natgillin/translations-raw huggingface dataset:
Poleg zahtev za farmakovigilanco, določenih v členih 21 do 29 Uredbe (ES) št. 726/2004 predlagatelj v vlogi za pridobitev dovoljenja za promet podrobno navede predvidene ukrepe, s katerimi zagotovi spremljanje učinkovitosti zdravil za napredno zdravljenje.
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.
Poleg zahtev za farmakovigilanco, določenih v členih 21 do 29 Uredbe (ES) št. 726/2004 predlagatelj v vlogi za pridobitev dovoljenja za promet podrobno navede predvidene ukrepe, s katerimi zagotovi spremljanje učinkovitosti in neželenih učinkov zdravil za napredno zdravljenje.
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 .
ČLEN 15, ODSTAVEK 2, PODODSTAVEK 1
ARTICLE 15, PARAGRAPH 2, SUBPARAGRAPH 1
Kadar obstaja poseben razlog za skrb, lahko Komisija na nasvet Agencije zahteva, da se kot del dovoljenja za promet vzpostavi sistem za obvladovanje tveganj, ki naj opredeli, prepreči ali zmanjša na najmanjšo možno raven tveganja, povezana z zdravili za napredno zdravljenje, vključno z oceno učinkovitosti navedenega sistema, ali da imetnik dovoljenja za promet izvede posebne post-marketinške študije in jih predloži Agenciji v pregled.
Where there is particular cause for concern, the Commission may, on the advice of the Agency, require as part of the marketing authorisation that a risk management system designed to identify, 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, Komisija na nasvet Agencije zahteva, da se kot del dovoljenja za promet vzpostavi sistem za obvladovanje tveganj, ki naj opredeli, opiše, prepreči ali zmanjša na najmanjšo možno raven tveganja, povezana z zdravili za napredno zdravljenje, vključno z oceno učinkovitosti navedenega sistema, ali da imetnik dovoljenja za promet izvede posebne študije po začetku trženja in jih predloži Agenciji v pregled.
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.
Da bi zagotovili učinkovitost sistema za obvladovanje tveganj, mora Komisija zahtevati izvedbo nujnih ukrepov, če obstaja razlog za skrb.
In order to ensure the effectiveness of the risk management system, the Commission should have an obligation to require necessary measures to be carried out when there is a cause for concern.
Imetnik dovoljenja za promet z zdravili za napredno zdravljenje vzpostavi in vzdržuje sistem, ki preko virov, proizvodnje, pakiranja, transporta in dostave bolnišnici, instituciji ali zasebni praksi, kjer se izdelek uporablja, zagotavlja sledljivost posameznega izdelka ter vhodnih snovi in surovin, vključno z vsemi snovmi, ki prihajajo v stik s tkivi ali celicami, ki jih lahko vsebuje.
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 tissues or cells it may contain, can be traced through the sourcing, manufacturing, packaging, 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, ki preko virov, proizvodnje, pakiranja, skladiščenja, transporta in dostave bolnišnici, instituciji ali zasebni praksi, kjer se izdelek uporablja, zagotavlja sledljivost posameznega izdelka ter vhodnih snovi in surovin, vključno z vsemi snovmi, ki prihajajo v stik s tkivi ali celicami, ki jih lahko vsebuje.
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 tissues or cells it may contain, can be traced through the sourcing, manufacturing, packaging, storing, transport and delivery to the hospital, institution or private practice where the product is used.
Sledljivost je treba zagotoviti tudi med skladiščenjem.
Traceability during storing steps should also be ensured.
Z dodatkom skladiščenja se uvede dosleden sistem sledljivosti izdelka, kar je v skladu z Direktivo 2004/23/ES.
Adding ‘storing’ establishes a coherent system of product traceability, and is in line with Directive 2004/23/EC.
ČLEN 16, ODSTAVEK 4
ARTICLE 16, PARAGRAPH 4
Imetnik dovoljenja za promet hrani podatke iz prvega odstavka najmanj 30 let potem, ko je bil izdelek dan v promet, ali dlje, če to zahteva Komisija kot pogoj za pridobitev dovoljenja za promet.
