natgillin/translations-raw huggingface dataset:
Pri oblikovanju smernic za obvladovanje tveganj po pridobitvi dovoljenja za promet se sprejmejo načela regulativnega sodelovanja in dialog z imetnikom dovoljenja za promet, da se omogoči združevanje omejenega strokovnega znanja na tem področju.
When drawing up post-authorisation risk management guidelines, principles of regulatory cooperation and dialogue with the marketing authorization holder should be enacted in order to allow a pooling of the limited expertise in this area.
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 jo 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 95 -odstotno znižanje pristojbine, ki jo je treba plačati Agenciji, za mala in srednje velika podjetja, in 80 -odstotno za druge prosilce .
By way of derogation from Article 8(1) of Regulation (EC) No 297/95, a 95% reduction for small and medium-sized enterprises and 80% 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.
Namen te uredbe je spodbuditi in podpreti MSP pri razvoju zdravil za napredno zdravljenje.
This Regulation seeks to encourage and support SME's in the development of ATMPs.
Zato bi bilo treba uvesti posebna odstopanja od plačila pristojbin za znanstveno svetovanje za MSP.
Therefore, special fee-waivers should be introduced for SME's on scientific advice.
5 % osnovne pristojbine, ki jih MSP krijejo sama, je simbolična vsota, namenjena preprečevanju morebitnih zlorab sistema.
The 5% of the basic fee which the SME's should cover themselves is a symbolic amount, in order to prevent any abuse of the system.
Za podporo predlagateljem, ki niso MSP, in za zagotovitev konkurenčnosti celotnega sektorja bi bilo treba uveljaviti 70-odstotno znižanje za vsa podjetja ne glede na njihovo velikost.
To support applicants which are not SMEs and to ensure the competitiveness of the whole sector, a reduction of 70% should be applied to all companies irrespective of their size.
Agencija to priporočilo predloži po posvetovanju z Odborom za napredno zdravljenje in s Komisijo ter v 60 dneh po prejemu zahteve .
The Agency shall deliver this recommendation, after consultation with the Committee for Advanced Therapies and the Commission, within 60 days of receipt of the request.
Predlog spremembe predvideva, da bo predlagatelju pravočasno pojasnjena razvrstitev zadevnih izdelkov ter s tem omogočena poslovno načrtovanje in nadaljnji razvoj izdelka.
The proposed amendment 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.
Proizvajalci zdravil za napredno zdravljenje, ki zaposlujejo do 500 ljudi in njihov promet ne presega 100 milijonov EUR ali 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 z dne 6. maja 2003 o opredelitvi mikro, malih in srednje velikih podjetij.
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 granted to small and medium–sized enterprises under Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises 1 .
Enako velja za podjetja, v katerih imajo druga podjetja do 50 % delež ter njihove naložbe v raziskovalne in razvojne dejavnosti presegajo 15 % njihovega letnega prometa.
The same shall apply to an enterprise in which other enterprises have an interest up to 50 % and which invests more than 15 % of its annual turnover in research and development activities.
1 UL L 124, 20.5.2003, str.
1 L 124, 20.5.2003, p.
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 one-off turnover which exceeds the current limitations.
Drugi razlog je, da številna podjetja ne izpolnjujejo trenutnega merila neodvisnosti (deleži pod 25 %), ker oblikujejo zavezništva z drugimi podjetji.
Another reason is that many enterprises don't comply with the current criteria of independence (interests below 25 %), since they built up alliances with other companies.
Te težave so lahko za biotehnološka podjetja izjemno pomembne.
These problems are likely to have the greatest relevance for biotech enterprises.
Pristojbina za dovoljenje za promet se zmanjša na 50 %, če lahko predlagatelj dokaže, da v Skupnosti obstaja poseben javni interes za zdravilo za napredno zdravljenje ali je donos iz naložb, ki se pričakuje pri trženju takšnega proizvoda, majhen.
The fee for marketing authorisation shall be reduced to 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 such a product is small.
Prvi odstavek se uporablja tudi za pristojbine za dejavnosti agencije po pridobitvi dovoljenja, in sicer v prvem letu po izdaji dovoljenja za promet za zdravilo.
The first paragraph shall also apply to fees for post-authorisation activities by the Agency 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 prvi odstavek 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, the first paragraph shall also apply to the fees for post-authorisation activities by the Agency without a time limit.
V primeru podjetij, v katerih imajo druga podjetja do 50 % delež ter njihove naložbe v raziskovalne in razvojne dejavnosti presegajo 15 % njihovega letnega prometa, se prvi odstavek brez časovne omejitve uporablja tudi za pristojbine za dejavnosti agencije po pridobitvi dovoljenja za promet.
