natgillin/translations-raw huggingface dataset:
(16) Proizvodnja zdravil za napredno zdravljenje mora biti v skladu z načeli dobre proizvodne prakse, kot je določeno v Direktivi Komisije 2003/94/ES z dne 8. oktobra 2003 o določitvi načel in smernic dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini in zdravili za uporabo v humani medicini v preskušanju , in prilagojena, če je potrebno, da izraža posebne lastnosti zdravila .
(16) The manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use , and adapted, where necessary, to reflect the specific nature of the products .
To vodi k pomembnim razlikam pri proizvodnem procesu (npr. člen 11(4) Direktive o načelih dobre proizvodnje zahteva, da se vzorci serij končnih izdelkov hranijo eno leto po datumu poteka veljavnosti.
That leads to important differences in their manufacturing process (e.g. in Article 11.4. the GMP Directive requires that sample batches of finished products should be kept for 1 year after expiry date.
Vendar je za nekatere vrste zdravil za napredno zdravljenje težko upoštevati datume poteka veljavnosti).
It is, however, difficult to consider expiry dates for certain classes of ATMPs).
(28) Direktivo 2001/83/ES in Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila je zato treba ustrezno spremeniti
(28) Directive 2001/83/EC and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing European Medicines Agency should therefore be amended accordingly,
(28) Direktivo 2001/83/ES , Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila in Direktivo 2004/23/ES je zato treba ustrezno spremeniti
(28) Directive 2001/83/EC , Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing European Medicines Agency and Directive 2004/23/EC should therefore be amended accordingly,
Ta predlog spremembe je posledica uvedbe člena 28a (novo), ki spreminja Direktivo 2004/23/ES o tkivih in celicah.
This is a consequential amendment to the introduction of Article 28(a) (new) modifying Directive 2004/23/EC on tissues and cells.
Ta uredba se ne uporablja za nobena zdravila za napredno zdravljenje, ki vsebujejo ali so izdelane na podlagi celic človeškega zarodka in plodu, primarnih zarodnih celic in celic izdelanih na njihovi podlagi.
This Regulation shall not apply to any advanced therapy medicinal products that contain or are derived from human embryonic and foetal cells, primordial germ cells and cells derived from those cells.
Kombinirano zdravilo je treba vedno šteti kot zdravilo za napredno zdravljenje, če vsebuje celice ali tkiva, ki niso sposobna živeti in delujejo na človeško telo na način, ki je primaren za delovanje dela, ki je pripomoček za zadevno zdravilo.
A combined product should always be considered as advanced therapy medicinal product when it contains non-viable cells or tissues which act upon human body in a manner that is considered as primary to the action of the device part of the product concerned.
ČLEN 2, ODSTAVEK 1, TOČKA (D A) (novo)
ARTICLE 2, PARAGRAPH 1, POINT (D A) (new)
(da) hibridno bitje pomeni:
(da) chimera means:
– zarodek, v katerega je bila vsajena celica kakršne koli nečloveške oblike življenja; ali
- an embryo into which a cell of any non-human life form has been introduced; or
– zarodek kakršne koli nečloveške oblike življenja, v katerega je bila vsajena človeška celica; ali
- an embryo of any non-human life form into which a human cell has been introduced; or
– zarodek, ki je sestavljen iz celic več kot enega zarodka, ploda ali človeškega bitja;
- an embryo that consists of cells of more than one embryo, foetus or human being;
To opredelitev je uvedena za namen člena 3c (novo) te uredbe.
This definition is introduced for the purpose of Article 3(c)(new) of the present Regulation.
ČLEN 2, ODSTAVEK 1, TOČKA (D B) (novo)
ARTICLE 2, PARAGRAPH 1, POINT (D B) (new)
(db) hibrid pomeni:
(db) hybrid means:
– človeško jajčno celico, ki je bila oplojena s spermo nečloveške oblike življenja;
- a human ovum that has been fertilised by a sperm of a non-human life form;
– jajčno celico nečloveške oblike življenja, ki je bila oplojena s človeško spermo;
- an ovum of a non-human life form that has been fertilised by a human sperm;
– človeško jajčno celico, v katero je bilo vsajeno jedro celice nečloveške oblike življenja;
- a human ovum into which the nucleus of a cell of a non-human life form has been introduced;
– jajčno celico nečloveške oblike življenja, v katero je bilo vsajeno jedro človeške celice; ali
- an ovum of a non-human life form into which the nucleus of a human cell has been introduced; or
– človeško jajčno celico ali jajčno celico nečloveške oblike življenja, ki kako drugače vsebuje haploidne nize kromosomov človeka in nečloveške oblike življenja.
