natgillin/translations-raw huggingface dataset:
The Committee for Advanced Therapies, with its unique expertise, should have a prominent role in the provision of such advice.
Odbor za napredno zdravljenje bi moral imeti zaradi posebnega strokovnega znanja pomembno vlogo pri zagotavljanju takega nasveta.
Studies necessary to demonstrate the quality and non-clinical safety of advanced therapy medicinal products are often carried out by small and medium-sized enterprises.
Študije, ki so potrebne za dokazovanje kakovosti in neklinične varnosti zdravil za napredno zdravljenje, pogosto izvajajo mala in srednje velika podjetja.
As an incentive to conduct those studies, a system of evaluation and certification of the resulting data by the Agency, independently of any marketing authorisation application, should be introduced.
Kot spodbudo za vodenje teh študij bi Agencija morala uvesti sistem za vrednotenje in potrjevanje dobljenih podatkov, neodvisno od kakršnih koli vlog za pridobitev dovoljenja za promet z zdravilom.
Even though the certification would not be legally binding, this system should also aim at facilitating the evaluation of any future application for clinical trials and marketing authorisation application based on the same data.
Čeprav potrjevanje ne bi bilo pravno zavezujoče, bi moral biti cilj tega sistema tudi lažje vrednotenje kakršnih koli prihodnjih vlog za klinična preskušanja in vlog za pridobitev dovoljenja za promet z zdravilom na podlagi istih podatkov.
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 the package leaflet.
Za upoštevanje znanstvenega in tehničnega napredka bi bilo treba Komisijo pooblastiti 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, označevanja in navodil za uporabo.
The Commission should ensure that relevant information on envisaged measures is made available to interested parties without delay.
Komisija bi morala zagotoviti, da so pomembne informacije o predvidenih ukrepih takoj dostopne zainteresiranim stranem.
Provisions should be laid down to report on the implementation of this Regulation after experience has been gained, with a particular attention to the different types of advanced therapy medicinal products authorised.
Treba bi bilo sprejeti določbe o poročanju glede izvajanja te uredbe po pridobitvi izkušenj in pri tem posebno pozornost posvetiti različnim vrstam odobrenih zdravil za napredno zdravljenje.
The opinions of the Scientific Committee for Medicinal Products and Medical Devices concerning tissue engineering and that of the European Group on Ethics in Science and New Technologies have been taken into account, as well as international experience in this field.
Upoštevano je bilo mnenje Znanstvenega odbora za zdravila in medicinske pripomočke v zvezi s tkivnim inženirstvom ter mnenje Evropske skupine za etiko znanosti in novih tehnologij, kakor tudi mednarodne izkušnje na tem področju.
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 [13].
Ukrepe, potrebne za izvajanje te uredbe, bi bilo treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [13].
In particular, the Commission should be empowered to adopt amendments to Annexes I to IV to this Regulation and to Annex I to Directive 2001/83/EC.
Zlasti bi bilo treba Komisijo pooblastiti za sprejetje sprememb prilog I do IV k tej uredbi in Priloge I k Direktivi 2001/83/ES.
Since those measures are of general scope and are designed to amend non-essential elements of this Regulation and of Directive 2001/83/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker so ti ukrepi splošnega pomena in so namenjeni spreminjanju nebistvenih določb te uredbe in Direktive 2001/83/ES, morajo biti sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Those measures are essential for the proper operation of the whole regulatory framework and should therefore be adopted as soon as possible.
Ti ukrepi so bistveni za pravilno delovanje celotnega regulatornega okvira in bi jih zato bilo treba sprejeti čim prej.
Directive 2001/83/EC and Regulation (EC) No 726/2004 should therefore be amended accordingly,
Direktivo 2001/83/ES in Uredbo (ES) št. 726/bi bilo zato treba ustrezno spremeniti –
SUBJECT MATTER AND DEFINITIONS
PREDMET IN OPREDELITVE
This Regulation lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products.
Ta uredba določa posebna pravila v zvezi s pridobivanjem dovoljenja za promet z zdravilom za napredno zdravljenje, nadzorom in farmakovigilanco.