In the case of an enterprise in which other enterprises have an interest up to 50 % and which invests more than 15 % of its annual turnover in research and development activities, the first paragraph shall also apply to the fees for post-authorisation activities by the Agency without a time limit.
(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, 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 medical doctors;
Da bi zajeli vsa medicinska področja, ki lahko zadevajo napredna zdravljenja, mora biti v Odboru za napredno zdravljenje zastopano splošnejše medicinsko strokovno znanje, tj. zdravniki.
In order to cover all medical fields which the advanced therapies may relate to, more general medical expertise, i.e. medical doctors, should be represented in the Committee for Advanced Therapies .
Razen 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.
(ca) dva člana in dva namestnika imenuje Komisija na podlagi javnega razpisa in po posvetovanju z Evropskim parlamentom, in sicer 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.
Z uvedbo nadomestnih članov bi želeli zagotoviti stalno zastopanost vključenih skupin.
By introducing alternate members, we would like to ensure a permanent representation of the groups involved.
Vsi člani in namestniki Odbora za napredno zdravljenje so izbrani zaradi svojih znanstvenih kvalifikacij ali izkušenj v zvezi 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.
Nadomestni člani Odbora za napredno zdravljenje, ki jih uvaja odstavek 1, izpolnjujejo enaka merila znanstvenih kvalifikacij 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.
ČLEN 23, TOČKA A
ARTICLE 23, POINT (A)
(a) Odboru za zdravila za uporabo v humani medicini svetuje v zvezi z vsemi podatki, pridobljenimi med razvojem zdravila za napredno zdravljenje, oblikuje mnenje o kakovosti, varnosti in učinkovitosti zdravila ;
(a) to advise the Committee for Medicinal Products for Human Use on any data generated in the development of an advanced therapy medicinal product, for the formulation of an opinion on its quality, safety and efficacy ;
(a) pripravi osnutek mnenja o kakovosti, varnosti in učinkovitosti zdravila za napredno zdravljenje , ki se predloži v pregled; ta osnutek mnenja se posreduje v odobritev Odboru za zdravila za uporabo v humani medicini .
(a) to draw up a draft opinion on the quality, safety and efficacy of an advanced therapy medicinal product submitted for review; this draft opinion shall be transmitted to the Committee for Medicinal Products for Human Use for approval.
Odbor za napredno zdravljenje svetuje Odboru za zdravila za uporabo v humani medicini v zvezi z vsemi podatki, pridobljenimi med razvojem zdravila ;
The Committee for Advanced Therapies shall advise the Committee for Medicinal Products for Human Use on any data generated in the product’s development ;
Njihovo strokovno znanje bi zato moralo predstavljati osnovo vsakega mnenja o proizvodu, ki ga poda CHMP.
Their expertise should therefore form the basis of any product opinion delivered by the CHMP.
(aa) Odboru za zdravila za humano uporabo svetuje o predlogih sprememb iz členov 4(2),8, 19 in 24;
(aa) to advise the Committee for Medicinal Products for Human Use on the amendments provided for in Articles 4(2),8, 19 and 24;
Ocena zdravil za napredno zdravljenje pogosto zahteva zelo posebno strokovno znanje, zaradi česar je bil ustanovljen specializirani Odbor za napredno zdravljenje.
The assessment of advanced therapy medicinal products often requires very specific expertise, for which reason the specialised Committee for Advanced Therapies is created.
Zato je logično, da ima specializirani odbor svetovalno vlogo v postopku komitologije pri spreminjanju prilog in drugih tehničnih zahtev.
Therefore, it is logical that this specialised committee should have an advisory role in the comitology procedure to amend the Annexes and other technical requirements.
(ea) zagotavlja svetovanje o postopkih znanstvenega svetovanja iz člena 17;
(ea) to provide advice on the scientific advice procedures referred to in Article 17;
ČLEN 23, ODSTAVEK (E B) (novo)
ARTICLE 23, POINT (E B) (new)
(eb) zagotavlja svetovanje o razvrstitvi izdelkov v skladu s členom 18.
(eb) to provide advice on product classification as referred to in Article 18.
Vsako svetovanje glede razvrščanja zdravil za napredno zdravljenje bi torej moralo črpati iz njihovega strokovnega znanja.
Their expertise should therefore be drawn upon for any advice issued regarding the classification of an advanced therapy medicinal product.
Člen 24
ARTICLE 24
Za prilagoditev znanstvenemu in tehničnemu razvoju Komisija v skladu s postopkom iz člena 26(2) prilagodi priloge II do IV.