- a human ovum or an ovum of a non-human life form that otherwise contains haploid sets of chromosomes from both a human being and a non-human life form.
To opredelitev je uvedena za namen člena 3c te uredbe.
This definition is introduced for the purpose of Article 3(c) of the present Regulation.
Vir: Kanadski zakon o umetni oploditvi 2004.
Source: Canadian assisted human reproduction act 2004.
Kadar zdravilo za napredno zdravljenje vsebuje človeške celice ali tkiva, se darovanje, pridobivanje in testiranje teh celic ali tkiv izvede v skladu z določbami iz Direktive 2004/23/ES.
Where an advanced therapy medicinal product contains human cells or tissues, the donation, procurement and testing of those cells or tissues shall be made in accordance with the provisions laid down in Directive 2004/23/EC.
Odbor za zdravila za uporabo v humani medicini pri Evropski agenciji za zdravila, v nadaljevanju „Agencija“, preveri trditve (ali dokumentacijo) imetnika dovoljenja za promet v zvezi s prostovoljnim in neplačanim darovanjem tkiv in celic, kot je določeno v Direktivi 2004/23/ES.
The Committee for Medicinal Products for Human Use of the European Medicines Agency, hereinafter “the Agency”, shall verify the assurances (or the documentation) of the holder of the marketing authorisation with regard to the voluntary and unpaid donation of tissues and cells as laid down in Directive 2004/23/EC.
Prepoved komercializacije človeškega telesa in njegovih delov
Prohibition of commercialisation of the human body and its parts as such
V ta namen in za namene te uredbe države članice zagotovijo:
To that end, and for the purposes of this Regulation, Member States shall ensure that:
– da je darovanje človeških celic in tkiv prostovoljno in neplačano ter da se opravi na podlagi svobodne volje darovalca brez plačila, razen nadomestila; in
- the donation of human cells and tissues is voluntary and unpaid and is made of the donor's free will without payment except compensation; and
– da se pridobivanje tkiv in celic kot takih izvaja neprofitno.
- the procurement of tissues and cells as such is carried out on a non-profit basis.
Hiter razvoj biotehnologije in biomedicine ne sme ogrožati zaščite temeljnih pravic.
Rapid developments in biotechnology and biomedicine must not undermine the protection of fundamental rights.
Te pravice, od katerih je najpomembnejša pravica do osebne celovitosti, so določene v patentni direktivi, Oviedski konvenciji in v Listini o temeljnih pravicah.
These rights, of which a very important one is the person's integrity, are laid down in the the patenting directive, the Oviedo Convention and the Charter of Fundamental Rights.
Prepoved izdelkov, ki spreminjajo človeško zarodno linijo.
Prohibition of products modifying the human germ line.
Za izdelke, ki spreminjajo genetsko identiteto zarodne linije človeških bitij, razen tistih, ki so namenjeni zdravljenju raka spolnih žlez, se ne izda dovoljenje.
No authorisation shall be granted for products which modify the germ line genetic identity of human beings, except for those intended to treat cancers of the gonads.
Izdelki, ki niso niti predmet kliničnega preskušanja v skladu z Direktivo 2001/20/ES, niti jih ni mogoče zakonito patentirati v skladu z Direktivo 98/44/ES, v skladu s to uredbo ne bi smeli biti upravičeni do pridobitve dovoljenja, razen v primeru zdravljenja raka.
Products which are neither properly subject to clinical trials under Directive 2001/20/EC nor legally patentable under Directive 98/44/EC should not be eligible for authorisation under this Regulation, with the exclusion of cancer treatment.
ČLEN 3 C (novo)
ARTICLE 3 C (new)
Prepoved izdelkov, izdelanih na podlagi človeško-živalskih hibridov ali hibridnih bitij
Prohibition of products derived from human-animal hybrids or chimeras
Za izdelke, ki so izdelani na podlagi človeško–živalskih hibridov ali hibridnih bitij, oziroma vsebujejo tkiva ali celice, ki izvirajo ali so izdelani na njihovi podlagi, se ne izda dovoljenje.
No authorisation shall be granted for products derived from human-animal hybrids or chimeras or containing tissues or cells originating or derived therefrom.