In addition to the definitions laid down in Article 1 of Directive 2001/83/EC and in Article 3, points (a) to (l) and (o) to (q) of Directive 2004/23/EC, the following definitions shall apply for the purposes of this Regulation:
Poleg opredelitev iz člena 1 Direktive 2001/83/ES in iz člena 3, točke (a) do (l) ter (o) do (q) Direktive 2004/23/ES se za na namen te uredbe uporabljajo naslednje opredelitve:
‘Advanced therapy medicinal product’ means any of the following medicinal products for human use:
„Zdravilo za napredno zdravljenje“ pomeni katero koli od naslednjih zdravil za uporabo v humani medicini:
a gene therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC,
zdravilo za gensko zdravljenje, kakor je opredeljeno v delu IV Priloge I k Direktivi 2001/83/ES,
a somatic cell therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC,
zdravilo za somatsko celično zdravljenje, kakor je opredeljeno v delu IV Priloge I k Direktivi 2001/83/ES,
a tissue engineered product as defined in point (b).
izdelek tkivnega inženirstva, kakor je opredeljen v točki (b).
‘Tissue engineered product’ means a product that:
„Izdelek tkivnega inženirstva“ pomeni izdelek, ki:
contains or consists of engineered cells or tissues, and
vsebuje inženirsko obravnavane celice ali tkiva, ali je sestavljen iz njih, in
is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue.
je predstavljen z lastnostmi za zdravljenje ali se uporablja pri ljudeh ali se daje ljudem za obnovitev, reparacijo ali nadomestitev človeškega tkiva.
A tissue engineered product may contain cells or tissues of human or animal origin, or both.
Izdelek tkivnega inženirstva lahko vsebuje celice ali tkiva človeškega ali živalskega izvora ali oboje.
The cells or tissues may be viable or non-viable.
Celice ali tkiva so lahko živa ali neživa.
It may also contain additional substances, such as cellular products, bio-molecules, bio-materials, chemical substances, scaffolds or matrices.
Vsebujejo lahko dodatne snovi, kot so celični produkti, biomolekule, biomateriali, kemične snovi, ogrodja ali matrice.
Products containing or consisting 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, shall be excluded from this definition.
Iz te opredelitve so izvzeti izdelki, ki vsebujejo ali so sestavljeni izključno iz neživih človeških ali živalskih celic in/ali tkiv, in ne vsebujejo živih celic ali tkiv ter katerih glavni način delovanja ni predvsem farmakološki, imunološki ali presnovni.
Cells or tissues shall be considered ‘engineered’ if they fulfil at least one of the following conditions:
Celice ali tkiva se štejejo za „inženirsko obravnavane“, če izpolnjujejo vsaj enega od naslednjih pogojev:
the cells or tissues have been subject to substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved.
celice ali tkiva so bila podvržena bistveni manipulaciji, tako da so bile dosežene biološke značilnosti, fiziološke funkcije ali strukturne lastnosti, pomembne za predvideno obnovitev, reparacijo ali nadomestitev.
The manipulations listed in Annex I, in particular, shall not be considered as substantial manipulations,
Predvsem se kot bistvene manipulacije ne štejejo manipulacije iz Priloge I,
the cells or tissues are not intended to be used for the same essential function or functions in the recipient as in the donor.
celice ali tkiva niso namenjena uporabi za enake bistvene funkcije ali funkcije pri prejemniku, kot so bile pri darovalcu.
‘Combined advanced therapy medicinal product’ means an advanced therapy medicinal product that fulfils the following conditions:
„Kombinirano zdravilo za napredno zdravljenje“ pomeni zdravilo za napredno zdravljenje, ki izpolnjuje naslednje pogoje:
it must incorporate, as an integral part of the product, one or more medical devices within the meaning of Article 1(2)(a) of Directive 93/42/EEC or one or more active implantable medical devices within the meaning of Article 1(2)(c) of Directive 90/385/EEC, and
kot sestavni del izdelka mora vključevati enega ali več medicinskih pripomočkov v smislu člena 1(2)(a) Direktive 93/42/EGS ali enega ali več aktivnih medicinskih pripomočkih za vsaditev v smislu člena 1(2)(c) Direktive 90/385/EGS in
its cellular or tissue part must contain viable cells or tissues, or
njegov celični ali tkivni del mora vsebovati žive celice ali tkiva ali
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.
njegov celični ali tkivni del, ki vsebuje nežive celice ali tkiva, mora imeti na človeško telo učinek, ki se lahko šteje za primarnega glede na učinek omenjenih pripomočkov.
Where a product contains viable cells or tissues, the pharmacological, immunological or metabolic action of those cells or tissues shall be considered as the principal mode of action of the product.