The marketing authorisation holder shall keep the data referred to in the first paragraph for a minimum of 30 years after placing the product on the market , or longer if required by the Commission as a term of the marketing authorisation.
Imetnik dovoljenja za promet hrani podatke iz prvega odstavka najmanj 30 let po izteku roka uporabe ali dlje, če to zahteva Komisija kot pogoj za pridobitev dovoljenja za promet.
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.
Besedilo je dvoumno, saj se "dajanje v promet" lahko razume na različne načine.
The proposed wording is unambiguous, whereas “placing on the market” might create difficulties in interpretation.
Predlagano besedilo je pragmatična rešitev za imetnika dovoljenja za promet, ki želi točno vedeti, kako dolgo mora hraniti podatke o sledljivosti.
The proposed wording provides a pragmatic solution for the marketing authorisation holder to know exactly from when traceability data must be kept.
Z odstopanjem od člena 8(1) Uredbe (ES) št. 297/95 se za vsak nasvet Agencije iz odstavka 1 in člena 57(1)(n) Uredbe (ES) št. 726/2004 v zvezi z zdravili za napredno zdravljenje, uporablja 90-odstotno znižanje pristojbine, ki jih je treba plačati Agenciji.
By way of derogation from Article 8(1) of Regulation (EC) No 297/95, a 90% reduction shall apply to the fee payable to the Agency for any advice referred to in paragraph 1 and in Article 57(1)(n) of Regulation (EC) No 726/2004 in respect of advanced therapy medicinal products.
Z odstopanjem od člena 8(1) Uredbe (ES) št. 297/95 se za vsak nasvet Agencije iz odstavka 1 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-odstotno , za druge predlagatelje pa 70-odstotno znižanje pristojbine, ki jo je treba plačati Agenciji.
By way of derogation from Article 8(1) of Regulation (EC) No 297/95, a 90% reduction for small and medium-sized enterprises and 65% for other applicants shall apply to the fee payable to the Agency for any advice referred to in paragraph 1 and in Article 57(1)(n) of Regulation (EC) No 726/2004 in respect of advanced therapy medicinal products.
Mala in srednje velika podjetja sama krijejo 10% osnovne pristojbine, kar je simbolična vsota, da bi preprečili vse zlorabe povsem brezplačnega sistema.
The 10% of the basic fee which the SME's should cover themselves is a symbolic amount, in order to prevent any abuse of the totally gratis system.
Poleg tega je treba za podporo predlagateljem, za katere ne veljajo merila MSP, in za zagotovitev konkurenčnosti celotnega sektorja uveljaviti 65-odstotno znižanje za vsa podjetja ne glede na velikost.
Moreover, to support the applicants which do not fall under the SME criteria and to ensure the competitiveness of the whole sector, a reduction of 65% should be applied to all companies irrespective of their size.
Kateri koli predlagatelj, ki razvija izdelek na osnovi celic ali tkiva, lahko Agencijo prosi za znanstveno priporočilo, ki naj določi, ali se zadevni izdelek na znanstveni podlagi šteje za zdravilo za napredno zdravljenje.
Any applicant developing a product based on 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.
Agencija to priporočilo predloži po posvetovanju s Komisijo.
The Agency shall deliver this recommendation after consultation with the Commission.
Kateri koli predlagatelj, ki razvija izdelek na osnovi genov, celic ali tkiva, lahko Agencijo prosi za znanstveno priporočilo, ki naj določi, ali se zadevni izdelek na znanstveni podlagi šteje za zdravilo za napredno zdravljenje.
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.
Agencija to priporočilo predloži v 60 dneh od prejema zahteve in po posvetovanju s Komisijo.
The Agency shall deliver this recommendation, after consultation with the Commission and within 60 days after receipt of the request.
Treba je pojasniti, da se lahko postopek iz tega člena uporablja za vse vrste zdravil za napredno zdravljenje, med drugim tudi za zdravila na osnovi genov.
