natgillin/translations-raw huggingface dataset:
Pursuant to Regulation (EC) No 1394/2007, the certification procedure should be independent from any application for marketing authorisation.
V skladu z Uredbo (ES) št. 1394/2007 mora biti postopek potrjevanja neodvisen od kakršnih koli vlog za pridobitev dovoljenja za promet.
Nevertheless, it should also aim at facilitating the evaluation of any future application for clinical trial and marketing authorisation based on the same data.
Vendar pa mora biti namen tega postopka tudi lažje vrednotenje kakršnih koli prihodnjih vlog za klinično preskušanje in pridobitev dovoljenja za promet na podlagi istih podatkov.
For this reason, the evaluation of an application for certification should be conducted in accordance with the same scientific and technical requirements as those applicable to a marketing authorisation application, as laid down in Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [3].
Zato je treba vrednotenje vloge za potrditev izvajati v skladu z istimi znanstvenimi in tehničnimi zahtevami, kot so bile uporabljene za vrednotenje vloge za pridobitev dovoljenja za promet, kot je določeno v Prilogi I k Direktivi 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [3].
It should be possible for applicants for certification to provide all or parts of quality and non-clinical data required by Annex I to Directive 2001/83/EC.
Predlagatelji morajo imeti možnost, da za potrditev v celoti ali delno predložijo podatke o kakovosti in neklinične podatke, kot jih zahteva Priloga I k Direktivi 2001/83/ES.
However, in order to ensure the added value of certifications, it is appropriate to lay down a minimum set of data required for certification.
Vendar je za zagotovitev dodane vrednosti potrditev primerno določiti minimalni sklop zahtevanih podatkov za potrditev.
Within the Agency, the Committee for Advanced Therapies has the appropriate expertise for the examination of quality and non-clinical data relating to advanced therapy medicinal products.
V okviru Agencije ima Odbor za napredno zdravljenje ustrezno strokovno znanje za preverjanje kakovosti in nekliničnih podatkov o zdravilih za napredno zdravljenje.
It should therefore be responsible for evaluating applications for certification.
Zato mora biti odgovoren za vrednotenje vlog za potrditev.
Where necessary, it should be possible for the Committee for Advanced Therapies to make completion of its evaluation subject to a site visit of the premises where the advanced therapy medicinal product is being developed.
Odbor za napredno zdravljenje bi moral imeti možnost, da po potrebi svoje vrednotenje dopolni z ogledom prostorov, v katerih se razvija zdravilo za napredno zdravljenje, na kraju samem.
Applications for certification may relate to combined advanced therapy medicinal products within the meaning of Regulation (EC) No 1394/2007.
Vloge za potrditev se lahko nanašajo na kombinirana zdravila za napredno zdravljenje v smislu Uredbe (ES) št. 1394/2007.
In such a case, additional requirements should apply in relation to the conformity of the medical device or active implantable medical device contained in the combined product with the essential requirements laid down in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [4] and Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices [5], respectively.
V takšnem primeru je treba uporabljati dodatne zahteve v povezavi s skladnostjo medicinskega pripomočka ali aktivnega medicinskega pripomočka za vsaditev, vgrajenega v kombinirano zdravilo, z bistvenimi zahtevami iz Direktive Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih [4] in Direktive Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev [5] v tem zaporedju.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Stalnega odbora za zdravila za uporabo v humani medicini –
This Regulation shall apply to micro, small and medium-sized enterprises, within the meaning of Recommendation 2003/361/EC, which develop an advanced-therapy medicinal product and are established in the Community.
Ta uredba se uporablja za mikro, mala in srednje velika podjetja, kot so opredeljena v Priporočilu 2003/361/ES, in ki razvijajo zdravila za napredno zdravljenje ter imajo sedež v Skupnosti.