Če izdelek vsebuje žive celice ali tkiva, se farmakološko, imunološko ali presnovno delovanje teh celic ali tkiv upošteva kot glavni način delovanja izdelka.
An advanced therapy medicinal product containing both autologous (emanating from the patient himself) and allogeneic (coming from another human being) cells or tissues shall be considered to be for allogeneic use.
Zdravilo za napredno zdravljenje, ki vsebuje avtologne (ki izvirajo od bolnika samega) ali alogenske (ki izvirajo od drugih ljudi) celice ali tkiva, se šteje, da je namenjeno alogenski uporabi.
A product which may fall within the definition of a tissue engineered product and within the definition of a somatic cell therapy medicinal product shall be considered as a tissue engineered product.
Izdelek, ki je lahko zajet z opredelitvijo izdelka tkivnega inženirstva in z opredelitvijo zdravila za somatsko celično zdravljenje, se šteje kot izdelek tkivnega inženirstva.
A product which may fall within the definition of:
Izdelek, ki je lahko zajet z opredelitvijo:
a somatic cell therapy medicinal product or a tissue engineered product, and
zdravilo za somatsko celično zdravljenje ali izdelek tkivnega inženirstva in
a gene therapy medicinal product,
zdravilo za gensko zdravljenje
shall be considered as a gene therapy medicinal product.
se šteje za zdravilo za gensko zdravljenje.
MARKETING AUTHORISATION REQUIREMENTS
ZAHTEVE ZA DOVOLJENJE ZA PROMET Z ZDRAVILOM
Donation, procurement and testing
Darovanje, pridobivanje in testiranje
Where an advanced therapy medicinal product contains human cells or tissues, the donation, procurement and testing of those cells or tissues shall be made in accordance with Directive 2004/23/EC.
Kadar zdravilo za napredno zdravljenje vsebuje človeške celice ali tkiva, se darovanje, pridobivanje in testiranje teh celic ali tkiv izvede v skladu z Direktivo 2004/23/ES.
Clinical trials
Klinična preskušanja
The rules set out in Article 6(7) and Article 9(4) and (6) of Directive 2001/20/EC in respect of gene therapy and somatic cell therapy medicinal products shall apply to tissue engineered products.
Pravila iz člena 6(7) in člena 9(4) in (6) Direktive 2001/20/ES glede zdravil za gensko in somatsko celično zdravljenje se uporabljajo za izdelke tkivnega inženirstva.
The Commission shall, after consulting the Agency, draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products.
Komisija po posvetovanju z Agencijo pripravi podrobne smernice o dobri klinični praksi, specifične za zdravila za napredno zdravljenje.
Good manufacturing practice
Dobra proizvodna praksa
The Commission shall, after consulting the Agency, draw up guidelines in line with the principles of good manufacturing practice and specific to advanced therapy medicinal products.
Komisija po posvetu z Agencijo oblikuje smernice v skladu z načeli dobre proizvodne prakse, specifične za zdravila za napredno zdravljenje.
Issues specific to medical devices
Vprašanja, značilna za medicinske pripomočke
A medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex I to Directive 93/42/EEC.
Medicinski pripomoček, ki je sestavni del kombiniranega zdravila za napredno zdravljenje, izpolnjuje bistvene zahteve iz Priloge I k Direktivi 93/42/EGS.
An active implantable medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex 1 to Directive 90/385/EEC.
Aktivni medicinski pripomoček za vsaditev, ki je sestavni del kombiniranega zdravila za napredno zdravljenje, izpolnjuje bistvene zahteve iz Priloge 1 k Direktivi 90/385/EGS.
Specific requirements for advanced therapy medicinal products containing devices
Posebne zahteve za zdravila za napredno zdravljenje, ki vključujejo pripomočke
In addition to the requirements laid down in Article 6(1) of Regulation (EC) No 726/2004, applications for the authorisation of an advanced therapy medicinal product containing medical devices, bio-materials, scaffolds or matrices shall include a description of the physical characteristics and performance of the product and a description of the product design methods, in accordance with Annex I to Directive 2001/83/EC.
Poleg zahtev iz člena 6(1) Uredbe (ES) št. 726/2004 vsebujejo vloge za pridobitev dovoljenja za promet z zdravilom za napredno zdravljenje, ki vključujejo medicinske pripomočke, biomateriale, ogrodja ali matrice, opis fizikalnih lastnosti izdelka in njegovega delovanja ter opis metod za načrtovanje izdelka v skladu s Prilogo I k Direktivi 2001/83/ES.
