natgillin/translations-raw huggingface dataset:
To ensure the highest levels of expertise and the functioning of the Pharmacovigilance Risk Assessment Committee, rapporteurs providing assessments for Union pharmacovigilance procedures, periodic safety update reports, post-authorisation safety study protocols and risk management systems should receive payment through the Agency.
Da se zagotovi najvišja raven strokovnega znanja in izkušenj ter delovanja Odbora za ocenjevanje tveganja na področju farmakovigilance, bi morali poročevalci, ki zagotavljajo oceno postopkov Unije za farmakovigilanco, redna posodobljena poročila o varnosti zdravil, protokole za študije varnosti po pridobitvi dovoljenja za promet in sisteme obvladovanja tveganj, prejemati plačilo prek Agencije.
Therefore, the Agency should be empowered to charge fees in return for performing the activities of the coordination group within the Union system of pharmacovigilance, as provided for in Directive 2001/83/EC, and the rapporteurs within the coordination group should, in turn, be paid by the Agency.
Zato bi bilo treba pooblastiti Agencijo, da zaračunava pristojbine v zameno za izvajanje dejavnosti skupine za usklajevanje v okviru sistema farmakovigilance Unije, kot je določeno v Direktivi 2001/83/ES in da nato Agencija plača poročevalce v skupini za usklajevanje.
It is necessary, from a public health perspective, to complement the data available at the time of authorisation with additional data about the safety and, in certain cases, also about the efficacy of medicinal products for human use authorised in accordance with Regulation (EC) No 726/2004.
Z vidika javnega zdravja je treba podatke, ki so na voljo ob izdaji dovoljenja, dopolniti z dodatnimi podatki o varnosti in v nekaterih primerih tudi o učinkovitosti zdravil za uporabo v humani medicini, odobrenih v skladu z Uredbo (ES) št. 726/2004.
The Commission should therefore be empowered to impose on the marketing authorisation holder the obligation to conduct post-authorisation studies on safety and on efficacy.
Komisija bi morala torej imeti pooblastilo, da naloži obveznost imetniku dovoljenja za promet, da opravi študije varnosti in učinkovitosti po pridobitvi dovoljenja.
It should be possible to impose that obligation at the time of granting the marketing authorisation or later, and it should be a condition of the marketing authorisation.
Obstajati bi morala možnost naložitve te obveznosti ob izdaji dovoljenja za promet ali pozneje in morala bi biti pogoj za dovoljenje za promet.
Such studies may be aimed at collecting data to enable the assessment of safety or efficacy of medicinal products for human use in everyday medical practice.
Cilj teh študij je lahko zbiranje podatkov, ki bi omogočili oceno varnosti ali učinkovitosti zdravil za uporabo v humani medicini v vsakodnevni medicinski praksi.
It is essential that a strengthened system of pharmacovigilance not lead to the premature granting of marketing authorisations.
Pomembno je, da krepitev sistema farmakovigilance ne povzroči prezgodnje odobritve dovoljenj za promet.
However, some medicinal products for human use are authorised subject to additional monitoring.
Za nekatera zdravila za uporabo v humani medicini pa se dovoljenje za promet izda pod pogojem, da se dodatno spremljajo.
This includes all medicinal products for human use with a new active substance and biological medicinal products, including biosimilars, which are priorities for pharmacovigilance.
To velja za vsa zdravila za uporabo v humani medicini z novimi zdravilnimi učinkovinami in biološka zdravila, tudi biološko podobna zdravila, za katere je farmakovigilanca prednostna.
Competent authorities may also require additional monitoring for specific medicinal products for human use that are subject to the obligation to conduct a post-authorisation safety study or to conditions or restrictions with regard to the safe and effective use of the medicinal product that will be specified in the risk management plan.
Pristojni organi lahko tudi zahtevajo, da se dodatno spremljajo določena zdravila za uporabo v humani medicini, za katera velja obveznost izvedbe študije varnosti zdravila po pridobitvi dovoljenja za promet, ali pogoji ali omejitve glede varnosti in učinkovite uporabe zdravila, ki bodo natančno opredeljeni v načrtu za obvladovanje tveganj.
Risk management plans are normally required for new active substances, biosimilars, medicinal products for paediatric use and for medicinal products for human use involving a significant change in the marketing authorisation, including a new manufacturing process of a biotechnologically-derived medicinal product.
Načrti za obvladovanje tveganj so običajno potrebni za nove zdravilne učinkovine, biološko podobna zdravila, zdravila za pediatrično uporabo ter za zdravila za uporabo v humani medicini, pri katerih je prišlo do bistvenih sprememb pri dovoljenju za promet, vključno z novim postopkom izdelave zdravila biotehnološkega izvora.
