natgillin/translations-raw huggingface dataset:
Države članice se poziva, naj z vsemi potrebnimi ukrepi spodbudijo javni in neprofitni sektor, da se intenzivno vključi v pridobivanje človeških celic ali tkiv, saj prostovoljno in brezplačno darovanje tkiv in celic lahko prispeva k visokim varnostnim standardom za tkiva in celice, s tem pa k varovanju zdravja ljudi.
Member States are urged to take all necessary steps to encourage a strong public and non-profit sector involvement in the procurement of human cells or tissues, as voluntary and unpaid tissue and cell donations may contribute to high safety standards for tissues and cells and therefore to the protection of human health.
(15) Klinično preskušanje zdravil za napredno zdravljenje je treba izvajati v skladu s prednostnimi načeli in etičnimi zahtevami iz Direktive 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.
(15) Clinical trials on advanced therapy medicinal products should be conducted in accordance with the overarching principles and the ethical requirements laid down in 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.
Vendar pa je treba določiti prirejena pravila za prilagoditev Direktivi 2005/28/ES z dne 8. aprila 2005 o načelih in podrobnih smernicah za dobro klinično prakso v zvezi z zdravili v preskušanju za humano uporabo ter o zahtevah za dovoljenje za proizvodnjo ali uvoz takšnih izdelkov, da se v celoti upoštevajo posebne tehnične značilnosti zdravil za napredno zdravljenje.
However, tailored rules should be laid down, adapting Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products, in order to fully take into account the specific technical characteristics of advanced therapy medicinal products.
Treba je določiti posebne proizvodne zahteve za zdravila v preskušanju, ki se morajo upoštevati pri proizvodnji zdravil za napredno uporabo, namenjenih kliničnemu preskušanju v bolnišnici, v kateri so bila izdelana.
Specific manufacturing requirements for investigational medicinal products to be applied to the production of advanced therapy medicinal products for clinical trials performed in the same hospital where the production took place should be laid down.
Ta pravila morajo zagotoviti ustrezen časovni presledek med posameznimi kliničnimi preskušanji (vključno s kliničnim preskušanjem v več centrih) in usklajen nadzor ter izmenjavo informacij.
Those rules should ensure an adequate time interval between single clinical trials (including multi-centre clinical trials) and a coordinated surveillance and information exchange.
V zvezi s proizvodnjo zdravil za napredno zdravljenje za uporabo v kliničnih preskušanjih v bolnišnici, v kateri so bila izdelana, uredba ne predvideva nobene posebne določbe.
No specific provision is foreseen in the regulation as far as the production of advanced therapy medicinal products to be used in clinical trials performed in the same hospital where the production took place is concerned.
Poleg tega je treba klinična preskušanja izvajati kar se da varno (ustrezen časovni presledek itd.).
Moreover, clinical trials should be conducted in the safest possible manner (adequate time interval, etc).
(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.
(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.
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 to properly reflect the particular nature of their manufacturing process.
(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 po potrebi prilagojena, 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.
Zdravila za napredno zdravljenje imajo posebne značilnosti, ki se zelo razlikujejo od običajnih zdravil.
Advanced Therapy medicinal products have specific characteristics that differ greatly from traditional medicinal products.
(17) Zdravila za napredno zdravljenje lahko vključujejo medicinske pripomočke ali aktivne medicinske pripomočke za vsaditev.
(17) Advanced therapy medicinal products may incorporate medical devices or active implantable medical devices.
Navedeni pripomočki morajo izpolnjevati bistvene zahteve iz Direktive Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih in iz Direktive Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev v tem vrstnem redu, da se zagotovi ustrezna raven kakovosti in varnosti.
Those devices should meet the essential requirements laid down in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, respectively, in order to ensure an appropriate level of quality and safety.
Agencija mora pri oceni kombiniranega zdravila, ki se uporablja v skladu s to uredbo, upoštevati oceno medicinskih pripomočkov ali aktivnih medicinskih pripomočkov za vsaditev, ki jo poda priglašeni organ v skladu s temi direktivami.
