natgillin/translations-raw huggingface dataset:
The Single European Code shall be printed with the Donation Identification Sequence and Product Identification Sequence separated by a single space or as two successive lines.
Enotna evropska koda je natisnjena z identifikacijskim zaporedjem darovanja in identifikacijskim zaporedjem izdelka, ki sta ločena z enojnim presledkom ali navedena v dveh zaporednih vrsticah.
Requirements related to the application of the Single European Code
Zahteve v zvezi z uporabo enotne evropske kode
Member States shall ensure that the following minimum requirements are complied with by tissue establishments, including importing tissue establishments as defined by Commission Directive (EU) 2015/566: (a) allocate a Single European Code to all tissues and cells requiring application of this code at the latest before their distribution for human application;
Države članice zagotovijo, da ustanove za tkiva, vključno z ustanovami uvoznicami za tkiva, kot so opredeljene z Direktivo Komisije (EU) 2015/566, izpolnjujejo naslednje minimalne zahteve: (a) dodelijo enotno evropsko kodo vsem tkivom in celicam, za katere se zahteva uporaba te kode, najpozneje pred razdeljevanjem za zdravljenje ljudi;
allocate a donation identification sequence after procuring the tissues and cells, or when receiving them from a procurement organisation, or when importing tissues and cells from a third country supplier.
dodelijo identifikacijsko zaporedje darovanja po pridobitvi tkiv in celic ali ko jih prejmejo od organizacije za pridobivanje ali ko tkiva in celice uvozijo od dobavitelja iz tretje države.
The donation identification sequence shall include:
Identifikacijsko zaporedje darovanja zajema:
their EU tissue establishment code as assigned in the EU Tissue Establishment Compendium;
EU-kodo ustanove za tkiva, kot je navedena v EU-kompendiju ustanov za tkiva;
a unique donation number allocated by the tissue establishment, unless such number is allocated centrally at national level or is a globally unique number as used by the ISBT128 coding system.
edinstveno številko darovanja, ki jo dodeli ustanova za tkiva, razen če se taka številka dodeli centralno na nacionalni ravni ali je edinstvena številka na globalni ravni, kot se uporablja v sistemu kodiranja ISBT128.
Where allowed, in case of pooling of tissues and cells, a new donation identification number shall be allocated to the final product; traceability with the individual donations shall be ensured by the tissue establishment in which pooling is carried out;
V primeru združevanja tkiv in celic se končnemu izdelku dodeli nova identifikacijska številka darovanja, kadar je to dovoljeno; sledljivost posameznih darovanj zagotovi ustanova za tkiva, v kateri se izvaja združevanje;
do not alter the donation identification sequence once it is allocated to tissues and cells released for circulation, unless it is necessary to correct an encoding error; any correction requires proper documentation;
ne spreminjajo identifikacijskega zaporedja darovanja, ko je enkrat dodeljeno tkivom in celicam, sproščenih v promet, razen če je treba popraviti napako v kodiranju; za vsak popravek je potrebna ustrezna dokumentacija;
use one of the permitted product coding systems and the corresponding tissue and cell product numbers included in the EU Tissue and Cell Product Compendium at the latest before their distribution for human application;
uporabijo enega od dovoljenih sistemov kodiranja izdelkov in ustrezne številke izdelkov iz tkiv in celic, vključene v EU-kompendij izdelkov iz tkiv in celic, najpozneje pred njihovo razdelitvijo za zdravljenje ljudi;
use an appropriate split number and expiry date.
uporabijo ustrezno številko podskupine lotov in datum izteka roka uporabnosti.
For tissues and cells for which no expiry date is defined, the expiry date shall be 00000000 at the latest before their distribution for human application;
Za tkiva in celice brez opredeljenega roka uporabnosti je datum izteka roka uporabnosti 00000000 najpozneje pred njihovo razdelitvijo za zdravljenje ljudi;
apply the Single European Code on the label of the product concerned in an indelible and permanent manner and mention that code in the relevant accompanying documentation at the latest before its distribution for human application.
enotno evropsko kodo neizbrisno in trajno navedejo na nalepki zadevnega izdelka ter v ustrezni priloženi dokumentaciji najpozneje pred njihovo razdelitvijo za zdravljenje ljudi.
