natgillin/translations-raw huggingface dataset:
For these products, whatever the role of the medical device, the pharmacological, immunological or metabolic action of these cells or tissues should be considered to be the principal mode of action of the combination product.
Za te izdelke bi se ne glede na vlogo medicinskega pripomočka kot glavni način delovanja kombiniranega izdelka moralo upoštevati farmakološko, imunološko ali presnovno delovanje teh celic ali tkiv.
Such combination products should always be regulated under this Regulation.
Tovrstni kombinirani izdelki bi morali biti vedno urejeni v skladu s to uredbo.
Because of the novelty, complexity and technical specificity of advanced therapy medicinal products, specially tailored and harmonised rules are needed to ensure the free movement of those products within the Community, and the effective operation of the internal market in the biotechnology sector.
Zaradi novosti, kompleksnosti in tehnične posebnosti zdravil za napredno zdravljenje so potrebna posebej prirejena in usklajena pravila, da se zagotovi prosti pretok navedenih izdelkov znotraj Skupnosti in učinkovito delovanje notranjega trga v biotehnološkem sektorju.
This Regulation is a lex specialis, which introduces additional provisions to those laid down in Directive 2001/83/EC.
Ta uredba je lex specialis, saj uvaja dodatne določbe k tistim iz Direktive 2001/83/ES.
The scope of this Regulation should be to regulate advanced therapy medicinal products which are intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process, in accordance with the general scope of the Community pharmaceutical legislation laid down in Title II of Directive 2001/83/EC.
Ta uredba bi morala urejati zdravila za napredno zdravljenje, ki se dajejo v promet v državah članicah in so izdelana industrijsko ali z uporabo metode, ki vključuje industrijski postopek, v skladu s splošnim obsegom farmacevtske zakonodaje Skupnosti, določenim v naslovu II Direktive 2001/83/ES.
Advanced therapy medicinal products which are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Regulation whilst at the same time ensuring that relevant Community rules related to quality and safety are not undermined.
Zdravila za napredno zdravljenje, ki so pripravljena nerutinsko v skladu s posebnimi standardi kakovosti in se uporabljajo v bolnišnici v isti državi članici ob izključni poklicni odgovornosti zdravnika v skladu s posameznim receptom za posamično zdravilo za posameznega bolnika, bi bilo treba izključiti iz področja uporabe te uredbe in istočasno zagotoviti, da to ne posega v ustrezne predpise Skupnosti o kakovosti in varnosti.
The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type of human cells, such as embryonic stem cells, or animal cells.
Uredba o zdravilih za napredno zdravljenje na ravni Skupnosti ne bi smela vplivati na odločitve držav članic o dovoljenju uporabe kakršne koli posebne vrste človeških celic, kot so embrionalne matične celice ali živalske celice.
It should also not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products containing, consisting of or derived from these cells.
Ravno tako ne bi smela vplivati na uporabo nacionalne zakonodaje, ki prepoveduje ali omejuje prodajo, dobavo ali uporabo zdravil, ki vsebujejo te celice ali jih te celice sestavljajo ali so izdelane na njihovi podlagi.
This Regulation respects the fundamental rights and observes the principles reflected in the Charter of Fundamental Rights of the European Union and also takes into account the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.
Ta uredba spoštuje temeljne pravice in upošteva načela, izražena v Listini o temeljnih pravicah Evropske unije, ter upošteva tudi Konvencijo Sveta Evrope o varovanju človekovih pravic in človeškega dostojanstva v zvezi z uporabo biologije in medicine: Konvencija o človekovih pravicah in biomedicini.
All other modern biotechnology medicinal products currently regulated at Community level are already subject to a centralised authorisation procedure, involving a single scientific evaluation of the quality, safety and efficacy of the product, which is carried out to the highest possible standard by the European Medicines Agency as established by 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 [4] (hereinafter referred to as the Agency).
Za vsa druga moderna biotehnološka zdravila, ki so trenutno urejena na ravni Skupnosti, se že uporablja centralizirani postopek za pridobitev dovoljenja, v katerem Evropska agencija za zdravila, ustanovljena z 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 [4] (v nadaljevanju „Agencija“) izvaja enotno znanstveno vrednotenje kakovosti, varnosti in učinkovitosti izdelka po najvišjih možnih standardih.
This procedure should also be compulsory for advanced therapy medicinal products in order to overcome the scarcity of expertise in the Community, ensure a high level of scientific evaluation of these medicinal products in the Community, preserve the confidence of patients and medical professions in the evaluation and facilitate Community market access for these innovative technologies.
