natgillin/translations-raw huggingface dataset:
2.2. kakovostna in količinska sestava zdravilnih učinkovin in drugih pomožnih snovi izdelka, kar je bistvenega pomena za ustrezno uporabo, dajanje ali implantacijo izdelka.
2.2. qualitative and quantitative composition in terms of the active substances and other constituents of the product, knowledge of which is essential for proper use, administration or implantation of the product.
Kadar izdelek vsebuje celice ali tkiva, se zagotovi podroben opis teh celic ali tkiv in njihovega posebnega izvora.
Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin shall be provided.
Kadar izdelek vsebuje celice ali tkiva, se zagotovi podroben opis teh celic ali tkiv in njihovega posebnega izvora , vključno z vrsto živali v primerih nečloveškega izvora .
Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin , including the species of animal in cases of non-human origin, shall be provided.
Cilj tega predloga spremembe je zagotoviti, da bodo potencialni prejemniki z različnimi kulturno pogojenimi pomisleki pred svojo odločitvijo ustrezno obveščeni.
This amendment aims at ensuring that potential recipients having various cultural considerations are duly informed before taking their decision.
PRILOGA III, TOČKA (B)
ANNEX III, POINT (B)
(b) kakovostni in količinski opis zdravilne(-ih) učinkovine(-e) ter kadar izdelek vsebuje celice ali tkiva, še izjava: „Ta izdelek vsebuje celice človeškega/živalskega [kot je ustrezno] izvora“, skupaj s kratkim opisom teh celic ali tkiv in njihovega posebnega izvora;
(b) A description of the active substance(s) expressed qualitatively and quantitatively, including, where the product contains cells or tissues, the statement “This product contains cells of human/animal [as appropriate] origin” together with a short description of these cells or tissues and of their specific origin;
(b) kakovostni in količinski opis zdravilne(-ih) učinkovine(-e) ter kadar izdelek vsebuje celice ali tkiva, še izjava: „Ta izdelek vsebuje celice človeškega/živalskega [kot je ustrezno] izvora“, skupaj s kratkim opisom teh celic ali tkiv in njihovega posebnega izvora , vključno z vrsto živali v primerih nečloveškega izvora ;
(b) A description of the active substance(s) expressed qualitatively and quantitatively, including, where the product contains cells or tissues, the statement “This product contains cells of human/animal [as appropriate] origin” together with a short description of these cells or tissues and of their specific origin , including the species of animal in cases of non-human origin ;
PRILOGA IV, TOČKA (A) (III)
ANNEX IV, POINT (A) (III)
(iii) Kadar izdelek vsebuje celice ali tkiva, se zagotovi podroben opis teh celic ali tkiva in njihovega posebnega izvora;
(iii) where the product contains cells or tissues, a description of those cells or tissues and of their specific origin;
(iii) Kadar izdelek vsebuje celice ali tkiva, se zagotovi podroben opis teh celic ali tkiva in njihovega posebnega izvora , vključno z vrsto živali v primerih nečloveškega izvora ;
(iii) where the product contains cells or tissues, a description of those cells or tissues and of their specific origin , including the species of animal in cases of non-human origin ;
Hiter razvoj na področju biologije, biotehnologije in medicine ter poskusi za neprestano izboljševanje varovanja zdravja v Evropski uniji vodijo do razvoja novih načinov zdravljenja in visoko inovativnih zdravil.
Rapid development in the fields of biology, biotechnology and medicine and attempts to achieve sustainable growth of health protection within the European Union lead to the development of new treatments and highly innovative medicinal products.
Pri tem so zelo pomembna zdravila, ki segajo na področja genskega zdravljenja, celičnega zdravljenja in tkivnega inženirstva ter imajo visok potencial za zdravljenje bolezni, kot je rak, bolezni ali poškodbe hrustanca ali kosti, odpravo genskih motenj, okrevanje po srčnem napadu in presaditev kože pri opeklinah.
In this context, products which involve intervention in gene therapy, cell therapy and tissue engineering are of great importance, having a high potential in the treatment of diseases such as cancer, cartilage or bone diseases or injuries, repair of genetic disorders, repair of post heart attack damage as well as skin replacement in burn victims.
Pravni okvir glede teh naprednih oblik zdravljenja na ravni Skupnosti je sedaj razdrobljen, saj so pravno opredeljena le zdravila za gensko zdravljenje in zdravila za somatsko celično zdravljenje.