The tissue establishment may entrust this task to a third party or third parties, provided the tissue establishment ensures compliance with this Directive, in particular in terms of uniqueness of the code.
Ustanova za tkiva lahko to nalogo zaupa tretjim osebam, če ustanova za tkiva zagotovi skladnost s to direktivo, zlasti v zvezi z edinstvenostjo kode.
Where the label size precludes the application of the Single European Code on the label, the code shall be unambiguously linked to tissues and cells packaged with such a label through the accompanying documentation;
Kadar velikost nalepke onemogoča navedbo enotne evropske kode na njej, se koda v priloženi dokumentaciji nedvoumno poveže s tkivi in celicami, pakiranimi s tako nalepko;
notify the competent authority or authorities when:
pristojne organe obvesti, ko:
information contained in the EU Tissue Establishment Compendium requires an update or correction;
je treba posodobiti ali popraviti informacije v EU-kompendiju ustanov za tkiva,
the EU Tissue and Cell Product Compendium requires an update;
je treba posodobiti EU-kompendij izdelkov iz tkiv in celic,
the tissue establishment observes a situation of significant non-compliance with the requirements relating to the Single European Code concerning tissues and cells received from other EU tissue establishments;
ustanova za tkiva odkrije primer bistvenega neizpolnjevanja zahtev glede enotne evropske kode v zvezi s tkivi in celicami, prejetimi od druge ustanove za tkiva v EU;
take the necessary measures in case of incorrect application of the Single European Code on the label.
sprejmejo potrebne ukrepe v primeru nepravilne uporabe enotne evropske kode na nalepki.
Member States shall ensure that the following minimum requirements are applied by all competent authorities:
Države članice zagotovijo, da vsi pristojni organi izpolnjujejo naslednje minimalne zahteve:
ensure the allocation of a unique tissue establishment number to all tissue establishments authorised, accredited, designated or licensed in its Member State.
zagotovijo dodelitev edinstvene številke ustanove za tkiva vsem ustanovam za tkiva z akreditacijo, imenovanjem, odobritvijo ali dovoljenjem v njihovi državi članici.
If a tissue establishment has different physical locations, but has one system for allocating unique donation numbers, it may be deemed to be one and the same tissue establishment.
Če ima ustanova za tkiva različne fizične lokacije, vendar ima en sistem za dodeljevanje edinstvene številke darovanja, se lahko šteje za eno in isto ustanovo za tkiva.
If a tissue establishment uses two or more systems to allocate unique donation numbers, such an entity shall be allocated separate tissue establishment numbers corresponding to the number of allocation systems used;
Če ustanova za tkiva uporablja dva sistema ali več sistemov za dodeljevanje edinstvene številke darovanja, se takemu subjektu dodelijo različne številke ustanov za tkiva, ki ustrezajo številu uporabljenih sistemov za dodeljevanje;
decide which system or systems shall be used for the allocation of unique donation numbers in their Member State.
določijo, kateri sistemi se uporabljajo za dodelitev edinstvene številke darovanja v njihovi državi članici.
Permitted systems of allocation include national systems establishing centralised allocation of the nationally unique donation number or systems requiring each tissue establishment to allocate unique donation numbers or international systems that allocate globally unique donation numbers that are compatible with the Single European Code.