MARKETING AUTHORISATION PROCEDURE
POSTOPEK ZA PRIDOBITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
Evaluation procedure
Postopek vrednotenja
The Committee for Medicinal Products for Human Use shall consult the Committee for Advanced Therapies on any scientific assessment of advanced therapy medicinal products necessary to draw up the scientific opinions referred to in Article 5(2) and (3) of Regulation (EC) No 726/2004.
Odbor za zdravila za uporabo v humani medicini se posvetuje z Odborom za napredno zdravljenje o vsaki znanstveni oceni zdravil za napredno zdravljenje, ki je potrebna za pripravo znanstvenega mnenja iz členov 5(2) in (3) Uredbe (ES) št. 726/2004.
The Committee for Advanced Therapies shall also be consulted in the event of re-examination of the opinion pursuant to Article 9(2) of Regulation (EC) No 726/2004.
Z Odborom za napredno zdravljenje se je treba posvetovati tudi v primeru ponovnega pregleda mnenja v skladu s členom 9(2) Uredbe (ES) št. 726/2004.
When preparing a draft opinion for final approval by the Committee for Medicinal Products for Human Use, the Committee for Advanced Therapies shall endeavour to reach a scientific consensus.
Odbor za napredno zdravljenje si pri pripravi osnutka mnenja za končno odobritev s strani Odbora za zdravila za humano uporabo prizadeva doseči znanstveno soglasje.
If such consensus cannot be reached, the Committee for Advanced Therapies shall adopt the position of the majority of its members.
Če takega soglasja ni mogoče doseči, Odbor za napredno zdravljenje sprejme stališče večine svojih članov.
The draft opinion shall mention the divergent positions and the grounds on which they are based.
V osnutku mnenja se navedejo ločena mnenja in razlogi, na katerih temeljijo.
The draft opinion given by the Committee for Advanced Therapies under paragraph 1 shall be sent to the Chairman of the Committee for Medicinal Products for Human Use in a timely manner so as to ensure that the deadline laid down in Article 6(3) or Article 9(2) of Regulation (EC) No 726/2004 can be met.
Osnutek mnenja, ki ga Odbor za napredno zdravljenje poda v skladu z odstavkom 1, se pošlje predsedniku Odbora za zdravila za uporabo v humani medicini pravočasno, da se zagotovi upoštevanje roka iz člena 6(3) ali člena 9(2) Uredbe (ES) št. 726/2004.
Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5(2) and (3) of Regulation (EC) No 726/2004 is not in accordance with the draft opinion of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences.
Kadar znanstveno mnenje o zdravilu za napredno zdravljenje, ki ga pripravi Odbor za zdravila za uporabo v humani medicini na podlagi člena 5(2) in (3) Uredbe (ES) št. 726/2004, ni v skladu z osnutkom mnenja Odbora za napredno zdravljenje, Odbor za zdravila za uporabo v humani medicini priloži svojemu mnenju podrobno znanstveno razlago za razhajanja.
The Agency shall draw up specific procedures for the application of paragraphs 1 to 4.
Agencija pripravi posebne postopke za uporabo odstavkov 1 do 4.
Combined advanced therapy medicinal products
Kombinirana zdravila za napredno zdravljenje
Where a combined advanced therapy medicinal product is concerned, the whole product shall be subject to final evaluation by the Agency.
Za kombinirano zdravilo za napredno zdravljenje velja, da za celoten izdelek končno ovrednotenje poda Agencija.
The application for a marketing authorisation for a combined advanced therapy medicinal product shall include evidence of conformity with the essential requirements referred to in Article 6.
Vloga za pridobitev dovoljenja za promet s kombiniranim zdravilom za napredno zdravljenje vključuje dokazilo o skladnosti z bistvenimi zahtevami iz člena 6.
The application for a marketing authorisation for a combined advanced therapy medicinal product shall include, where available, the results of the assessment by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC of the medical device part or active implantable medical device part.
Vloga za pridobitev dovoljenja za promet s kombiniranim zdravilom za napredno zdravljenje vsebuje, če je ta na voljo, oceno vključenih medicinskih pripomočkov ali aktivnih medicinskih pripomočkov za vsaditev, ki jo pripravi priglašeni organ v skladu z Direktivo 93/42/EGS ali Direktivo 90/385/EGS.
