natgillin/translations-raw huggingface dataset:
Vsi posredni interesi, ki bi lahko bili povezani s temi sektorji , se vnesejo v register iz člena 63(2) Uredbe (ES) št. 726/2004.
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 farmacevtskim sektorjem, sektorjem medicinskih pripomočkov ali biotehnološkim sektorjem , se vnesejo v register iz člena 63(2) Uredbe (ES) št. 726/2004.
All indirect interests that could relate to the pharmaceutical sector, medical device sector or biotechnology sector shall be entered in the register referred to in Article 63(2) of Regulation (EC) No 726/2004 .
Treba je pojasniti, da je za Odbor za napredno zdravljenje (v skladu s členom 63 Uredbe (ES) št. 726/2004) potrebna enaka mera preglednosti kot za obstoječe odbore v okviru Evropske agencije za zdravila .
It should be clarified that an identical level of transparency as for existing Committees within the EMEA (pursuant to Article 63 of Regulation (EC) No 726/2004) applies for the new Committee for Advanced Therapies.
Treba je tudi pojasniti, da so prepovedani interesi v biotehnološkim sektorju ali sektorju medicinskih pripomočkov.
It should also be clarified that interests in the biotechnology or medical device sector are forbidden.
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) 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;
(a) 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;
Zaradi zelo posebnih in edinstvenih značilnosti zdravil za napredno zdravljenje, se v okviru EMEA ustanovi novi Odbor za napredno zdravljenje, ki ga sestavljajo strokovnjaki s posebnim strokovnim znanjem ali izkušnjami na tem zelo inovativnem in hitro razvijajočem področju.
Due to the highly specific and unique character of the advanced therapy medicinal products, a new Committee for Advanced Therapies is established within EMEA, composed of experts having specific qualification or experience in this highly innovative and quickly developing field.
Zato mora biti nova struktura odgovorna za oblikovanje osnutka mnenja o kakovosti, varnosti in učinkovitosti zdravil, da ga končno odobri CHMP.
Therefore, the new structure should be responsible for drafting an opinion on the quality, safety, and efficacy of products for the final approval by the CHMP.
Poleg tega se je treba z Odborom za napredno zdravljenje posvetovati za vrednotenje katerih koli drugih zdravil v okviru njegovih pristojnosti.
Furthermore, the committee should be consulted for the evaluation of other products under its competence.
ČLEN 23, TOČKA (A A) (novo)
ARTICLE 23, POINT (A A) (new)
(aa) v skladu s členom 18 svetuje o tem, ali se zdravilo šteje za zdravilo za napredno zdravljenje;
(aa) to provide advice, pursuant to Article 18, on whether a product falls within the definition of an advanced therapy medicinal product;
Odbor za napredno zdravljenje mora zaradi posebnega strokovnega znanja o zdravilih za napredno zdravljenje imeti pomembno vlogo pri razvrščanju zdravil na tista za napredno zdravljenje in tista, ki niso namenjena za napredno zdravljenje.
Having specific expertise in advanced therapy medicinal products, the Committee for Advanced Therapies should have a prominent role in the classification task of whether a product is or is not an advanced therapy medicinal product.
ČLEN 23, TOČKA (E A) (novo)
ARTICLE 23, POINT (E A) (new)
(ea) prispeva k postopkom znanstvenega svetovanja iz člena 17 te uredbe in člena 57(1)(n) Uredbe (ES) št. 726/2004;
(ea) to contribute to the scientific advice procedures referred to in Article 17 of this Regulation and in Article 57(1)(n) of Regulation (EC) No 726/2004;
Odbor za napredno zdravljenje bi morali sestavljati najboljši možni strokovnjaki iz držav članic.
The Committee on Advanced Therapies should consist of the best possible experts from Member States.
Vsako svetovanje glede zdravil za napredno zdravljenje bi torej moralo črpati iz njihovega strokovnega znanja.
Their expertise should therefore be drawn upon for any advice issued regarding 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 I do IV.
The Commission shall, in accordance with procedure referred to in Article 26(2), amend Annexes I to IV in order to adapt them to scientific and technical evolution.