Where available, the results of the assessment of the medical device or the active implantable medical device by a notified body in accordance with those Directives should be taken into account by the Agency in the evaluation of a combined product carried out under this Regulation.
Da bi zagotovili nepretrgano uporabo obsežnih izkušenj in strokovnega znanja priglašenih organov pri ocenjevanju medicinskih pripomočkov ali aktivnih medicinskih pripomočkov za vsaditev, lahko priglašeni organi ocenijo medicinski pripomoček ali aktivni medicinski pripomoček za vsaditev, ki je del kombiniranega zdravila za napredno zdravljenje.
In order to ensure the continuous utilisation of the vast experience and expertise of the notified bodies on the evaluation of medical devices or active implantable medical devices, the notified bodies may assess the medical device or the active implantable medical device part of the combined advanced therapy medicinal product.
V takem primeru mora Agencija te ocene upoštevati pri zadnjem vrednotenju kombiniranega zdravila.
In that case, the Agency should take into account the results of these assessments in its final evaluation of the combined product.
(18) Določiti je treba posebna pravila za prilagoditev zahtev iz Direktive 2001/83/ES, kar zadeva povzetek glavnih značilnosti zdravila, ovojnino in navodila za uporabo za tehnične posebnosti zdravil za napredno zdravljenje.
(18) Specific rules should be laid down, adapting the requirements in Directive 2001/83/EC as regards the summary of product characteristics, labelling and package leaflet to the technical specificities of advanced therapy medicinal products.
Ta pravila morajo biti popolnoma v skladu s pravico bolnikov, da poznajo izvor vseh tkiv in celic, ki se uporabljajo pri pripravi zdravil za napredno zdravljenje, istočasno pa spoštovati anonimnosti darovalca.
These rules should comply fully with the p atient's right to know the origin of any cells or tissues used in the preparation of advanced therapy medicinal products, while respecting donor anonymity.
(19) Dolgoročno pozorno spremljanje in farmakovigilanca sta odločilna vidika zdravil za napredno zdravljenje.
(19) Long-term patient follow-up and pharmacovigilance are crucial aspects of advanced therapy medicinal products.
Kadar to upravičuje javno zdravje, je treba od imetnika dovoljenja za promet zahtevati, da uvede ustrezen sistem za obvladovanje tveganj, da se obravnavajo navedeni vidiki .
Where justified on public health grounds, the holder of the marketing authorisation should therefore be required to put in place a suitable risk management system to address those aspects .
(19) Spremljanje učinkovitosti in neželeni učinki sta odločilna vidika zdravil za napredno zdravljenje.
(19) Follow-up of efficacy and adverse reactions are crucial aspects of advanced therapy medicinal products.
Zato mora predlagatelj v vlogi za pridobitev dovoljenja za promet razložiti, ali so predvideni ukrepi, ki zagotavljajo tako spremljanje, in kateri so ti ukrepi.
The applicant should therefore detail in its application for marketing authorisation which measures if any are envisaged to ensure such follow-up.
Kadar to upravičuje javno zdravje, je treba od imetnika dovoljenja za promet zahtevati tudi , da uvede ustrezen sistem za obvladovanje tveganj, da se obravnavajo tveganja, povezana z zdravili za napredno zdravljenje .
Where justified on public health grounds, the holder of the marketing authorisation should also be required to put in place a suitable risk management system to address risks related to advanced therapy medicinal products.
Predlog spremembe naj bi zagotovil večjo skladnost z obstoječo farmacevtsko zakonodajo in visok standard farmakovigilance.
This amendment would ensure a better coherence with existing pharmaceutical legislation and a high standard of pharmacovigilance.
UVODNA IZJAVA 19A (new)
RECITAL 19A (new)
(19a) Za izvajanje te uredbe so potrebne smernice, ki jih določa Agencija ali Komisija.
