natgillin/translations-raw huggingface dataset:
The provisions on the monitoring of medicinal products in Directive 2001/83/EC constitute specific provisions within the meaning of Article 15(2) of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products [10].
Določbe o nadzoru zdravil v Direktivi 2001/83/ES so posebne določbe v smislu člena 15(2) Uredbe (ES) št. 765/2008 Evropskega Parlamenta in Sveta z dne 9. julija 2008 o določitvi zahtev za akreditacijo in nadzor trga v zvezi s trženjem proizvodov [10].
The pharmacovigilance activities provided for in this Directive require that uniform conditions be established as concerns the contents and maintenance of the pharmacovigilance system master file, as well as the minimum requirements for the quality system for the performance of pharmacovigilance activities by the national competent authorities and marketing authorisation holders, the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities, and the minimum requirements for the monitoring of the data contained in the Eudravigilance database to determine whether there are new risks or whether risks have changed.
Dejavnosti farmakovigilance iz te direktive zahtevajo, da se vzpostavijo enaki pogoji za vzdrževanje in vsebino glavnega dosjeja o sistemu farmakovigilance, pa tudi minimalne zahteve za sistem kakovosti izvajanja dejavnosti farmakovigilance pri pristojnih nacionalnih organih in imetnikih dovoljenj za promet z zdravili, uporabo mednarodno sprejete terminologije, oblike in standardov izvajanja dejavnosti farmakovigilance ter minimalne zahteve za spremljanje podatkov v podatkovni bazi Eudravigilance, da bi se določilo, ali so nastala nova tveganja ali so se tveganja spremenila.
The format and content of the electronic transmission of suspected adverse reactions by Member States and marketing authorisation holders, the format and content of electronic periodic safety update reports and risk management plans as well as the format of protocols, abstracts and final study reports for the post-authorisation safety studies should also be established.
Določiti bi bilo treba obliko in vsebino elektronskega prenosa o domnevnih neželenih učinkih, ki ga izvajajo države članice in imetniki dovoljenj za promet z zdravili, obliko in vsebino elektronskih rednih posodobljenih poročil o varnosti zdravila, načrtov za obvladovanje tveganj ter obliko protokolov, povzetkov in končnih poročil študij varnosti po odobritvi.
In accordance with Article 291 of the Treaty on the Functioning of the European Union (TFEU), rules and general principles concerning mechanisms for the control by Member States of the Commission’s exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure.
V skladu s členom 291 Pogodbe o delovanju Evropske unije (PDEU) se pravila in splošna načela v zvezi z mehanizmi, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije, določijo vnaprej z uredbo, sprejeto po rednem zakonodajnem postopku.
Pending the adoption of that new regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [11] continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable.
Do sprejetja te nove uredbe se še naprej uporablja Sklep Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [11], razen regulativnega postopka s pregledom, ki se ne uporablja.
The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to supplement the provisions in Articles 21a and 22a of Directive 2001/83/EC.
Komisija bi morala biti pooblaščena za sprejemanje delegiranih aktov v skladu s členom 290 PDEU, da lahko dopolni določbe v členih 21a in 22a Direktive 2001/83/ES.
The Commission should be empowered to adopt supplementary measures laying down the situations in which post-authorisation efficacy studies may be required.
Komisija bi morala biti pooblaščena za sprejetje dodatnih ukrepov za primere, kjer se lahko zahtevajo študije učinkovitosti po pridobitvi dovoljenja.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.
Še posebej je pomembno, da Komisija pri svojem pripravljalnem delu izvede ustrezna posvetovanja, tudi na ravni strokovnjakov.
In accordance with point 34 of the Interinstitutional Agreement on better law-making [12], Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.
V skladu s točko 34 Med-institucionalnega sporazuma o boljši pripravi zakonodaje [12] se države članice spodbujajo, naj za svoje potrebe in v interesu Unije izdelajo in objavijo lastne tabele, ki naj kar se da nazorno prikažejo odnos med to direktivo in ukrepi za prenos v nacionalno pravo ter jih objavijo.