The Commission shall, in accordance with procedure referred to in Article 26(2), amend Annexes II to IV in order to adapt them to scientific and technical evolution.
Priloga I vsebuje temeljno in bistveno opredelitev.
Annex I contains a fundamental and substantial definition.
Zato se je v postopku komitologije ne sme spreminjati.
Therefore, it should not be subject to any changes through comitology.
Če so katere koli spremembe nujne zaradi znanstvenega napredka, jih je treba sprejeti s postopkom soodločanja, ki v celoti vključuje Evropski parlament.
Should any changes be necessary due to scientific progress, they should be adopted in codecision, fully involving the European Parliament.
V 5 letih po začetku veljavnosti te uredbe Komisija objavi splošno poročilo o njeni uporabi, ki vključuje izčrpne podatke o različnih oblikah zdravil za napredno zdravljenje, odobrenih v skladu s to uredbo.
Within 5 years of entry into force of this Regulation, the Commission shall publish a general report on its application, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation.
V 5 letih po začetku veljavnosti te uredbe Komisija objavi splošno poročilo o njeni uporabi, ki vključuje izčrpne podatke o različnih oblikah zdravil za napredno zdravljenje, odobrenih v skladu s to uredbo ter o uporabi in učinkih ukrepov iz poglavja 6 te uredbe in členov 9, 14(9) in 70(2) Uredbe (ES) št. 726/2004 .
Within 5 years of entry into force of this Regulation, the Commission shall publish a general report on its application, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation and on the use and effect of the measures provided for in Chapter 6 of this Regulation and in Articles 9, 14(9) and 70(2) of Regulation (EC) No 726/2004 .
Komisija lahko na podlagi tega poročila predlaga spremembe te uredbe in Uredbe (ES) št. 726/2004.
On the basis of that report, the Commission may propose amendments to this Regulation and Regulation (EC) No 726/2004.
Komisija na podlagi poročila ponovno ovrednoti sedanje predpise in predlaga spremembe za njihovo izboljšanje, pri čemer upošteva tudi usklajevanje različnih predpisov in postopkov, ki jih sedaj uporablja Evropska agencija za zdravila.
On the basis of this report, the Commission should re-evaluate the current provisions and propose amendments to improve them, also with a view of harmonizing the different provisions and procedures currently in use within the EMEA.
Komisija zagotovi, da so ustrezne informacije o predvidenih ukrepih pravočasno na voljo vsem zainteresiranim stranem.
The Commission shall ensure that relevant information about envisaged measures is made available to all interested parties in due time.
To je potrebno, da se zagotovi udeležba industrije in drugih zainteresiranih strani že od samega začetka priprave sekundarne zakonodaje in priprave dokumentov, v katerih se določajo smernice.
This is necessary to ensure that Industry and other stakeholders are involved from the very beginning in the elaboration of secondary legislation as well as of guidance documents.
Tovrsten koncept je že prisoten v zakonodaji Skupnosti (glej čl.
This is a concept already introduced in Community legislation (see art.
15.5 Direktive 2004/22/ES z dne 21. marca 2004 o merilnih instrumentih).
15.5 of Directive 2004/22/EC of 21 March 2004 on measuring instruments).
Priloga, točka 1 a (Uredba (ES) št. 726/2004)
Annex, point 1 a (Regulation (EC) No. 726/2004)
Zdravila za napredno zdravljenje, kot so opredeljena v Uredbi (ES) št. […/Evropskega parlamenta in Sveta (Uredba o zdravilih za napredno zdravljenje)].
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)].
Zdravila za napredno zdravljenje, kot so opredeljena v Uredbi (ES) št. […/Evropskega parlamenta in Sveta (Uredba o zdravilih za napredno zdravljenje)] , razen zdravil za napredno zdravljenje za avtologno ali namensko uporabo, ki se proizvajajo in so naprodaj izključno v eni državi članici in za katera je ta država članica kot alternativo predvidela postopek pridobitve nacionalnega dovoljenja za promet za obdobje petih let po izdaji dovoljenja za promet na nacionalni ravni.
Advanced therapy medicinal products, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)] , except for advanced therapy medicinal products for autologous or intended use which are exclusively manufactured and distributed in one Member State and for which that Member State has envisaged the national marketing authorisation procedure as an alternative, for a period of five years subsequent to the granting of the marketing authorisation at national level .
Po tem je potrebna vloga za podaljšanje v okviru centraliziranega postopka, ki ima za posledico, da nacionalno dovoljenje za promet po podaljšanju postane centralizirano dovoljenje za promet .