(19a) The operation of this Regulation requires the establishment of guidelines, to be drawn up either by the Agency or by the Commission.
V obeh primerih se uveljavljajo načela odprtega posvetovanja vseh zainteresiranih strani, zlasti industrije, da se omogoči združevanje omejenega strokovnega znanja na tem področju in zagotovi sorazmernost.
In both cases, open consultation with all interested parties, in particular the industry, should be enacted in order to allow a pooling of the limited expertise in this area and ensure proportionality.
Pri oblikovanju smernic za izvajanje te uredbe se uveljavljajo načela odprtega posvetovanja vseh zainteresiranih strani, zlasti industrije, da se omogoči združevanje omejenega strokovnega znanja na tem področju in zagotovi sorazmernost.
When drawing up guidelines for the implementation of this Regulation, principles of open consultation with all interested parties, in particular the industry should be enacted in order to allow a pooling of the limited expertise in this area and ensure proportionality.
(21) Ker je znanstveni napredek na tem področju zelo velik, mora biti podjetjem, ki razvijajo zdravila za napredno zdravljenje, omogočeno, da dobijo znanstveni nasvet od Agencije, vključno z nasvetom o dejavnostih po pridobitvi dovoljenja.
(21) As science evolves very rapidly in this field, undertakings developing advanced therapy medicinal products should be enabled to request scientific advice from the Agency, including advice on post-authorisation activities.
Za spodbudo mora biti pristojbina za navedeni znanstveni nasvet minimalna.
As an incentive, the fee for that scientific advice should be kept at a minimal level.
Za spodbudo mora biti pristojbina za navedeni znanstveni nasvet za mala in srednje velika podjetja minimalna in bi se morala znižati tudi za druge predlagatelje .
As an incentive, the fee for that scientific advice should be kept at a minimal level for small and medium-sized enterprises, and should also be reduced for other applicants .
Namen te uredbe je spodbuditi in podpreti mala in srednje velika podjetja pri razvoju zdravil za napredno zdravljenje.
This Regulation seeks to encourage and support SMEs in the development of ATMPs.
Zato je treba nujno uvesti posebne opustitve pristojbin, ki veljajo za mala in srednje velika podjetja po znanstvenem nasvetu.
Therefore, it is necessary to introduce special fee-waivers applicable to SMEs on scientific advice.
(22) Agencija mora biti pooblaščena za dajanje znanstvenih priporočil o tem, ali dani izdelek, ki temelji na celicah ali tkivih, izpolnjuje znanstvena merila, ki opredeljujejo zdravila za napredno zdravljenje, da se lahko v najkrajšem času obravnavajo vprašanja razmejitev z drugimi področji, kot so kozmetika ali medicinski pripomočki, ki se lahko pojavijo med razvojem znanosti.
(22) The Agency should be empowered to give scientific recommendations on whether a given product based on cells or tissues meets the scientific criteria which define advanced therapy medicinal products, in order to address, as early as possible, questions of borderline with other areas such as cosmetics or medical devices, which may arise as science develops.
(22) Agencija mora biti pooblaščena za dajanje znanstvenih priporočil o tem, ali dani izdelek, ki temelji na genih, celicah ali tkivih, izpolnjuje znanstvena merila, ki opredeljujejo zdravila za napredno zdravljenje, da se lahko v najkrajšem času obravnavajo vprašanja razmejitev z drugimi področji, kot so kozmetika ali medicinski pripomočki, ki se lahko pojavijo med razvojem znanosti.
(22) The Agency should be empowered to give scientific recommendations on whether a given product based on genes, cells or tissues meets the scientific criteria which define advanced therapy medicinal products, in order to address, as early as possible, questions of borderline with other areas such as cosmetics or medical devices, which may arise as science develops.
Odbor za napredno zdravljenje mora imeti zaradi posebnega strokovnega znanja pomembno vlogo pri zagotavljanju takega nasveta.