Directive 2001/83/EC should be amended accordingly,
Zato bi bilo treba Direktivo 2001/83/ES ustrezno spremeniti –
Amendments to Directive 2001/83/EC
Spremembe Direktive 2001/83/ES
Adverse reaction A response to a medicinal product which is noxious and unintended.’;
Neželeni učinek Odziv na zdravilo, ki je škodljiv in nenameren.“;
point 14 is deleted;
točka 14 se črta;
Post-authorisation safety study Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.’;
Študija o varnosti zdravila po pridobitvi dovoljenja za promet Vsaka študija o zdravilu, ki je pridobilo dovoljenje za promet, katere cilj je ugotovitev, opredelitev značilnosti ali količinska določitev tveganja, ki potrjuje varnostne lastnosti zdravila, ali merjenje učinkovitosti ukrepov za obvladovanje tveganj.“;
the following points are inserted:
vstavijo se naslednje točke:
Risk management system a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions.
Sistem obvladovanja tveganj Sklop dejavnosti farmakovigilance in posegov za ugotovitev, opredelitev značilnosti, preprečevanje ali zmanjševanje tveganj v zvezi z zdravilom, vključno z oceno učinkovitosti navedenih dejavnosti in posegov.
Risk management plan a detailed description of the risk management system.
Načrt za obvladovanje tveganj Natančen opis sistema obvladovanja tveganj.
Pharmacovigilance system a system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.
Sistem farmakovigilance Sistem spremljanja in poročanja, ki ga uporabljajo imetniki dovoljenja za promet in države članice za izpolnjevanje nalog in odgovornosti, navedenih v naslovu IX in katerega namen je spremljati zdravila, ki so pridobila dovoljenje za promet, in odkrivanje sprememb razmerja med tveganjem in koristjo zdravil.
Pharmacovigilance system master file A detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products.’.
Glavni dosje o sistemu farmakovigilance Podroben opis sistema farmakovigilance, ki ga uporabljajo imetniki dovoljenj za promet glede enega ali več zdravil, ki so pridobila dovoljenje za promet.“;
Article 8(3) is amended as follows:
člen 8(3) se spremeni:
point (ia) is replaced by the following:
točka (ia) se nadomesti z naslednjim:
A summary of the applicant’s pharmacovigilance system which shall include the following elements:
Povzetek sistema farmakovigilance vlagatelja, ki vsebuje naslednje elemente:
proof that the applicant has at his disposal a qualified person responsible for pharmacovigilance,
dokazilo, da ima vlagatelj na voljo storitve usposobljene osebe, odgovorne za farmakovigilanco,
the Member States in which the qualified person resides and carries out his/her tasks,
države članice, kjer ima usposobljena oseba prebivališče in opravlja svoje delo,
the contact details of the qualified person,
kontaktni podatki usposobljene osebe,
a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Title IX,
izjava, ki jo podpiše vlagatelj, da ima vlagatelj potrebna sredstva za izpolnjevanje nalog in odgovornosti, navedenih v naslovu IX,
a reference to the location where the pharmacovigilance system master file for the medicinal product is kept.’,
napotilo na mesto, kjer se hrani glavni dosje o sistemu farmakovigilance za zdravilo.“;
the following point is inserted after point (ia):
za točko (ia) se vstavi naslednja točka:
The risk management plan describing the risk management system which the applicant will introduce for the medicinal product concerned, together with a summary thereof.’;
Načrt za obvladovanje tveganj z opisom sistema obvladovanja tveganja, ki ga bo vlagatelj uvedel za zadevno zdravilo, skupaj s povzetkom načrta.“;
point (l) is replaced by the following:
točka (l) se nadomesti z naslednjim:
Copies of the following:
Izvodi:
any authorisation, obtained in another Member State or in a third country, to place the medicinal product on the market, a summary of the safety data including the data contained in the periodic safety update reports, where available, and suspected adverse reactions reports, together with a list of those Member States in which an application for authorisation submitted in accordance with this Directive is under examination;
vseh dovoljenj za dajanje zdravil na trg, pridobljenih v drugi državi članici ali v tretji državi, povzetka varnostnih podatkov vključno tistih iz rednih posodobljenih poročil o varnosti, če so na voljo, in poročil o domnevnih neželenih učinkih, skupaj s seznamom tistih držav članic, v katerih je bila vloga za pridobitev dovoljenja predložena v skladu s to direktivo in je v postopku obravnave,