Nowadays, the legal framework at the Community level related to these advanced therapies remains fragmented, as only gene therapy and somatic cell therapy medicinal products benefit from a legal definition.
Za izdelke tkivnega inženirstva zaenkrat še ne veljajo nobeni predpisi, kar povzroča drobljenje trga, bolnikom pa ne omogoča lažjega dostopa do potrebnega zdravljenja.
Tissue engineered products remain unregulated, which leads to the fragmentation of the market and which does not allow patients to have easy access to the necessary treatments.
Zdajšnji predlog uvaja enoten usklajevalni ureditveni okvir za vrednotenje, pridobivanje dovoljenja in nadzor nad zdravili za napredno zdravljenje: zahteve in postopek za dovoljenje za promet, nadzor po pridobitvi dovoljenja in sledljivost.
The current proposal introduces a single harmonising regulatory framework for the evaluation, authorisation and supervision of advanced therapy medicinal products: marketing authorisation requirements and procedure, post-authorisation vigilance and traceability.
Na predlagano uredbo je treba gledati z vidika obstoječe zakonodaje na tem področju, kot je Direktiva 2001/83/ES o zdravilih, Uredba (ES) št. 726/2004 o Evropski agenciji za zdravila (EMEA) ali Direktiva 2004/23/ES, ki določa kakovostne in varstvene standarde za človeška tkiva in celice.
The proposed Regulation should be seen within the wider perspective of the existing legislation in this field, such as Directive 2001/83/EC on medicinal products, Regulation (EC) No 726/2004 on the European Medicines Agency (EMEA) or Directive 2004/23/EC laying down quality and safety standards of human tissues and cells.
Predlog uvaja centraliziran evropski postopek za pridobitev dovoljenja za promet in v okviru EMEA ustanavlja nov odbor za napredno zdravljenje, sestavljen iz visoko usposobljenih in izkušenih strokovnjakov z vseh področij, ki so povezana s temi izdelki.
The proposal introduces a European centralised marketing authorisation procedure and creates a new Committee for Advanced Therapies within EMEA, composed of highly qualified and experienced experts in all fields related to these products.
Poleg tega so v predlagani uredbi predvidene okrepljena zahteva po sistemu nadzora po pridobitvi dovoljenja in sledljivosti bolnika ter posebne tehnične zahteve za izdelke tkivnega inženirstva.
In addition, the proposed Regulation sets up a strengthened requirement for the post-authorisation monitoring system and for traceability of the patient and foresees specific technical requirements for tissue engineered products.
Za spodbujanje konkurenčnosti v EU so uvedene tudi dodatne posebne spodbude za predlagatelje in zlasti za mala in srednje velika podjetja.
Moreover, additional specific incentives for the applicants and especially for SMEs are introduced, in order to promote competitiveness within the EU.
Poročevalec pozdravlja ta predlog uredbe in uvedbo novega usklajenega pravnega okvira za tovrstna inovativna, posebna in kompleksna zdravila.
The rapporteur welcomes this proposal for a Regulation and the introduction of a new coherent legal framework for these innovative, specific and complex medicinal products.
Strinja se, da je za olajšanje dostopa do trga in zagotovitev prostega pretoka zdravil za napredno zdravljenje v Skupnosti potreben centraliziran postopek za pridobitev dovoljenja.
He agrees on the necessity of a centralised authorisation procedure in order to facilitate the market access and to ensure the free movement of advanced therapy medicinal products within the Community.
Za zagotovitev visoke ravni varovanja zdravja v EU bi bilo treba dati prednost dokazovanju kakovosti, varnosti in učinkovitosti teh izdelkov.
Priority should be given to the demonstration of quality, safety and efficacy of these products in order to ensure a high level of health protection within the EU.
Poleg zadostne prožnosti na tehnični ravni bi bilo treba zagotoviti najvišjo možno raven pravne varnosti.
The highest possible level of legal certainty should be guaranteed while allowing sufficient flexibility at the technical level.
Poročevalec bi vseeno želel poudariti pomen jasnih opredelitev, da se s tem prepreči pravna negotovost ali sive cone, zlasti glede opredelitve kombiniranih zdravil za napredno zdravljenje in njihovega vrednotenja.
