natgillin/translations-raw huggingface dataset:
Za varnost bolnikov in visokih standardov vrednotenja kombiniranega zdravila bi morala biti sposobnost preživetja celičnega ali tkivnega dela izdelka najpomembnejše merilo.
For the patient's safety and the high standards of the evaluation of a combined product, the most important criterion should be the viability of the cellular or tissue part of such a product.
ČLEN 4, ODSTAVEKS 2 IN 3
ARTICLE 4, PARAGRAPHS 2 AND 3
Komisija v skladu s postopkom iz člena 26(2) spremeni Direktivo 2005/28/ES, da se upoštevajo posebne značilnosti zdravil za napredno zdravljenje.
The Commission shall, in accordance with the procedure referred to in Article 26(2), amend Directive 2005/28/EC in order to take account of the specific characteristics of advanced therapy medicinal products.
Komisija po posvetu z Agencijo in v skladu s postopkom iz člena 26(2) spremeni Direktivo 2005/28/ES, da se upoštevajo posebne značilnosti zdravil za napredno zdravljenje.
The Commission shall, after consultation of the Agency and in accordance with the procedure referred to in Article 26(2), amend Directive 2005/28/EC in order to take account of the specific characteristics of advanced therapy medicinal products.
Komisija pripravi podrobne smernice o dobri klinični praksi, značilni za zdravila za napredno zdravljenje.
The Commission shall draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products.
Komisija po posvetu z Agencijo pripravi podrobne smernice o dobri klinični praksi, značilni za zdravila za napredno zdravljenje.
The Commission shall , after consultation of the Agency, draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products.
V uredbi mora biti jasno navedeno, da mora Komisija v postopke spreminjanja dobre klinične prakse ali oblikovanja smernic za zdravila za napredno zdravljenje 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 good clinical practice requirements need to be amended or guidelines related to advanced therapy medicinal products need to be drawn up.
ČLEN 5, ODSTAVEK -1 (novo)
ARTICLE 5, PARAGRAPH -1 (new)
Komisija v skladu s postopkom iz člena 26(2) spremeni Direktivo 2003/94/ES, da se upoštevajo posebne značilnosti zdravil za napredno zdravljenje in zlasti izdelkov tkivnega inženirstva.
The Commission shall, in accordance with the procedure referred to in Article 26(2), amend Directive 2003/94/EC to take into account the specific characteristics of advanced therapy medicinal products and in particular tissue engineered products.
Zdravila za napredno zdravljenje imajo posebne značilnosti, ki se zelo razlikujejo od običajnih zdravil.
Advanced therapy medicinal products have specific characteristics that differ greatly from traditional medicinal products.
Komisija objavi podrobne smernice v skladu z načeli dobre proizvodne prakse, značilne za zdravila za napredno zdravljenje.
Detailed guidelines in line with the principles of good manufacturing practice and specific to advanced therapy medicinal products shall be published by the Commission .
Komisija oblikuje podrobne smernice v skladu z načeli dobre proizvodne prakse, značilne za zdravila za napredno zdravljenje.
The Commission shall draw up detailed guidelines in line with the principles of good manufacturing practice and specific to advanced therapy medicinal products.
Zaradi doslednosti bi bilo treba besedilo uskladiti z ustreznim določilom iz člena 4(3).
For the sake of consistency, the wording should be put in line with the equivalent provision in Article 4(3).
Posebne zahteve za izdelke tkivnega inženirstva
Specific requirements for tissue engineered products
Posebne zahteve za zdravila za napredno zdravljenje s pripomočki
Specific requirements for advanced therapy medicinal products containing devices
Poleg zahtev iz člena 6(1) Uredbe (ES) št. 726/2004 vsebujejo vloge za pridobitev dovoljenja za promet z izdelki tkivnega inženirstva opis fizikalnih značilnosti izdelka in njegovega delovanja ter opis metod za načrtovanje izdelka v skladu s Prilogo I k Direktivi 2001/83/ES.
In addition to the requirements laid down in Article 6(1) of Regulation (EC) No 726/2004, applications for the authorisation of a tissue engineered product shall include a description of the physical characteristics and performance of the product and a description of the product design methods, in accordance with Annex I to Directive 2001/83/EC.
Poleg zahtev iz člena 6(1) Uredbe (ES) št. 726/2004 vloge za pridobitev dovoljenja za zdravila za napredno zdravljenje z zdravstvenimi pripomočki, biomateriali, vgraditvami ali matricami vsebujejo opis fizikalnih značilnosti izdelka in njegovega delovanja ter opis metod za načrtovanje izdelka v skladu s Prilogo I k Direktivi 2001/83/ES.