The Committee for Advanced Therapies, with its unique expertise, should have a prominent role in the provision of such advice.
Odbor za napredno zdravljenje mora zaradi posebnega strokovnega znanja o zdravilih za napredno zdravljenje imeti pomembno vlogo pri svetovanju izvajalcem o tem, ali je zdravilo namenjeno za napredno zdravljenje ali ne.
Due to its specific expertise in advanced therapy medicinal products, the Committee for Advanced Therapies should be instrumental in providing advice to operators on whether a product is or is not an advanced therapy medicinal product.
(24) Za upoštevanje znanstvenega in tehničnega napredka mora biti Komisija pooblaščena za sprejemanje kakršnih koli potrebnih sprememb glede tehničnih zahtev za vloge za pridobitev dovoljenja za promet z zdravili za napredno zdravljenje, povzetka glavnih značilnosti zdravila, ovojnine in navodil za uporabo.
(24) In order to take into account scientific and technical developments, the Commission should be empowered to adopt any necessary changes regarding the technical requirements for applications for marketing authorisation of advanced therapy medicinal products, the summary of product characteristics, labelling, and package leaflet.
Komisija mora zagotoviti, da so pomembne informacije o predvidenih ukrepih takoj dostopne zainteresiranim stranem.
The Commission should ensure that relevant information on envisaged measures is made available to interested parties without delay.
Večja predvidljivost prihodnjih ukrepov je zelo pomembna za industrijo, da lahko izvede skrbno načrtovana in stroškovno učinkovita vlaganja v raziskave, razvoj in proizvodnjo.
Better predictability of future regulations is of the greatest importance for industry in order to make well-planned and cost-effective investments in R&D and production.
Zato je treba pomembne informacije o predvidenih ukrepih objaviti čim prej.
Therefore, relevant information about envisaged measures should be made known as quickly as possible.
(27) Ukrepe, potrebne za izvajanje te uredbe, je treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil.
(27) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission.
(27) Ukrepe, potrebne za izvajanje te uredbe, je treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil.
(27) The measures necessary for the implementation of this Regulation should be adopted in accordance with the Council Decision 1999/468/EC of 28 June 1999 laying down the procedures of the exercise of implementing powers conferred to the Commission.
Regulativni postopek z nadzorom iz člena 5a tega sklepa se uporablja za sprejetje predlogov sprememb prilog II do IV k tej uredbi in priloge I k Direktivi 2001/83/ES.
The regulatory procedure with scrutiny provided for in Article 5a of that Decision should apply to the adoption of amendments to Annexes II to IV to this Regulation and to Annex I to Directive 2001/83/EC.
Ti ukrepi so bistveni za pravilno delovanje celotnega ureditvenega okvira in jih je zato treba hitro sprejeti, in sicer 9 mesecev po začetku veljavnosti te uredbe.
Since these measures are essential for the proper operation of the whole regulatory framework, they should be adopted swiftly, within 9 months after the entry into force of this Regulation.
Proizvajalci ne bodo mogli oblikovati razvojnih protokolov, dokler se ne objavijo tehnične zahteve in zaključijo prilagajanja direktive o dobri klinični praksi in direktive o dobri proizvodni praksi.
Manufacturers will not be in a position to design development protocols until the technical requirements are published and the adaptations of the Good Clinical Practice Directive and the Good Manufacturing Practice Directive are finalised.
Zato predlagamo časovno omejitev 9 mesecev, da Komisija sprejme potrebne ukrepe.
Therefore, we propose 9 months time limit for the Commission to adopt the necessary measures.
Ta uredba se ne uporablja za zdravila za napredno zdravljenje, ki vsebujejo ali so izdelane na podlagi celic človeškega zarodka ali plodu, primarnih zarodnih celic ali iz njih nastalih celic.
This Regulation shall not apply to advanced therapy medicinal products that contain or are derived from human embryonic or foetal cells, primordial germ cells or cells derived from those cells.