Ta določba ne prepoveduje presaditve somatskih živalskih celic ali tkiv na telo človeka za terapevtske namene, če ta ne posega v zarodno linijo.
This provision shall not preclude the transplantation of somatic animal cells or tissues to the human body for therapeutic purposes, in so far as it does not interfere with the germ line.
Spoštovati je treba človekovo telesno in duševno celovitost ter človekovo dostojanstvo, kot je poudarjeno v Listini Unije o temeljnih pravicah.
The physical and mental integrity of the person and human dignity must be respected, as underlined by the Charter of fundamental rights of the EU.
Ustvarjanje človeško-živalskih hibridov ali hibridnih bitij krši pravico do osebne celovitosti in človekovo dostojanstvo.
The creation of human-animal hybrids or chimeras is a breach of the right to integrity of a person and a violation of human dignity.
Poleg tega Direktiva 98/44/ES o pravnem varstvu biotehnoloških izumov poudarja, da ustvarjanja hibridnih bitij iz zarodnih celic ni mogoče patentirati.
In addition, the Directive 98/44/EC on the legal protection of biotechnological inventions stresses that the production of chimeras from germ cells is excluded from patentability.
Zato se v skladu s to uredbo ne smejo odobriti dovoljenja za zdravila, ki vsebujejo taka tkiva in celice, ali so izdelana na njihovi podlagi.
Therefore, no authorisation under this regulation should be granted to products containing or derived from such tissues and cells.
Komisija v skladu s postopkom iz člena 26(2) spremeni Direktivo 2003/94/ES, da se upoštevajo posebne značilnosti zdravil za napredno zdravljenje in zlasti izdelkov tkivnega inženirstva.
The Commission shall, in accordance with the procedure referred to in Article 26(2), amend Directive 2003/94/EC to take into account the specific characteristics of advanced therapy medicinal product and, especially, tissue engineered products.
To vodi k pomembnim razlikam pri proizvodnem procesu (npr. člen 11(4) Direktive o dobri proizvodni praksi zahteva, da se vzorci serij končnih izdelkov hranijo eno leto po datumu poteka veljavnosti.
That leads to important differences in their manufacturing process (e.g. Article 11.4. of the GMP Directive requires that sample batches of finished products should be kept for 1 year after the expiry date.
Specifične zahteve za izdelke, ki vsebujejo živalske celice
Specific requirements for products containing animal cells
Zato je treba iz področja uporabe te uredbe izključiti izdelke, ki uporabljajo etično 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 ethically controversial and for which differing Member States legislative provisions are intended to remain.
Poročevalec ali soporočevalec, ki ga imenuje Odbor za zdravila za uporabo v humani medicini v skladu s členom 62 Uredbe (ES) št. 726/2004, je član Odbora za napredno zdravljenje , ki ga le-ta predlaga, in ima posebno strokovno znanje o zadevnem izdelku.
The rapporteur or co-rapporteur appointed by the Committee for Medicinal Products for Human Use pursuant to Article 62 of Regulation (EC) No 726/2004 shall be a member of the Committee for Advanced Therapies , shall be proposed by the Committee for Advanced Therapies and shall possess specific expertise in relation to the product concerned .
Za zagotavljanje najvišje stopnje strokovnega znanja Odbor za napredno zdravljenje predlaga poročevalca in soporočevalca, ki ju imenuje CHMP in morata imeti posebno strokovno znanje o zadevnem zdravilu.
In order to ensure the highest level of expertise, the rapporteur and co-rapporteur appointed by the CHMP should be proposed by the Committee for Advanced Therapies and should have specific expertise for the relevant product.
Osnutek mnenja , ki ga Odbor za napredno zdravljenje da po odstavku 1, se pošlje predsedniku Odbora za zdravila za uporabo v humani medicini pravočasno, da se zagotovi upoštevanje rokov iz člena 6(3) ali člena 9(2) Uredbe (ES) št. 726/2004.
The draft opinion given by the Committee for Advanced Therapies under paragraph 1 shall be sent to the chairman of the Committee for Medicinal Products for Human Use in a timely manner so as to ensure that the deadlines laid down in Articles 6(3) or 9(2) of Regulation (EC) No 726/2004 can be met.
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 the highly specific and unique character of the advanced therapy medicinal products, a new Committee for Advanced Therapies is established within EMEA, composed of experts having specific qualifications or experience in this highly innovative and quickly developing field.