the summary of the product characteristics proposed by the applicant in accordance with Article 11 or approved by the competent authorities of the Member State in accordance with Article 21 and the package leaflet proposed in accordance with Article 59 or approved by the competent authorities of the Member State in accordance with Article 61;
povzetka glavnih značilnosti zdravila, ki ga vlagatelj predlaga v skladu s členom 11 ali ki so ga odobrili pristojni organi države članice v skladu s členom 21 in navodila za uporabo, predlaganega v skladu s členom 59 ali odobrenega s strani pristojnih organov države članice v skladu s členom 61,
details of any decision to refuse authorisation, whether in the Union or in a third country, and the reasons for such a decision.’,
podrobnosti vsake odločitve o zavrnitvi izdaje dovoljenja za promet z zdravilom bodisi v Uniji ali v tretji državi, ter razloge za tako odločitev.“;
point (n) is deleted;
točka (n) se črta;
the following subparagraphs are added after the second subparagraph:
za drugim pododstavkom se dodata naslednja pododstavka:
‘The risk management system referred to in point (iaa) of the first subparagraph shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.
„Načrt obvladovanja tveganj z opisom sistema obvladovanja tveganja iz točke (iaa) prvega pododstavka je sorazmeren z ugotovljenimi tveganji in možnimi tveganji zdravila ter potrebo po podatkih o varnosti zdravila po pridobitvi dovoljenja za promet.
The information referred to in the first subparagraph shall be updated where and when appropriate.’.
Podatki iz prvega pododstavka se posodobijo, če in ko je to potrebno.“;
In Article 11 the following subparagraphs are added:
v členu 11 se dodata naslednja pododstavka:
‘For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary of product characteristics shall include the statement: “This medicinal product is subject to additional monitoring”.
„Za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 povzetek glavnih značilnosti zdravila vključuje izjavo: ‚Za to zdravilo se izvaja dodatno spremljanje varnosti.‘.
This statement shall be preceded by the black symbol referred to in Article 23 of Regulation (EC) No 726/2004 and followed by an appropriate standardised explanatory sentence.
Pred to izjavo je črn simbol iz člena 23 Uredbe (ES) št. 726/2004, sledi pa ji standardna kratka obrazložitev.
For all medicinal products, a standard text shall be included expressly asking healthcare professionals to report any suspected adverse reaction in accordance with the national spontaneous reporting system referred to in Article 107a(1).
Za vsa zdravila se vključi standardno besedilo, ki od zdravstvenih delavcev izrecno zahteva, naj poročajo o vseh domnevnih neželenih učinkih v skladu z nacionalnim sistemom spontanega poročanja iz člena 107a(1).
Different ways of reporting, including electronic reporting, shall be available in compliance with the second subparagraph of Article 107a(1).’.
V skladu z drugim pododstavkom člena 107a(1) so na voljo različni načini poročanja, vključno z elektronskim poročanjem.“;
Article 16g(1) is replaced by the following:
člen 16g(1) se nadomesti z naslednjim:
Article 3(1) and (2), Article 4(4), Article 6(1), Article 12, Article 17(1), Articles 19, 20, 23, 24, 25, 40 to 52, 70 to 85, 101 to 108b, Article 111(1) and (3), Articles 112, 116, 117, 118, 122, 123, 125, the second paragraph of Article 126, and Article 127 of this Directive as well as Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use shall apply, by analogy, to traditional-use registration granted under this Chapter.
Za registracijo zaradi tradicionalne uporabe, odobreno na podlagi tega poglavja, se po analogiji uporabljajo člen 3(1) in (2), člen 4(4), člen 6(1), člen 12, člen 17(1), členi 19, 20, 23, 24, 25, 40 do 52, 70 do 85, 101 do 108b, člen 111(1) in (3), členi 112, 116, 117, 118, 122, 123, 125, drugi odstavek člena 126 in člen 127 te direktive in tudi Direktiva Komisije 2003/94/ES z dne 8. oktobra 2003 o določitvi načel in smernic dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini in zdravili za uporabo v humani medicini v preskušanju.
Article 17 is amended as follows:
člen 17 se spremeni:
in the second subparagraph of paragraph 1, the words ‘Articles 27’ are replaced by the words ‘Articles 28’;
v drugem pododstavku odstavka 1 se besede „členi 27“ nadomestijo z besedami „členi 28“;
in paragraph 2, the words ‘Articles 27’ are replaced by the words ‘Articles 28’;
v odstavku 2 se besede „členi 27“ nadomestijo z besedami „členi 28“;
In Article 18, the words ‘Articles 27’ are replaced by the words ‘Articles 28’.
v členu 18 se besede „členi 27“ nadomestijo z besedami „členi 28“;
In Article 21, paragraphs 3 and 4 are replaced by the following:
v členu 21 se odstavka 3 in 4 nadomestita z naslednjim:
The national competent authorities shall, without delay, make publicly available the marketing authorisation together with the package leaflet, the summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for the fulfilment of those conditions for each medicinal product which they have authorised.
Pristojni nacionalni organi nemudoma dajo na voljo javnosti dovoljenje za promet z zdravilom skupaj z navodilom za uporabo in povzetkom glavnih značilnosti zdravila ter pogoji, določenimi v skladu s členi 21a, 22 in 22a, skupaj z roki za izpolnitev teh pogojev za vsako zdravilo, ki so jo odobrili.
The national competent authorities shall draw up an assessment report and make comments on the file as regards the results of the pharmaceutical and pre-clinical tests, the clinical trials, the risk management system and the pharmacovigilance system of the medicinal product concerned.
Pristojni nacionalni organi pripravijo poročilo o oceni in pripombe na dokumentacijo v zvezi z rezultati farmacevtskih in predkliničnih preskusov ter kliničnih preskušanj ter sistema obvladovanja tveganj in sistema farmakovigilance zadevnega zdravila.
The assessment report shall be updated whenever new information becomes available which is important for the evaluation of the quality, safety or efficacy of the medicinal product concerned.
Poročilo o oceni se dopolni vedno, ko so na voljo novi podatki, ki so pomembni za vrednotenje kakovosti, varnosti ali učinkovitosti zadevnega zdravila.
The national competent authorities shall make the assessment report publicly accessible without delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature.
Pristojni nacionalni organi nemudoma dajo na voljo javnosti poročilo o oceni skupaj z razlogi za svoje mnenje, po izbrisu vseh podatkov poslovno zaupne narave.
The justification shall be provided separately for each indication applied for.
Utemeljitev se predloži ločeno za vsako indikacijo, za katero se zaprosi.
The public assessment report shall include a summary written in a manner that is understandable to the public.
Javno poročilo o oceni vključuje povzetek, pisan tako, da je razumljiv javnosti.
The summary shall contain, in particular, a section relating to the conditions of use of the medicinal product.’.
Povzetek vsebuje zlasti del, ki se nanaša na pogoje uporabe zdravila.“;
In addition to the provisions laid down in Article 19, a marketing authorisation for a medicinal product may be granted subject to one or more of the following conditions:
Poleg določb iz člena 19 se dovoljenje za promet z zdravilom lahko izda, če je izpolnjen eden ali več naslednjih pogojev:
to take certain measures for ensuring the safe use of the medicinal product to be included in the risk management system;
izvedba nekaterih ukrepov za zagotovitev varne uporabe zdravila, ki se vključi v sistem obvladovanja tveganj;
to conduct post-authorisation safety studies;
izvedba študij o varnosti zdravila po pridobitvi dovoljenja za promet;
to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Title IX;
izpolnjevanje obveznosti evidentiranja ali poročanja o domnevnih neželenih učinkih, ki so strožje od zahtev iz naslova IX;
any other conditions or restrictions with regard to the safe and effective use of the medicinal product;
drugi pogoji ali omejitve glede varne in učinkovite uporabe zdravila;
the existence of an adequate pharmacovigilance system;
obstoj ustreznega sistema farmakovigilance;
to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed.
opravljanje študij učinkovitosti po pridobitvi dovoljenja, v katerih se opredelijo nekatera vprašanja o učinkovitosti zdravila in se nanje lahko odgovori le po tem, ko je zdravilo bilo dano na trg.
Such an obligation to conduct such studies shall be based on the delegated acts adopted pursuant to Article 22b while taking into account the scientific guidance referred to in Article 108a.
Obveznost opravljanja študij sledi delegiranim aktom, sprejetim v skladu s členom 22b ob upoštevanju znanstvenih smernic iz člena 108a.
The marketing authorisation shall lay down deadlines for the fulfilment of these conditions where necessary.’.
Dovoljenje za promet z zdravilom določa roke za izpolnitev teh pogojev, kadar je to potrebno.“;
Article 22 is replaced by the following:
člen 22 se nadomesti z naslednjim:
In exceptional circumstances and following consultation with the applicant, the marketing authorisation may be granted subject to certain conditions, in particular relating to the safety of the medicinal product, notification to the national competent authorities of any incident relating to its use, and action to be taken.
V izjemnih okoliščinah in po posvetu s predlagateljem se dovoljenje za promet z zdravilom lahko izda pod določenimi pogoji, predvsem v zvezi z varnostjo zdravila, uradnim obveščanjem pristojnih nacionalnih organov o vseh dogodkih v zvezi z uporabo zdravila ter potrebnimi ukrepi.
The marketing authorisation may be granted only when the applicant can show that he is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, for objective, verifiable reasons and must be based on one of the grounds set out in Annex I.
Dovoljenje za promet z zdravilom se lahko izda samo, če vlagatelj lahko dokaže, da ne more predložiti obširnih podatkov o učinkovitosti in varnosti zdravila v običajnih pogojih uporabe zaradi objektivnih in preverljivih razlogov, ki morajo temeljiti na enem od razlogov iz Priloge I.
Continuation of the marketing authorisation shall be linked to the annual reassessment of these conditions.’.
Podaljšanje dovoljenja za promet z zdravilom je vezano na vsakoletno ponovno oceno teh pogojev.“;
The following Articles are inserted:
vstavijo se naslednji členi:
After the granting of a marketing authorisation, the national competent authority may impose an obligation on the marketing authorisation holder:
Po izdaji dovoljenja za promet z zdravilom lahko pristojni nacionalni organ imetniku dovoljenja za promet z zdravilom naloži obveznost:
to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product.
izvedbe študije o varnosti zdravila po pridobitvi dovoljenja za promet, če obstajajo skrbi glede tveganj zdravila, ki je pridobilo dovoljenje za promet.
If the same concerns apply to more than one medicinal product, the national competent authority shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study;
Če se iste varnostne zahteve uporabljajo za več kot eno zdravilo, pristojni nacionalni organ po posvetu z Odborom za ocenjevanje tveganja na področju farmakovigilance pozove zadevne imetnike dovoljenj za promet z zdravilom, naj opravijo skupno študijo o varnosti zdravila po pridobitvi dovoljenja za promet;
to conduct a post-authorisation efficacy study when the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly.
izvedbe študije učinkovitosti po pridobitvi dovoljenja, ko razumevanje bolezni ali klinična metodologija nakazujeta, da bi se predhodne ocene učinkovitosti lahko bistveno spremenile.
The obligation to conduct the post-authorisation efficacy study shall be based on the delegated acts adopted pursuant to Article 22b while taking into account the scientific guidance referred to in Article 108a.
Obveznost izvedbe študije o učinkovitosti po pridobitvi dovoljenja za promet temelji na delegiranih aktih, sprejetih v skladu s členom 22b, ob upoštevanju znanstvenih smernic iz člena 108a.
The imposition of such an obligation shall be duly justified, notified in writing, and shall include the objectives and timeframe for submission and conduct of the study.
Naložitev te obveznosti se ustrezno utemelji in se pisno uradno sporoči, ter vsebuje cilje in časovni okvir za predložitev in izvedbo študije.