Za prilagoditev znanstvenemu in tehničnemu razvoju Komisija po posvetu z Agencijo in v skladu s postopkom iz člena 26(2a) prilagodi priloge II do IV.
The Commission shall, after consultation of the Agency and in accordance with the procedure referred to in Article 26(2a), amend Annexes II to IV in order to adapt them to scientific and technical evolution.
Če se zaradi znanstvenega napredka pojavi potreba po kakršnih koli spremembah, 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 co-decision, fully involving the European Parliament.
V uredbi mora biti jasno navedeno, da mora Komisija v prilagajanje prilog k tehničnemu napredku v okviru Odbora za napredno zdravljenje vplesti tudi Evropsko agencijo za zdravila.
The regulation should set out very clearly that the Commission must involve the EMEA, through the Committee for Advanced Therapies, whenever adaptation of the Annexes to technical progress is required.
Prilagajanje prilog II do IV bi moralo soditi v nov ureditveni postopek z nadzorom.
The adaptation of Annexes II to IV should fall under the new regulatory procedure with scrutiny.
ČLEN 25, NASLOV
ARTICLE 25, TITLE
Poročilo in revizija
Report and review
Znanstveni napredek lahko omogoči dodatne nove oblike zdravljenja, ki niso ne gensko ne celično zdravljenje in niti gensko inženirstvo.
Scientific advances may make additional novel therapies possible which are neither gene therapy, nor cell therapy nor tissue engineering.
Bilo bi v interesu pacientov, da bi jih v prihodnosti vključili in omogočili izdajanje dovoljenj za iz njih izhajajoča zdravila na evropski ravni.
It would be in the interests of patients for these to be included at some future date in order to allow European authorisation of the resulting products.
ČLEN 25, ODSTAVEK 1 A (novo)
ARTICLE 25, PARAGRAPH 1 A (new)
Znanstveni napredek bo morda omogočil nove terapije, ki niso niti gensko zdravljenje niti celično zdravljenje niti gensko inženirstvo.
Scientific advances may make additional novel therapies possible which are neither gene therapy, cell therapy nor tissue engineering.
Bilo bi v interesu pacientov, da bi jih v prihodnosti vključili in omogočili izdajanje dovoljenj za iz njih izhajajoča zdravila na evropski ravni.
It would be in the interests of patients for these to be included at some future date, in order to allow European authorisation of the resulting products.
ČLEN 26, ODSTAVEK 2 A (novo)
ARTICLE 26, PARAGRAPH 2 A (new)
Pri sklicevanju na ta odstavek se uporabljata člen 5a (1) do (4) in člen 7 Sklepa 1999/468/ES ob upoštevanju določb člena 8 tega sklepa.
Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Predlog spremembe je v skladu z novimi komitološkimi določbami (regulativni postopek z nadzorom).
This amendment is in line with the new comitology provisions (regulatory procedure with scrutiny).
ČLEN 27, TOČKA -1 (novo)
ARTICLE 27, POINT -1 (new)
Člen 13, odstavek 1 (Uredba (ES) št. 726/2004)
Article 13, paragraph 1 (Regulation (EC) No 726/2004)
(-1) V členu 13 se prvi stavek odstavka 1 nadomesti z naslednjim besedilom:
(-1) In Article 13, the first sentence of paragraph 1 is replaced by the following:
"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."
"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."
Ta predlog spremembe k členu 28(2) sledi zaradi zagotavljanja pravne usklajenosti.
This is a consequential amendment to Article 28(2) to ensure legal coherence.
ČLEN 27, TOČKA 2 A (novo)
ARTICLE 27, POINT 2 A (new)
Priloga, točka 3, pododstavek 2 (Uredba (ES) št. 726/2004)
Annex, point 3, subparagraph 2 (Regulation (EC) No 726/2004)
(2a) V prilogi se drugi pododstavek točke 3 nadomesti z naslednjim besedilom:
(2a) In the Annex, the second subparagraph of point 3 is replaced by the following:
"Po 20. maju 2008 lahko Komisija po posvetu z Agencijo predloži kakršen koli ustrezen predlog, ki bo spremenil to točko, Evropski parlament in Svet pa v skladu s Pogodbo o tem sprejmeta odločitev."