Osnutek mnenja je treba podati pravočasno, da se zagotovi upoštevanje roka iz člena 9(2) Uredbe (ES) št. 726/2004.
The draft opinion should be given in a timely manner so the deadline laid down in Article 9(2) of Regulation (EC) No 726/2004 can also be met.
Kjer izdelke na bolnikih uporabljajo izključno zdravniki, se lahko povzetek glavnih značilnosti zdravila v skladu s členom 11 Direktive 2001/83/ES uporabi kot navodilo za uporabo .
Where products are exclusively applied to patients by medical practitioners, the summary of product characteristics pursuant to Article 11 of Directive 2001/83/EC may be used as the package leaflet .
Kadar obstaja poseben razlog za skrb, lahko Komisija na nasvet Agencije zahteva, da se kot del dovoljenja za promet vzpostavi sistem za obvladovanje tveganj, ki naj opredeli, prepreči ali zmanjša na najmanjšo možno raven tveganja, povezana z zdravili za napredno zdravljenje, vključno z oceno učinkovitosti navedenega sistema, ali da imetnik dovoljenja za promet izvede posebne post-marketinške študije in jih predloži Agenciji v pregled.
Where there is particular cause for concern, the Commission may , on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the marketing authorisation and submitted for review to the Agency.
Kadar obstaja poseben razlog za skrb, Komisija na nasvet Agencije zahteva, da se kot del dovoljenja za promet vzpostavi sistem za obvladovanje tveganj, ki naj opredeli, prepreči ali zmanjša na najmanjšo možno raven tveganja, povezana z zdravili za napredno zdravljenje, vključno z oceno učinkovitosti navedenega sistema, ali da imetnik dovoljenja za promet izvede posebne študije po začetku trženja in jih predloži Agenciji v pregled.
Where there is particular cause for concern, the Commission shall , on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the marketing authorisation and submitted for review to the Agency.
Z odstopanjem od člena 8(1) Uredbe (ES) št. 297/95 se za vsak nasvet Agencije iz odstavka 1 in člena 57(1)(n) Uredbe (ES) št. 726/2004 v zvezi z zdravili za napredno zdravljenje, uporablja za MSP 95-odstotno , za druge predlagatelje pa 70-odstotno znižanje pristojbine, ki jo je treba plačati Agenciji.
By way of derogation from Article 8(1) of Regulation (EC) No 297/95, a 95% reduction for SMEs and 70% for other applicants shall apply to the fee payable to the Agency for any advice referred to in paragraph 1 and in Article 57(1)(n) of Regulation (EC) No 726/2004 in respect of advanced therapy medicinal products.
Zato je nujno uvesti posebne opustitve pristojbin, ki veljajo za MSP po znanstvenem nasvetu.
Therefore, it is necessary to introduce special fee-waivers applicable to SME's on scientific advice.
MSP krijejo 5 % osnovne pristojbine sami, kar je simbolična vsota, da bi preprečili vse zlorabe povsem brezplačnega sistema.
The 5% of the basic fee which the SME's should cover themselves is a symbolic amount, in order to prevent any abuse of the totally gratis system.
Razen tega je treba za podporo predlagateljem, za katere ne veljajo merila MSP, in za zagotovitev konkurenčnosti celotnega sektorja uveljaviti 70-odstotno znižanje za vsa podjetja ne glede na velikost.
Moreover, to support the applicants which do not fall under the SME criteria and to ensure the competitiveness of the whole sector, a reduction of 70% should be applied to all companies irrespective of their size.
Agencija to priporočilo predloži v 60 dneh od prejema zahteve, po posvetovanju z Odborom za napredno zdravljenje in s Komisijo.
The Agency shall deliver this recommendation, after consultation with the Committee for Advanced Therapies and the Commission , within 60 days after receipt of the request .
Proizvajalci zdravil za napredno zdravljenje, ki zaposlujejo do 500 ljudi in njihov promet ne presega 100 milijonov EUR ali njihova bilančna vsota ne presega 70 milijonov EUR, so upravičeni do vseh spodbud, ki se dodeljujejo malim in srednje velikim podjetjem v skladu s priporočilom Komisije 2003/361/ES 1 .
Manufacturers of advanced therapy medicinal products which employ not more than 500 persons and have a turnover not exceeding EUR 100 million, or a balance-sheet total not exceeding EUR 70 million, shall be eligible for all incentives which are granted to small and medium–sized enterprises as defined in Commission Recommendation 2003/361/EC 1 .
