natgillin/translations-raw huggingface dataset:
Za zagotovitev zakonske skladnosti mora ta uredba prepovedati vsako pridobivanje dovoljenja zdravil, ki spreminjajo človeški genom v zarodni liniji.
To ensure legal coherence, this Regulation should prohibit any authorisation of products that modify the germ line genetic identity of human beings.
Kot pojasnjujeta člena 1 in 13 Oviedske konvencije, je s spremembo dedovanja genoma ogroženo človekovo dostojanstvo.
As Articles 1 and 13 of the Oviedo Convention make it clear, human dignity is compromised when the inheritance of genetic identity is altered.
Zdravila, ki niso niti predmet kliničnih raziskav v skladu z Direktivo 2001/20/ES niti jih ni mogoče zakonito patentirati v skladu z Direktivo 98/44/ES, se v skladu s to uredbo ne smejo dovoliti.
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.
(7c) Ta uredba mora prepovedati vsako pridobivanje dovoljenja zdravil, izdelanih na podlagi človeško-živalskih hibridov ali hibridnih bitij ali ki vsebujejo tkiva ali celice, ki izhajajo iz ali so izdelana na podlagi človeško-živalskih hibridov ali hibridnih bitij.
(7c) This Regulation should prohibit any authorisation of products derived from human-animal hybrids or chimeras or containing tissues or cells originating or derived from human-animal hybrids or chimeras.
Ta določba ne sme izključevati presaditve somatskih živalskih celic ali tkiv na telo človeka za terapevtske namene, če ne posega v zarodno linijo.
This provision should not exclude 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 fizično in mentalno integriteto ter človekovo dostojanstvo, kot je poudarjeno v členih 1 in 3 Listine Evropske 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 človekove integritete 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 sme odobriti dovoljenje za zdravila, ki vsebujejo človeško-živalske hibride ali hibridna bitja ali izhajajo iz njih.
Therefore, no authorisation for products containing or originating from human-animal hybrids or chimeras should be granted under this regulation.
Vseeno se ne sme 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, 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 .
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 znotraj Agencije.
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 se 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 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.
Razen tega se je treba z Odborom za napredno zdravljenje posvetovati za vrednotenje katerih koli drugih zdravil v okviru njegovih pristojnosti.
Furthermore, the committee should be consulted for the evaluation of other products under its competence.
(9a) Odbor za napredno zdravljenje mora svetovati Odboru za zdravila za humano uporabo o tem, ali zdravilo spada v opredelitev zdravila 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.
Odbor za napredno zdravljenje mora zaradi posebnega strokovnega znanja o zdravilih za napredno zdravljenje pomagati CHMP pri nalogi razvrščanja, ali zdravila spadajo med zdravila za napredno zdravljenje ali ne.
Due to its 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.
Ta uvodna izjava se lahko črta zaradi uvedbe nove uvodne izjave 7a ter novih členov 3a in 28a.
This recital can be deleted as a consequence to the introduction of a new recital 7a and new articles 3a and 28a.
(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 , ter prilagojena, kjer je to primerno, da upošteva posebne lastnosti zdravil za napredno zdravljenje, zlasti izdelkov tkivnega inženirstva.
(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 , adapted where appropriate to take account of specific characteristics of advanced therapy medicinal products, especially tissue engineered products .
Poleg tega je treba pripraviti posebne smernice za zdravila za napredno zdravljenje, da se ustrezno odrazi posebna narava njihovega proizvodnega procesa.
Furthermore, guidelines specific to advanced therapy medicinal products should be drawn up, so as properly to reflect the particular nature of their manufacturing process.
V povezavi z zdravili za napredno zdravljenje mogoče niso povsem ustrezna obstoječa načela dobre proizvodnje, ki jih določa direktiva 2003/94/ES.
The existing Good Manufacturing principles established by Directive 2003/94/EC may not be fully appropriate as regards to advanced therapy products.
Primerna bi bila nova direktiva o načelih dobre proizvodnje, ki bi se posebej osredotočala na zdravila za napredno zdravljenje, in ne le smernice glede obstoječih načel dobre proizvodnje.
A new GMP Directive, especially focusing on Advanced Therapy products, would be appropriate, not just guidance on existing GMP.
(25) Treba je predpisati določbe za poročanje o izvajanju te uredbe po pridobitvi izkušenj in pri tem posebno pozornost posvetiti različnim oblikam odobrenih zdravil za napredno zdravljenje.
(25) Provisions should be laid down to report on the implementation of this Regulation after experience has been gained, with a particular attention to the different types of advanced therapy medicinal products authorised.
(25) Treba je predpisati določbe za poročanje o izvajanju te uredbe po pridobitvi izkušenj in pri tem posebno pozornost posvetiti različnim oblikam odobrenih zdravil za napredno zdravljenje in ukrepom iz poglavja 6 ter členov 9, 14(9) in 70(2) Uredbe (ES) št. 726/2004 .
(25) Provisions should be laid down to report on the implementation of this Regulation after experience has been gained, with a particular attention to the different types of advanced therapy medicinal products authorised and the measures provided for in Chapter 6 and in Articles 9, 14(9) and 70(2) of Regulation (EC) No 726/2004 .