Afterwards an application for renewal within the centralised procedure is necessary with the effect that after the renewal the national marketing authorisation becomes a centralised marketing authorisation .
Da bi se številnim MSP, ki želijo tržiti svoj proizvod le v eni državi članici, olajšala faza nastopa na trgu, bi bilo treba za proizvode, ki se tržijo na nacionalni ravni, omogočiti pridobitev dovoljenja za promet na nacionalni ravni.
In order to facilitate the stage of market entry for many SMEs wanting to market their product only in one member state, a marketing authorisation at national level for products marketed at national level should be rendered possible.
To nacionalno dovoljenje za promet bi moralo biti omejeno na obdobje petih let.
This national marketing authorisation should be limited to a period of five years.
Po tem prvem petletnem obdobju se podaljšanje lahko opravi s centraliziranim dovoljenjem za promet.
The renewal after this first period of five years can be conducted through a centralised marketing authorisation.
Člen 3, odstavek 7 (Direktiva 2001/83/ES)
Article 3, paragraph 7 (Directive 2001/83/EC)
Katero koli zdravilo za napredno zdravljenje, kot je opredeljeno v Uredbi (ES) št. […/Evropskega parlamenta in Sveta (Uredba o zdravilih za napredno zdravljenje)], ki je v isti bolnišnici v celoti pripravljeno in uporabljeno za posameznega bolnika v skladu z receptom.
Any advanced therapy medicinal product, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)], which is both prepared in full and used in a hospital, in accordance with a medical prescription for an individual patient.
Katero koli zdravilo za napredno zdravljenje, kot je opredeljeno v Uredbi (ES) št. […/Evropskega parlamenta in Sveta (Uredba o zdravilih za napredno zdravljenje)*], ki je v bolnišnici v celoti pripravljeno za posamičen primer v skladu s posebnim, nestandardiziranim in nepatentiranim postopkom ter se uporabi v bolnišnici zaradi upoštevanja posameznega recepta za posameznega bolnika.
Any advanced therapy medicinal product, as defined in Regulation (EC) No […/of the European Parliament and of the Council (Regulation on Advanced Therapy Medicinal Products)], which is prepared in full in a hospital on a one-off basis according to a specific, non-standardised and non-patented process, and used in a hospital, in order to comply with an individual medical prescription for an individual patient.
Odstavka 1 in 2 ne veljata za zdravila za napredno zdravljenje.
Paragraphs 1 and 2 do not apply to advanced therapy medicinal products.
Izjeme iz Direktive 2001/83/ES omogočajo lekarnam, da pripravijo zdravila v skladu z receptom in ne da bi upoštevale zakonodajo o zdravilih.
Exceptions given in Directive 2001/83/EC allow pharmacies to prepare medicinal products in accordance with a medical prescription without complying with medicinal product legislation.
Ta izjema omogoča tudi lekarnam v bolnišnicah možnost proizvajanja izdelkov tkivnega inženirstva z uporabo standardiziranih metod in po običajnih postopkih.
This exception would as well give the in-house pharmacies of hospitals the possibility producing TEP using standardized methods and on routinely basis.
Zato je ta predlog spremembe ključen za zagotovilo, da so s področja uporabe te uredbe izključeni le izdelki, pripravljeni enkrat.
Therefore this amendment is crucial to ensure that only one-off basis products are excluded from the scope of this Regulation.
ČLEN 28, TOČKA 2
ARTICLE 28, POINT 2
Člen 4, odstavek 5 (Direktiva 2001/83/ES)
Article 4, paragraph 5 (Directive 2001/83/EC)
Države članice Komisijo obvestijo o zadevni nacionalni zakonodaji.“
The Member States shall communicate the national legislation concerned to the Commission.”
Ta direktiva in vse v njej navedene uredbe ne vplivajo na uporabo nacionalne zakonodaje, ki iz etičnih razlogov prepoveduje ali omejuje uporabo kakršne koli posebne vrste človeških ali živalskih celic ali prodajo, dobavo ali uporabo zdravil, ki vsebujejo te celice ali jih te celice sestavljajo ali so izdelane na njihovi podlagi.
This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells , on ethical grounds .
Države članice Komisijo obvestijo o zadevni nacionalni zakonodaji.
The Member States shall communicate the national legislation concerned to the Commission .
Komisija objavi izsledke v javnem registru.“
The Commission shall publish the results in a public register. ”
Države članice bi morale ohraniti pravico, da na etični podlagi prepovedo ali dovolijo proizvode, s čimer se odražajo pogledi teh držav članic.
Member States should retain the rights to prohibit or allow products on ethical grounds reflecting the views held by that Member State.