It should be clarified that the procedure foreseen in this Article may apply to all types of advanced therapy medicinal products, including products based on genes.
Predlog spremembe predvideva, da se predlagatelju pravočasno pojasni razvrstitev zadevnih izdelkov ter s tem omogoča poslovno načrtovanje in nadaljnji razvoj izdelka.
The proposed amendment also foresees that an applicant will get clarity on the classification of the concerned product in a timely manner, thus facilitating business planning and further development of the product.
ČLEN 19 A (novo)
ARTICLE 19 A (new)
Spodbude za mala in srednje velika biotehnološka podjetja
Incentives for small and medium-sized biotech enterprises
Proizvajalci zdravil za napredno zdravljenje, ki zaposlujejo do 500 ljudi in njihov promet ne presega 100 milijonov EUR ter njihova bilančna vsota ne presega 70 milijonov EUR, so upravičeni do vseh spodbud, ki se dodeljujejo malim in srednje velikim podjetjem v skladu s priporočilom Komisije 2003/361/ES 1 .
Manufacturers of advanced therapy medicinal products which employ not more than 500 persons and have a turnover not exceeding EUR 100 million, or a balance-sheet total not exceeding EUR 70 million, shall be eligible for all incentives which are granted to small and medium–sized enterprises as defined in Commission Recommendation 2003/361/EC 1 .
1 UL L 124, 20.05.2003, str.
1 OJ L 124, 20.5.2003, p.
Za številna mlada biotehnološka podjetja je težko izpolnjevati merila za MSP.
For many young biotech enterprises it is difficult to meet the criteria for an SME.
Eden od razlogov je, da se lahko z nakupom patenta ali tehnološke platforme ustvari velik enkraten prihodek, ki presega obstoječe omejitve.
One of the reasons is that a purchase or sale of a patent or platform technology may generate a big oneoff turnover which exceeds the current limitations.
Nenazadnje bi morala ta podjetja uživati ugodnejše finančne pogoje.
These companies should nevertheless enjoy more favourable financial terms.
ČLEN 19 B (novo)
ARTICLE 19 B (new)
Člen 19b
Article 19b
Zmanjšanje pristojbine za dovoljenje za promet
Reduction of the fee for marketing authorisation
Pristojbina za dovoljenje za promet se zmanjša za 50 %, če lahko predlagatelj dokaže, da v Skupnosti obstaja poseben javni interes za zdravilo za napredno zdravljenje ali da je donos iz naložb, ki se pričakuje pri trženju takšnega proizvoda, majhen.
The fee for marketing authorisation shall be reduced by 50% if the applicant can prove that there is a particular public interest in the Community in the advanced therapy medicinal product or if the return on investment to be expected from the marketing of that product is small.
Odstavek 1 se uporablja tudi za pristojbine, ki jih opravlja Agencija za dejavnosti, po pridobitvi dovoljenja v prvem letu po izdaji dovoljenja za promet za zdravilo.
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 medicinal product.
V primeru malih in srednje velikih podjetij ali podjetij, ki zaposlujejo do 500 ljudi in njihov promet ne presega 100 milijonov EUR ali njihova bilančna vsota ne presega 70 milijonov EUR, se odstavek 1 brez časovne omejitve uporablja tudi za pristojbine za dejavnosti Agencije po pridobitvi dovoljenja za promet.
In the case of small and medium-sized enterprises or enterprises which employ not more than 500 persons and have a turnover not exceeding EUR 100 million, or a balance-sheet total not exceeding EUR 70 million, paragraph 1 shall also apply, without any time limit, to the fees charged by the Agency for post-authorisation activities.
Zmanjšanje pristojbin za dovoljenje za promet je potrebno v primerih, ko so zdravila za napredno zdravljenje namenjena javnemu interesu, kot v primeru zdravil sirot, ali kjer je predlagatelj MSP.
Reductions of the fee for marketing authorisations is necessary in cases of ATMPs serving public interest like orphan drugs or where the applicant is an SME.
