natgillin/translations-raw huggingface dataset:
The competent authorities allowing such practices were requested to evaluate if and/or how traceability and reporting requirements are ensured by the tissue establishments distributing gametes to individuals and to take the necessary measures in case such practices do not fulfil the safety and quality requirements laid down in the EU tissue and cell legislation.
Od pristojnih organov, ki take prakse dovoljujejo, se je zahtevalo, naj ocenijo, če in/ali kako ustanove za tkiva in celice, ki razdeljujejo gamete posameznicam, zagotavljajo izpolnjevanje zahtev glede sledljivosti in poročanja, ter sprejmejo potrebne ukrepe, če take prakse ne izpolnjujejo zahtev glede varnosti in kakovosti iz zakonodaje EU o tkivih in celicah.
Even though most respondents confirmed respecting the required 2-year interval between inspections, some Member States suggested that prioritising inspections based on factors like the size of establishment, range of activity, experience of inspectors and compliance history may prove valuable especially in a period when financial constraints have a considerable influence on the staffing of departments in charge of inspections.
Čeprav je večina anketirancev potrdila, da upoštevajo zahtevano dveletno obdobje med inšpekcijskimi pregledi, je nekaj držav članic predlagalo, da je lahko koristno določiti prednostni vrstni red inšpekcijskih pregledov glede na dejavnike, kot so velikost ustanove, razpon dejavnosti, izkušnje inšpektorjev in izpolnjevanje zakonskih obveznosti v preteklosti, zlasti v obdobju, ko finančne omejitve znatno vplivajo na kadrovske zmogljivosti oddelkov, odgovornih za inšpekcijske preglede.
As underlined by several national competent authorities, a more harmonised procedure for the accreditation, designation, authorisation or licensing of tissue establishments would foster mutual trust and acceptance between Member States which are essential for ensuring a prompt supply of tissues and cells to the patients in need for the cases in which tissues and cells are distributed from another Member State than the one where the patient is treated.
Kot je poudarilo več nacionalnih pristojnih organov, bi bolj usklajen postopek akreditacije, imenovanja, odobritve ali izdaje dovoljenja ustanovam za tkiva in celice spodbudil vzajemno zaupanje in sprejemanje med državami članicami, ki sta bistvena za zagotavljanje hitre dostave tkiv in celic pacientom, ki jih potrebujejo, kadar tkiva in celice prihajajo iz druge države članice, ki ni tista, v kateri se pacient zdravi.
The fact that third parties may be involved in all steps of the chain from donation and procurement to distribution in most Member States highlights the importance that needs to be given to the written agreements established by tissue establishments and their verification by the national competent authorities.
Dejstvo, da so lahko v večini držav članic v vse stopnje v verigi od darovanja in pridobivanja do razdeljevanja vključene tretje osebe, poudarja pomen, ki ga je treba dati pisnim sporazumom z ustanovami za tkiva in celice ter njihovemu preverjanju s strani nacionalnih pristojnih organov.
The full analysis of the Member States' replies to the 2013 implementation survey and the 2014 survey on the implementation of the VUD principle is included in the two staff working documents accompanying this report.
Celotna analiza odgovorov držav članic na anketo o izvajanju iz leta 2013 in anketo o izvajanju načela PBD iz leta 2014 je vključena v delovna dokumenta služb Komisije, priložena temu poročilu.
However, it has to be noted that, as for import and export, data collected by the Member States probably serve different purposes and use various methodologies, so it is very difficult to draw a clear conclusion on the importance of EU distribution compared to import/export from/to third countries and therefore to evaluate tissue and cell sufficiency at EU level.
Vendar je treba opozoriti, da se podatki, ki so jih države članice zbrale v zvezi z uvozom in izvozom, verjetno uporabljajo za različne namene in da se zanje uporabljajo različne metodologije, zato je zelo težko oblikovati jasen sklep glede pomena razdeljevanja v EU v primerjavi z uvozom v tretje države in izvozom iz njih ter ovrednotiti zadostnost glede tkiv in celic na ravni EU.
Accreditation, designation, authorisation or licensing of tissue establishments.
Akreditacija, imenovanje, odobritev ali izdajanje dovoljenj ustanovam za tkiva in celice.
Concerning the number of competent authorities, in some Member States only one authority is responsible for the oversight of the tissue and cell sector, whereas in other countries the tasks are divided amongst two or three authorities (based either on type of tissues and cells or on duties e.g. accreditation/authorisation v. inspections/vigilance or the allocation of tasks between federal and regional levels).