Procedure for evaluation and certification
Postopek vrednotenja in potrjevanja
Applications for the scientific evaluation and certification of quality and non-clinical data relating to an advanced therapy medicinal product shall be submitted to the Agency and shall contain the following:
Vloge za znanstveno vrednotenje ter potrjevanje kakovosti in nekliničnih podatkov o zdravilu za napredno zdravljenje se predložijo Agenciji in vsebujejo naslednje:
all information necessary to demonstrate that the applicant falls within the scope of this Regulation as set out in Article 1;
vse podatke, ki so potrebni, da se dokaže, da predlagatelj spada v področje uporabe te uredbe, kot je določeno v členu 1;
an indication as to whether the application relates to quality data only or to quality and non-clinical data;
navedbo, ali se vloga nanaša le na podatke o kakovosti ali na podatke o kakovosti in neklinične podatke;
a reference to any applications for certification previously submitted for the same advanced therapy medicinal product, an indication as to whether a certificate has been granted or not and an explanation of the added value of the new application and of the differences between the new application and the application previously submitted;
sklicevanje na kakršno koli vlogo za potrditev, ki je bila v preteklosti vložena za isto zdravilo za napredno zdravljenje, navedba o tem, ali je bila potrditev odobrena ali ne, ter obrazložitev dodane vrednosti nove vloge in razlik med novo vlogo in v preteklosti vloženo vlogo;
the relevant fee as provided for in Council Regulation (EC) No 297/95 [6];
ustrezno pristojbino, kot je določena v Uredbi Sveta (ES) št. 297/95 [6];
the data referred to in module 3 of Part I of Annex I to Directive 2001/83/EC which is submitted for certification in accordance with the second subparagraph, taking into account the specific requirements laid down in Part IV of that Annex and the scientific guidelines referred to in Article 5.
podatke iz modula 3 dela I Priloge I k Direktivi 2001/83/ES, ki se predložijo v potrditev v skladu z drugim pododstavkom, pri čemer se upoštevajo posebne zahteve iz dela IV navedene priloge ter znanstvene smernice iz člena 5;
where the application relates to both quality data and non-clinical data, the data referred to in module 4 of Part I of Annex I to Directive 2001/83/EC which is submitted for certification in accordance with the third subparagraph, taking into account the specific requirements laid down in Part IV of that Annex and the scientific guidelines referred to in Article 5.
kadar se vloga nanaša na podatke o kakovosti in neklinične podatke, podatke iz modula 4 dela I Priloge I k Direktivi 2001/83/ES, ki se predloži v potrditev v skladu s tretjim pododstavkom, pri čemer se upoštevajo posebne zahteve iz dela IV navedene priloge ter znanstvene smernice iz člena 5:
For the purposes of point (e) of the first subparagraph, the application shall contain at least the following data:
Za namene točke (e) prvega pododstavka vloga vsebuje vsaj naslednje podatke:
general information and information related to the starting and raw materials;
splošne podatke in podatke o vhodnih snoveh in surovinah;
manufacturing process of the active substance(s), with the exception of data on process validation;
postopek izdelave zdravilnih učinkovin z izjemo podatkov o vrednotenju postopka;
characterisation of the active substance(s), limited to the data necessary to adequately describe the active substance(s);
značilnosti zdravilnih učinkovin, omejene na podatke, ki so potrebni za ustrezen opis zdravilnih učinkovin;
control of active substance(s), with the exception of data on the validation of the assays;
nadzor zdravilnih učinkovin z izjemo podatkov o vrednotenju vsebnosti;
description and composition of the finished product.
opis in sestavo končnega zdravila.
For the purposes of point (f) of the first subparagraph, the application shall contain at least the following data:
Za namene točke (f) prvega pododstavka vloga vsebuje vsaj naslednje podatke:
primary pharmacodynamic data supporting the rationale for the proposed therapeutic use;
primarne farmakodinamične podatke v podporo utemeljitvi za predlagano terapevtsko uporabo;
pharmacokinetics bio-distribution data, if relevant to corroborate the primary pharmacodynamic data;
farmakokinetične podatke o biološki porazdelitvi, če so pomembni za podkrepitev primarnih farmakodinamičnih podatkov;
at least one toxicity study.
vsaj eno študijo toksičnosti.
If the application fulfils the requirements laid down in paragraph 1 the Agency shall acknowledge receipt of a valid application.
Če vloga izpolnjuje zahteve iz odstavka 1, Agencija potrdi prejem veljavne vloge.
The Committee for Advanced Therapies shall evaluate the valid application within 90 days following its acknowledgment of receipt.