Ta postopek bi moral biti obvezen tudi za zdravila za napredno zdravljenje, da se premosti pomanjkanje strokovnega znanja v Skupnosti, zagotovi visoka raven znanstvenega vrednotenja teh zdravil v Skupnosti, ohrani zaupanje bolnikov in zdravstvenih poklicev v vrednotenje ter tem inovativnim tehnologijam olajša dostop na trg Skupnosti.
The evaluation of advanced therapy medicinal products often requires very specific expertise, which goes beyond the traditional pharmaceutical field and covers areas bordering on other sectors such as biotechnology and medical devices.
Vrednotenje zdravil za napredno zdravljenje pogosto zahteva zelo posebno strokovno znanje, ki presega okvire tradicionalnega farmacevtskega področja in zajema mejna področja z drugimi sektorji, kot so biotehnologija in medicinski pripomočki.
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 Agency’s Committee for Medicinal Products for Human Use.
Zato je primerno v okviru Agencije ustanoviti Odbor za napredno zdravljenje, ki bi moral biti odgovoren za pripravo osnutka mnenja o kakovosti, varnosti in učinkovitosti vsakega zdravila za napredno zdravljenje, ki ga končno odobri Odbor za zdravila za uporabo v humani medicini.
In addition, the Committee for Advanced Therapies should be consulted for the evaluation of any other medicinal product which requires specific expertise falling within its area of competence.
Poleg tega bi se bilo treba z Odborom za napredno zdravljenje posvetovati za vrednotenje katerega koli drugega zdravila, ki zahteva posebno strokovno znanje v okviru njegovih pristojnosti.
The Committee for Advanced Therapies should gather the best available expertise on advanced therapy medicinal products in the Community.
Odbor za napredno zdravljenje bi moral združevati najboljše razpoložljivo strokovno znanje o zdravilih za napredno zdravljenje v Skupnosti.
The composition of the Committee for Advanced Therapies should ensure appropriate coverage of the scientific areas relevant to advanced therapies, including gene therapy, cell therapy, tissue engineering, medical devices, pharmacovigilance and ethics.
Sestava Odbora za napredno zdravljenje bi morala zagotoviti primerno pokritost znanstvenih področij, pomembnih za napredno zdravljenje, vključno z genskim zdravljenjem, celičnim zdravljenjem, tkivnim inženirstvom, medicinskimi pripomočki, farmakovigilanco in etiko.
Patient associations and clinicians with scientific experience of advanced therapy medicinal products should also be represented.
Zastopana bi morala biti tudi združenja bolnikov in kliničnih zdravnikov z znanstvenimi izkušnjami z zdravili za napredno zdravljenje.
To ensure scientific consistency and the efficiency of the system, the Agency should ensure the coordination between the Committee for Advanced Therapies and its other Committees, advisory groups and working parties, notably the Committee for Medicinal Products for Human Use, the Committee on Orphan Medicinal Products, and the Scientific Advice Working Party.
Za zagotovitev znanstvene doslednosti in učinkovitosti sistema bi morala Agencija zagotoviti koordinacijo med Odborom za napredno zdravljenje in njenimi drugimi odbori, svetovalnimi skupinami in delovnimi skupinami, zlasti Odborom za zdravila za uporabo v humani medicini, Odborom za zdravila sirote in Delovno skupino za znanstveno svetovanje.
Advanced therapy medicinal products should be subject to the same regulatory principles as other types of biotechnology medicinal products.
Za zdravila za napredno zdravljenje bi morala veljati enaka ureditvena načela, kot veljajo za druge vrste biotehnoloških zdravil.
However, technical requirements, in particular the type and amount of quality, pre-clinical and clinical data necessary to demonstrate the quality, safety and efficacy of the product, may be highly specific.
Vendar so lahko tehnične zahteve, zlasti vrsta in količina podatkov o kakovosti ter nekliničnih in kliničnih podatkov, potrebnih za dokazovanje kakovosti, varnosti in učinkovitosti izdelka, izredno specifične.
While those requirements are already laid down in Annex I to Directive 2001/83/EC for gene therapy medicinal products and somatic cell therapy medicinal products, they need to be established for tissue engineered products.
Ker so navedene zahteve že določene za zdravila za gensko zdravljenje in zdravila za somatsko celično zdravljenje v Prilogi I k Direktivi 2001/83/ES, jih je treba uvesti še za izdelke tkivnega inženirstva.