"After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal to amend this point, and the European Parliament and the Council shall take a decision thereon in accordance with the Treaty."
Ta del Uredbe 726/2004 določa, kdaj je potrebno pridobiti dovoljenje Skupnosti.
This part of Regulation 726/2004 determines when a Community authorisation must be obtained.
Seznam bolezni iz točke 3 lahko sedaj Svet na predlog Komisije razširi, ne da bi pri tem moral sodelovati Evropski parlament.
Currently, the list of diseases in point 3 can be extended by the Council on a Commission proposal, without recourse to the EP.
Sklepi, ki določajo obseg zakonodajnih aktov, se morajo sprejemati s soodločanjem.
Decisions determining the scope of legislative acts must be dealt with by co-decision.
ČLEN 28, TOČKA -1 (novo)
ARTICLE 28, POINT -1 (new)
Člen 1, točka 4 a (novo) (Direktive 2001/83/ES)
Article 1, point 4 a (new) (Directive 2001/83/EC)
(-1) V členu 1 se doda točka 4a:
(-1) In Article 1, the following point 4a is added:
Izdelek tkivnega inženirstva:
Tissue engineered product:
Izdelek, kot je opredeljen v členu 2 Uredbe (ES) št. **/** o zdravilih za napredno zdravljenje."
A product as defined in Article 2 of Regulation (EC) No **/** on advanced therapy medicinal products."
Zaradi pravne usklajenosti in jasnosti je treba vključiti sklicevanje na opredelitve o izdelku tkivnega inženirstva iz Direktive 2001/83/ES o zdravilih, ki že vsebuje opredelitve o zdravilu za gensko zdravljenje in zdravilu za somatsko celično zdravljenje.
For the sake of legal coherence and clarity, it is necessary to include a cross reference to the definition of a tissue engineered product in Directive 2001/83/EC on medicinal products, which already contains the definitions of a gene therapy medicinal product and a somatic cell therapy medicinal product.
ČLEN 28, TOČKA 1
ARTICLE 28, POINT 1
Člen 3, točka 7 (Direktive 2001/83/ES)
Article 3, point 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 na neprofitni osnovi za posamičen primer v skladu s posebnim, nestandardiziranim in nepatentiranim postopkom ter se uporabi v bolnišnici zaradi upoštevanja posameznega recepta za posameznega bolnika ob izključni poklicni odgovornosti zdravnika ali za klinično raziskavo .
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 in a non-profit manner 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 under the exclusive professional responsibility of a medical practitioner or for clinical research .
Odstavka 1 in 2 se ne uporabljata za zdravila za napredno zdravljenje.
Points 1 and 2 do not apply to advanced therapy medicinal products.
Za obrazložitev v zvezi z bolnišnicami glej predlog spremembe uvodne izjave 5.
For the justification concerning hospitals, see amendment to Recital 5.
Izjeme iz Direktive 2001/83/ES (člen 3(1) in (2)) lekarnam omogočajo, da pripravijo zdravila v skladu z receptom brez usklajevanja z zakonodajo o zdravilih.
Exceptions given in Directive 2001/83/EC (Article 3, points 1 and 2) 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 also give the in-house pharmacies of hospitals the possibility of producing TEP using standardized methods and on a routine basis.
Zato je ta predlog spremembe ključen, da se zagotovi zgolj izključitev izdelkov za enkratno uporabo iz področja uporabe te uredbe.
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 Člen 4, odstavek 5 (Direktive 2001/83/ES)
ARTICLE 28, POINT 2 Article 4, paragraph 5 (Directive 2001/83/EC)
Ta direktiva in vse v njej navedene uredbe ne vplivajo na uporabo nacionalne zakonodaje, ki 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.
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 nediskriminatorne nacionalne zakonodaje, ki iz razlogov, ki jih ne obravnava prej omenjena zakonodaja Skupnosti, 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 non-discriminatory 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 grounds not dealt with in the aforementioned Community legislation.
