natgillin/translations-raw huggingface dataset:
In addition to the requirements for pharmacovigilance laid down in Articles 21 to 29 of Regulation (EC) No 726/2004, the applicant shall detail, in the marketing authorisation application, the measures envisaged to ensure the follow-up of efficacy of advanced therapy medicinal products and of adverse reactions thereto.
Poleg zahtev za farmakovigilanco, določenih v členih 21 do 29 Uredbe (ES) št. 726/2004 vlagatelj v vlogi za pridobitev dovoljenja za promet z zdravilom podrobno navede predvidene ukrepe, s katerimi zagotovi spremljanje učinkovitosti in neželenih učinkov zdravil za napredno zdravljenje.
Where there is particular cause for concern, the Commission shall, on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, characterise, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system, be set up, or that specific post-marketing studies be carried out by the holder of the marketing authorisation and submitted for review to the Agency.
Kadar obstaja poseben razlog za skrb, lahko Komisija po nasvetu Agencije zahteva, da se kot del dovoljenja za promet z zdravilom vzpostavi sistem za obvladovanje tveganj, s katerim se opredeli, opiše, prepreči ali zmanjša na najmanjšo možno raven tveganja, povezana z zdravili za napredno zdravljenje, vključno z vrednotenjem učinkovitosti navedenega sistema, ali da imetnik dovoljenja za promet izvede posebne študije po začetku trženja in jih predloži Agenciji v pregled.
In addition, the Agency may request submission of additional reports evaluating the effectiveness of any risk management system and the results of any such studies performed.
Poleg tega Agencija lahko zahteva predložitev dodatnih poročil o vrednotenju učinkovitosti katerega koli sistema za obvladovanje tveganj in rezultatov izvedenih študij.
Evaluation of the effectiveness of any risk management system and the results of any studies performed shall be included in the periodic safety update reports referred to in Article 24(3) of Regulation (EC) No 726/2004.
Ovrednotenje učinkovitosti katerega koli sistema za obvladovanje tveganj in rezultati izvedenih študij so vključeni v periodična posodobljena poročila o varnosti iz člena 24(3) Uredbe (ES) št. 726/2004.
The Agency shall forthwith inform the Commission if it finds that the marketing authorisation holder has failed to comply with the requirements referred to in paragraph 2.
Agencija nemudoma obvesti Komisijo, če ugotovi, da imetnik dovoljenja za promet ne izpolnjuje zahtev iz odstavka 2.
The Agency shall draw up detailed guidelines relating to the application of paragraphs 1, 2 and 3.
Agencija pripravi podrobne smernice za uporabo odstavkov 1, 2 in 3.
If serious adverse events or reactions occur in relation to a combined advanced therapy medicinal product, the Agency shall inform the relevant national competent authorities responsible for implementing Directives 90/385/EEC, 93/42/EEC and 2004/23/EC.
Če se zaradi kombiniranega zdravila za napredno zdravljenje pojavijo neželeni učinki in dogodki, Agencija o tem obvesti zadevne nacionalne pristojne organe, odgovorne za izvajanje direktiv 90/385/EGS, 93/42/EGS in 2004/23/ES.
The holder of a marketing authorisation for an advanced therapy medicinal product shall establish and maintain a system ensuring that the individual product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the hospital, institution or private practice where the product is used.
Imetnik dovoljenja za promet z zdravili za napredno zdravljenje vzpostavi in vzdržuje sistem zagotavljanja sledljivosti posameznega izdelka ter vhodnih snovi in surovin, vključno z vsemi snovmi, ki prihajajo v stik z vsebovanimi tkivi ali celicami, od virov, izdelave, pakiranja, skladiščenja, transporta do dostave bolnišnici, instituciji ali zasebni praksi, kjer se izdelek uporablja.
The hospital, institution or private practice where the advanced therapy medicinal product is used shall establish and maintain a system for patient and product traceability.
Bolnišnica, institucija ali zasebna praksa, kjer se zdravilo za napredno zdravljenje uporablja, vzpostavi in vzdržuje sistem sledljivosti bolnika in izdelka.
That system shall contain sufficient detail to allow linking of each product to the patient who received it and vice versa.
Sistem vsebuje dovolj podatkov za povezavo vsakega izdelka in bolnika, ki je ta izdelek prejel, in obratno.
Where an advanced therapy medicinal product contains human cells or tissues, the marketing authorisation holder, as well as the hospital, institution or private practice where the product is used, shall ensure that the traceability systems established in accordance with paragraphs 1 and 2 of this Article are complementary to, and compatible with, the requirements laid down in Articles 8 and 14 of Directive 2004/23/EC as regards human cells and tissues other than blood cells, and Articles 14 and 24 of Directive 2002/98/EC as regards human blood cells.