Poročilo o izvajanju te uredbe mora zajeti celoten obseg sedanje uredbe, skupaj s spodbujevalnimi ukrepi za mala in srednja podjetja, "hitrimi" odobritvami in pritožbenim postopkom.
The report on the implementation of this Regulation should cover the whole scope of the present regulation, including the incentive measures for SMEs, the 'fast-track' approvals and the appeal procedure.
Izključitev s področja uporabe
Exclusion from the scope
Ta uredba ne velja za zdravila za napredno zdravljenje, ki so v isti bolnišnici v celoti in enkratno pripravljena v skladu s posebnim, nestandardiziranim in nepatentiranim postopkom ter uporabljena za posameznega bolnika, zato da so skladna s posameznim receptom.
This Regulation shall not apply to any advanced therapy medicinal product which is 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 .
Če bolnišnice ali druge institucije pripravijo izdelke z uporabo uveljavljenih postopkov za zaporedno in rutinsko zdravljenje bolnikov, morajo ravnati v skladu z določbami te uredbe, ob zagotavljanju kakovosti, varnosti in učinkovitosti proizvodov.
Where hospitals or other institutions prepare products by 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, ensuring quality, safety and efficacy of products.
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 ATPs for research purposes or on an exceptional, one-off basis, they should not have to comply with the centralised authorisation process.
Za zagotovitev skladnosti s členom 28(1) uvajamo izključitev s področja uporabe te uredbe.
To ensure the coherence with the Article 28, paragraph 1 we introduce the exclusion from the scope in the present Regulation.
Za namene uredbe mora biti najpomembnejše merilo pri opredeljevanju kombiniranega zdravila za napredno zdravljenje sposobnost preživetja njegovega celičnega oziroma tkivnega dela.
For the purposes of this Regulation, the most important criterion when defining a combined advanced therapy medicinal product should be the viability of its cellular or tissue part.
– njegov celični ali tkivni del , ki vsebuje celice ali tkiva, ki niso sposobna živeti, mora imeti na človeško telo učinek, ki se lahko šteje za primaren glede na učinek omenjenih pripomočkov.
- its cellular or tissue part containing non-viable cells or tissues must be liable to act upon the human body with action that can be considered as primary to that of the devices referred to.
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 tistega 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.
Prepoved trženja človeškega telesa
Ban on commercialisation of the human body
Če zdravilo za napredno zdravljenje vsebuje človeška tkiva ali celice, se vsaka faza postopka za pridobitev dovoljenja izvede v skladu z načelom netrženja človeškega telesa in njegovih delov.
Where an advanced therapy medicinal product contains human tissues or cells, every stage of the authorisation procedure shall be carried out in accordance with the principle of non-commercialisation of the human body or its parts as such.
Zato in za namene te uredbe države članice zagotovijo, da je:
To this end, and for the purposes of this Regulation, Member States shall ensure that:
– darovanje človeških celic in tkiv prostovoljno in brezplačno ter se izvaja s svobodno voljo 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
– pridobivanje tkiv in celic neprofitno.
- the procurement of tissues and cells is carried out on a non-profit basis.
Hiter razvoj biotehnologije in biomedicine ne bi smel ogrožati zaščite temeljnih pravic.
Rapid developments in biotechnology and biomedicine shouldn't compromise the protection of fundamental rights.
Te pravice, vključno s pravico do osebne integritete, so določene v Oviedski konvenciji in v Listini o temeljnih človekovih pravicah.
These rights, including the right to the integrity of the person, are laid down in the Oviedo Convention as well as in the Charter of Fundamental Rights.
Ti standardi se lahko potrdijo, če se pozorno spremljajo v vseh fazah postopka za pridobitev dovoljenja.
These standards can only be upheld if they are carefully observed at every stage of the authorisation process.
Zato mora EMEA izpolnjevati to posebno obveznost.
Therefore, EMEA should be subject to this specific obligation.
Države članice bi morale biti obvezane zagotavljati prostovoljno in neplačano darovanje ter zajamčiti neprofitno pridobivanje tkiv in celic.
Member States should have an obligation to ensure voluntary and unpaid donation and to guarantee the procurement of tissues or cells on a non-profit basis.
ČLEN 3 B (novo)
ARTICLE 3 B (new)
Prepoved izdelkov, ki spreminjajo človeško zarodno linijo
Ban on products modifying the human germ line
Za zdravila, ki spreminjajo človeški genom v zarodni liniji, se dovoljenje ne odobri.
No authorisation shall be granted to products modifying the germ line genetic identity of human beings.
Zdravila, ki niso niti predmet kliničnih raziskav v skladu z Direktivo 2001/20/ES niti jih ni mogoče zakonito patentirati v skladu z Direktivo 98/44/ES, se v skladu s to uredbo ne smejo dovoliti.
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.
ČLEN 4, ODSTAVEK 3
ARTICLE 4, PARAGRAPH 3
Komisija pripravi podrobne smernice o postopkih pridobivanja dovoljenj za klinično preskušanje in dobri klinični praksi, značilni za zdravila za napredno zdravljenje in zlasti za izdelke tkivnega inženirstva .