Dovoljeni sistemi dodeljevanja vključujejo nacionalne sisteme z vzpostavitvijo centraliziranega dodeljevanja nacionalno edinstvene številke darovanja ali sisteme, ki od vsake ustanove za tkiva zahtevajo dodelitev edinstvene številke darovanja, ali mednarodne sisteme, ki dodeljujejo edinstvene številke darovanja na globalni ravni, ki so združljive z enotno evropsko kodo;
monitor and enforce the full implementation of the Single European Code in their Member State;
spremljajo in zagotavljajo celovito uporabo enotne evropske kode v njihovi državi članici;
ensure the validation of the data on the tissue establishments contained in the EU Tissue Establishment Compendium for their Member State and update the Compendium without undue delay in particular in the following situations:
zagotavljajo potrjevanje podatkov o ustanovah za tkiva iz EU-kompendija ustanov za tkiva za njihovo državo članico in kompendij posodabljajo brez nepotrebnega odlašanja zlasti v naslednjih primerih:
when a new tissue establishment is authorised, designated, accredited, or licensed;
ko nova ustanova za tkiva prejme odobritev, imenovanje, akreditacijo ali dovoljenje;
when tissue establishment information changes or is not correctly recorded in the EU Tissue Establishment Compendium;
ko se spremenijo informacije o ustanovi za tkiva ali te informacije niso pravilno navedene v EU-kompendiju ustanov za tkiva;
when the accreditation, designation, authorisation or licence details of a tissue establishment, as listed in Annex VIII to this Directive, change, including:
ko se spremenijo podatki v akreditaciji, imenovanju, odobritvi ali dovoljenju ustanove za tkiva, kot je navedeno v Prilogi VIII k tej direktivi, vključno z:
accreditation, designation, authorisation or licence for a new tissue or cell type,
akreditacijo, imenovanjem, odobritvijo ali dovoljenjem za novo vrsto tkiv ali celic,
accreditation, designation, authorisation or licence for a new prescribed activity,
akreditacijo, imenovanjem, odobritvijo ali dovoljenjem za novo določeno dejavnost,
details of any conditions and or exemptions added to an authorisation,
podatki o kakršnih koli pogojih oz. izjemah, dodanih odobritvi,
suspension, in part or in full, of a specific accreditation, designation, authorisation or licence for a particular activity or tissue or cell type;
delno ali popolno začasno prekinitvijo specifične akreditacije, imenovanja, odobritve ali dovoljenja za določeno dejavnost ali vrsto tkiv ali celic,
revocation, in part or in full, of an accreditation, designation, authorisation or licence for a tissue establishment,
delnim ali popolnim preklicem akreditacije, imenovanja, odobritve ali dovoljenja ustanove za tkiva,
situations when a tissue establishment voluntarily ceases, in part or in full, the activity or activities for which it is authorised, accredited, designated or licensed.
primeri, v katerih ustanova za tkiva delno ali v celoti prostovoljno preneha z dejavnostmi, za katere ima odobritev, akreditacijo, imenovanje ali dovoljenje.
Without undue delay means in not later than 10 working days for any changes substantially affecting the authorisation, accreditation, designation or licence of the tissue establishments concerned.
Nepotrebno odlašanje pomeni najpozneje deset delovnih dni za kakršne koli spremembe, ki bistveno vplivajo na odobritev, akreditacijo, imenovanje ali dovoljenje zadevne ustanove za tkiva.
When a tissue establishment is authorised by two or more competent authorities for different types of tissues and cells or different activities, each competent authority shall update the information relating to those activities for which it is responsible;
Ko ima ustanova za tkiva odobritev dveh ali več pristojnih organov za različne vrste tkiv in celic ali različne dejavnosti, vsak pristojni organ posodobi informacije v zvezi z navedenimi dejavnostmi, za katere je pristojen;
Alert the competent authorities of another Member State when they observe incorrect information in the EU Tissue Establishment Compendium relating to the other Member State or when they observe a situation of significant non-compliance with the provisions relating to the Single European Code relating to the other Member State;
opozorijo pristojne organe druge države članice, ko odkrijejo nepravilne informacije v EU-kompendiju ustanov za tkiva, ki se nanašajo na drugo državo članico, ali ko odkrijejo primer bistvenega neizpolnjevanja določb glede enotne evropske kode, ki se nanaša na drugo državo članico;
Alert the Commission and the other Competent Authorities when in their assessment the EU Tissue and Cell Product Compendium requires an update.
opozorijo Komisijo in druge pristojne organe, ko je EU-kompendij izdelkov iz tkiv in celic po njihovi oceni treba posodobiti.