Komisija te podatke javno objavi v registru.
The Commission shall make this information publicly available in a register.
Predlog Komisije predstavlja resen problem glede združljivosti s pravno podlago (člen 95 Pogodbe o Evropski skupnosti).
The Commission’s proposal poses serious problems of compatibility with the legal base (Art. 95 ECT).
Trenutno besedilo člena 28(5) daje preveč priložnosti za omejevanje prostega pretoka določenih izdelkov za napredno zdravljenje.
The reason is that the current wording of Article 28(5) gives a too wide opportunity to restrict the free movement of certain advanced therapy products.
Zakonodajni akti na podlagi člena 95 so namenjeni izboljšanju pogojev za vzpostavitev in delovanje notranjega trga.
Legislative acts based on Art. 95 are intended to improve the conditions of the establishment and functioning of the internal market.
Predlog Komisije ne in zagotovo ne sme pokrivati in usklajevati vidikov javne morale in političnih vidikov napredne tehnologije.
The Commission’s proposal does not and should certainly not cover or harmonise aspects of public morality and public policy aspects of advanced therapy.
Vendar pa trenutno besedilo dovoljuje omejitve, ki niso povezane zgolj s temi stranskimi vidiki in ga je zato treba spremeniti v skladu s predlogi pravne službe Parlamenta.
However, the current wording allows restrictions not only related to these subsidiary aspects and should, therefore, be amended in line with suggestions of Parliament’s legal service.
Zdravila za napredno zdravljenje, ki so bila v času začetka veljavnosti te uredbe v skladu z nacionalno zakonodajo ali zakonodajo Skupnosti legalno na trgu Skupnosti, je treba uskladiti s to uredbo najkasneje 2 leti po začetku njene veljavnosti.
Advanced therapy medicinal products which were legally on the Community market in accordance with national or Community legislation at the time of entry into force of this Regulation shall comply with this Regulation no later than 2 years after its entry into force.
Zdravila za napredno zdravljenje, razen izdelkov tkivnega inženirstva, ki so bila v času začetka veljavnosti te uredbe v skladu z nacionalno zakonodajo ali zakonodajo Skupnosti legalno na trgu Skupnosti, je treba uskladiti s to uredbo najkasneje 4 leta po začetku njene veljavnosti.
Advanced therapy medicinal products , other than tissue engineered products, which were legally on the Community market in accordance with national or Community legislation at the time of entry into force of this Regulation shall comply with this Regulation no later than 4 years after its entry into force.
Danes podjetja že proizvajajo in tržijo izdelke tkivnega inženirstva na nacionalni ravni prek sistemov nacionalnega izdajanja dovoljenj.
Today companies are already producing and marketing TEP at national level through national authorisation systems.
Da bi podjetje pridobilo centralizirano dovoljenje za promet (npr. oblikovanje novih preskušanj skupaj z EMEA, vodenje preskušanj, razvoj dokumentacije in predložitev EMEA za vrednotenje), je predlagani časovni okvir dveh let prekratek.
In order for a company to obtain a centralised marketing authorisation (e.g. design the new trials together with the EMEA, to conduct the trials, to develop the dossier and to submit it to the EMEA for evaluation) the proposed timeframe of 2 years is too short.
Ob upoštevanju časa, ki je potreben za zgoraj omenjene korake, in da bi preprečili, da bolniki v prehodnem obdobju ne bi prejemali zdravil, s katerimi so se do zdaj varno zdravili, predlagamo obdobje 4 let.
Taking into account the time required for the above-mentioned steps and in order to avoid products that have been safely treating patients up to now being removed from those patients during the transitional period, we suggest a period of 4 years.
ČLEN 29, ODSTAVEK 1 A (novo)
ARTICLE 29, PARAGRAPH 1 A (new)
Izdelki tkivnega inženirstva, ki so bili v času uvedbe, navedene v drugem odstavku člena 30, v skladu z nacionalno zakonodajo ali zakonodajo Skupnosti legalno na trgu Skupnosti, morajo biti usklajeni s to uredbo najpozneje 4 leta po tem datumu.