Kar zadeva število pristojnih organov, je v nekaterih državah članicah samo en organ odgovoren za nadzor nad sektorjem tkiv in celic, v drugih pa so naloge razdeljene med dva ali tri organe (glede na vrsto tkiv in celic ali glede na naloge, npr. akreditacija/odobritev v primerjavi z inšpekcijskimi pregledi/vigilanco, ali glede na razdelitev nalog med zvezno in regionalno ravnjo).
In relation to the supply-demand balance, 17 Member States and one EEA country reported experiencing regular shortages of tissues and cells on a national level, mostly for bone marrow and haematopoietic stem cells, corneas and bone.
V zvezi z ravnotežjem med ponudbo in povpraševanjem je 17 držav članic in ena država EGP poročalo o rednem pomanjkanju tkiv in celic na nacionalni ravni, večinoma za kostni mozeg in krvotvorne matične celice, roženice in kosti.
Development of follow-up registries as an additional tool for ensuring safety of living donors was also addressed in the survey.
Anketa se je nanašala tudi na razvoj registrov za nadaljnje spremljanje kot dodatnega orodja za zagotavljanje varnosti živih darovalcev.
In most of the Member States compliance with the requirements for tissue and cell procurement set by Directive 2006/17/EC is verified by the competent authorities when performing inspections, but also by auditing procurement organisations and centres of human application.
V večini držav članic skladnost z zahtevami glede pridobivanja tkiv in celic iz Direktive 2006/17/ES pristojni organi preverjajo pri opravljanju inšpekcijskih pregledov, pa tudi pri revizijskih pregledih organizacij za pridobivanje in centrov za zdravljenje ljudi.
The main reasons for shortages were the lack of donors, followed by insufficient procurement capacity at national level and technical reasons (e.g. practical difficulties in finding a compatible match for patients in need of an HSC transplantation).
Glavni razlogi za pomanjkanje so pomanjkanje darovalcev ter nezadostna zmogljivost pridobivanja na nacionalni ravni in tehnični razlogi (npr. praktične težave pri iskanju ustreznega darovalca za paciente, ki potrebujejo presaditev krvotvornih matičnih celic).
Best practices to ensure tissue and cell sufficiency/self-sufficiency or measures to reduce shortages might be addressed as well as best practices on verification of the implementation of the VUD principle by the competent authorities.
Obravnavajo se lahko dobre prakse za zagotavljanje zadostnosti/samozadostnosti glede tkiv in celic ali ukrepi za zmanjšanje pomanjkanja ter dobre prakse preverjanja, kako pristojni organi izvajajo načelo PBD.
The survey showed that a donor identification system was implemented by most Member States, with a unique code for each donation being assigned, predominantly at the level of the tissue establishment.
Anketa je pokazala, da je večina držav članic vzpostavila sistem identifikacije darovalcev z določitvijo edinstvene kode za vsako darovanje, predvsem na ravni ustanove za tkiva in celice.
Nevertheless, it has to be underlined that a small number of countries rely only on the medical records of the donor and/or the autopsy report without interviewing the donor's family or his/her treating physician/general practitioner.
Kljub temu pa je treba poudariti, da se le majhno število držav zanaša samo na zdravstveno kartoteko darovalca in/ali obdukcijski izvid, ne da bi bil opravljen razgovor z družino darovalca ali zdravnikom, ki ga zdravi, oziroma izbranim splošnim zdravnikom.
Only six Member States have national registries of oocyte and sperm donors.
Samo šest držav članic ima nacionalne registre darovalcev jajčnih celic in sperme.
Even though most of the Member States reported using the Operational Manual for Competent Authorities on inspection of tissue and cell procurement and tissue establishments, there is no common agreement on the classification of shortcomings identified during inspections (e.g. classification of minor, major and critical deficiencies).
Čeprav je večina držav članic poročala, da uporabljajo Operativni priročnik za pristojne organe o inšpekcijskih pregledih pridobivanja tkiv in celic ter ustanov za tkiva in celice, niso soglasne glede razvrščanja pomanjkljivosti, ugotovljenih pri inšpekcijskih pregledih (npr. razvrščanje manjših, velikih in kritičnih pomanjkljivosti).
Good practices developed by the EU-funded initiatives were also included by the Council of Europe in a dedicated Guide to the Quality and Safety of Tissues and Cells.
Dobre prakse, razvite v okviru pobud, ki jih financira EU, je Svet Evrope vključil tudi v namenski vodnik za kakovost in varnost tkiv in celic (Guide to the Quality and Safety of Tissues and Cells).