The application of the Single European Code does not preclude the additional application of other codes in accordance with Member States' national requirements.
Uporaba enotne evropske kode ne izključuje dodatne uporabe drugih kod v skladu z nacionalnimi zahtevami držav članic.
Accessibility and maintenance of the European coding system
Dostopnost in vzdrževanje evropskega sistema kodiranja
The Commission shall host and maintain an IT platform (“EU Coding Platform”) which contains:
Komisija gosti in vzdržuje informacijsko platformo (‚platformo EU za kodiranje‘), ki zajema:
the EU Tissue Establishment Compendium;
EU-kompendij ustanov za tkiva;
the EU Tissue and Cell Product Compendium.
EU-kompendij izdelkov iz tkiv in celic.
The Commission shall ensure that the information contained in the EU Coding Platform is publicly available before 29 October 2016.
Komisija zagotovi, da so informacije na platformi EU za kodiranje javno dostopne pred 29. oktobrom 2016.
The Commission shall update when needed the EUTC and ensure the overall update of the EU Tissue and Cell Product Compendium.
Komisija po potrebi posodobi EUTC in zagotovi splošno posodabljanje EU-kompendija izdelkov iz tkiv in celic.
The Commission considers that it is necessary that agreements are established with the organisations managing ISBT128 and Eurocode to ensure that updated product codes are regularly made available to the Commission for inclusion in the EU Tissue and Cell Product Compendium.
Komisija meni, da je treba sprejeti sporazume z organizacijami, ki upravljajo ISBT128 in Eurocode, za zagotovitev, da so posodobljene kode izdelkov redno na voljo Komisiji za vključitev v EU-kompendij izdelkov iz tkiv in celic.
If such organisations do not comply with the terms of the memoranda of understanding, the Commission may suspend, partially or in full, the future use of their respective product codes, having considered the sufficient supply of the concerned type of products in the Member States including a transitional period and having consulted the Member State experts through the Competent Authorities on Substances of Human Origin Expert Group.
Če takšne organizacije ne izpolnjujejo pogojev iz memorandumov o soglasju, lahko Komisija deloma ali v celoti začasno prekine nadaljnjo uporabo njihovih ustreznih kod izdelkov, ob upoštevanju zadostne dobave zadevne vrste izdelkov v državah članicah, vključno s prehodnim obdobjem, in po posvetovanju s strokovnjaki držav članic prek pristojnih organov strokovne skupine za snovi človeškega izvora.
Tissues and cells already in storage on 29 October 2016 shall be exempted from the obligations relating to the Single European Code, provided the tissues and cells are released for circulation in the Union within five years following that date and under the condition that full traceability is ensured by alternative means.
Tkiva in celice, ki se že hranijo 29. oktobra 2016, so izvzete iz obveznosti v zvezi z enotno evropsko kodo, če se tkiva in celice sprostijo v promet v Uniji v petih letih po navedenem datumu in pod pogojem, da se popolna sledljivost zagotovi na drugačne načine.
For tissues and cells which remain in storage and which are only released for circulation after the expiry of this five-year period and for which the application of the Single European Code is not possible, in particular because the tissues and cells are stored under deep-freeze conditions, the tissue establishments shall use the procedures applicable to products with small labels as laid down in Article 10b paragraph 1(f).
Za tkiva in celice, ki se še naprej hranijo in so v promet sproščeni šele po izteku tega petletnega obdobja ter za katere uporaba enotne evropske kode ni možna, zlasti ker se tkiva in celice hranijo globoko zamrznjeni, ustanove za tkiva uporabijo postopke, ki se uporabljajo za izdelke z majhnimi nalepkami, kot je določeno v odstavku 1(f) člena 10b.
The Annexes are amended in accordance with Annex I to this Directive.