In addition to the requirements laid down in Article 6(1) of Regulation (EC) No 726/2004, applications for the authorisation of an advanced therapy medicinal product containing medical devices, bio-materials, scaffolds or matrices shall include a description of the physical characteristics and performance of the product and a description of the product design methods, in accordance with Annex I to Directive 2001/83/EC.
Področje uporabe tega člena bi bilo treba pojasniti in spremeniti, tako da bi vsebovalo vse izdelke, ki potrebujejo specifične zahteve.
The scope of this article should be clarified and amended to encompass all those products in need of these specific requirements.
S tem, ko bi zahteve omejili zgolj na izdelke tkivnega inženirstva, bi izločili zdravila za napredno zdravljenje, ki zaradi posebnih fizikalnih lastnosti prav tako lahko vplivajo na delovanje izdelka.
Restricting the requirements to tissue engineered products would exclude those advanced therapy medicinal products that also have special physical characteristics possibly affecting the performance of the product.
Vseeno pa bi razširitev zahtev na vsa zdravila za napredno zdravljenje pomenilo dodatno delo za podjetja; vsa zdravila za napredno zdravljenje namreč nimajo posebnih fizikalnih lastnosti, ki bi lahko vplivala na njihovo delovanje.
However, extending these requirements to all advanced therapy products would create unnecessary work for enterprises; all advanced therapy products do not have special physical characteristics that could affect their performance.
Komisija v skladu s postopkom iz člena 26(2) te uredbe spremeni Prilogo I k Direktivi 2001/83/ES, da določi tehnične zahteve, ki so značilne za izdelke tkivnega inženirstva, zlasti tiste iz člena 7, in s tem upošteva znanstveni in tehnični razvoj.
The Commission shall, in accordance with the procedure referred to in Article 26(2) of this Regulation, amend Annex I to Directive 2001/83/EC in order to lay down technical requirements that are specific to tissue engineered products, in particular those referred to in Article 7, with a view to taking account of scientific and technical evolution.
Komisija po posvetu z Agencijo in v skladu s postopkom iz člena 26(2a) te uredbe spremeni Prilogo I k Direktivi 2001/83/ES, da določi tehnične zahteve, ki so značilne za izdelke tkivnega inženirstva, zlasti tiste iz člena 7, in s tem upošteva znanstveni in tehnični razvoj.
The Commission shall, after consultation of the Agency and in accordance with the procedure referred to in Article 26(2a) of this Regulation, amend Annex I to Directive 2001/83/EC in order to lay down technical requirements that are specific to tissue engineered products, in particular those referred to in Article 7, with a view to taking account of scientific and technical evolution.
V uredbi mora biti jasno navedeno, da mora Komisija v postopke spreminjanja tehničnih zahtev iz Priloge I k Direktivi 2001/83/ES 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 the technical requirements laid down in Annex I to Directive 2001/83/EC need to be amended.
Poročevalec ali soporočevalec, ki ga imenuje Odbor za zdravila za uporabo v humani medicini v skladu s členom 62 Uredbe (ES) št. 726/2004, je član Odbora za napredno zdravljenje.
The rapporteur or co-rapporteur appointed by the Committee for Medicinal Products for Human Use pursuant to Article 62 of Regulation (EC) No 726/2004 shall be a member of the Committee for Advanced Therapies.
Ta član je tudi poročevalec ali soporočevalec za Odbor za napredno zdravljenje.
This member shall also act as rapporteur or co-rapporteur for the Committee for Advanced Therapies.
Poročevalec ali soporočevalec, ki ga imenuje Odbor za zdravila za uporabo v humani medicini v skladu s členom 62 Uredbe (ES) št. 726/2004, je član Odbora za napredno zdravljenje , ki ga predlaga, in ima posebno strokovno znanje o zdravilu .
The rapporteur or co-rapporteur appointed by the Committee for Medicinal Products for Human Use pursuant to Article 62 of Regulation (EC) No 726/2004 shall be a member of the Committee for Advanced Therapies, proposed by the Committee for Advanced Therapies and having specific expertise for the product.
Za zagotavljanje najvišje stopnje strokovnega znanja Odbor za napredno zdravljenje predlaga poročevalca in soporočevalca, ki ju imenuje Odbor za zdravila za uporabo v humani medicini (CHMP) in ki morata imeti posebno strokovno znanje o zadevnem zdravilu.
