation (EC) No 726/2004 and Directive 2004/23/EC
Naslov predloga je treba spremeniti, ker se spremeni tudi Direktiva 2004/23/ES (glej predlog spremembe 45).
The title of the proposal need to be changed, as Directive 2004/23/EC is also amended (see amendment 45).
(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.
(6) Veljavna zakonodaja glede uporabe 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 cells.
(7a) Ta uredba v celoti spoštuje prepoved, po kateri človeško telo in njegovi deli ne smejo predstavljati vira finančnega dobička, ki je določena kot neodtujljiva minimalna zaščita v Listini Unije o temeljnih pravicah in ki jo je Evropski parlament še dodatno poudaril v svoji Resoluciji z dne 10. marca 2005 o trgovini s človeškimi jajčnimi celicami 1 in v resoluciji z dne 26. oktobra 2005 o patentih za biotehnološke izume 2 .
(7a) This Regulation fully respects the prohibition on making the human body and its parts as such a source of financial gain, as set out as an inalienable minimum safeguard in the Charter of Fundamental Rights of the European Union and further underlined by the European Parliament in its resolutions of 10 March 2005 on the trade in human egg cells 1 and of 26 October 2005 on patents for biotechnological inventions 2 .
V ta namen je treba zagotoviti, da je darovanje tkiv in celic prostovoljno in neplačano, ter da je njihovo pridobivanje neprofitno.
To that end, it is necessary to ensure that the donation of tissues and cells is voluntary and unpaid and that their procurement is carried out on a non-profit basis.
Prostovoljno in neplačano darovanje tkiv in celic prav tako prispeva k visokim varnostnim standardom za tkiva in celice, s tem pa k varovanju zdravja ljudi.
Voluntary and unpaid tissue and cell donations also contribute to high safety standards for tissues and cells and therefore to the protection of human health.
2 Sprejeta besedila na ta dan, P6_TA(2005)0407 .
2 Texts Adopted of that date, P6_TA(2005)0407 .
Hiter razvoj biotehnologije in biomedicine ne sme ogrožati zaščite temeljnih pravic.
Rapid developments in biotechnology and biomedicine must not be allowed to compromise the protection of fundamental rights.
Te pravice, od katerih je najpomembnejša pravica do človekove integritete, so določene v Oviedski konvenciji in v Listini o temeljnih človekovih pravicah.
These rights of which one of the most important one is the right to the integrity of the person are laid down in the Oviedo Convention as well as in the Charter of Fundamental Rights.
Te standarde je treba izpolnjevati zlasti pri zdravilih za napredno zdravljenje na podlagi tkiv in celic, ki predstavljajo zelo inovativna nova zdravila.
These standards should be met especially for tissue- and cell-based advanced therapy medicinal products as highly innovative new products.
V zvezi s tem so prostovoljno in neplačano darovanje ter neprofitno pridobivanje glavna načela, ki jih je v Skupnosti obvezno treba spoštovati.
In this context, voluntary and unpaid donation as well as procurement on a non-profit basis are the key principles that should be imperatively respected in the Community.
(7b) Direktiva 2001/20/ES 1 prepoveduje preskuse z genskim zdravljenjem, ki bi povzročili spremembe genetske identitete v zarodni liniji preskušanca.
(7b) Directive 2001/20/EC 1 prohibits gene therapy trials that result in modifications to a subject's germ line genetic identity.
Direktiva 98/44/ES 2 določa, da je treba postopke za spreminjanje genetske identitete človeške zarodne linije obravnavati kot postopke, ki jih ni mogoče patentirati.
Directive 98/44/EC 2 provides that processes for modifying the human germ line genetic identity are to be regarded as unpatentable.
Za zagotavljanje zakonske skladnosti mora ta uredba prepovedati vsako izdajanje dovoljenj za izdelke, ki spreminjajo genetsko identiteto zarodne linije človeških bitij.
To ensure legal consistency, this Regulation should prohibit any authorisation of products that modify the germ line genetic identity of human beings.
Izredno se prepoved za izdajo dovoljenja ne nanaša na izdelke, ki so namenjeni zdravljenju raka spolnih žlez.
By way of exception, the prohibition of authorisation should not apply to products intended to treat cancers of the gonads.
1 Direktiva 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi (UL L 121, 1.5.2001, str.
1 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p.
2 Direktiva 98/44/ES Evropskega parlamenta in Sveta z dne 6. julija 1998 o pravnem varstvu biotehnoloških izumov (UL L 213, 30.7.1998, str.
2 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p.
Vseeno pa bi morala biti izdelkom za zdravljenje raka spolnih žlez omogočena pridobitev evropskega dovoljenja za promet.
Nevertheless, products for the treatment of cancer of the gonades should be permitted to have European marketing authorisation.
(7c) Ta uredba mora prepovedati vsako izdajanje dovoljenj za izdelke, izdelane na podlagi človeško-živalskih hibridov ali hibridnih bitij, oziroma izdelke, ki vsebujejo tkiva ali celice, ki izvirajo ali so izdelani na njihovi podlagi.
(7c) This Regulation should prohibit any authorisation of products derived from human-animal hybrids or chimeras or containing tissues or cells originating or derived therefrom.
Spoštovati je treba telesno in duševno celovitost osebe ter človekovo dostojanstvo, kot je poudarjeno v členih 1 in 3 Listine Unije o temeljnih pravicah.
The physical and mental integrity of the person and human dignity must be respected, as underlined in Articles 1 and 3 of the Charter of fundamental rights of the European Union.
Ustvarjanje človeško-živalskih hibridov ali hibridnih bitij ogroža pravico do osebne celovitosti in krši človekovo dostojanstvo.
The creation of human-animal hybrids or chimeras is a threat to the right to integrity of a person and a violation of human dignity.
Zato se v skladu s to uredbo ne bi smelo izdati dovoljenja za izdelke, ki vsebujejo ali izhajajo iz človeško-živalskih hibridov ali hibridnih bitij.
Therefore, no authorisation for products containing or originating from human-animal hybrids or chimeras should be granted under this Regulation.
Vseeno pa se ne bi smelo izključiti ksenotransplantacije za terapevtske namene, če ne posega v zarodno linijo.
However, the Xenotransplantation for therapeutic purposes should not be excluded, as far as it does not interfere with the germ line.
Zato je primerno znotraj Agencije ustanoviti Odbor za napredno zdravljenje, ki mora biti 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.
Zaradi zelo posebnih in edinstvenih značilnosti zdravil za napredno zdravljenje je novi Odbor za napredno zdravljenje ustanovljen v okviru EMEA, 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.
(9a) Odbor za napredno zdravljenje mora Odboru za zdravila za humano uporabo svetovati o tem, ali se zdravilo šteje za zdravilo za napredno zdravljenje.
(9a) The Committee for Advanced Therapies should provide advice to the Committee for Medicinal Products for Human Use on whether a product falls within the definition of an advanced therapy medicinal product.
Zaradi natančnosti je treba uporabiti tehnični izraz.
For the sake of being more precise it is necessary to apply the technical term.
Ta uvodna izjava se črta zaradi uvedbe nove uvodne izjave 7a ter novih členov 3a in 28a.
This recital shall be deleted as a consequence to the introduction of a new recital 7(a) and new Articles 3(a) and 28(a).