Nevertheless, the rapporteur would like to underline the importance of clear definitions in order to avoid a legal uncertainty or grey zones, particularly as regards the definition of combined advanced therapy medicinal products and their evaluation.
Prav tako bi moralo biti kristalno jasno, da za izdelke, pripravljene v bolnišnici za posameznega bolnika, ne bi bilo treba upoštevati centraliziranega postopka za pridobitev dovoljenja.
It should also be made crystal clear that products prepared in a hospital, on a one-off basis for an individual patient, should not comply with the centralised authorisation procedure.
Poleg tega ne smemo pozabiti na izdelke, ki se uporabljajo v proizvodnji zdravil za napredno uporabo, namenjenih za klinične poskuse, in izdelke za klinične raziskave.
Moreover, products applied in the production of advance therapy medicinal products for clinical trials and products for clinical research should not be forgotten.
Poročevalec bi želel poudariti tudi pomembno vlogo Odbora za napredno zdravljenje v okviru EMEA.
In addition, the rapporteur would like to stress the important role of the Committee for Advanced Therapies within EMEA.
To visoko usposobljeno telo bi moralo igrati ključno vlogo v procesu znanstvenega vrednotenja zdravil za napredno zdravljenje, njegov notranji postopek sprejemanja odločitev pa bi bilo treba jasno opredeliti.
This highly qualified body should play a vital role in the process of scientific evaluation of advanced therapy medicinal products and its internal decision procedure should be clearly defined.
Zdravila za napredno zdravljenje bi lahko sprožila resne etične pomisleke, saj utegnejo vsebovati človeške celice ali tkiva.
Moreover, advanced therapy medicinal products could raise serious ethical concerns, as they are likely to contain human cells or tissues.
Predlog Komisije ne bi smel vplivati na nacionalno zakonodajo, ki prepoveduje ali omejuje uporabo določenih vrst človeških ali živalskih celic (kot so embrionalne matične celice), ali prodajo, dobavo ali uporabo zdravil na podlagi takšnih celic.
The Commission's proposal should not have an impact on the national legislation prohibiting or restricting the use of certain type of human or animal cells (such as embryonic stem cells) or the sale, supply or use of medicinal products derived from these cells.
Po mnenju pravne službe Parlamenta prvotna ubeseditev te določbe sproža resne pomisleke v luči pravne podlage predloga.
According to Parliament's legal service, the original drafting of this provision raises serious concerns in the light of the legal basis of the proposal.
Razvoj na področju biotehnologije in biomedicine bi moral potekati ob polnem spoštovanju temeljnih pravic.
The development in biotechnology and biomedicine should be carried out while fully respecting fundamental rights.
V celoti je treba spoštovati pravice, kot sta pravica do človeškega dostojanstva ali pravica do osebne celovitosti, ki sta zapisani v Oviedski konvenciji in listini o temeljnih pravicah.
Rights such as the right to human dignity or to the integrity of the person laid down in the Oviedo Convention as well as in the Charter of fundamental rights should be entirely respected.
Poročevalec zato v svojem prvem osnutku poročila poudarja, da bi moral postopek pridobitve dovoljenja potekati v skladu z načelom nekomercializacije človeškega telesa ali njegovih delov kot takšnih.
Therefore, in his first draft report the rapporteur underlined that authorisation procedure should be carried out in accordance with the principle of non commercialisation of the human body or its parts as such.
Poleg tega je poročevalec predlagal spremembe, da uredba ne bi zajemala evropskega dovoljenja za promet z izdelki, ki spreminjajo genetsko identiteto zarodne linije človeških bitij, in izdelki, ki so izdelani na podlagi človeško–živalskih hibridov ali hibridnih bitij (vendar bi omogočala presaditve somatskih živalskih celic ali tkiv na človeško telo v terapevtske namene, npr. ksenotransplantacijo).
Moreover, the rapporteur proposed amendments in order to exclude the European marketing authorization under this regulation for products modifying the germ line genetic identity of human beings and for products derived from human-animal hybrids or chimeras (but allowing the transplantation of somatic animal cells or tissues to the human body for therapeutic purposes, i.e. Xenotransplantation).
Predloge sprememb je sprejel Odbor za pravna vprašanja.
These amendments were adopted by the Committee on Legal Affairs.