In order to ensure the highest level of expertise, the rapporteur and co-rapporteur appointed by the CHMP should be proposed by the Committee for Advanced Therapies and should have specific expertise for the relevant product.
ČLEN 9, ODSTAVEK 2 A (novo)
ARTICLE 9, PARAGRAPH 2 A (new)
Odbor za napredno zdravljenje si pri pripravi osnutka mnenja, ki ga končno odobri Odbor za zdravila za humano uporabo, prizadeva doseči znanstveno soglasje.
When preparing a draft opinion for final approval by the Committee for Medicinal Products for Human Use, the Committee for Advanced Therapies shall endeavour to reach a scientific consensus.
Če takega soglasja ni mogoče doseči, Odbor za napredno zdravljenje sprejme stališče večine članov.
If such consensus cannot be reached, the Committee for Advanced Therapies shall adopt the position of the majority of its members.
Osnutek mnenja navaja odstopajoča stališča in razloge, na katerih temeljijo.
The draft opinion shall mention the divergent positions and the grounds on which they are based.
V okviru Odbora za napredno zdravljenje je treba opredeliti jasen postopek odločanja, da bi zagotovili preglednost postopka priprave osnutka mnenja.
In order to guarantee transparency in the process of preparation of a draft opinion, a clear decision procedure should be defined within Committee for Advanced Therapies.
Zato predlagamo, da člani dosežejo znanstveno soglasje.
Consequently, we suggest that a scientific consensus should be reached by its members.
ČLEN 9, ODSTAVEK 2 B (novo)
ARTICLE 9, PARAGRAPH 2 B (new)
Poročevalec ali soporočevalec ima pravico do neposrednega zaslišanja predlagatelja.
The rapporteur or co-rapporteur shall be entitled to question the applicant directly.
Poročevalec ali soporočevalec nemudoma pisno obvesti sodelujoče odbore o podrobnostih stikov s predlagateljem.
The rapporteur or co-rapporteur shall inform the Committees involved in writing without delay of the details of contacts with the applicant.
Če se predlagatelj ne strinja z osnutkom mnenja Odbora za napredno zdravljenje, lahko v 15 dneh od prejema osnutka mnenja predloži pisne opazke Odboru za zdravila za uporabo v humani medicini.
In case of disagreement with the draft opinion of the Committee for Advanced Therapies, the applicant may submit, within 15 days of receipt of the draft opinion, written observations to the Committee for Medicinal Products for Human Use.
Odbor za zdravila za uporabo v humani medicini pred izdajo mnenja zasliši predlagatelja, če ta v svojih pisnih opazkah to zahteva.
The applicant shall be heard by the Committee for Medicinal Products for Human Use before it issues its opinion, if the applicant so requests in its written observations.
Namen predloga spremembe je povečati preglednost postopka.
The amendment aims at enhancing a more transparent procedure.
Zaradi člena 9(2) Uredbe (ES) št. 726/2004, v skladu s katerim ima predlagatelj možnost, da s pisnim obvestilom Agenciji zahteva ponoven pregled mnenja Odbora za zdravila za humano uporabo, mora tudi predlagatelj, ki prejme mnenje Odbora za napredno zdravljenje, imeti možnost za pritožbo, da se znotraj Agencije zagotovi doslednost.
Due to Article 9 (2) of Regulation (EC) No 726/2004 where the applicant is given the opportunity to request a re-examination of the opinion of the Committee for Medicinal Products for Human Use in giving written notice to the agency, an applicant receiving an opinion from the Committee of Advanced Therapies shall also receive the opportunity of appeal in order to ensure consistency within the Agency.
Nasvet , ki ga Odbor za napredno zdravljenje da po odstavku 1, se pošlje predsedniku Odbora za zdravila za uporabo v humani medicini pravočasno, da se zagotovi upoštevanje roka iz člena 6(3) Uredbe (ES) št. 726/2004.
The advice given by the Committee for Advanced Therapies under paragraph 1 shall be sent to the chairman of the Committee for Medicinal Products for Human Use in a timely manner so as to ensure that the deadline laid down in Article 6(3) of Regulation (EC) No 726/2004 can be met.
Osnutek mnenja , ki ga Odbor za napredno zdravljenje da po odstavku 1, se pošlje predsedniku Odbora za zdravila za uporabo v humani medicini pravočasno, da se zagotovi upoštevanje roka iz člena 6(3) ali 9(2) Uredbe (ES) št. 726/2004.