Enako velja za podjetja, v katerih imajo druga podjetja do 50-odstotni delež ter njihove naložbe v raziskovalne in razvojne dejavnosti presegajo 15 % njihovega letnega prometa.
The same shall apply to enterprises in which other enterprises have an interest up to 50%, if those enterprises invest more than 15% of their annual turnover in research and development activities.
Te težave so lahko zelo pomembne za biotehnološka podjetja.
These problems are likely to have the greatest relevance for biotech enterprises.
V primeru malih in srednje velikih podjetij ali podjetij, ki zaposlujejo do 500 ljudi in njihov promet ne presega 100 milijonov EUR ali njihova bilančna vsota ne presega 70 milijonov EUR, se odstavek 1 brez časovne omejitve uporablja tudi za pristojbine za dejavnosti agencije po pridobitvi dovoljenja za promet.
In the case of small and medium-sized enterprises or enterprises which employ not more than 500 persons and have a turnover not exceeding EUR 100 million, or a balance-sheet total not exceeding EUR 70 million, paragraph 1 shall also apply, without any time limit, to the fees charged by the Agency for post-authorisation activities.
V primeru podjetij, v katerih imajo druga podjetja do 50-odstotni delež ter njihove naložbe v raziskovalne in razvojne dejavnosti presegajo 15 % njihovega letnega prometa, se prvi odstavek brez časovne omejitve uporablja tudi za pristojbine za dejavnosti agencije po pridobitvi dovoljenja za promet.
In the case of an enterprise in which other enterprises have an interest up to 50% and which invests more than 15% of its annual turnover in research and development activities, paragraph 1 shall also apply, without any time limit, to the fees charged by the Agency for post-authorisation activities.
(c) štiri člane imenuje Komisija na podlagi javnega razpisa, dva izmed njih zastopata zdravnike , dva pa združenja bolnikov.
(c) four members appointed by the Commission, on the basis of a public call for expressions of interest, two of them to represent physicians and two of them to represent patients associations.
ČLEN 21, ODSTAVEK 1, TOČKA (C) IN TOČKA (C A) (novo)
ARTICLE 21, PARAGRAPH 1, POINT (C) AND POINT (C A) (new)
(c) dva člana in dva namestnika imenuje Komisija na podlagi javnega razpisa, po posvetovanju z Evropskim parlamentom, za zastopanje zdravnikov ;
(c) two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consultation of the European Parliament , to represent physicians ;
(a) oblikovanje osnutka mnenja o kakovosti, varnosti in učinkovitosti zdravila za napredno zdravljenje, da ga končno odobri Odbor za zdravila za uporabo v humani medicini , in svetovanje v zvezi z vsemi podatki, pridobljenimi med razvojem takšnega zdravila;
(a) to formulate a draft opinion on the quality, safety and efficacy of an advanced therapy medicinal product for final approval by the Committee for Medicinal Products for Human Use and to advise it on any data generated in the development of such a product;
(aa) v skladu s členom 18 svetuje Odboru za zdravila za humano uporabo o tem, ali se zdravilo šteje za zdravilo za napredno zdravljenje;
(aa) to provide advice, pursuant to Article 18, to the Committee for Medicinal Products for Human Use on whether a product falls within the definition of an advanced therapy medicinal product;
Odbor za napredno zdravljenje ima posebno strokovno znanje o zdravilih za napredno zdravljenje in pomaga CHMP pri nalogi razvrščanja, ali zdravila spadajo med zdravila za napredno zdravljenje ali ne.
Having specific expertise in advanced therapy medicinal products, the Committee for Advanced Therapies should assist the CHMP in its classification task of whether a product is or is not an advanced therapy medicinal product.
ČLEN 23, ODSTAVEK 1 A (novo)
ARTICLE 23, PARAGRAPH 1 A (new)
Odbor za napredno zdravljenje si pri pripravi osnutka mnenja, da ga končno odobri Odbor za zdravila za humano uporabo, prizadeva doseči znanstveno soglasje.
When preparing a draft opinion for final approval by the Committee for Medicinal Products for Human Use, the Committee for Advanced Therapies shall endeavour to reach a scientific consensus.
Osnutek mnenja omenja odstopajoča stališča in razloge, na katerih temeljijo.
The draft opinion shall mention the divergent positions and the grounds on which they are based.
Zato menimo, da se je ne sme spreminjati s komitologijo.
We therefore consider that it should not be subject to any changes through comitology.