The Agency shall recognise the results of that assessment in its evaluation of the medicinal product concerned.
Agencija prizna rezultate navedene ocene pri vrednotenju zadevnega zdravila.
The Agency may request the relevant notified body to transmit any information related to the results of its assessment.
Agencija lahko od priglašenega organa zahteva, da pošlje katere koli informacije v zvezi z izsledki njegove ocene.
The notified body shall transmit the information within a period of one month.
Priglašeni organ pošlje informacije v enem mesecu.
If the application does not include the results of the assessment, the Agency shall seek an opinion on the conformity of the device part with Annex I to Directive 93/42/EEC or Annex 1 to Directive 90/385/EEC from a notified body identified in conjunction with the applicant, unless the Committee for Advanced Therapies advised by its experts for medical devices decides that involvement of a notified body is not required.
Če vloga ne vsebuje ocene, Agencija od priglašenega organa, ki ga določi skupaj z vlagateljem, pridobi mnenje o skladnosti pripomočka s Prilogo I k Direktivi 93/42/EGS ali Prilogo 1 k Direktivi 90/385/EGS, razen če Odbor za napredno zdravljenje po nasvetu svojih strokovnjakov za medicinske pripomočke odloči, da sodelovanje priglašenega organa ni potrebno.
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
Summary of product characteristics
Povzetek glavnih značilnosti zdravila
By way of derogation from Article 11 of Directive 2001/83/EC, the summary of the product characteristics for advanced therapy medicinal products shall contain the information listed in Annex II to this Regulation, in the order indicated therein.
Z odstopanjem od člena 11 Direktive 2001/83/ES vsebuje povzetek glavnih značilnosti zdravil za napredno zdravljenje informacije iz Priloge II k tej uredbi v tam navedenem vrstnem redu.
Labelling of outer/immediate packaging
Označevanje zunanje/stične ovojnine
By way of derogation from Articles 54 and 55(1) of Directive 2001/83/EC, the particulars listed in Annex III to this Regulation shall appear on the outer packaging of advanced therapy medicinal products or, where there is no outer packaging, on the immediate packaging.
Z odstopanjem od členov 54 in 55(1) Direktive 2001/83/ES se na zunanji ovojnini zdravil za napredno zdravljenje ali kadar zunanje ovojnine ni, na stični ovojnini, navedejo podrobni podatki, našteti v Prilogi III k tej uredbi.
Special immediate packaging
Posebna stična ovojnina
In addition to the particulars mentioned in Article 55(2) and (3) of Directive 2001/83/EC, the following particulars shall appear on the immediate packaging of advanced therapy medicinal products:
Poleg podrobnih podatkov iz člena 55(2) in (3) Direktive 2001/83/ES se na stični ovojnini zdravil za napredno zdravljenje navedejo še naslednji podrobni podatki:
the unique donation and product codes, as referred to in Article 8(2) of Directive 2004/23/EC;
enotne oznake darovanja in izdelkov, kakor so navedene v členu 8(2) Direktive 2004/23/ES;
in the case of advanced therapy medicinal products for autologous use, the unique patient identifier and the statement ‘For autologous use only’.
enotna identifikacijska oznaka bolnika in navedba „samo za avtologno uporabo“ v primeru zdravil za napredno zdravljenje za avtologno uporabo.
Package leaflet
Navodilo za uporabo
By way of derogation from Article 59(1) of Directive 2001/83/EC, the package leaflet for an advanced therapy medicinal product shall be drawn up in accordance with the summary of product characteristics and shall include the information listed in Annex IV to this Regulation, in the order indicated therein.
Z odstopanjem od člena 59(1) Direktive 2001/83/ES so navodila za uporabo zdravil za napredno zdravljenje sestavljena v skladu s povzetkom glavnih značilnosti zdravila in vsebujejo podatke, naštete v Prilogi IV k tej uredbi in v vrstnem redu, navedenem v njej.
The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.
Navodilo za uporabo odraža izsledke posvetovanj s ciljnimi skupinami bolnikov, da se zagotovi berljivost, jasnost in enostavna uporaba navodil.
POST-AUTHORISATION REQUIREMENTS
ZAHTEVE PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM
Post-authorisation follow-up of efficacy and adverse reactions, and risk management
Spremljanje učinkovitosti in neželenih učinkov ter obvladovanje tveganj po pridobitvi dovoljenja za promet z zdravilom