The draft opinion given by the Committee for Advanced Therapies under paragraph 1 shall be sent to the chairman of the Committee for Medicinal Products for Human Use in a timely manner so as to ensure that the deadline laid down in Article 6(3) or 9(2) of Regulation (EC) No 726/2004 can be met.
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 se 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 qualifications or experience in this highly innovative and quickly developing field.
Zato je nova struktura odgovorna za sestavo osnutka mnenja o kakovosti, varnosti in učinkovitosti zdravil, da ga končno odobri CHMP.
Therefore, this new structure should be responsible for drafting an opinion on the quality, safety, and efficacy of products for the final approval by the CHMP.
Osnutek mnenja je treba pravočasno poslati, da se zagotovi upoštevanje roka iz člena 9(2) Uredbe (ES) št. 726/2004.
The draft opinion should be given in a timely manner so the deadline laid down in Article 9(2) of Regulation (EC) No 726/2004 can also be met.
ČLEN 9, ODSTAVEK 4
ARTICLE 9, PARAGRAPH 4
Kadar znanstveno mnenje o zdravilu za napredno zdravljenje, ki ga pripravi Odbor za zdravila za uporabo v humani medicini na podlagi odstavkov 2 in 3 člena 5 Uredbe (ES) 726/2004, ni v skladu z nasvetom Odbora za napredno zdravljenje, Odbor za zdravila za humano uporabo priloži svojemu mnenju podrobno razlago znanstvenih razlogov za razhajanja.
Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5, paragraphs 2 and 3 of Regulation (EC) No 726/2004 is not in accordance with the advice of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences.
Kadar znanstveno mnenje o zdravilu za napredno zdravljenje, ki ga pripravi Odbor za zdravila za uporabo v humani medicini na podlagi člena 5(2) in (3) Uredbe (ES) 726/2004, ni v skladu z osnutkom mnenja Odbora za napredno zdravljenje, Odbor za zdravila za humano uporabo priloži svojemu mnenju podrobno razlago znanstvenih razlogov za razhajanja.
Where the scientific opinion on an advanced therapy medicinal product drawn up by the Committee for Medicinal Products for Human Use under Article 5(2) and (3) of Regulation (EC) No 726/2004 is not in accordance with the draft opinion of the Committee for Advanced Therapies, the Committee for Medicinal Products for Human Use shall annex to its opinion a detailed explanation of the scientific grounds for the differences.
Glej obrazložitev predloga spremembe člena 9(3).
See the justification for the amendment of the Article 9, paragraph 3.
Za kombinirano zdravilo za napredno zdravljenje velja, da celoten izdelek, vključno s kakršnim koli vključenim medicinskim pripomočkom ali aktivnim medicinskim pripomočkom za vsaditev, vrednoti Agencija.
Where a combined advanced therapy medicinal product is concerned, the whole product, including any medical device or any active implantable medical device incorporated in the medicinal product, shall be evaluated by the Agency.
Za kombinirano zdravilo za napredno zdravljenje velja, da celoten izdelek, vključno s kakršnim koli vključenim medicinskim pripomočkom ali aktivnim medicinskim pripomočkom za vsaditev, dokončno oceni Agencija.
Where a combined advanced therapy medicinal product is concerned, the whole product, including any medical device or any active implantable medical device incorporated in the medicinal product, shall be subject to final evaluation by the Agency.
V skladu z odstavkom 2 mora medicinski pripomoček ali aktivni medicinski pripomoček za vsaditev, ki je del kombiniranega zdravila za napredno zdravljenje, oceniti priglašeni organ, da bi imeli koristi od posebnih bogatih izkušenj.
According to paragraph 2, a medical device or the active implantable medical device part of a combined advanced therapy medicinal product have to be assessed by a notified body in order to benefit from its extensive specific experience.
Zadnje vrednotenje mora opraviti Agencija, ki v končno mnenje vključi oceno priglašenega organa.
The final evaluation should be carried out by the Agency who should incorporate the assessment of a notified body in its final opinion.
Vloga za pridobitev dovoljenja za promet kombiniranega zdravila za napredno zdravljenje vključuje dokazilo o skladnosti z nujnimi zahtevami iz člena 6.
The application for a marketing authorisation for a combined advanced therapy medicinal product shall include evidence of conformity with the essential requirements referred to in Article 6.
Pripomoček, ki je del kombiniranega zdravila za napredno zdravljenje, mora v skladu s členom 6 predlagane uredbe izpolnjevati ustrezne bistvene zahteve za pripomočke.
