natgillin/translations-raw huggingface dataset:
– začasnem preklicu ali ukinitvi dovoljenja za promet;
- suspending or revoking of a marketing authorisation;
– prepoved izdajanja zdravila;
- prohibiting the supply of a medicinal product;
– zavrnitvi podaljšanja dovoljenja za promet;
- refusing the renewal of a marketing authorisation;
Zaradi razjasnitve postopka Skupnosti.
Clarification of the Community procedure
Po informacijah iz člena 107i(1) Agencija javno objavi sprožitev postopka na evropskem spletnem portalu o varnosti zdravil.
Following the information referred to in Article 107i(1), the Agency shall publicly announce the initiation of the procedure by means of the European medicines safety web-portal.
Po informacijah iz člena 107i(1) Agencija obvesti zadevne imetnike dovoljenja za promet in objavi sprožitev postopka na evropskem spletnem portalu o varnosti zdravil.
Following the information referred to in Article 107i(1), the Agency shall notify the concerned marketing authorisation holders and publicly announce the initiation of the procedure by means of the European medicines safety web-portal.
Komisija po posvetovanju z Agencijo, državami članicami in zainteresiranimi stranmi sprejme in objavi smernice za dobro farmakovigilančno prakso za zdravila, odobrena v skladu s členom 6(1), na naslednjih področjih:
Following consultation with the Agency, Member States and interested parties, the Commission shall adopt and make public guidelines on good pharmacovigilance practice for medicinal products authorised in accordance with Article 6(1) in the following areas:
(1) vzpostavitev in izvajanje sistema farmakovigilance s strani imetnika dovoljenja za promet ter vsebina in vodenje glavne dokumentacije sistema farmakovigilance;
(1) the establishment and operation of the pharmacovigilance system by the marketing authorisation holder and the content and maintenance of the pharmacovigilance system master file;
(2) zagotavljanje kakovosti in obvladovanje kakovosti s strani imetnika dovoljenja za promet, pristojnih nacionalnih organov in Agencije pri opravljanju farmakovigilančnih dejavnosti;
(2) quality assurance and quality control by the marketing authorisation holder, the national competent authorities and the Agency of their performance of pharmacovigilance activities .
(2) zagotavljanje kakovosti in obvladovanje kakovosti s strani imetnika dovoljenja za promet, pristojnih nacionalnih organov in Agencije pri opravljanju farmakovigilančnih dejavnosti;
(2) quality assurance and quality control by the marketing authorisation holder, the national competent authorities and the Agency of their performance of pharmacovigilance activities ;
(3) uporaba mednarodno dogovorjenih terminologij, oblik in standardov za izvajanje farmakovigilance;
(3) the use of internationally agreed terminologies, formats and standards for the conduct of pharmacovigilance;
(3) uporaba mednarodno dogovorjenih terminologij, oblik in standardov za izvajanje farmakovigilance , ki omogočajo, da se klinični pomen posredovanih primerov ohrani ;
(3) the use of internationally agreed terminologies, formats and standards for the conduct of pharmacovigilance allowing the clinical significance of reported cases to be preserved ;
(4) metodologija za spremljanje podatkov v podatkovni bazi Eudravigilance, da se ugotovi, ali je prišlo do novih ali spremenjenih tveganj;
(4) the methodology for the monitoring of data in the Eudravigilance database to determine whether there are new or changed risks;
(5) oblika elektronskega poročanja o neželenih učinkih s strani državi članic in imetnikov dovoljenja za promet;
(5) the format of electronic reporting of adverse reactions by Member States and marketing authorisation holders;
(6) oblika elektronskih rednih poročil o varnosti zdravila;
(6) the format of electronic periodic safety update reports;
(7) oblika protokolov, izvlečkov in zaključnih poročil o študiji za študije o varnosti zdravila po pridobitvi dovoljenja za promet;
(7) the format of protocols, abstracts and final study reports for the post-authorisation safety studies;
(8) postopki in oblike za farmakovigilančne komunikacije.
(8) the procedures and formats for pharmacovigilance communications.
Navedene smernice upoštevajo mednarodno usklajevalno delo, opravljeno na področju farmakovigilance, in se po potrebi spremenijo, da se upošteva tehnični in znanstveni napredek.
Those guidelines shall take account of international harmonisation work carried out in the field of pharmacovigilance and shall where necessary be revised to take account of technical and scientific progress.