Čeprav je večina članov Odbora za okolje, javno zdravje in varnost hrane (ENVI) sprejela predloge sprememb, je bil v končnem glasovanju spremenjen osnutek poročila zavrnjen.
Even though these amendments were adopted by the majority in ENVI committee, the first draft report as amended was rejected in the final vote.
V poročilo sta bila v skladu z okrepljenim sodelovanjem (člen 47) z Odborom za pravna vprašanja vključena dva predloga sprememb, in sicer 3 in 17, o katerih Odbor za okolje ni glasoval.
Two amendments, 3 and 17, were incorporated in the report without vote in the Environment Committee, following enhanced cooperation (Rule 47) with the Legal Affairs Committee.
Napredno zdravljenje uporablja inovativna zdravila na podlagi genov (gensko zdravljenje), celic (celično zdravljenje) ali tkiv (tkivno inženirstvo).
Advanced therapies are highly innovative medical products based on genes (gene therapy), cells (cell therapy) or tissues (tissue engineering).
Z naprednimi oblikami zdravljenja bo mogoče revolucionarno zdraviti bolezni in poškodbe, npr. raka, Parkinsonovo bolezen, opekline ali resne poškodbe hrustanca, po napovedih pa se bo z njimi bistveno spremenila medicinska praksa.
These advanced therapies enable revolutionary treatment of diseases and injuries, such as cancer, Parkinson's disease, skin in burn victims or serious cartilage damage, and are expected to change medical practice significantly.
Razvoj na področju naprednega zdravljenja dandanes ovira neusklajena zakonodaja EU.
Currently, the development of the field of advanced therapies is hampered by the lack of harmonised EU legislation.
Na ravni Skupnosti je zlasti neurejeno področje izdelkov tkivnega inženirstva, kar vodi do različne nacionalne zakonodaje in odobritev.
Especially tissue-engineered products are at the moment not regulated on Community level, which leads to divergent national legislation and authorisation.
To ovira delovanje notranjega trga in negativno vpliva na inovativno sposobnost in konkurenčnost EU.
This hampers the internal market and negatively affects EU's innovative capacity and competitiveness.
Namen predlagane uredbe je zapolniti sedanjo ureditveno vrzel z obravnavanjem vseh izdelkov za napredno zdravljenje v enotnem, združenem pravnem okviru.
This proposed Regulation intends to bridge the existing regulatory gap by addressing all advanced therapy products within a single, integrated legal framework.
Uredba gradi na že obstoječi zakonodaji (zlasti na Direktivi 2001/83/ES o zdravilih in Uredbi (ES) št. 726/2004 o Evropski agenciji za zdravila) in jo je zato treba obravnavati kot celoto.
The Regulation builds on already-existing legislation (in particular Directive 2001/83/EC on medical products and Regulation (EC) No 726/2004 on the European Medicines Agency), and should therefore be seen in their totality.
Glavne značilnosti predloga Komisije so:
The main elements of the Commission's proposal are:
· centraliziran postopek za dovoljenja za promet, da bi izkoristili združevanje strokovnega znanja na evropski ravni in neposredni dostop do trga EU;
· A centralised marketing authorisation procedure, to benefit from the pooling of expertise at European level and direct access to the EU market;
· nov in večdisciplinaren strokovni odbor (Odbor za napredno zdravljenje) v okviru Evropske agencije za zdravila (EMEA), ki naj bi ocenjeval izdelke za napredno zdravljenje in spremljal znanstveni razvoj na tem področju;
· A new and multidisciplinary expert Committee (Committee for Advanced Therapies), within the European Medicines Agency (EMEA), to assess advanced therapy products and follow scientific developments in the field;
· prilagojene tehnične zahteve, ki ustrezajo posebnim lastnostim teh izdelkov;
· Tailor-made technical requirements, which are adapted to the particular characteristics of these products;
· strožje zahteve za obvladovanje tveganj in sledljivost;
· Strengthened requirements for risk management and traceability;
· sistem nizkocenovnega vrhunskega znanstvenega svetovanja, ki ga zagotavlja EMEA;
· A system of low-cost, top-quality scientific advice provided by EMEA;
· posebne spodbude za mala in srednja podjetja.
· Special incentives for small and medium-sized enterprises (SMEs).
Pripravljavka mnenja pozdravlja predlog Komisije.