In accordance with Article 6 of the proposed Regulation, the device part of a combined advanced therapy medicinal product must meet the relevant device essential requirements.
Dokaz o skladnosti z zahtevami je treba navesti v vlogi za dovoljenje za promet.
Evidence of conformity with these requirements should be provided in the marketing authorisation application.
Kadar je medicinski pripomoček ali aktivni medicinski pripomoček za vsaditev, ki je del kombiniranega zdravila za napredno zdravljenje , že ocenil priglašeni organ v skladu z Direktivo 93/42/EGS ali Direktivo 90/385/EGS , Agencija upošteva rezultate navedene ocene pri vrednotenju zadevnega zdravila .
Where the medical device or active implantable medical device which is part of a combined advanced therapy medicinal product has already been assessed by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC, the Agency shall take account of the results of that assessment in its evaluation of the medicinal product concerned.
Vloga za pridobitev dovoljenja za promet kombiniranega zdravila za napredno zdravljenje lahko po potrebi vključuje oceno medicinskih pripomočkov ali aktivnih medicinskih pripomočkov za vsaditev, ki jo pripravi priglašeni organ v skladu z Direktivo 93/42/EGS ali Direktivo 90/385/EGS .
The application for a marketing authorisation for a combined advanced therapy medicinal product shall include, where available, the results of the assessment by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC of the medical device or active implantable medical device part.
Agencija pri vrednotenju zadevnega zdravila upošteva rezultate navedene ocene.
The Agency shall take account of the results of that assessment in its evaluation of the medicinal product concerned.
Agencija lahko od priglašenega organa zahteva, da pošlje kakršne koli informacije v zvezi z rezultati njegove ocene.
The Agency may request the relevant notified body to transmit any information related to the results of its assessment.
Priglašeni organ pošlje informacije v enem mesecu.
The notified body shall transmit the information within a period of one month.
Če vloga ne vsebuje ocene, lahko Agencija od priglašenega organa, ki se določi skupaj s predlagateljem, pridobi mnenje o skladnosti dela pripomočka s Prilogo I k Direktivi 93/42/EGS ali Direktivi 90/385/EGS.
If the application does not include the results of the assessment, then the Agency may seek an opinion on the conformity of the device part with Annex I to Directive 93/42/EEC or Directive 90/385/EEC from a notified body identified in conjunction with the applicant.
Navodilo za uporabo odraža rezultate posvetovanj s ciljnimi skupinami bolnikov, da se zagotovi berljivost, jasnost in enostavna uporaba navodil.
The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.
Kjer izdelke na bolnikih uporabljajo izključno zdravniki, se lahko povzetek glavnih značilnosti zdravila v skladu s členom 11 Direktive 2001/83/ES uporabi kot navodilo za uporabo.
Where products are exclusively applied to patients by medical practitioners, the summary of product characteristics pursuant to Article 11 of Directive 2001/83/EC can be used as the package leaflet.
Glede na to, da večina zdravil za napredno zdravljenje ne bo prišla v roke bolnikov, ampak jih bodo neposredno uporabljali zdravniki, je treba bolnikom zagotoviti informacije o zdravljenju, zlasti v primerih avtolognih proizvodov, še pred odstranitvijo vhodnih snovi.
Since the predominant majority of Advanced Therapy Medicinal Products will not come into the hands of patients but will be applied by medical practitioners directly, information about the therapy, especially in cases of autologous products, must be given to patients even before the starting material is removed.
Zato bi bilo treba vpeljati možnost, da se povzetek glavnih značilnosti zdravila uporabi kot navodilo za uporabo.
Therefore the possibility should be introduced to use the summary of product characteristics as package leaflet.
Ker bolniki ne bodo prišli v stik z navodili za uporabo, se lahko izbriše besedilo o potrebi po posvetovanju s ciljnimi skupinami bolnikov.
Because the package will not come into the hand of patients the necessity for consultations with target patient groups could be deleted.
ČLEN 15, NASLOV
ARTICLE 15, TITLE
Obvladovanje tveganj po pridobitvi dovoljenja za promet
Post-authorisation Risk Management
Spremljanje učinkovitosti in neželenih učinkov ter obvladovanje tveganj po pridobitvi dovoljenja za promet
Post-authorisation follow-up of efficacy and adverse reactions, and Risk Management
Ta predlog spremembe sledi predlogu spremembe 38(člen 15(1)).
This is a consequential amendment to amendment 38 (Article 15, paragraph 1).