Kadar zdravilo za napredno zdravljenje vsebuje človeške celice ali tkiva, tako imetnik dovoljenja za promet, kakor tudi bolnišnica, institucija ali zasebna praksa, kjer se izdelek uporablja, zagotovijo, da so sistemi sledljivosti, vzpostavljeni v skladu z odstavkoma 1 in 2 tega člena, komplementarni in združljivi z zahtevami iz členov 8 in 14 Direktive 2004/23/ES v zvezi s človeškimi tkivi in celicami, ki niso krvne celice, ter iz členov 14 in 24 Direktive 2002/98/ES v zvezi s krvnimi celicami človeškega izvora.
The marketing authorisation holder shall keep the data referred to in paragraph 1 for a minimum of 30 years after the expiry date of the product, or longer if required by the Commission as a term of the marketing authorisation.
Imetnik dovoljenja za promet hrani podatke iz odstavka 1 najmanj 30 let po izteku roka uporabnosti izdelka ali dlje, če to zahteva Komisija kot pogoj za pridobitev dovoljenja za promet z zdravilom.
In case of bankruptcy or liquidation of the marketing authorisation holder, and in the event that the marketing authorisation is not transferred to another legal entity, the data referred to in paragraph 1 shall be transferred to the Agency.
V primeru stečaja ali likvidacije imetnika dovoljenja za promet in v primeru, da dovoljenje za promet z zdravilom ni preneseno na drug pravni subjekt, se podatki iz odstavka 1 prenesejo na Agencijo.
In the event that the marketing authorisation is suspended, revoked or withdrawn, the holder of the marketing authorisation shall remain subject to the obligations laid down in paragraphs 1, 3 and 4.
V primeru, da se dovoljenje za promet z zdravilom začasno prekliče, prekliče ali umakne, ostane imetnik dovoljenja za promet zavezan obveznostim, določenim v odstavkih 1, 3 in 4.
The Commission shall draw up detailed guidelines relating to the application of paragraphs 1 to 6, in particular the type and amount of data referred to in paragraph 1.
Komisija pripravi podrobne smernice v zvezi z uporabo odstavkov 1 do 6, zlasti vrsto in količino podatkov iz odstavka 1.
INCENTIVES
SPODBUDE
Scientific advice
Znanstveno svetovanje
The applicant or holder of a marketing authorisation may request advice from the Agency on the design and conduct of pharmacovigilance and of the risk management system referred to in Article 14.
Vlagatelj ali imetnik dovoljenja za promet lahko zahteva od Agencije nasvet glede oblikovanja in izvajanja farmakovigilančnih aktivnosti in sistema za obvladovanje tveganj iz člena 14.
By way of derogation from Article 8(1) of Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products [14], a 90 % reduction for small and medium-sized enterprises and 65 % for other applicants shall apply to the fee for scientific advice payable to the Agency for any advice given in respect of advanced therapy medicinal products pursuant to paragraph 1 of this Article and Article 57(1)(n) of Regulation (EC) No 726/2004.
Z odstopanjem od člena 8(1) Uredbe Sveta (ES) št. 297/95 z dne 10. februarja 1995 o pristojbinah, ki se plačujejo Evropski agenciji za vrednotenje zdravil [14] se za vsak nasvet Agencije iz odstavka 1 tega člena in člena 57(1)(n) Uredbe (ES) št. 726/2004 v zvezi z zdravili za napredno zdravljenje, uporablja za mala in srednje velika podjetja 90 %, za druge vlagatelje pa 65 % znižanje pristojbine, ki jo je treba plačati Agenciji.
Scientific recommendation on advanced therapy classification
Znanstveno priporočilo o razvrstitvi naprednega zdravljenja
Any applicant developing a product based on genes, cells or tissues may request a scientific recommendation of the Agency with a view to determining whether the referred product falls, on scientific grounds, within the definition of an advanced therapy medicinal product.
Kateri koli vlagatelj, ki razvija izdelek na osnovi genov, celic ali tkiv, lahko od Agencije zahteva znanstveno priporočilo, ki naj določi, ali se zadevni izdelek na znanstveni podlagi šteje za zdravilo za napredno zdravljenje.
The Agency shall deliver this recommendation after consultation with the Commission and within 60 days after receipt of the request.
Agencija to priporočilo izda v 60 dneh od prejema zahteve in po posvetovanju s Komisijo.
The Agency shall publish summaries of the recommendations delivered in accordance with paragraph 1, after deletion of all information of commercial confidential nature.