In conclusion, this Report reveals an overall adequate application of the current quality and safety requirements of the EU tissues and cells legislation in most of the responding EU Member States and EEA countries.
To poročilo kaže, da se obstoječe zahteve glede kakovosti in varnosti iz zakonodaje EU o tkivih in celicah na splošno ustrezno uporabljajo v večini držav članic EU in držav EGP, ki so se odzvale.
The present implementation survey confirmed that Member States are trying to ensure an appropriate level of training for their tissue establishment personnel, and the compliance with the requirements of Directive 2004/23/EC is systematically verified during inspections and also before granting authorisation/accreditation/licence to tissue establishments.
Anketa o izvajanju je potrdila, da države članice poskušajo zagotoviti ustrezno raven usposabljanja za osebje ustanov za tkiva in celice ter da se izpolnjevanje zahtev Direktive 2004/23/ES sistematično preverja med inšpekcijskimi pregledi in pred odobritvijo/akreditacijo/izdajo dovoljenja ustanovam za tkiva in celice.
Moreover, the inclusion in the EU Tissue Establishment Compendium will reinforce the credentials of the EU tissue establishments to their partners and customers around the world.
Poleg tega bo vključitev v EU-kompendij ustanov za tkiva in celice okrepila zaupanje partnerjev in strank po vsem svetu v ustanove za tkiva EU.
By updating the data in this Compendium, the tissues and cells competent authorities demonstrate full transparency and provide support to healthcare professionals searching for an authorised tissue or cell provider within the Union.
Pristojni organi za tkiva in celice s posodabljanjem podatkov v tem kompendiju dokažejo celovito preglednost in zagotavljajo podporo zdravstvenim delavcem, ki iščejo odobrenega dobavitelja tkiv in celic v Uniji.
In terms of inspection outcomes, mostly minor shortcomings were recorded with few suspensions and revocations of authorisations (Fig. 6).
Rezultati inšpekcijskih pregledov kažejo, da so bili ugotovljene samo manjše pomanjkljivosti, pri čemer je bilo samo nekaj odobritev začasno odvzetih ali preklicanih (slika 6).
Additionally, for cases in which tissues/cells from one donor will be used for both transplantation and manufacturing of ATMP, consideration should be given on how to best exchange relevant data between the pharmacovigilance and biovigilance systems (e.g. donation of cells from a living donor which may be found to develop a tumour after donating cells to an ATMP manufacturer or recipient developing a tumour/communicable disease following therapy with donated cells from a donor who may have donated cells transplanted in another recipient).
Poleg tega je treba za primere, v katerih se tkiva/celice enega darovalca uporabijo za presaditev in izdelavo zdravil za napredno zdravljenje, razmisliti o tem, kako najbolje izmenjati zadevne podatke med sistemoma farmakovigilance in biovigilance (npr. darovanje celic živega darovalca, pri katerem se lahko po darovanju celic proizvajalcu zdravil za napredno zdravljenje odkrije tumor, ali prejemnik, pri katerem se tumor/nalezljiva bolezen pojavi po zdravljenju z darovanimi celicami darovalca, ki je morda daroval celice, presajene na drugega prejemnika).
Verification during inspections of standard operating procedures (SOP) prepared by the tissue establishments and inspecting patient and donor information provided by licensed fertility clinics were reported only by two Member States.
O preverjanju med inšpekcijskimi pregledi standardnih operativnih postopkov, ki so jih pripravile ustanove za tkiva in celice, ter inšpekcijskem pregledovanju informacij o pacientih in darovalcih, ki jih pošljejo klinike za zdravljenje neplodnosti, sta poročali samo dve državi članici.
New processing methodologies, unthought-of of when the Directives were adopted, are now commonly applied: pre-cutting of corneas with the transplant of only the anterior or posterior segment to one patient, decellularisation of skin and heart valves in the tissue establishment to enhance cellularisation in vivo in the recipient, numerous new pathogen inactivation or sterilisation techniques including the use of radioprotectants to allow treatment with high doses of gamma irradiation, transplantation of highly selected cell populations to be used for the same essential function in the recipient as in the donor, have all increased the importance of robust preparation process authorisation.
Nove metodologije predelave, ki si jih ob sprejetju direktiv ni bilo mogoče zamišljati, so danes v splošni rabi: predhodno rezanje roženice, pri čemer se na enega pacienta presadi samo prednji ali zadnji del, decelularizacija kože in srčnih zaklopk v ustanovah za tkiva in celice za povečanje celularizacije in vivo pri prejemniku, številne nove tehnike inaktivacije patogenov in sterilizacije, vključno z uporabo radioprotektorjev, ki omogočajo zdravljenje z velikimi odmerki obsevanja z žarki gama, presajanje strogo izbranih populacij celic, ki se pri prejemniku uporabljajo za isto bistveno funkcijo kot pri darovalcu, in zaradi vsega tega se je povečal pomen odobritve postopkov priprave.