Odbor za napredno zdravljenje ovrednoti veljavno vlogo v 90 dneh od potrditve njenega prejema.
For the purposes of that evaluation, the Committee for Advanced Therapies shall, in particular with a view to the subsequent evaluation of any future application for clinical trial and marketing authorisation, determine whether:
Za namene navedenega vrednotenja Odbor za napredno zdravljenje zlasti zaradi naknadnega vrednotenja kakršnih koli prihodnjih vlog za klinično preskušanje in pridobitev dovoljenja za promet določi, ali:
the quality data submitted and the quality testing methodology followed by the applicant comply with the scientific and technical requirements set out in sections 2.3 and 3 of Part I, in Part IV and, where relevant to quality data, in the Introduction and General Principles of Annex I to Directive 2001/83/EC;
predloženi podatki o kakovosti in metodologija za preskušanje kakovosti, ki jo je uporabil predlagatelj, izpolnjujejo znanstvene in tehnične zahteve iz razdelkov 2.3 in 3 dela I, dela IV ter, kjer je to pomembno za podatke o kakovosti, Uvoda in Splošnih načel Priloge I k Direktivi 2001/83/ES;
where applicable, the non-clinical data and the non-clinical testing methodology followed by the applicant comply with the scientific and technical requirements set out in sections 2.4 and 4 of Part I, in Part IV and, where relevant to non-clinical data, in the Introduction and General Principles of Annex I to Directive 2001/83/EC.
če je primerno, neklinični podatki in metodologija predkliničnega preskušanja, ki jo je uporabil predlagatelj, izpolnjujejo znanstvene in tehnične zahteve iz razdelkov 2.4 in 4 dela I, dela IV ter, kjer je to pomembno za predklinične podatke, Uvoda in Splošnih načel Priloge I k Direktivi 2001/83/ES.
Within the period referred to in paragraph 3, the Committee for Advanced Therapies may request the applicant to provide supplementary information within a given time limit.
V obdobju iz odstavka 3 Odbor za napredno zdravljenje lahko zahteva, da predlagatelj v določenem roku predloži dodatne informacije.
In that case, the period referred to in paragraph 3 shall be suspended until the supplementary information requested has been provided.
V tem primeru se obdobje iz odstavka 3 podaljša do predložitve zahtevanih dodatnih informacij.
When the Committee for Advanced Therapies has completed its evaluation, the Agency shall inform the applicant accordingly and provide him without delay with the following documents:
Ko Odbor za napredno zdravljenje konča vrednotenje, Agencija predlagatelja ustrezno obvesti in mu takoj pošlje naslednje dokumente:
an evaluation report detailing in particular the reasons for the conclusion reached by the Committee for Advanced Therapies on the application;
poročilo o vrednotenju, v katerem so natančno opredeljeni zlasti razlogi za odločitev, ki jo je o vlogi sprejel Odbor za napredno zdravljenje;
if appropriate on the basis of this evaluation, a certificate identifying the quality and, where applicable, non-clinical data submitted and the corresponding testing methodologies followed by the applicant, which meet the scientific and technical requirements referred to in the second subparagraph of paragraph 3;
če je glede na vrednotenje primerno, potrdilo o kakovosti in, če je primerno, predložene neklinične podatke ter zadevne metodologije preskušanja, ki jih je predlagatelj uporabil in ki izpolnjujejo znanstvene in tehnične zahteve iz drugega pododstavka odstavka 3;
where deemed appropriate by the Committee for Advanced Therapies, a list of issues for future consideration by the applicant as regards the compliance with the scientific and technical requirements of Annex I to Directive 2001/83/EC of the quality and, where applicable, non-clinical data submitted, and the corresponding testing methodologies followed by the applicant.
če Odbor za napredno zdravljenje meni, da je primerno, seznam vprašanj, ki bi jih moral predlagatelj v prihodnosti proučiti, kar zadeva izpolnjevanje znanstvenih in tehničnih zahtev iz Priloge I k Direktivi 2001/83/ES v zvezi s kakovostjo in, če je primerno, predloženimi nekliničnimi podatki ter zadevnimi metodologijami preskušanja, ki jih je predlagatelj uporabil.
Site visits
Ogledi na kraju samem
The Committee for Advanced Therapies may inform the applicant that a site visit of the premises where the advanced therapy medicinal product concerned is being developed is necessary in order to complete its evaluation in accordance with Article 2.
Odbor za napredno zdravljenje lahko predlagatelja obvesti, da je za zaključek vrednotenja v skladu s členom 2 potreben ogled prostorov, v katerih se razvija zadevno zdravilo za napredno zdravljenje, na kraju samem.
It shall inform the applicant of the objectives of the site visit.
Predlagatelja obvesti o namenu ogleda.
If the applicant accepts the conduct of a site visit, it shall be carried out by inspectors from the Member States who hold the appropriate qualifications.
Če predlagatelj sprejme ogled na kraju samem, ga opravijo ustrezno usposobljeni inšpektorji iz države članice.
In that case, the time-limit laid down in Article 2(3) shall be suspended until the visit report has been made available to the Committee for Advanced Therapies and to the applicant.
V tem primeru se rok iz člena 2(3) podaljša do predložitve poročila o ogledu na kraju samem Odboru za napredno zdravljenje in predlagatelju.
Where an application for certification relates to combined advanced therapy medicinal products, the additional requirements set out in paragraphs 2 and 3 shall apply.
Kadar se vloga za potrditev nanaša na kombinirana zdravila za napredno zdravljenje, se uporabljajo dodatne zahteve iz odstavkov 2 in 3.
The application for certification of data related to a combined advanced therapy medicinal product may include evidence of conformity with the essential requirements referred to in Article 6 of Regulation (EC) No 1394/2007.
Vloga za potrditev podatkov o kombiniranem zdravilu za napredno zdravljenje lahko vključuje dokazilo o skladnosti z bistvenimi zahtevami iz člena 6 Uredbe (ES) št. 1394/2007.
The application for certification of data related to 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 part or active implantable medical device part.
Vloga za potrditev podatkov o kombiniranem zdravilu za napredno zdravljenje po potrebi vsebuje rezultate ocene dela medicinskega pripomočka ali dela aktivnega medicinskega pripomočka za vsaditev, ki jo pripravi priglašeni organ v skladu z Direktivo 93/42/EGS ali Direktivo 90/385/EGS.
The Agency shall recognise the results of that assessment in its evaluation of the data concerning the medicinal product concerned.
Agencija prizna rezultate navedene ocene pri vrednotenju podatkov o zadevnem zdravilu.
The Agency may request the relevant notified body to transmit any information related to the results of its assessment.
Agencija lahko od priglašenega organa zahteva, da pošlje katere koli informacije v zvezi z rezultati njegove ocene.
In that case, the period referred to in Article 2(3) shall be suspended until the information requested has been provided.
V tem primeru se obdobje iz člena 2(3) podaljša do predložitve zahtevanih informacij.
If the application does not include the results of the assessment, the Agency may
Če vloga ne vsebuje rezultatov ocene, lahko Agencija
seek an opinion on the conformity of the device part with Annex I to Directive 93/42/EEC or Annex 1 to Directive 90/385/EEC from a notified body identified in conjunction with the applicant, unless the Committee for Advanced Therapies advised by its experts for medical devices decides that involvement of a notįfied body is not required; or
od priglašenega organa, ki ga določi skupaj z predlagateljem, pridobi mnenje o skladnosti dela pripomočka s Prilogo I k Direktivi 93/42/EGS ali Prilogo 1 k Direktivi 90/385/EGS, razen če Odbor za napredno zdravljenje po nasvetu svojih strokovnjakov za medicinske pripomočke odloči, da sodelovanje priglašenega organa ni potrebno, ali
exclude from the evaluation the check of conformity of the medical device with the essential requirements referred to in Article 6 of Regulation (EC) No 1394/2007.
iz vrednotenja izključi preverjanje skladnosti medicinskega pripomočka z bistvenimi zahtevami iz člena 6 Uredbe (ES) št. 1394/2007.
In the case referred to in point (a), the period referred to in Article 2(3) shall be suspended until the opinion requested has been provided.
V primeru iz točke (a) se obdobje iz člena 2(3) podaljša do predložitve zahtevanega mnenja.
In the case referred to in point (b), the evaluation report and any certificate provided shall record the fact that the evaluation excludes the check of conformity of the medical device with the essential requirements.
V primeru iz točke (b) se v poročilo o vrednotenju in katero koli predloženo potrdilo vpiše, da je preverjanje skladnosti medicinskega pripomočka z bistvenimi zahtevami izključeno iz vrednotenja.
The evaluation report and any certificate provided may also conclude that the interaction and compatibility between the cells or tissues and the medical device cannot be evaluated in the absence of the results of the assessment by a notified body.
V poročilu o vrednotenju in katerem koli potrdilu je lahko tudi navedeno, da interakcije med celicami ali tkivi ter medicinskim pripomočkom in njihove združljivosti ni mogoče ovrednotiti, ker ni rezultatov ocene priglašenega organa.
Scientific guidelines
Znanstvene smernice
In assembling the dossier for application for certification, applicants shall take into account the scientific guidelines published by the Agency relating to the minimum quality and non-clinical data set out in the second and third subparagraphs of Article 2(1) for the certification of advanced therapy medicinal products.
Pri zbiranju dokumentacije za vlogo za potrditev predlagatelji upoštevajo znanstvene smernice, ki jih v zvezi z minimalnimi podatki o kakovosti in nekliničnimi podatki iz drugega in tretjega pododstavka člena 2(1) za potrjevanje zdravil za napredno zdravljenje objavi Agencija.
The Agency shall include in the Annual Report of its activities a section on the experience gained as a result of the application of this Regulation.
Agencija v letno poročilo o svojih dejavnostih vključi tudi razdelek o izkušnjah, pridobljenih pri uporabi te uredbe.
This section shall in particular contain statistical information on the type and number of applications submitted pursuant to this Regulation.
Ta razdelek zajema zlasti statistične podatke o vrsti in številu vlog, vloženih v skladu s to uredbo.
Commission Regulation (EC) No 669/2009
Uredba Komisije (ES) št. 669/2009
implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC
o izvajanju Uredbe (ES) št. 882/2004 Evropskega parlamenta in Sveta glede poostrenega uradnega nadzora pri uvozu nekatere krme in nekaterih živil neživalskega izvora ter spremembi Odločbe 2006/504/ES
Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules [1], and in particular Article 15(5) and Article 63(1) thereof,
ob upoštevanju Uredbe (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali [1], ter zlasti člena 15(5) in člena 63(1) Uredbe,
Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [2], and in particular Article 53(1),
ob upoštevanju Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane [2], ter zlasti člena 53(1) Uredbe,
Regulation (EC) No 882/2004 establishes a harmonised framework of general rules for the organisation of official controls at Community level, including official controls on the introduction of food and feed from third countries.
Uredba (ES) št. 882/2004 vzpostavlja usklajen okvir splošnih pravil za organizacijo uradnega nadzora na ravni Skupnosti, vključno z uradnim nadzorom uvoza živil in krme iz tretjih držav.
In addition, it provides for a list to be drawn up of feed and food of non-animal origin that is on the basis of a known or emerging risk to be subject to an increased level of official controls at the point of entry into the territories referred to in Annex I thereto (the list).
Poleg tega določa, da se oblikuje seznam krme in živil neživalskega izvora, za katere zaradi znanega ali nepričakovanega tveganja velja poostren uradni nadzor na vstopni točki na območje iz Priloge I k navedeni uredbi („seznam“).
Such an increased level of control should allow, on the one hand, the known or emerging risk to be countered more effectively, and, on the other hand, the collection of accurate monitoring data on the occurrence and prevalence of unfavourable results from laboratory analysis.
Takšen poostren nadzor mora omogočiti učinkovitejše obvladovanje znanega ali nepričakovanega tveganja in zbiranje natančnih podatkov, pridobljenih s spremljanjem, o pojavljanju in razširjenosti neugodnih rezultatov laboratorijske analize.
In order to draw up the list, certain criteria, which would allow the identification of a known or emerging risk linked to a specific feed or food of non-animal origin, should be taken into account.
Pri pripravi seznama je treba upoštevati nekatera merila, ki bi omogočila ugotovitev znanega ali nepričakovanega tveganja, povezanega s posebno krmo ali s posebnimi živili neživalskega izvora.