Agencija objavi povzetke priporočil, izdanih v skladu s odstavkom 1, potem ko izbriše vse poslovne podatke zaupne narave.
Certification of quality and non-clinical data
Potrjevanje kakovosti in nekliničnih podatkov
Small and medium-sized enterprises developing an advanced therapy medicinal product may submit to the Agency all relevant quality and, where available, non-clinical data required in accordance with modules 3 and 4 of Annex I to Directive 2001/83/EC, for scientific evaluation and certification.
Mala in srednja podjetja, ki razvijajo zdravilo za napredno zdravljenje, lahko za znanstveno vrednotenje in potrjevanje predložijo Agenciji vse ustrezne podatke o kakovosti in, če so dostopni, neklinične podatke, zahtevane v skladu z moduloma 3 in 4 Priloge I k Direktivi 2001/83/ES.
The Commission shall lay down provisions for the evaluation and certification of such data, in accordance with the regulatory procedure referred to in Article 26(2).
Komisija sprejme določbe za vrednotenje in potrjevanje takih podatkov v skladu z regulativnim postopkom iz člena 26(2).
Reduction of the fee for marketing authorisation
Znižanje pristojbine za dovoljenje za promet
By way of derogation from Regulation (EC) No 297/95, the fee for marketing authorisation shall be reduced by 50 % if the applicant is a hospital or a small or medium-sized enterprise and can prove that there is a particular public health interest in the Community in the advanced therapy medicinal product concerned.
Z odstopanjem od Uredbe (ES) št. 297/95 se pristojbina za dovoljenje za promet zmanjša za 50 %, če je vlagatelj bolnišnica ali malo ali srednje podjetje, ki lahko dokaže, da gre za poseben interes javnega zdravja v Skupnosti za zadevno zdravilo za napredno zdravljenje.
Paragraph 1 shall also apply to fees charged by the Agency for post-authorisation activities in the first year following the granting of the marketing authorisation for the advanced therapy medicinal product.
Odstavek 1 se uporablja tudi za pristojbine, ki jih zaračunava Agencija za dejavnosti po pridobitvi dovoljenja za promet z zdravilom v prvem letu po izdaji dovoljenja za promet z zdravilom za napredno zdravljenje.
Paragraphs 1 and 2 shall apply during the transitional periods laid down in Article 29.
Odstavka 1 in 2 se uporabljata v prehodnem obdobju, določenem v členu 29.
COMMITTEE FOR ADVANCED THERAPIES
ODBOR ZA NAPREDNO ZDRAVLJENJE
Committee for Advanced Therapies
Odbor za napredno zdravljenje
A Committee for Advanced Therapies shall be established within the Agency.
Znotraj Agencije se ustanovi Odbor za napredno zdravljenje.
Save where otherwise provided in this Regulation, Regulation (EC) No 726/2004 shall apply to the Committee for Advanced Therapies.
Razen kadar je s to uredbo določeno drugače, se za Odbor za napredno zdravljenje uporablja Uredba (ES) št. 726/2004.
The Executive Director of the Agency shall ensure appropriate coordination between the Committee for Advanced Therapies and the other Committees of the Agency, in particular the Committee for Medicinal Products for Human Use and the Committee for Orphan Medicinal Products, their working parties and any other scientific advisory groups.
Izvršni direktor Agencije zagotovi ustrezno sodelovanje med Odborom za napredno zdravljenje in drugimi odbori Agencije, zlasti Odborom za zdravila za uporabo v humani medicini, Odborom za zdravila sirote, njihovimi delovnimi telesi in drugimi znanstvenimi svetovalnimi skupinami.
Composition of the Committee for Advanced Therapies
Sestava Odbora za napredno zdravljenje
The Committee for Advanced Therapies shall be composed of the following members:
Odbor za napredno zdravljenje sestavljajo naslednji člani:
five members or co-opted members of the Committee for Medicinal Products for Human Use from five Member States, with alternates either proposed by their respective Member State or, in the case of co-opted members of the Committee for Medicinal Products for Human Use, identified by the latter on the advice of the corresponding co-opted member.
pet članov ali kooptiranih članov Odbora za zdravila za uporabo v humani medicini, ki prihajajo iz petih držav članic, in nadomestni člani, ki jih predlagajo posamezne države članice ali v primeru nadomestnih članov kooptiranih članov Odbor za zdravila za uporabo v humani medicini po nasvetu ustreznega kooptiranega člana.