Concerning testing laboratories, the survey showed that in most of the reporting Member States accreditation/designation/authorisation or licensing of testing laboratories is the responsibility of authorities other than the tissue and cell competent authorities.
Anketa je v zvezi z laboratoriji za testiranje pokazala, da je v večini držav članic poročevalk akreditacija/imenovanje/odobritev/izdajanje dovoljenj laboratorijem za testiranje odgovornost drugih organov in ne pristojnih organov za tkiva in celice.
In addition, in several Member States, only tissue establishments are authorised to procure tissues and cells, with some countries authorising tissue establishments just for procurement activities.
Poleg tega je v nekaterih državah članicah samo ustanovam za tkiva in celice dovoljeno pridobivanje tkiv in celic, pri čemer nekatere države odobrijo ustanove za tkiva in celice samo za dejavnosti pridobivanja.
Issues to be addressed include transparency of the decisions regarding donor compensation, the type and value of the compensations for donors, especially for the situations when such decisions were conveyed to procurement organisations or tissue establishments.
Vprašanja, ki jih je treba obravnavati, vključujejo preglednost odločitev glede nadomestil darovalcem ter vrste in vrednosti nadomestil darovalcem, zlasti kadar so take odločitve prepuščene organizacijam za pridobivanje ali ustanovam za tkiva in celice.
Furthermore, besides procurement of replacement tissues, haematopoietic stem cells and reproductive cells, some Member States also reported a significant number of procurement organisations carrying out procurement of tissue and cells to be used for manufacturing of advanced therapy medicinal products (ATMP) (Fig. 3).
Poleg tega so nekatere države poleg pridobivanja nadomestnih tkiv, krvotvornih matičnih celic in reproduktivnih celic poročale tudi o znatnem številu organizacij za pridobivanje, ki pridobivajo tkivo in celice, ki se uporabljajo za izdelavo zdravil za napredno zdravljenje (slika 3).
An important issue is how and by whom the decision concerning the value and form of compensations for tissue and cell donors is taken.
Pomembno vprašanje je, kako se sprejme odločitev o vrednosti in obliki nadomestila za darovalce tkiv in celic ter kdo jo sprejme.
The findings of the VUD survey suggest that Member States should collect more information on the day-to-day practices vis-à-vis donors in both procurement organisations and tissue establishments, especially when these operators are responsible for deciding the type and/or value of the compensation provided to donors.
Ugotovitve ankete o PBD kažejo, da bi morale države članice zbirati več informacij o dnevnih praksah glede darovalcev v organizacijah za pridobivanje in ustanovah za tkiva in celice, zlasti kadar so ti subjekti odgovorni za odločanje o vrsti in/ali vrednosti nadomestila darovalcem.
The analysis of the annual SARE reports submitted by the Member States demonstrates notable efforts to comply with the requirements in Article 7 of Directive 2006/86/EC.
Analiza letnih poročil o hudih neželenih reakcijah in dogodkih, ki so jih predložile države članice, dokazuje vidna prizadevanja za izpolnjevanje zahtev iz člena 7 Direktive 2006/86/ES.
The survey revealed a variety of approaches for the implementation of the procurement requirements laid down in Directive 2006/17/EC, especially when granting authorisation (e.g. prior on-site inspection vs. desk-based review of documentation, differing criteria for major changes requiring a notification of the competent authorities, differing duration of authorisation and conditions of renewal).
Anketa je razkrila raznolikost pristopov k izvajanju zahtev glede pridobivanja iz Direktive 2006/17/ES, zlasti v zvezi z odobritvijo (npr. predhodni inšpekcijski pregled na kraju samem v primerjavi s pisarniškim pregledom dokumentacije, različna merila za pomembne spremembe, ki jih je treba priglasiti pristojnim organom, različno trajanje odobritve in različni pogoji za njeno obnovo).
Register of tissue establishments and reporting obligations.
Register ustanov za tkiva in celice ter obveznosti poročanja.
Provisions associated with procurement, but also with donation and testing, are regulated by the tissue and cell legislation and verified during tissue establishment inspection.
Določbe v zvezi s pridobivanjem ter darovanjem in testiranjem so urejene z zakonodajo o tkivih in celicah ter preverjene pri inšpekcijskem pregledu ustanove za tkiva in celice.
Donor selection and evaluation.