Priloge se spremenijo v skladu s Prilogo I k tej direktivi.
A new Annex VIII is added, the text of which is set out in Annex II to this Directive.
Doda se nova Priloga VIII, katere besedilo je navedeno v Prilogi II k tej direktivi.
They shall apply the legislation from 29 April 2017.
Način sklicevanja določijo države članice.
Article 4
V Bruslju, 8. aprila 2015
Done at Brussels, 8 April 2015.
Predsednik
For the Commission
UL L 102, 7.4.2004, str.
The President
48.
OJ L 102, 7.4.2004, p. 48.
Direktiva Komisije 2006/86/ES z dne 24. oktobra 2006 o izvajanju Direktive 2004/23/ES Evropskega parlamenta in Sveta o zahtevah po sledljivosti, obveščanju o hudih in neželenih reakcijah in pojavih ter nekaterih tehničnih zahtevah za kodiranje, predelavo, konzerviranje, shranjevanje in razdeljevanje človeških tkiv in celic (UL L 294, 25.10.2006, str.
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L 294, 25.10.2006, p.
32).
32).
Direktiva Komisije (EU) 2015/566 z dne 8. aprila 2015 o izvajanju Direktive 2004/23/ES v zvezi s postopki za preverjanje ustreznosti standardov kakovosti in varnosti uvoženih tkiv in celic (UL L 93, 9.4.2015, str.
Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissue (OJ L 93, 9.4.2015, p. 56).’
56).“
The Annexes to Directive 2006/86/EC are amended as follows:
Priloge k Direktivi 2006/86/ES se spremenijo:
Annex II, Part E, is amended as follows:
del E Priloge II se spremeni:
in point 1 the following point (g) is added:
v točki 1 se doda naslednja točka (g):
Single European Code as applicable to the tissues and cells being distributed for human application or the donation identification sequence as applicable to the tissues and cells released for circulation, other than distributed for human application’
enotno evropsko kodo, kot se uporablja za tkiva in celice, ki se razdeljujejo za zdravljenje ljudi, ali identifikacijsko zaporedje darovanja, kot se uporablja za tkiva in celice, ki so sproščene v promet in niso namenjene razdeljevanju za zdravljenje ljudi.“
the second subparagraph of point 1 is replaced by the following:
drugi pododstavek točke 1 se nadomesti z naslednjim:
‘If any of the information under points (d), (e) and (g) above cannot be included on the primary container label, it must be provided on a separate sheet accompanying the primary container.
„Če kateri koli podatek iz točk (d), (e) in (g) ne more biti naveden na nalepki prvotne embalaže, ga je treba priložiti na posebnem listu, priloženem prvotni embalaži.
This sheet must be packaged with the primary container in a manner that ensures that they remain together.’
Ta list mora biti zapakiran s prvotno embalažo na način, ki zagotavlja, da ostaneta skupaj.“
in point 2, the following point (j) is added:
v točki 2 se doda naslednja točka (j):
for imported tissues and cells, the country of procurement and the exporting country (if different from the procurement country)’
v primeru uvoženih tkiv in celic, državo pridobitve in državo izvoznico (če se razlikuje od države pridobitve).“
Annexes III and IV are replaced by the following:
prilogi III in IV se nadomestita z naslednjim:
NOTIFICATION OF SERIOUS ADVERSE REACTIONS
OBVEŠČANJE O RESNIH NEŽELENIH REAKCIJAH
Rapid notification for suspected serious adverse reactions
Hitro obveščanje o sumu resnih neželenih reakcij
Tissue establishment
Ustanova za tkiva
EU tissue establishment code (if applicable)
EU-koda ustanove za tkiva (če je ustrezno)
Reporting date (year/month/day)
Datum poročanja (leto/mesec/dan)
Date and place of procurement or human application (year/month/day)
Datum in kraj pridobitve ali uporabe za zdravljenje ljudi (leto/mesec/dan)