These five members with their alternates shall be appointed by the Committee for Medicinal Products for Human Use;
Teh pet članov in nadomestne člane imenuje Odbor za zdravila za uporabo v humani medicini;
one member and one alternate appointed by each Member State whose national competent authority is not represented among the members and alternates appointed by the Committee for Medicinal Products for Human Use;
član in nadomestni član, ki ga imenuje vsaka država članica, razen tistih, ki že imajo člana in nadomestnega člana, imenovanega s strani Odbora za zdravila za uporabo v humani medicini, in ki zastopa pristojni nacionalni organ;
two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent clinicians;
dva člana in dva nadomestna člana, ki jih imenuje Komisija na podlagi javnega razpisa in po posvetovanju z Evropskim parlamentom, da zastopajo klinične zdravnike;
two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent patients’ associations.
dva člana in dva nadomestna člana, ki jih imenuje Komisija na podlagi javnega razpisa po posvetovanju z Evropskim parlamentom, da zastopajo združenja bolnikov.
The alternates shall represent and vote for the members in their absence.
Nadomestni člani zastopajo člane in ob njihovi odsotnosti glasujejo namesto njih.
All members of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products.
Vsi člani Odbora za napredno zdravljenje so izbrani zaradi svojih znanstvenih usposobljenosti ali izkušenj v zvezi z zdravili za napredno zdravljenje.
For the purposes of paragraph 1(b), the Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Committee for Advanced Therapies provides appropriate and balanced coverage of the scientific areas relevant to advanced therapies, including medical devices, tissue engineering, gene therapy, cell therapy, biotechnology, surgery, pharmacovigilance, risk management and ethics.
Za doseganje cilja iz odstavka 1(b) izvršni direktor Agencije usklajuje sodelovanje držav članic za zagotovitev končne sestave Odbora za napredno zdravljenje, ki naj ustrezno in enakomerno zajema znanstvena področja, pomembna za napredno zdravljenje, vključno z medicinskimi pripomočki, tkivnim inženirstvom, genskim zdravljenjem, celičnim zdravljenjem, biotehnologijo, kirurgijo, farmakovigilanco, obvladovanjem tveganj in etiko.
At least two members and two alternates of the Committee for Advanced Therapies shall have scientific expertise in medical devices.
Vsaj dva člana Odbora za napredno zdravljenje in dva nadomestna člana imata strokovno znanje o medicinskih pripomočkih.
The members of the Committee for Advanced Therapies shall be appointed for a renewable period of three years.
Člani Odbora za napredno zdravljenje so imenovani za obdobje treh let z možnostjo obnovitve mandata.
At meetings of the Committee for Advanced Therapies, they may be accompanied by experts.
Na sestankih Odbora za napredno zdravljenje jih lahko spremljajo strokovnjaki.
The Committee for Advanced Therapies shall elect its Chairman from among its members for a term of three years, renewable once.
Odbor za napredno zdravljenje izmed svojih članov izvoli predsednika za obdobje treh let z možnostjo enkratne obnovitve.
The names and scientific qualifications of all members shall be made public by the Agency, in particular on the Agency’s website.
Agencija objavi imena in podatke o znanstveni usposobljenosti vseh članov, zlasti na spletni strani Agencije.
Conflicts of interest
Navzkrižje interesov
In addition to the requirements laid down in Article 63 of Regulation (EC) No 726/2004, members and alternates of the Committee for Advanced Therapies shall have no financial or other interests in the biotechnology sector and medical device sector that could affect their impartiality.
Poleg zahtev iz člena 63 Uredbe (ES) št. 726/2004 člani in nadomestni člani Odbora za napredno zdravljenje nimajo finančnih ali drugih interesov v biotehnološkem sektorju in sektorju medicinskih pripomočkov, ki bi lahko vplivali na njihovo nepristranskost.
All indirect interests that could relate to these sectors shall be entered in the register referred to in Article 63(2) of Regulation (EC) No 726/2004.
Vsi posredni interesi, ki bi lahko bili povezani s temi sektorji, se vnesejo v register iz člena 63(2) Uredbe (ES) št. 726/2004.