Izbiranje in vrednotenje darovalcev.
An alert issued in RATC accompanied by recall of products from an EU tissue establishment revealed that the consent form and its verification may be very different from one Member State to another, depending also on the legal framework under which the EU tissue and cell legislation has been transposed.
Opozorilo, poslano prek platforme za hitro obveščanje o tkivih in celicah (RATC), je skupaj z odpoklicem proizvodov ustanove za tkiva in celice iz EU razkrilo, da se lahko obrazec za soglasje in njegovo preverjanje po posameznih državah članicah zelo razlikujeta, odvisno tudi od pravnega okvira, v katerem je bila prenesena zakonodaja EU o tkivih in celicah.
Import/export of human tissues and cells to/from third countries.
Uvoz človeških tkiv in celic v tretje države članice in izvoz iz njih.
Responses to the survey showed that this is also the case for procurement of tissues and cells for ATMP manufacturers, in line with Article 3 of the ATMP Regulation.
Odgovori na anketo so pokazali, da je tako tudi v primeru pridobivanja tkiv in celic za proizvajalce zdravil za napredno zdravljenje v skladu s členom 3 uredbe o zdravilih za napredno zdravljenje.
Such difficulties were also reported by operators manufacturing ATMP from human tissues and cells.
O takih težavah so poročali tudi subjekti, ki proizvajajo zdravila za napredno zdravljenje iz človeških tkiv in celic.
This report shows that Member States overall comply with Article 12 of Directive 2004/23/EC requiring Member States to take the necessary measures to endeavour to ensure VUD of tissues and cells.
To poročilo kaže, da države članice na splošno ravnajo v skladu s členom 12 Direktive 2004/23/ES, ki od držav članic zahteva, da sprejmejo potrebne ukrepe ter si prizadevajo zagotoviti prostovoljno in brezplačno darovanje tkiv in celic.
Where appropriate data gathered through other channels and supporting the findings of the two surveys (e.g. exchanges with the national competent authorities during the bi-annual meetings with the Commission, mandatory annual reporting to the Commission of serious adverse reactions and events (SARE), alerts launched in the Rapid Alerts for Tissues and Cells (RATC) platform, Eurobarometer survey exploring the views of EU citizens on tissue and cell donation and the output of a number of relevant EU-funded projects and studies) were also taken into account.
Kadar je bilo to ustrezno, so bili upoštevani tudi podatki, zbrani po drugih poteh in v podporo ugotovitvam obeh anket (npr. izmenjava informacij s pristojnimi nacionalnimi organi na dveletnih srečanjih s Komisijo, obvezno letno poročanje Komisiji o hudih neželenih reakcijah in dogodkih, opozorila, poslana prek platforme za hitro obveščanje o tkivih in celicah (RATC), raziskava Eurobarometra o mnenju državljanov EU o darovanju tkiv in celic ter rezultati več zadevnih projektov in študij, ki jih je financirala EU).
On the other hand, ten Member States indicated that, especially for sperm donors, such registries are maintained by the tissue establishments.
Po drugi strani pa je deset držav članic navedlo, da take registre vzdržujejo ustanove za tkiva in celice, zlasti za darovalce sperme.
It has to be noted that similar to donor selection, more stringent testing requirements introduced by some Member States are sometimes perceived by healthcare professionals ordering tissues or cells from other Member States as barriers hampering development and the cross-border movement of tissues and cells between Member States.
Opozoriti je treba, da - podobno kot pri izbiranju darovalcev - zdravstveni delavci, ki naročajo tkiva ali celice iz drugih držav članic, včasih strožje zahteve, ki so jih uvedle nekatere države članice, vidijo kot ovire, ki zavirajo razvoj in čezmejni prenos tkiv in celic med državami članicami.
Fig. 8.
Slika 8
Legend: HSC = haematopietic stem cells
Legenda: KMC = krvotvorne matične celice
As regards the implementation of the VUD principle, the Commission survey showed that Member States overall comply with Article 12 of Directive 2004/23/EC requiring them to take the necessary measures to encourage VUD.
V zvezi z izvajanjem načela PBD je anketa Komisije pokazala, da države članice na splošno ravnajo v skladu s členom 12 Direktive 2004/23/ES, ki zahteva, da sprejmejo potrebne ukrepe za spodbujanje prostovoljnega in brezplačnega darovanja.
Tissue and cell reception, processing, storage, labelling and packaging.
Prevzem, predelava, hranjenje, označevanje in pakiranje tkiv in celic.
Non-reproductive tissues and cells.
Nereproduktivna tkiva in celice.