Unique donation identification number
Edinstvena identifikacijska številka darovanja
Date of suspected serious adverse reaction (year/month/day)
Datum suma resne neželene reakcije (leto/mesec/dan)
Type of tissues and cells involved in the suspected serious adverse reaction
Vrste tkiv in celic, uporabljenih v zvezi s sumom resne neželene reakcije
Single European Code of tissues or cells involved in the suspected serious adverse reaction (if applicable)
Enotna evropska koda tkiv in celic, uporabljenih v zvezi s sumom resne neželene reakcije (če je ustrezno)
Type of suspected serious adverse reaction(s)
Vrsta suma resnih neželenih reakcij
Conclusions of Serious Adverse Reactions Investigation
Sklepne ugotovitve preiskave resnih neželenih reakcij
Confirmation date (year/month/day)
Datum potrditve (leto/mesec/dan)
Date of serious adverse reaction (year/month/day)
Datum resne neželene reakcije (leto/mesec/dan)
Confirmation of serious adverse reaction (Yes/No)
Potrditev resne neželene reakcije (da/ne)
Single European Code of tissues or cells involved in the confirmed serious adverse reaction (if applicable)
Enotna evropska koda tkiv ali celic, uporabljenih v zvezi s potrjeno resno neželeno reakcijo (če je ustrezno)
Change of type of serious adverse reaction (Yes/No) If YES, specify
Sprememba vrste resne neželene reakcije (da/ne).
Clinical outcome (if known)
Če je odgovor DA, opredeliti.
Complete recovery
Klinični izid (če je znan)
Minor sequelae
popolna ozdravitev
Serious sequelae
manjše posledice
Death
resne posledice
Outcome of the investigation and final conclusions
smrt
Recommendations for preventive and corrective actions
Rezultat preiskave in končne ugotovitve
ANNEX IV
Priporočila za preventivne in popravne ukrepe
NOTIFICATION OF SERIOUS ADVERSE EVENTS
PRILOGA IV
Rapid notification for suspected serious adverse events
OBVEŠČANJE O RESNIH NEŽELENIH DOGODKIH
Date of serious adverse event (year/month/day)
Hitro obveščanje o sumu resnih neželenih dogodkov
Serious adverse event, which may affect quality and safety of tissues and cells due to a deviation in:
Datum resnega neželenega dogodka (leto/mesec/dan)
Specification
Resen neželeni dogodek, ki lahko vpliva na kakovost in varnost tkiv in celic zaradi nepravilnosti pri:
Tissues and cells defect
Specifikacija
Equipment failure
napake tkiv in celic
Human error
napake v opremi
Other (specify)
človeške napaka
Procurement
drugo (navedite)
Testing
pridobivanju
Transport
testiranju
Processing
prevozu
Storage
predelavi
Distribution
shranjevanju
Materials
razdeljevanju
Others (specify)
materialih
Conclusions of Serious Adverse Events investigation
drugo (navesti)
Root cause analysis (details)
Sklepne ugotovitve preiskave resnih neželenih dogodkov
Corrective measures taken (details)
Analiza izvornega vzroka (podrobnosti)
Annexes VI and VII are replaced by the following:
Sprejeti ukrepi za izboljšanje stanja (podrobnosti) “
ANNEX VI
prilogi VI in VII se nadomestita z naslednjim:
Minimum data to be kept in accordance with Article 9(2)
PRILOGA VI
A. BY TISSUE ESTABLISHMENTS
Najmanjši obseg podatkov, ki jih je treba hraniti v skladu s členom 9(2)
Donor identification
A. PODATKI, KI JIH HRANI USTANOVA ZA TKIVA
Donation identification that will include at least:
Identifikacija darovalca
Identification of the procurement organisation (including contact details) or the tissue establishment
Identifikacija darovanja, ki zajema vsaj naslednje podatke:
Unique donation number
identifikacijo organizacije pridobitve (vključno s kontaktnimi podatki) ali ustanove za tkiva
Date of procurement
edinstveno številko darovanja