Za te proizvode in podjetja predstavlja centraliziran postopek veliko upravno breme, ki ga je treba zmanjšati z znižanjem pristojbin.
For those products and enterprises the centralised procedure is a big administrative burden which should be eased by minimised fees.
Določeno zmanjšanje stroškov je potrebno tudi v primerih avtolognih zdravil za napredno zdravljenje in zdravil za namensko uporabo, ker je te proizvode mogoče tržiti le v omejenem obsegu.
The stipulated cost reductions are also necessary in case of autologous ATMPs and those for intended use because these products can only be introduced into the market to a limited extent.
ČLEN 19 C (novo)
ARTICLE 19 C (new)
Article 19c
Article 19c
Tehnična podpora
Technical support
Države članice v zvezi z uporabo te uredbe predlagateljem in imetnikom dovoljenja za promet zagotovijo posebno tehnično podporo.
Member States shall, with regard to the application of this Regulation, provide specific technical support for applicants and marketing authorisation holders.
To poročilo je na voljo pri pristojnih nacionalnih organih in se osredotoča zlasti na podporo posameznim bolnišnicam ali drugim manjšim ustanovam, npr. univerzitetnim oddelkom, ki ne izpolnjujejo pogojev iz člena 3(7) Uredbe št. 2001/83/ES.
This support shall be made available through the competent national authorities and focus in particular on support for individual hospitals or other small-scale institutions, e.g. departments of universities, which do not fulfil the conditions of Article 3(7) of Directive 2001/83/EC.
Podpora se zagotovi pod pogojem, da se zdravila za napredno zdravljenje pripravljajo in uporabljajo znotraj tehnične odgovornosti specializiranega zdravnika in v skladu z zdravniškim receptom posameznega pacienta.
Support shall be provided under the condition that advanced therapy medicinal products are prepared and used under the technical responsibility of a specialised physician and in accordance with a medical prescription for individual patients.
Izvzetja iz področja uporabe direktive se kolikor je mogoče omejijo, da bodo nova zdravila hitreje pomagala vsem bolnikom v Evropi.
Exemptions from the scope of the Directive shall be as limited as possible in order to bring the benefit of new medicines quickly to all patients in Europe.
Glede na posebnosti tega zelo inovativnega sektorja pa je treba dati posebno podporo skupinam morebitnih predlagateljev.
However, special support shall be given to groups of possible applicants with regard to the particularities of this highly innovative sector.
To se najbolje doseže na nacionalni ravni.
This can be best achieved at the national level.
ČLEN 21, ODSTAVEK 1, TOČKA (C)
ARTICLE 21, PARAGRAPH 1, POINT (C)
(c) štiri člane imenuje Komisija na podlagi javnega razpisa, dva izmed njih zastopata kirurge, dva pa združenja bolnikov.
(c) four members appointed by the Commission, on the basis of a public call for expressions of interest, two of them to represent surgeons and two of them to represent patients associations.
(c) dva člana in dva namestnika imenuje Komisija na podlagi javnega razpisa, in po posvetovanju z Evropskim parlamentom, za zastopanje zdravnikov;
(c) two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consultation of the European Parliament , to represent physicians ;
(ca) dva člana in dva namestnika imenuje Komisija na podlagi javnega razpisa, po posvetovanju z Evropskim parlamentom, za zastopanje združenj bolnikov.
(ca) two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consultation of the European Parliament, to represent patients associations.
Da bi zajeli vsa medicinska področja, ki lahko zadevajo napredna zdravljenja, mora Odbor za napredno zdravljenje predstavljati splošnejše medicinsko strokovno znanje, tj. zdravnike s kliničnim strokovnim znanjem.
In order to cover all medical fields which the advanced therapies may relate to, more general medical expertise, i.e. physicians with clinical expertise, should be represented in the Committee for Advanced Therapies.
Poleg tega bi z uvedbo nadomestnih članov želeli zagotoviti stalno zastopanost vključenih skupin.