This should be done through a procedure that provides for sufficient flexibility, so as to easily accommodate the rapid evolution of science and technology.
To bi bilo treba narediti po postopku, ki zagotavlja zadostno prožnost za lažje prilagajanje hitremu razvoju znanosti in tehnologije.
Directive 2004/23/EC of the European Parliament and of the Council [5] sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
Direktiva 2004/23/ES Evropskega parlamenta in Sveta [5] določa standarde kakovosti in varnosti darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja in razdeljevanja človeških tkiv in celic.
This Regulation should not derogate from the basic principles laid down in Directive 2004/23/EC, but should supplement them with additional requirements, where appropriate.
Ta uredba ne bi smela odstopati od osnovnih načel iz Direktive 2004/23/ES, ampak bi jih morala dopolnjevati z dodatnimi zahtevami, kjer je primerno.
Where an advanced therapy medicinal product contains human cells or tissues, Directive 2004/23/EC should apply only as far as donation, procurement and testing are concerned, since the further aspects are covered by this Regulation.
Kadar zdravilo za napredno zdravljenje vsebuje človeške celice ali tkiva, bi bilo treba Direktivo 2004/23/ES uporabljati samo za darovanje, pridobivanje in testiranje, ker druge vidike zajema ta uredba.
As regards the donation of human cells or tissues, principles such as the anonymity of both donor and recipient, altruism of the donor and solidarity between donor and recipient should be respected.
Pri darovanju človeških tkiv ali celic bi bilo treba spoštovati načela, kot so anonimnost tako darovalca kot prejemnika, altruizem darovalca ter solidarnost med darovalcem in prejemnikom.
As a matter of principle, human cells or tissues contained in advanced therapy medicinal products should be procured from voluntary and unpaid donation.
Načeloma bi bilo treba človeške celice ali tkiva, ki so v zdravilih za napredno zdravljenje, pridobivati samo s prostovoljnim in brezplačnim darovanjem.
Member States should be 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 cell and tissue donations may contribute to high safety standards for cells and tissues and therefore to the protection of human health.
Države članice bi bilo treba pozvati, 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 celic in tkiv lahko prispeva k visokim varnostnim standardom za celice in tkiva, s tem pa k varovanju zdravja ljudi.
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 [6].
Klinično preskušanje zdravil za napredno zdravljenje bi bilo 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 [6].
However, Commission 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 [7] should be adapted by laying down rules tailored to fully take into account the specific technical characteristics of advanced therapy medicinal products.
Vendar pa bi bilo treba Direktivo Komisije 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 [7] prilagoditi z določitvijo ustreznih pravil, ki bodo v celoti upoštevala posebne tehnične značilnosti zdravil za napredno zdravljenje.
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 [8], and adapted, where necessary, to reflect the specific nature of those products.
Izdelava zdravil za napredno zdravljenje bi morala biti v skladu z načeli dobre proizvodne prakse, kakor 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 [8], in po potrebi prilagojena, da bi odražala posebne lastnosti teh zdravil.
Furthermore, guidelines specific to advanced therapy medicinal products should be drawn up, so as to properly reflect the particular nature of their manufacturing process.
Poleg tega bi bilo treba pripraviti posebne smernice za zdravila za napredno zdravljenje, ki bi ustrezno odražale posebno naravo njihovega postopka izdelave.
Advanced therapy medicinal products may incorporate medical devices or active implantable medical devices.
Zdravila za napredno zdravljenje lahko vključujejo medicinske pripomočke ali aktivne medicinske pripomočke za vsaditev.
Those devices should meet the essential requirements laid down in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [9] 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 [10], respectively, in order to ensure an appropriate level of quality and safety.
Navedeni pripomočki bi morali izpolnjevati bistvene zahteve iz Direktive Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih [9] oziroma iz Direktive Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev [10], da se zagotovi ustrezna raven kakovosti in varnosti.
The results of the assessment of the medical device part or the active implantable medical device part by a notified body in accordance with those Directives should be recognised by the Agency in the evaluation of a combined advanced therapy medicinal product carried out under this Regulation.
Agencija bi morala pri vrednotenju kombiniranega zdravila za napredno zdravljenje, izvedenem v skladu s to uredbo, upoštevati izsledke ocene vključenega medicinskega pripomočka ali aktivnega medicinskega pripomočka za vsaditev, ki jo poda priglašeni organ v skladu s tema direktivama.