Medicinal products for human use subject to additional monitoring should be identified as such by a black symbol, which will be selected by the Commission on the basis of a recommendation by the Pharmacovigilance Risk Assessment Committee, and an appropriate standardised explanatory sentence in the summary of product characteristics and in the package leaflet.
Zdravila za uporabo v humani medicini, ki se dodatno spremljajo, bi bilo treba označiti s črnim simbolom, ki ga bo izbrala Komisija na podlagi priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance, ter z ustrezno standardno obrazložitvijo na povzetku glavnih značilnosti zdravila in navodilih za uporabo.
The Agency should keep an up-to-date, publicly available list of such medicinal products.
Agencija pa bi morala sproti posodabljati javno dostopen seznam takih zdravil.
Experience has shown that the responsibilities of marketing authorisation holders with regard to pharmacovigilance of authorised medicinal products for human use should be clarified.
Izkušnje so pokazale, da bi bilo treba razjasniti odgovornosti imetnikov dovoljenj za promet v zvezi s farmakovigilanco odobrenih zdravil za uporabo v humani medicini.
The marketing authorisation holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorisation, and for ensuring that the product information is kept up to date.
Imetnik dovoljenja za promet bi moral biti odgovoren za stalno spremljanje varnosti svojih zdravil za uporabo v humani medicini, obveščanje organov o kakršnih koli spremembah, ki bi lahko vplivale na dovoljenje za promet in za zagotovitev, da se informacije o zdravilu sproti dopolnjujejo.
As medicinal products for human use could be used outside the terms of the marketing authorisation, the marketing authorisation holder’s responsibilities should include providing all available information, including the results of clinical trials or other studies, as well as reporting any use of the medicinal product which is outside the terms of the marketing authorisation.
Ker se zdravila za uporabo v humani medicini lahko uporabljajo izven pogojev dovoljenja za promet, bi morale odgovornosti imetnika dovoljenja za promet vključevati zagotavljanje vseh razpoložljivih informacij, vključno z rezultati kliničnih preskušanj ali drugih študij, ter poročanje o uporabi zdravila izven pogojev dovoljenja za promet.
It is also appropriate to ensure that all relevant information collected on the safety of the medicinal product for human use is taken into account when the marketing authorisation is being renewed.
Prav tako je primerno zagotoviti, da se pri podaljšanju dovoljenja za promet upoštevajo vse pomembne informacije o varnosti zdravila za uporabo v humani medicini.
Scientific and medical literature is an important source of information on suspected adverse reaction case reports.
Znanstvena in medicinska literatura je pomemben vir informacij o poročilih o primerih domnevnih neželenih učinkov.
Currently, for active substances included in more than one medicinal product for human use, literature cases are reported in adverse reaction case reports in a duplicative way.
Trenutno pri zdravilnih učinkovinah, vključenih v več kot eno zdravilo za uporabo v humani medicini, prihaja do podvajanja poročil o neželenih učinkih v prijavljanju primerov v literaturi.
In order to enhance the efficiency of reporting, the Agency should monitor a defined list of literature for a defined list of active substances used in medicinal products for which there are several marketing authorisations.
Da se poveča učinkovitost poročanja, bi Agencija morala spremljati opredeljen seznam literature za opredeljen seznam zdravilnih učinkovin, ki se uporabljajo v zdravilih, za katere je bilo izdanih več dovoljenj za promet.
As a result of the submission of all suspected adverse reaction data for medicinal products for human use authorised by the Member States directly to the Eudravigilance database, it is not necessary to provide for different reporting rules for medicinal products for human use authorised in accordance with Regulation (EC) No 726/2004.
Ker se vsi podatki o domnevnih neželenih učinkih zdravil za uporabo v humani medicini, ki so jih odobrile države članice, sporočajo neposredno v podatkovno bazo Eudravigilance, ni treba določiti drugih pravil poročanja o zdravilih za uporabo v humani medicini, odobrenih v skladu z Uredbo (ES) št. 726/2004.
The rules on suspected adverse reaction recording and reporting laid down in Directive 2001/83/EC should therefore apply to medicinal products for human use authorised in accordance with Regulation (EC) No 726/2004.
Pravila o evidentiranju in poročanju o domnevnih neželenih učinkih iz Direktive 2001/83/ES bi se zato morala uporabljati za zdravila za uporabo v humani medicini, odobrena v skladu z Uredbo (ES) št. 726/2004.
It is necessary to increase the shared use of resources between competent authorities for the assessment of periodic safety update reports.
Potrebno je povečati skupno uporabo virov med pristojnimi organi pri oceni rednih posodobljenih poročil o varnosti.
The assessment procedures provided for in Directive 2001/83/EC should therefore apply for the single assessment of periodic safety update reports for different medicinal products for human use containing the same active substance or the same combination of active substances, including joint assessments of medicinal products for human use authorised both nationally and through the centralised procedure.
Zato bi bilo treba postopke ocenjevanja iz Direktive 2001/83/ES uporabljati pri enotni oceni rednih posodobljenih poročil o varnosti za različna zdravila za uporabo v humani medicini z isto zdravilno učinkovino ali kombinacijo te zdravilne učinkovine z drugimi zdravilnimi učinkovinami, vključno z enotnimi ocenami zdravil za uporabo v humani medicini, odobrenih na nacionalni ravni in na podlagi centraliziranega postopka.
It is appropriate to strengthen the supervisory role for medicinal products for human use authorised through the centralised procedure by providing that the supervisory authority for pharmacovigilance should be the competent authority of the Member State in which the pharmacovigilance system master file of the marketing authorisation holder is located.
Primerno je okrepiti nadzor nad zdravili za uporabo v humani medicini, odobrenimi na podlagi centraliziranega postopka, tako da bi vlogo nadzornika v zvezi s farmakovigilanco prevzel pristojni organ države članice, v kateri imetnik dovoljenja za promet hrani glavni dosje o sistemu farmakovigilance.
This Regulation shall apply without prejudice to 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 [7] and 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 [8].
Ta uredba se uporablja brez poseganja v Direktivo 95/46/ES Evropskega parlamenta in Sveta z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov [7] ter Uredbo (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 [8].
In order to detect, assess, understand and prevent adverse reactions, and to identify and take actions to reduce the risks of, and increase the benefits from, medicinal products for human use for the purpose of safeguarding public health, it should be possible to process personal data within the Eudravigilance system while respecting the Union legislation relating to data protection.
Za odkrivanje, oceno, razumevanje in preprečevanje neželenih učinkov ter za prepoznavanje in izvajanje ukrepov za zmanjšanje tveganj in povečanje koristi zdravil za uporabo v humani medicini z namenom varovanja javnega zdravja, bi morala obstajati možnost obdelave osebnih podatkov v okviru sistema Eudravigilance, ob spoštovanju zakonodaje Unije o varstvu osebnih podatkov.
The purpose of safeguarding public health constitutes a substantial public interest and consequently the processing of personal data can be justified if identifiable health data are processed only when necessary and only when the parties involved assess this necessity at every stage of the pharmacovigilance process.
Namen varovanja javnega zdravja pomeni pomemben javni interes, zaradi katerega je obdelava osebnih podatkov lahko upravičena, če se določljivi zdravstveni podatki obdelajo le kadar je to potrebno in le kadar udeležene strani to potrebo ocenijo na vsaki stopnji procesa farmakovigilance.
This Regulation and Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use [9] widen the tasks of the Agency with regard to pharmacovigilance, including the monitoring of literature cases, the improved use of information technology tools and the provision of more information to the general public.
S to uredbo in Direktivo 2010/84/EU Evropskega parlamenta in Sveta z dne 15. decembra 2010 [9] o spremembah Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini, glede farmakovigilance, se širijo naloge Agencije na področju farmakovigilance, vključno s spremljanjem primerov iz literature, izboljšanjem uporabe orodij informacijske tehnologije in boljšim zagotavljanjem informacij širši javnosti.
The Agency should be enabled to fund these activities from fees charged to marketing authorisation holders.
Agencija bi morala imeti možnost, da te dejavnosti financira iz pristojbin, ki jih zaračuna imetnikom dovoljenj za promet.
These fees should not cover tasks carried out by national competent authorities for which such authorities charge fees in accordance with Directive 2001/83/EC.
Te pristojbine ne bi smele vključevati nalog, ki jih izvajajo pristojni nacionalni organi, za katere ti organi obračunajo pristojbine v skladu z Direktivo 2001/83/ES.
The pharmacovigilance activities provided for in this Regulation 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 Agency, 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 na področju farmakovigilance iz te uredbe zahtevajo, da se vzpostavijo enaki pogoji za vsebino in vzdrževanje glavnega dosjeja o sistemu farmakovigilance pa tudi minimalne zahteve za sistem kakovosti za dejavnosti, ki jih izvaja Agencija na področju farmakovigilance, uporabo mednarodno sprejete terminologije, oblike in standardov za izvajanje dejavnosti farmakovigilance ter minimalne zahteve za spremljanje podatkov v podatkovni bazi Eudravigilance, da bi se določilo, ali so nastala nova tveganja in 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 poročil pri sumu na neželene učinke, ki ga izvajajo države članice in imetniki dovoljenja za promet, obliko in vsebino elektronskih rednih posodobljenih poročil o varnosti zdravila, načrtov za obvladovanje tveganj ter obliko protokolov, povzetkov in končnih poročil za študije 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, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije določijo vnaprej in sicer 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 [10] 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 [10], 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 point (cc) of Article 9(4) and in point (b) of Article 10a(1) of Regulation (EC) No 726/2004.
Komisijo bi bilo treba pooblastiti, da v skladu s členom 290 PDEU sprejme delegirane akte z namenom dopolnitve določb člena 9(4)(cc) in člena 10a(1)(b) Uredbe (ES) št. 726/2004.
The provisions on the monitoring of medicinal products for human use in Regulation (EC) No 726/2004 constitute specific provisions in 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 [11].
Določbe o spremljanju zdravil za uporabo v humani medicini v Uredbi (ES) št. 726/2004 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 [11].
Proper coordination between the newly established Pharmacovigilance Risk Assessment Committee and the other Committees of the Agency, in particular the Committee for Medicinal Products for Human Use, the Committee for Orphan Medicinal Products and the Committee for Advanced Therapies established under Regulation (EC) No 1394/2007 [12] should be ensured.
Zagotoviti bi bilo treba ustrezno koordinacijo med novo ustanovljenem Odborom za ocenjevanje tveganja na področju farmakovigilance in drugimi odbori Agencije, zlasti Odborom za zdravila za humano uporabo, Odborom za zdravila sirote in Odborom za napredno zdravljenje, ustanovljenim z Uredbo (ES) št. 1394/2007 [12].
Regulations (EC) No 726/2004 and (EC) No 1394/2007 should therefore be amended accordingly,
Zato bi bilo treba Uredbi (ES) št. 726/2004 in (ES) št. 1394/2007 ustrezno spremeniti –
Amendments to Regulation (EC) No 726/2004
Spremembe Uredbe (ES) št. 726/2004
in Article 5(2) the following sentence is added:
členu 5(2) se doda naslednji stavek:
‘For the fulfilment of its pharmacovigilance tasks, including the approval of risk management systems and monitoring their effectiveness provided for under this Regulation, the Committee for Medicinal Products for Human Use shall rely on the scientific assessment and recommendations of the Pharmacovigilance Risk Assessment Committee referred to in Article 56(1)(aa).’;
„Pri izpolnjevanju nalog v zvezi s farmakovigilanco, vključno z odobritvijo in spremljanjem učinkovitosti sistemov obvladovanja tveganj iz te uredbe, se Odbor za zdravila za humano uporabo opira na znanstvene ocene in priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance iz točke (aa) člena 56(1).“;
Article 9(4) is amended as follows:
člen 9(4) se spremeni:
a recommendation on the frequency of submission of periodic safety update reports;’;
priporočilo o pogostosti pošiljanja rednih posodobljenih poročil o varnosti zdravil;“;
details of any recommended measures for ensuring the safe use of the medicinal product to be included in the risk management system;
podatki o kakršnih koli priporočenih ukrepih za zagotovitev varne uporabe zdravil, ki se jih navede v sistemu obvladovanja tveganj;
(cb) if appropriate, details of any recommended obligation to conduct post-authorisation safety studies or to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Chapter 3;
(cb) če je to potrebno, podrobnosti o priporočeni obveznosti izvedbe študije varnosti po pridobitvi dovoljenja ali izpolnitvi obveznosti evidentiranja domnevnih neželenih učinkov ali poročanja o njih, ki so strožja od zahtev iz poglavja 3;
(cc) if appropriate, details of any recommended obligation 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.
(cc) če je to potrebno, podrobnosti o priporočeni obveznosti izvedbe študije učinkovitosti po pridobitvi dovoljenja, v katerih se opredelijo nekateri pomisleki o učinkovitosti zdravila in se lahko razrešijo 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 10b while taking into account the scientific guidance referred to in Article 108a of Directive 2001/83/EC;’;
Navedena obveznost izvedbe teh študij temelji na delegiranih aktih, sprejetih v skladu s členom 10b, ob upoštevanju znanstvenih smernic iz člena 108a Direktive 2001/83/ES;“;
the assessment report as regards the results of the pharmaceutical and pre-clinical tests and of the clinical trials, and as regards the risk management system and the pharmacovigilance system for the medicinal product concerned.’;
poročilo o oceni rezultatov farmacevtskih in pred-kliničnih preskusov, kliničnih preskušanj ter sistema obvladovanja tveganj in sistema farmakovigilance za zadevno zdravilo.“;
Within 15 days after receipt of the opinion referred to in Article 5(2), the Commission shall prepare a draft of the decision to be taken in respect of the application.
V 15 dneh po prejemu mnenja iz člena 5(2) Komisija pripravi osnutek odločitve, ki se sprejme v zvezi z vlogo.
Where a draft decision envisages the granting of a marketing authorisation, it shall include or make reference to the documents mentioned in points (a) to (d) of Article 9(4).
Kadar osnutek odločitve predvideva izdajo dovoljenja za promet, ta vključi ali se sklicuje na dokumente, navedene v točkah od (a) do (d) člena 9(4).