The draftswoman welcomes the Commission's proposal.
Tkivno inženirstvo je razvijajoče se področje biotehnologije, ki združuje medicino, celično in molekularno biologijo, znanost o snoveh in inženirstvo.
Tissue engineering is an emerging biotechnology sector at the interface between medicine, cellular and molecular biology, materials science and engineering.
Z razvojem izdelkov, s katerimi se nadomesti, obnovi ali regenerira človeško tkivo, morda ne bi bilo več pomanjkanja organov in vsako leto bi lahko rešili tisoče ljudi v Evropi.
By developing products designed to replace, repair or regenerate human tissues, it could mean the end of organ shortage, saving every year thousands of people in Europe.
Pripravljavka mnenja zato pozdravlja oblikovanje trdnega in celostnega ureditvenega okvira, ki bo sektorju omogočil usklajen dostop do trga, hkrati pa spodbudil konkurenčnost in zagotovil visoko raven varovanja zdravja.
The draftswoman therefore welcomes the creation of a robust and comprehensive regulatory framework, that will give the sector harmonised market access, while at the same time foster the competitiveness and guarantee a high level of health protection.
Pripravljavka mnenja bi rada posebej poudarila, da morajo biti opredelitve dovolj natančne, da zagotovijo potrebno pravno varnost, hkrati pa dovolj prožne, da je mogoče slediti razvoju znanosti in tehnologije.
The draftswoman would like to emphasise the fact that the definitions should be precise enough to provide the necessary legal certainty, but at the same time sufficient flexible in order to keep the pace with the evolution of science and technology.
Tako ravnovesje je treba doseči tudi pri postopku za pridobitev dovoljenja.
Such a balance should also be sought for the marketing authorisation procedure.
Pripravljavka mnenja podpira oblikovanje povsem centraliziranega postopka, da bi izkoristili združevanje strokovnega znanja, hkrati pa poudarja, da je treba zmanjšati ureditveno breme, ki ga lahko povzroči tak postopek, zlasti za mala in srednja podjetja.
The draftswoman supports the creation of a fully centralised authorisation procedure to benefit from the pooling of expertise, but at the same time stresses the need to alleviate the regulatory burden that such a procedure might entail, especially on SMEs.
Podlaga nekaterih izdelkov za napredno zdravljenje so lahko tudi človeške celice, kar lahko sproži pomembna etična vprašanja.
As certain advanced therapy products may be based on human cells, they can raise important ethical issues.
Danes so odločitve o odobritvi ali prepovedi uporabe kakršnih koli celic, skupaj z embrionalnimi matičnimi celicami, v nacionalni pristojnosti.
Currently, decisions on the use or prohibition of any type of cells, including embryonic stem cells, are a national responsibility.
(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.
Zdravila za napredno zdravljenje, ki so v isti bolnišnici v celoti pripravljena za posamezen primer v skladu s posebnim, nestandardiziranim in nepatentiranim postopkom , in uporabljena za posameznega bolnika , je treba zaradi upoštevanja posameznega recepta izključiti iz obsega te uredbe.
Advanced therapy medicinal products which are prepared in full in a hospital 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, should thus be excluded from the scope of this Regulation.
Če bolnišnice ali druge institucije pripravijo izdelke z uporabo uveljavljenih postopkov za večkratno in 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 serial and routine basis, they should have to comply with the provisions of this Regulation.
Vendar, če bolnišnice proizvajajo zdravila za napredno zdravljenje za raziskovalne namene ali le izjemno in enkratno, jim ni treba izpolnjevati centraliziranega postopka za pridobitev dovoljenja.
However, when hospitals produce advanced therapy products for research purposes or on an exceptional, one-off basis, they should not have to comply with the centralised authorisation procedure.
(7b) 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 prepoveduje preskušanje genskega zdravljenja, ki ima za posledico spremembe genetske identitete zarodne linije osebe.
(7b) 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 1 prohibits gene therapy trials that result in modifications to a subject's germ line genetic identity.
Direktiva 98/44/ES Evropskega parlamenta in Sveta z dne 6. julija 1998 o pravnem varstvu biotehnoloških izumov 2 obravnava postopke za spreminjanje genetske identitete človeške zarodne linije kot nekaj, česar ni mogoče patentirati.
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions 2 considers processes for modifying the human germ line genetic identity non-patentable.