Tissue engineered products which were legally on the Community market in accordance with national or Community legislation at the date of application specified in the second paragraph of Article 30 must comply with this Regulation no later than 4 years after that date.
Proizvajalci ne bodo mogli oblikovati razvojnih protokolov, dokler se ne objavijo vse zahteve, ki se nanašajo posebej na izdelke tkivnega inženirstva.
Manufacturers will not be in a position to design development protocols until all the requirements specific to tissue engineering products are published.
Prehodno obdobje za te izdelke mora zato upoštevati čas, potreben za objavo teh zahtev.
The transitional period for these products must therefore take into account the time to publish all these necessary requirements.
Z odstopanjem od člena 3(1) Uredbe (ES) št. 297/95 se Agenciji v zvezi z vlogami, predloženimi za dovoljenje za promet z zdravili za napredno zdravljenje, navedenimi v odstavku 1, ne plačujejo pristojbine.
By way of derogation from Article 3(1) of Regulation (EC) No 297/95, no fee shall be payable to the Agency in respect of applications submitted for the authorisation of the advanced therapy medicinal products mentioned in paragraph 1.
Z odstopanjem od člena 3(1) Uredbe (ES) št. 297/95 se Agenciji v zvezi z vlogami, predloženimi za dovoljenje za promet z zdravili za napredno zdravljenje, navedenimi v odstavkih 1 in 1a , ne plačujejo pristojbine.
By way of derogation from Article 3(1) of Regulation (EC) No 297/95, no fee shall be payable to the Agency in respect of applications submitted for the authorisation of the advanced therapy medicinal products mentioned in paragraphs 1 and 1a .
Glej predlog spremembe člena 29(1a)(novo).
See the amendment for Article 29, paragraph 1a (new).
ČLEN 29, ODSTAVEK 2 A (novo)
ARTICLE 29, PARAGRAPH 2 A (new)
Komisija lahko v primerih avtolognih proizvodov, na upravičeno zahtevo države članice in z odstopanjem od člena 3 Uredbe (ES) št. 726/2004, v skladu s postopkom iz člena 26(2) in po posvetu z Odborom za napredno zdravljenje, za obdobje petih let izda nacionalno dovoljenje, ki je v skladu z načeli te uredbe.
W ith regard to autologous products, on the reasoned request of a Member State and by way of derogation from Article 3 of Regulation (EC) No 726/2004, the Commission may in accordance with the procedure laid down in Article 26(2) and after consultation of the Committee on Advanced Therapies approve for a period of five years a national authorisation in accordance with the principles of this Regulation.
Komisija lahko tako odloči le, če meni, da:
The Commission may only take such a decision if it judges that:
- ima regulatorni organ zadevne države članice zadostno strokovno znanje o zdravilih za napredno zdravljenje in
- the regulatory authority of the Member State concerned has sufficient expertise in the field of advanced therapy medicinal products; and
– trženje določenega zdravila zunaj zadevne države članice ni mogoče.
- the marketing of the specific medicinal product outside the given Member State is not possible.
Komisija določi natančna postopkovna pravila za uporabo tega člena in jih objavi v Uradnem listu Evropske unije.
Detailed procedural rules for the application of this Article shall be laid down by the Commission and published in the Official Journal of the European Union.
ČLEN 30, ODSTAVKA 2 A in 2 B (novo)
ARTICLE 30, PARAGRAPHS 2 A AND 2 B (new)
Za izdelke tkivnega inženirstva se ta uredba uporablja od začetka veljavnosti vseh zahtev iz členov 4, 5 in 8.
For tissue engineered products this Regulation shall apply as of the entry into force of all the requirements referred to in Articles 4, 5 and 8.
Izvedbeni ukrepi iz členov 4, 5 in 8 se sprejmejo čim prej, najpozneje pa 9 mesecev po začetku veljavnosti te uredbe.
The implementing measures envisaged in Articles 4, 5 and 8 shall be adopted as soon as possible and, in any event, no later than 9 months after the entry into force of this Regulation .
PRILOGA II, TOČKA 2.2.
ANNEX II, POINT 2.2.