The Commission shall draw up detailed guidelines on clinical trial authorization procedures and good clinical practice specific to advanced therapy medicinal and in particular tissue engineered products.
Ta predlog spremembe priznava, da je treba razviti zakonodajo in smernice, ki danes še ne obstajajo, zlasti za izdelke tkivnega inženirstva, in to ne le ob upoštevanju dobre klinične prakse, temveč tudi glede dovoljenj za klinična preskušanja.
This amendment recognizes that in particular for tissue engineered products for which no legislation and hence no guidelines exist today, these need to be developed, not only with regard to Good Clinical Practice but also related to Clinical trial authorizations.
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 se 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.
Kadar znanstveno mnenje o zdravilu za napredno zdravljenje, ki ga pripravi Odbor za zdravila za uporabo v humani medicini na podlagi člena 5(2) in(3) Uredbe (ES) 726/2004, ni v skladu z osnutkom mnenja Odbora za napredno zdravljenje, Odbor za zdravila za humano uporabo priloži svojemu mnenju podrobno razlago znanstvenih razlogov za razhajanja.
Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5(2) and (3) of Regulation (EC) No 726/2004 is not in accordance with the draft opinion of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences.
Glej obrazložitev predloga spremembe k členu 9(3).
See the justification for the amendment of the Article 9, paragraph 3.
Za kombinirano zdravilo za napredno zdravljenje velja, da celoten izdelek, vključno s kakršnim koli vključenim medicinskim pripomočkom ali aktivnim medicinskim pripomočkom za vsaditev, dokončno ovrednoti Agencija.
Where a combined advanced therapy medicinal product is concerned, the whole product, including any medical device or any active implantable medical device incorporated in the medicinal product, shall be subject to final evaluation by the Agency.
V skladu z odstavkom 2 mora medicinski pripomoček ali aktivni medicinski pripomoček za vsaditev, ki je del kombiniranega zdravila za napredno zdravljenje, oceniti priglašeni organ, da bi imeli koristi od njegovih bogatih posebnih izkušenj.
According to paragraph 2, a medical device or the active implantable medical device part of a combined advanced therapy medicinal product have to be assessed by a notified body in order to benefit from its extensive specific experience.
Kadar je medicinski pripomoček ali aktivni medicinski pripomoček za vsaditev, ki je del kombiniranega zdravila za napredno zdravljenje, že ocenil priglašeni organ v skladu z Direktivo 93/42/EGS ali Direktivo 90/385/EGS, Agencija upošteva rezultate navedene ocene pri vrednotenju zadevnega zdravila.
Where the medical device or active implantable medical device which is part of a combined advanced therapy medicinal product has already been assessed by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC , the Agency shall take account of the results of that assessment in its evaluation of the medicinal product concerned.
Vloga za pridobitev dovoljenja za promet kombiniranega zdravila za napredno zdravljenje vključuje oceno medicinskega pripomočka ali aktivnega medicinskega pripomočka za vsaditev, ki je del kombiniranega zdravila za napredno zdravljenje, ki jo pripravi priglašeni organ , določen v soglasju s predlagateljem, v skladu z Direktivo 93/42/EGS ali Direktivo 90/385/EGS .
The application for a marketing authorisation for a combined advanced therapy medicinal product shall include an assessment by a notified body identified in conjunction with the applicant in accordance with Directive 93/42/EEC or Directive 90/385/EEC of the medical device or active implantable medical device which forms part of the combined advanced therapy medicinal product.
Agencija vključi rezultate navedene ocene pri vrednotenju zadevnega zdravila.
The Agency shall incorporate the results of that assessment in its evaluation of the medicinal product concerned.
Da bi zagotovili stalno uporabo obsežnih izkušenj in strokovnega znanja priglašenega organa v zvezi z vrednotenjem medicinskih pripomočkov ali aktivnih medicinskih pripomočkov za vsaditev, priglašeni organi ocenijo medicinski pripomoček ali aktivni medicinski pripomoček, ki je del kombiniranega zdravila za napredno zdravljenje.
In order to ensure the continuous utilisation of the vast experience and expert knowledge of the notified bodies concerning the evaluation of medical devices or active implantable medical devices, the notified bodies should assess the medical device or the active implantable medical device part of the combined advanced therapy medicinal product.
Agencija v skladu z odstavkom 1 te ocene vključi v zadnje vrednotenje kombiniranega zdravila.
The Agency should incorporate these assessments in its final evaluation of the combined product in accordance with paragraph 1.
Navodilo za uporabo odraža rezultate posvetovanj s ciljnimi skupinami bolnikov, da se zagotovi berljivost, jasnost in enostavna uporaba navodil .
The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use .
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 can be used as package leaflet .
Kadar obstaja poseben razlog za skrb, lahko Komisija po nasvetu 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 po nasvetu 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.
ČLEN 15, ODSTAVEK 4
ARTICLE 15, PARAGRAPH 4
Agencija pripravi podrobne smernice za uporabo odstavkov 1, 2 in 3.
The Agency shall draw up detailed guidelines relating to the application of paragraphs 1, 2 and 3.