Predlog spremembe odbora JURI, ki se je v skladu s členom 47 vključil v poročilo brez glasovanja.
JURI amendment, which was incorporated in the report without vote following Rule 47.
ČLEN 2, ODSTAVEK 1, TOČKA (B), UVODNI DEL
ARTICLE 2, PARAGRAPH 1, POINT (B), INTRODUCTORY PART
(b) izdelek tkivnega inženirstva pomeni izdelek , ki:
(b) tissue engineered product means a product that:
(b) izdelek tkivnega inženirstva pomeni zdravilo , ki:
(b) tissue engineered product means a medicinal product that:
Predlog spremembe pojasnjuje, da uredba ne more zajemati izdelkov, ki niso opredeljeni kot zdravila.
Adding the term "medicinal" clarifies that products which do not meet the definition of a medicinal product cannot be covered by this regulation.
ČLEN 2, ODSTAVEK 1, TOČKA (B), PODODSTAVEK 2 A (novo)
ARTICLE 2, PARAGRAPH 1, POINT (B), SUBPARAGRAPH 2 A (new)
Iz te opredelitve so izvzeti izdelki, ki vsebujejo ali so izdelani izključno na podlagi človeških ali živalskih celic in/ali tkiv, ki niso sposobna živeti in ki ne vsebujejo tkiv ali celic, ki so sposobne živeti, in katerih način delovanja ni predvsem farmakološki, imunološki ali presnovni.
Products containing or made exclusively of non-viable human or animal cells and/or tissues, which do not contain any viable cells or tissues and which do not act principally by pharmacological, immunological or metabolic action, are excluded from this definition.
ČLEN 2, ODSTAVEK 1, TOČKA (D), ALINEA 1 A (novo)
ARTICLE 2, PARAGRAPH 1, POINT (D), INDENT 1 A (new)
– njegov celični ali tkivni del vsebuje celice ali tkiva, ki so sposobna živeti; ali
- its cellular or tissue part contains viable cells or tissues; or
Za namene uredbe mora biti najpomembnejše merilo pri opredeljevanju kombiniranega zdravila za napredno zdravljenje sposobnost preživetja njegovega celičnega in 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.
Za varnost bolnikov in visokih standardov vrednotenja zdravila je treba kombinirano zdravilo vedno opredeliti kot zdravilo za napredno zdravljenje, če vsebuje tkiva ali celice, ki so sposobne živeti.
For the patient's safety and the high standards of the evaluation of a product, a combined product should be always classified as an advanced therapy medicinal product when it contains viable tissues or cells.
ČLEN 2, ODSTAVEK 1, TOČKA (D), ALINEA 2
ARTICLE 2, PARAGRAPH 1, POINT (D), INDENT 2
– njegov celični ali tkivni del mora imeti na človeško telo učinek, ki se ne more šteti za dopolnilen glede na učinek omenjenih pripomočkov.
– its cellular or tissue part must be liable to act upon the human body with action that cannot be considered as ancillary to that of the devices referred to.
– 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, 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, PODODSTAVEK 1 A (novo)
ARTICLE 2, PARAGRAPH 1, SUBPARAGRAPH 1 A (new)
Če izdelek vsebuje celice ali tkiva, ki so sposobna živeti, se farmakološko, imunološko ali presnovno delovanje teh celic ali tkiv upošteva kot primarni način delovanja izdelka.
Where a product contains viable cells or tissues, the pharmacological, immunological or metabolic action of those cells or tissues shall be considered as the primary mode of action of the product.
Nova določba pojasnjuje zakon o izdelkih, ki vsebujejo celice ali tkiva, ki so sposobna živeti, hkrati pa pri mejnem razvrščanju načeloma ohranja merilo primernega načina delovanja.
This new provision clarifies the rule concerning products which contain viable cells or tissues, whilst maintaining in principle the criterion of “primary mode of action” for borderline classification.