Tasks of the Committee for Advanced Therapies
Naloge Odbora za napredno zdravljenje
The Committee for Advanced Therapies shall have the following tasks:
Naloge Odbora za napredno zdravljenje so:
to formulate a draft opinion on the quality, safety and efficacy of an advanced therapy medicinal product for final approval by the Committee for Medicinal Products for Human Use and to advise the latter on any data generated in the development of such a product;
oblikuje osnutek mnenja o kakovosti, varnosti in učinkovitosti zdravila za napredno zdravljenje, da ga končno odobri Odbor za zdravila za uporabo v humani medicini, in mu svetuje v zvezi z vsemi podatki, pridobljenimi med razvojem takšnega zdravila;
to provide advice, pursuant to Article 17, on whether a product falls within the definition of an advanced therapy medicinal product;
v skladu s členom 17 svetuje o tem, ali se zdravilo šteje za zdravilo za napredno zdravljenje;
at the request of the Committee for Medicinal Products for Human Use, to advise on any medicinal product which may require, for the evaluation of its quality, safety or efficacy, expertise in one of the scientific areas referred to in Article 21(2);
na zahtevo Odbora za zdravila za uporabo v humani medicini svetuje o vseh zdravilih, za katera se za vrednotenje kakovosti, varnosti in učinkovitosti lahko zahteva posebno strokovno znanje na enem od znanstvenih področij iz člena 21(2);
to provide advice on any question related to advanced therapy medicinal products, at the request of the Executive Director of the Agency or the Commission;
na zahtevo izvršnega direktorja Agencije ali Komisije svetuje o vseh vprašanjih v zvezi z zdravili za napredno zdravljenje;
to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation;
nudi znanstveno pomoč pri izdelavi vseh dokumentov v zvezi z izpolnjevanjem ciljev te uredbe;
at the Commission’s request, to provide scientific expertise and advice for any Community initiative related to the development of innovative medicines and therapies which requires expertise in one of the scientific areas referred to in Article 21(2);
na zahtevo Komisije zagotavlja znanstveno strokovno znanje in svetuje pri vseh spodbudah Skupnosti, povezanih z razvojem inovativnih zdravil in zdravljenj, ki zahtevajo posebno strokovno znanje na enem od znanstvenih področij iz člena 21(2);
to contribute to the scientific advice procedures referred to in Article 16 of this Regulation and in Article 57(1)(n) of Regulation (EC) No 726/2004.
prispeva k postopkom znanstvenega svetovanja iz člena 16 te uredbe in člena 57(1)(n) Uredbe (ES) št. 726/2004.
Adaptation of Annexes
Prilagoditev prilog
The Commission shall, after consulting the Agency and in accordance with the regulatory procedure with scrutiny referred to in Article 26(3), amend Annexes I to IV in order to adapt them to scientific and technical evolution.
Zaradi prilagoditve znanstvenemu in tehničnemu razvoju Komisija po posvetu z Agencijo in v skladu z regulativnim postopkom s pregledom iz člena 26(3) spremeni priloge I do IV.
Report and review
Poročilo in revizija
By 30 December 2012, the Commission shall publish a general report on the application of this Regulation, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation.
Do 30. decembra 2012 Komisija objavi splošno poročilo o uporabi te uredbe, ki vključuje izčrpne podatke o različnih oblikah zdravil za napredno zdravljenje, odobrenih v skladu s to uredbo.
In this report, the Commission shall assess the impact of technical progress on the application of this Regulation.
Komisija v tem poročilu oceni vpliv tehničnega napredka na uporabo te uredbe.
It shall also review the scope of this Regulation, including in particular the regulatory framework for combined advanced therapy medicinal products.
Pregleda tudi področje uporabe te uredbe, še posebej pa vključi pregled regulatornega okvira za kombinirana zdravila za napredno zdravljenje.
The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use set up by Article 121(1) of Directive 2001/83/EC.
Komisiji pomaga Stalni odbor za zdravila za uporabo v humani medicini, ustanovljen na podlagi člena 121(1) Direktive 2001/83/ES.
Amendments to Regulation (EC) No 726/2004
Spremembe k Uredbi (ES) št. 726/2004
Regulation (EC) No 726/2004 is hereby amended as follows:
Uredba (ES) št. 726/2004 se spremeni:
in the first subparagraph of Article 13(1), the first sentence shall be replaced by the following:
v prvem pododstavku člena 13(1) se prvi stavek nadomesti z naslednjim:
‘Without prejudice to Article 4(4) and (5) of Directive 2001/83/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community.’;
„Brez poseganja v člen 4(4) in (5) Direktive 2001/83/ES je dovoljenje za promet, izdano v skladu s to uredbo, veljavno v vsej Skupnosti.“;
Article 56 shall be amended as follows:
člen 56 se spremeni:
in paragraph 1, the following point shall be inserted:
v odstavku 1 se vstavi naslednja točka:
the Committee for Advanced Therapies;’
Odbor za napredno zdravljenje;“
in the first sentence of the first subparagraph of paragraph 2, the words ‘paragraph 1(a) to (d)’ shall be replaced by ‘paragraph 1(a) to (da)’;
v prvem stavku prvega pododstavka odstavka 2 se besedilo „v odstavku 1(a) do (d)“ nadomesti z besedilom „v odstavku 1(a) do (da)“;
the Annex shall be amended as follows:
Priloga se spremeni: