natgillin/translations-raw huggingface dataset:
That report shall include an assessment of the impact that the Regulation has had on scientific and technological progress, comprehensive information on the different types of clinical trials authorised pursuant to this Regulation, and the measures required in order to maintain the competitiveness of European clinical research.
V Strasbourgu, 16. aprila 2014
The Commission shall, if appropriate, present a legislative proposal based on that report in order to update the provisions set out in this Regulation.
Za Evropski parlament
Article 98
Predsednik
Transitional provision
Za Svet
By way of derogation from Article 96(1) of this Regulation, where the request for authorisation of a clinical trial has been submitted before the date referred to in the second paragraph of Article 99 of this Regulation pursuant to Directive 2001/20/EC, that clinical trial shall continue to be governed by that Directive until three years from that date.
UL C 44, 15.2.2013, str. 99.
By way of derogation from Article 96(1) of this Regulation, where the request for authorisation of a clinical trial is submitted between six months after the date of publication of the notice referred to in Article 82(3) of this Regulation and 18 months after the date of publication of that notice, or, if the publication of that notice occurs earlier than 28 November 2015, where that request is submitted between 28 May 2016 and 28 May 2017, that clinical trial may be started in accordance with Articles 6, 7 and 9 of Directive 2001/20/EC.
Stališče Evropskega parlamenta z dne 3. aprila 2014 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 14. aprila 2014.
That clinical trial shall continue to be governed by that Directive until 42 months after the date of publication of the notice referred to in Article 82(3) of this Regulation, or, if that publication occurs earlier than 28 November 2015, until 28 May 2019.
Direktiva 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi (UL L 121, 1.5.2001, str. 34).
Article 99
Uredba (ES) št. 141/2000 Evropskega parlamenta in Sveta z dne 16. decembra 1999 o zdravilih sirotah (UL L 18, 22.1.2000, str. 1).
Entry into force
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, 28.11.2001, str. 67).
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila (UL L 136, 30.4.2004, str. 1).
It shall apply as from six months after the publication of the notice referred to in Article 82(3), but in any event no earlier than 28 May 2016.
Uredba (EU) št. 182/2011 Evropskega parlamenta in Sveta z dne 16. februarja 2011 o določitvi splošnih pravil in načel, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije (UL L 55, 28.2.2011, str. 13).
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Direktiva Evropskega parlamenta in Sveta 95/46/ES z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov (UL L 281, 23.11.1995, str. 31).
Done at Strasbourg, 16 April 2014.
Uredba (ES) št. 45/2001 Evropskega parlamenta in Sveta z dne 18. decembra 2000 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti in o prostem pretoku takih podatkov (UL L 8, 12.1.2001, str. 1).
For the European Parliament
UL C 253, 3.9.2013, str. 10.
The President
Uredba (ES) št. 1394/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o zdravilih za napredno zdravljenje ter o spremembi Direktive 2001/83/ES in Uredbe (ES) št. 726/2004 (UL L 324, 10.12.2007, str. 121).
For the Council
Uredba (ES) št. 1901/2006 Evropskega parlamenta in Sveta z dne 12. decembra 2006 o zdravilih za pediatrično uporabo in spremembi Uredbe (EGS) št. 1768/92, Direktive 2001/20/ES, Direktive 2011/83/ES in Uredbe (ES) št. 726/2004 (UL L 378, 27.11.2006, str. 1).
OJ C 44, 15.2.2013, p. 99.
Direktiva Sveta 97/43/Euratom z dne 30. junija 1997 o varstvu posameznikov pred nevarnostjo ionizirajočega sevanja zaradi izpostavljenosti sevanju v zdravstvu in o razveljavitvi Direktive 84/466/Euratom (UL L 180, 9.7.1997, str. 22).
Position of the European Parliament of 3 April 2014 (not yet published in the Official Journal) and decision of the Council of 14 April 2014.
Direktiva Sveta 96/29/Euratom z dne 13. maja 1996 o določitvi temeljnih varnostnih standardov za varstvo zdravja delavcev in prebivalstva pred nevarnostmi zaradi ionizirajočega sevanja (UL L 159, 29.6.1996, str. 1).
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
Direktiva 2001/18/ES Evropskega parlamenta in Sveta z dne 12. marca 2001 o namernem sproščanju gensko spremenjenih organizmov v okolje in o razveljavitvi Direktive Sveta 90/220/EGS (UL L 106, 17.4.2001, str. 1).
Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
Direktiva 2004/23/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o določitvi standardov kakovosti in varnosti, darovanja, pridobivanja, testiranja, predelave, konzerviranja, shranjevanja in razdeljevanja človeških tkiv in celic (UL L 102, 7.4.2004, str. 48).
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 (OJ L 311, 28.11.2001, p. 67).
Direktiva 2002/98/ES Evropskega parlamenta in Sveta z dne 27. januarja 2003 o določitvi standardov kakovosti in varnosti za zbiranje, preskušanje, predelavo, shranjevanje in razdeljevanje človeške krvi in komponent krvi ter o spremembi Direktive 2001/83/ES (UL L 33, 8.2.2003, str. 30).
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1.)
Direktiva 2010/53/EU Evropskega parlamenta in Sveta z dne 7. julija 2010 o standardih kakovosti in varnosti človeških organov, namenjenih za presaditev (UL L 207, 6.8.2010, str. 14).
Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Direktiva 2009/41/ES Evropskega parlamenta in Sveta z dne 6. maja 2009 o uporabi gensko spremenjenih mikroorganizmov v zaprtih sistemih (UL L 125, 21.5.2009, str. 75).
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
PRILOGA I
Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
DOSJE VLOGE ZA PRVOTNO VLOGO
OJ C 253, 3.9.2013, p. 10.
A. UVOD IN SPLOŠNA NAČELA
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
Sponzor se, kadar je to primerno, sklicuje na katero koli predhodno vlogo.
Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.11.2006, p. 1).
Če je te vloge predložil drug sponzor, se predloži njegovo pisno soglasje.
Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom (OJ L 180, 9.7.1997, p. 22).
Kadar ima klinično preskušanje več kot enega sponzorja, se v dosjeju vloge predložijo podrobne informacije o njihovih pristojnostih.
Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation (OJ L 159, 29.6.1996, p. 1).
Vlogo podpiše sponzor ali njegov zastopnik.
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
S tem podpisom sponzor potrjuje, da:
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
so informacije popolne;
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30).
so v priloženih dokumentih natančno navedene informacije, ki so na voljo;
Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14).
se klinično preskušanje izvede v skladu s protokolom in
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (OJ L 125, 21.5.2009, p. 75).
se klinično preskušanje izvede v skladu s to uredbo.
ANNEX I
Dosje vloge za vlogo, omejeno na del I poročila o oceni iz člena 11, je omejen na oddelke B do J in Q te priloge.
APPLICATION DOSSIER FOR THE INITIAL APPLICATION
Brez poseganja v člen 26 sta dosje vloge za vlogo, omejeno na del II poročila o oceni iz člena 11, in dosje vloge za vlogo iz člena 14 omejena na oddelke K do R te priloge.
A. INTRODUCTION AND GENERAL PRINCIPLES
B. SPREMNI DOPIS
The sponsor shall, where appropriate, refer to any previous applications.
V spremnem dopisu se navede številka EU preskušanja in splošna številka preskušanja in opozori na vse posebne značilnosti kliničnega preskušanja.
If these applications have been submitted by another sponsor, the written agreement from that sponsor shall be submitted.
Vendar pa v spremnem dopisu ni potrebno znova navesti informacij, ki so že navedene na obrazcu vloge EU, razen:
Where a clinical trial has more than one sponsor, detailed information of the responsibilities of each of the sponsors shall be submitted in the application dossier.
posebnih značilnosti udeležencev kliničnega preskušanja, kot so udeleženci, ki niso sposobni dati prostovoljne privolitve po poučitvi, mladoletniki in nosečnice ali doječe matere;
The application shall be signed by the sponsor or a representative of the sponsor.
ali klinično preskušanje vključuje prvo uporabo nove zdravilne učinkovine pri ljudeh;
This signature confirms that the sponsor is satisfied that:
informacij o tem, ali znanstveno svetovanje v zvezi s kliničnim preskušanjem ali zdravilom v preskušanju zagotovi Agencija, država članica ali tretja država;
the information provided is complete;
informacij o tem, ali je klinično preskušanje del načrta pediatričnih raziskav iz naslova II, poglavja 3 Uredbe (ES) št. 1901/2006 (če je Agencija že izdala sklep o načrtu pediatričnih raziskav, se v spremnem dopisu navede povezava do sklepa Agencije na njeni spletni strani);
the attached documents contain an accurate account of the information available;
informacij o tem, ali so zdravila v preskušanju ali pomožna zdravila narkotiki, psihotropi ali radiofarmaki;
the clinical trial is to be conducted in accordance with the protocol; and
ali zdravila v preskušanju sestavljajo ali vsebujejo genetsko spremenjen organizem ali organizme;
the clinical trial is to be conducted in accordance with this Regulation.
informacij o tem, ali je sponzor za zdravilo v preskušanju ali bolezen pridobil status zdravila za redke bolezni;
The application dossier for an application limited to Part I of the assessment report referred to in Article 11 shall be limited to sections B to J and Q of this Annex.
izčrpen seznam, vključno z zakonsko urejenim statusom vseh zdravil v preskušanju, in seznam vseh pomožnih zdravil ter
Without prejudice to Article 26, the application dossier for an application limited to Part II of the assessment report referred to in Article 11 and the application dossier for an application referred to in Article 14 shall be limited to sections K to R of this Annex.
seznam vseh medicinskih pripomočkov, ki bodo raziskani v kliničnem preskušanju, ki pa niso del zdravila v preskušanju ali zdravil, skupaj z izjavo, ali imajo medicinski pripomočki oznako CE za predvideno uporabo.
B. COVER LETTER
V spremnem dopisu se navede, kje so informacije iz odstavka 7 navedene v dosjeju vloge.
The cover letter shall specify the EU trial number and the universal trial number and shall draw attention to any features which are particular to the clinical trial.
V spremnem dopisu se navede, ali gre po mnenju sponzorja za klinično preskušanje z minimalno intervencijo, in priloži podrobna utemeljitev.
However, in the cover letter it is not necessary to reproduce information already contained in the EU application form, with the following exceptions:
V spremnem dopisu se navede, ali metodologija kliničnega preskušanja zahteva, da se za prejemanje različnih zdravil v kliničnem preskušanju namesto posameznih udeležencev uporabijo skupine posameznikov, in se posledično pridobi prostovoljna privolitev po poučitvi po poenostavljenem postopku.
specific features of the clinical trial population, such as subjects not able to give informed consent, minors and pregnant or breastfeeding women;
V spremnem dopisu se navede, kje v dosjeju vloge so navedene potrebne informacije, da se oceni, ali gre pri neželenem učinku za sum na nepričakovan resen neželeni učinek, in sicer referenčne informacije o varnosti.
whether the clinical trial involves the first administration of a new active substance to humans;
V primeru ponovne predložitve vloge mora biti v spremnem dopisu navedena številka EU preskušanja za predhodno vlogo za klinično preskušanje, označene morajo biti spremembe v primerjavi s prejšnjo vlogo in po potrebi mora biti navedeno, kako so bila obravnavana morebitna nerešena vprašanja iz predhodne vloge.
whether scientific advice relating to the clinical trial or the investigational medicinal product has been given by the Agency, a Member State or a third country;
C. OBRAZEC VLOGE EU
whether the clinical trial is part or is intended to be part of a Paediatric Investigation Plan (PIP) as referred to in Title II, Chapter 3, of Regulation (EC) No 1901/2006 (if the Agency has already issued a decision on the PIP, the cover letter contains the link to the decision of the Agency on its website);
Pravilno izpolnjen obrazec vloge EU.
whether investigational medicinal products or auxiliary medicinal products are a narcotic, psychotropic or radiopharmaceutical;
D. PROTOKOL
whether the investigational medicinal products consist of or contain a genetically-modified organism or organisms;
V protokolu so opisani cilji, načrt, metodologija, statistična obdelava, namen in organizacija kliničnega preskušanja.
whether the sponsor has obtained an orphan designation for the investigational medicinal product for an orphan condition;
Protokol vsebuje naslednje:
a comprehensive list, including the regulatory status, of all investigational medicinal products and a list of all auxiliary medicinal products; and
naslov kliničnega preskušanja;
a list of medical devices which are to be investigated in the clinical trial but which are not part of the investigational medicinal product or products, together with a statement as to whether the medical devices are CE-marked for the intended use.
številko EU preskušanja;
The cover letter shall indicate where the information listed in paragraph 7 is contained in the application dossier.
sponzorjevo številčno oznako protokola za vsako različico (če je ustrezno);
The cover letter shall indicate if the clinical trial is considered by the sponsor to be a low-intervention clinical trial and shall contain a detailed justification thereof.
datum in številko različice, ki se posodobi, ko se različica spremeni;
The cover letter shall indicate if the methodology of the clinical trial requires that groups of subjects rather than individual subjects are allocated to receive different investigational medicinal products in a clinical trial, and as a consequence whether informed consent will be obtained by simplified means.
kratek naslov ali ime protokola ter
The cover letter shall indicate the location in the application dossier of the information necessary for assessing whether an adverse reaction is a suspected unexpected serious adverse reaction, that is the reference safety information.
ime in naslov sponzorja ter ime in funkcijo zastopnika ali zastopnikov sponzorja, ki so pooblaščeni za podpis protokola ali vsako bistveno spremembo protokola.
In the case of a resubmission, the cover letter shall specify the EU trial number for the previous clinical trial application, highlight the changes as compared to the previous submission and, if applicable, specify how any unresolved issues in the first submission have been addressed.
Protokol je po možnosti zapisan v lahko dostopni obliki, ki omogoča enostavno iskanje, ne pa v obliki skeniranih slik.
C. EU APPLICATION FORM
Protokol vključuje vsaj:
The EU application form, duly completed.
izjavo, da se klinično preskušanje izvede v skladu s protokolom, s to uredbo in z načeli dobre klinične prakse;
D. PROTOCOL
izčrpen seznam vseh zdravil v preskušanju in vseh pomožnih zdravil;
The protocol shall describe the objective, design, methodology, statistical considerations, purpose and organisation of the clinical trial.
povzetek ugotovitev nekliničnih študij, ki imajo potencialno klinični pomen, in drugih kliničnih preskušanj, ki so relevantna za klinično preskušanje;
The protocol shall be identified by:
povzetek znanih in potencialnih tveganj in koristi ter oceno pričakovanih koristi in tveganj, da se omogoči ocena v skladu s členom 6; za udeležence v kliničnem preskušanju v izjemnem primeru se dokumentirajo znanstveni razlogi, na podlagi katerih se lahko pričakuje, da bo sodelovanje udeleženca lahko dalo relevantne klinične koristi;
the title of the clinical trial;
kadar so bili v načrtovanje preskušanja vključeni pacienti, opis njihove vključitve;
the EU trial number;
opis in utemeljitev odmerka, režim odmerka, način dajanja zdravila ter obdobje zdravljenja za vsa zdravila v preskušanju in pomožna zdravila;
the sponsor's protocol code number specific for all versions of it (if relevant);
izjavo, ali so zdravila v preskušanju in pomožna zdravila, ki se uporabljajo v kliničnem preskušanju, odobrena; če so odobrena, ali se bodo v kliničnem preskušanju uporabljala v skladu s pogoji iz dovoljenja za promet, ter, če niso odobrena, utemeljitev uporabe neodobrenih pomožnih zdravil v kliničnem preskušanju;
the date and number of the version, to be updated when it is amended;
opis skupin in podskupin udeležencev v kliničnem preskušanju, po potrebi tudi skupin s posebnimi potrebami, na primer starost, spol in sodelovanje zdravih prostovoljcev in udeležencev z redkimi in zelo redkimi boleznimi;
a short title or name assigned to the protocol; and
navedba literature in podatkov, ki so relevantni za klinično preskušanje in so osnova za klinično preskušanje;
the name and address of the sponsor, as well as the name and function of the representative or representatives of the sponsor authorised to sign the protocol or any substantial modification to the protocol.
obravnavo pomena kliničnega preskušanja, da se omogoči ocena v skladu s členom 6;
The protocol shall, when possible, be written in an easily accessible and searchable format, rather than scanned images.
opis vrste kliničnega preskušanja, ki bo izvedeno, in obravnava načrta preskušanja (po potrebi vključno s shematskim prikazom načrta, postopkov in stopenj);
The protocol shall at least include:
specifikacijo morebitnih primarnih in sekundarnih meril učinkovitosti, ki se bodo merili med kliničnim preskušanjem;
a statement that the clinical trial is to be conducted in compliance with the protocol, with this Regulation and with the principles of good clinical practice;
opis sprejetih ukrepov, da se čim bolj zmanjša pristranskost, ki po potrebi vključujejo randomizacijo in zakrivanje;
a comprehensive list of all investigational medicinal products and of all auxiliary medicinal products;
opis pričakovanega trajanja sodelovanja udeležencev in opis zaporedja in trajanja celotnega kliničnega preskušanja, vključno z nadaljnjih spremljanjem;
a summary of findings from non-clinical studies that potentially have clinical significance and from other clinical trials that are relevant to the clinical trial;
jasno in nedvoumno opredelitev konca zadevnega kliničnega preskušanja in točno navedbo predvidenega datuma zaključka kliničnega preskušanja ter ustrezno utemeljitev, če to ni datum zadnjega obiska zadnjega udeleženca;
a summary of the known and potential risks and benefits including an evaluation of the anticipated benefits and risks to allow assessment in accordance with Article 6; for subjects in a clinical trial in an emergency situation, the scientific grounds for expecting that the participation of the subjects has the potential to produce a direct clinically relevant benefit shall be documented;
opis meril za nenadaljevanje delov kliničnega preskušanja ali celotnega kliničnega preskušanja;
where patients were involved in the design of the clinical trial, a description of their involvement;
ureditev za vzdrževanje randomizacijskih številk za klinično preskušanje in po potrebi postopke za njihovo dešifriranje;
a description of, and justification for, the dosage, the dosage regime, the route and mode of administration, and the treatment period for all investigational medicinal products and auxiliary medicinal products;
opis postopkov za identifikacijo podatkov, ki se vpišejo neposredno v obrazce za poročanje o primerih, ki veljajo kot izvorni podatki;
a statement of whether the investigational medicinal products and auxiliary medicinal products used in the clinical trial are authorised; if authorised, whether they are to be used in the clinical trial in accordance with the terms of their marketing authorisations, and, if not authorised, a justification for the use of non-authorised auxiliary medicinal products in the clinical trial;
opis ureditev za izpolnjevanje veljavnih pravil na področju zbiranja, shranjevanja in prihodnje uporabe bioloških vzorcev udeležencev kliničnega preskušanja, kadar je ustrezno, če ureditve niso zajete v ločenem dokumentu;
a description of the groups and subgroups of the subjects participating in the clinical trial, including, where relevant, groups of subjects with specific needs, for example. age, gender, participation of healthy volunteers, subjects with rare and ultra rare diseases;
opis ureditev za sledenje, hranjenje, uničenje ter vračanje zdravila v preskušanju in neodobrenega pomožnega zdravila v skladu s členom 51;