In addition, by introducing alternate members, we would like to ensure a permanent representation of the groups involved.
O imenovanju teh članov in njihovih namestnikov se je treba posvetovati z Evropskim parlamentom.
The appointment of these members and their alternates should take place in consultation with the European Parliament.
Vsi člani Odbora za napredno zdravljenje so izbrani zaradi svojih znanstvenih kvalifikacij ali izkušenj v zvezi z zdravili za napredno zdravljenje.
All members of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products.
Za doseganje cilja iz točke (b) odstavka 1 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, farmakovigilanco, obvladovanjem tveganj in etiko.
For the purposes of point (b) of paragraph 1, 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 appropriately and in a balanced way covers the scientific areas relevant to advanced therapies, including medical devices, tissue-engineering, gene therapy, cell therapy, biotechnology, pharmacovigilance , risk management and ethics.
Vsi člani in namestniki Odbora za napredno zdravljenje so izbrani zaradi svojih znanstvenih kvalifikacij ali izkušenj z zdravili za napredno zdravljenje.
All members and alternates of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products.
Za doseganje cilja iz točke (b) odstavka 1 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, farmakovigilanco, obvladovanjem tveganj in etiko.
For the purposes of point (b) of paragraph 1, 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 appropriately and in a balanced way covers the scientific areas relevant to advanced therapies, including medical devices, tissue-engineering, gene therapy, cell therapy, biotechnology, pharmacovigilance, risk management and ethics.
Vsaj dva člana Odbora za napredno zdravljenje in dva namestnika imata strokovno znanje za zdravstvene pripomočke.
At least two members and two alternates of the Committee for Advanced Therapies shall have scientific expertise in medical devices.
Nadomestni člani Odbora za napredno zdravljenje, ki jih uvaja odstavek 1, izpolnjujejo enaka merila znanstvene usposobljenosti ali izkušenj s področja zdravil za napredno zdravljenje kot člani.
The alternate members of the Committee for Advanced therapies introduced in paragraph 1 shall comply with the same criteria of scientific qualification or experience in the field of advanced therapy medicinal products as its members.
Za zagotovitev ustrezne ravni strokovnega znanja je potrebno vključiti strokovnjake kot člane, ki imajo osnovno znanje o vrednotenju medicinskih pripomočkov, ker imajo številni zadevni proizvodi veliko značilnosti medicinskih pripomočkov.
In order to ensure an appropriate level of expertise, it would be important to include experts as members that have a background in the evaluation of medical devices, as many of the products concerned share many characteristics of medical devices.
ČLEN 21, ODSTAVEK 5
ARTICLE 21, PARAGRAPH 5
Agencija objavi imena in znanstvene kvalifikacije članov.
The names and scientific qualifications of the members shall be published by the Agency .
Imena in znanstvene kvalifikacije člankov se ob prvi priložnosti objavijo na spletni strani Agencije.
The names and scientific qualifications of the members shall be published on the Agency’s website at the earliest opportunity.
Zdi se pomembno, da so informacije o članih odbora javne in objavljene na spletni strani Agencije.
It seems essential for the information on the members of the Committee to be made public and disseminated via the Agency’s website.
Člani in strokovnjaki Odbora za napredno zdravljenje delujejo neodvisno in v javnem interesu.
Members of the Committee for Advanced Therapies and its experts shall undertake to act in the public interest and in an independent manner.
Nimajo finančnih ali drugih interesov v farmacevtskem sektorju, sektorju medicinskih pripomočkov ali biotehnološkem sektorju , ki bi lahko vplivali na njihovo nepristranskost.
They shall not have financial or other interests in the pharmaceutical sector, medical device sector or biotechnology sector that could affect their impartiality.
Poleg zahtev iz člena 63 Uredbe (ES) št. 726/2004 člani in namestniki Odbora za napredno zdravljenje nimajo finančnih ali drugih interesov v biotehnološkim sektorju in sektorju medicinskih pripomočkov, ki bi lahko vplivali na njihovo nepristranskost.
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.