The requirements in Directive 2001/83/EC as regards the summary of product characteristics, labelling and the package leaflet should be adapted to the technical specificities of advanced therapy medicinal products by laying down specific rules on those products.
Zahteve iz Direktive 2001/83/ES o povzetku glavnih značilnosti zdravila, označevanju in navodilu za uporabo bi bilo treba prilagoditi glede tehničnih posebnosti zdravil za napredno zdravljenje z določitvijo posebnih pravil za ta zdravila.
These rules should comply fully with the patient’s right to know the origin of any cells or tissues used in the preparation of advanced therapy medicinal products, while respecting donor anonymity.
Ta pravila bi morala v celoti upoštevati pravico bolnikov, da poznajo izvor vseh celic ali tkiv, ki se uporabljajo pri pripravi zdravil za napredno zdravljenje, hkrati pa spoštovati anonimnost darovalca.
Follow-up of efficacy and adverse reactions is a crucial aspect of the regulation of advanced therapy medicinal products.
Spremljanje učinkovitosti in neželenih učinkov je odločilni vidik uredbe o zdravilih za napredno zdravljenje.
The applicant should therefore detail in its marketing authorisation application whether measures are envisaged to ensure such follow-up and, if so, what those measures are.
Zato bi moral vlagatelj v vlogi za pridobitev dovoljenja za promet z zdravilom obrazložiti, ali so predvideni ukrepi, ki zagotavljajo tako spremljanje, in kateri so ti ukrepi.
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.
Kadar je utemeljeno z varovanjem javnega zdravja, bi bilo treba od imetnika dovoljenja za promet zahtevati tudi, da uvede ustrezen sistem za obvladovanje tveganj, povezanih z zdravili za napredno zdravljenje.
The operation of this Regulation requires the establishment of guidelines to be drawn up either by the Agency or by the Commission.
Za izvajanje te uredbe so potrebne smernice, ki jih oblikuje Agencija ali Komisija.
Open consultation with all interested parties, in particular Member State authorities and the industry, should be carried out in order to allow a pooling of the limited expertise in this area and ensure proportionality.
Izvajati bi bilo treba načelo odprtega posvetovanja z vsemi zainteresiranimi stranmi, zlasti z organi držav članic in industrijo, da se omogoči združevanje omejenega strokovnega znanja na tem področju in zagotovi sorazmernost.
The guidelines on good clinical practice and good manufacturing practice should be laid down as soon as possible, preferably during the first year after entry into force and before the date of application of this Regulation.
Čim prej bi bilo treba določiti smernice o dobri klinični praksi in o dobri proizvodni praksi, po možnosti v prvem letu po začetku veljavnosti in pred dnevom začetka uporabe te uredbe.
A system allowing complete traceability of the patient as well as of the product and its starting materials is essential to monitor the safety of advanced therapy medicinal products.
Sistem, ki omogoča popolno sledljivost bolnika in izdelka ter njegovih vhodnih snovi, je bistvenega pomena za spremljanje varnosti zdravil za napredno zdravljenje.
The establishment and maintenance of that system should be done in such a way as to ensure coherence and compatibility with traceability requirements laid down in Directive 2004/23/EC in respect of human tissues and cells, and in Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components [11].
Sistem bi bilo treba vzpostaviti in vzdrževati tako, da se zagotovi skladnost in združljivost z zahtevami za sledljivost človeških tkiv in celic iz Direktive 2004/23/ES in Direktive 2002/98/ES Evropskega parlamenta in Sveta z dne 27. januarja 2003 o določitvi standardov kakovosti in varnosti za zbiranje, preskušanje, predelavo, shranjevanje in razdeljevanje človeške krvi in komponent krvi [11].
The traceability system should also respect the provisions laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and the free movement of such data [12].
Sistem sledljivosti bi moral upoštevati tudi določbe iz Direktive 95/46/ES Evropskega parlamenta in Sveta z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov [12].
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.
Ker je znanstveni napredek na tem področju zelo hiter, bi moralo biti podjetjem, ki razvijajo zdravila za napredno zdravljenje, omogočeno, da zahtevajo znanstveni nasvet od Agencije, vključno z nasvetom o dejavnostih po pridobitvi dovoljenja za promet z zdravilom.
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.
Za spodbudo bi morala biti pristojbina za navedeni znanstveni nasvet za mala in srednje velika podjetja minimalna in bi se morala znižati tudi za druge vlagatelje.
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.
Agencija bi morala 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 z razvojem znanosti.