Navedene smernice temeljijo na potrebah bolnikov z znanstvenega vidika in upoštevajo mednarodno usklajevalno delo, opravljeno na področju farmakovigilance, in se po potrebi spremenijo, da se upošteva tehnični in znanstveni napredek.
Those guidelines shall be based on patient needs from a scientific perspective, shall take account of international harmonisation work carried out in the field of pharmacovigilance and shall where necessary be revised to take account of technical and scientific progress.
Za namene člena 102(3) in tega člena Komisija v sodelovanju z Agencijo, državami članicami in zainteresiranimi stranmi pripravi natančne smernice o dobrem vodenju evidence za lekarne in druge, ki izdajajo zdravila ali jih dodeljujejo, da se zagotovi hranjenje evidenc, ki so potrebne, če je treba vložiti farmakovigilančno poročilo, ali da se omogočijo informacije, ki jih zahteva imetnik dovoljenja za promet, ki pripravlja vrednotenje neželenega učinka, ter da se imetniku dovoljenja za promet in nacionalnim pristojnim organom olajšajo nadaljnje preiskave.
For the purposes of Article 102(3) and this Article, the Commission, in cooperation with the Agency, Member States, and stakeholders, shall prepare detailed guidelines on good record-keeping practices for pharmacies and others that dispense or administer medicinal products, to ensure retention of records required in the event of needing to file a pharmacovigilance report or to provide information required by a marketing authorisation holder conducting an evaluation of an adverse event, and to facilitate follow-up investigations by the marketing authorisation holder and national competent authorities.
Upoštevanje standardov mednarodne konference o usklajevanju krepi pojmovno in tehnično odvisnost zdravstvenih organov od farmacevtskih laboratorijev.
The need to comply with the standards of the international conference on harmonisation strengthens the conceptual and technical dependence of the healthcare authorities on pharmaceutical laboratories.
Evropska dobra praksa na področju farmakovigilance bo pogojevala organizacijo evropskega sistema farmakovigilance.
Good European pharmacovigilance practice would influence the organisation of the European pharmacovigilance system.
Oblikovati jo je treba javno s preglednim postopkom posvetovanja, ki bo temeljil na potrebah evropskih bolnikov in znanstvenih vidikih.
That good practice must be drawn up openly, by means of a transparent consultation process based on the needs of European patients and from a scientific perspective.
Glede zahteve po vključitvi bistvenih lastnosti neželenih učinkov zdravila, v povzetek glavnih značilnosti zdravila in navodilo za uporabo iz točke 3a člena 11 in točke (aa) člena 59(1) Direktive 2001/83/ES, kakor je bila spremenjena s to direktivo, države članice zagotovijo, da se zahteva uporablja za dovoljenje za promet, izdano pred datumom, določenim v drugem pododstavku člena 3(1) te direktive, od podaljšanja navedenega dovoljenja za promet ali po izteku triletnega obdobja, ki se začne na navedeni datum, kar nastopi prej.
With regard to the requirement for the inclusion of the medicinal product’s adverse reaction profile in the summary of the product characteristics and the package leaflet provided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by this Directive, the Member States shall ensure that the requirement applies to a marketing authorisation granted before the date set out in the second subparagraph of Article 3(1) of this Directive from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.
Zdravila znatno prispevajo k zdravju državljanov EU.
Medicinal products contribute considerably to the health of EU citizens.
Lahko pa imajo tudi neželene učinke, ki po ocenah Evropske komisije povzročijo približno 5 % vseh sprejemov v bolnišnico (čeprav nepopolno poročanje ne omogoča natančnih ocen).
They can however also have adverse effects, leading to about 5% of all hospital admissions according to the European Commission (underreporting does however not allow for accurate estimates).
Primer zdravila proti vnetju rofekoksib (Vioxx), ki je bilo zaradi povečanja tveganja za bolezni srca in ožilja umaknjeno s trga leta 2004 (po oceni več kot 30 000 možganskih kapi v ZDA, od katerih je bilo nekaj usodnih), je povečal ozaveščenost o tem, da je treba okrepiti farmakovigilanco.
The rofecoxib (Vioxx) case, an anti-inflammatory that was withdrawn of the market in 2004 because of increased cardiovascular risks (more than 30.000 estimated strokes in the US, some of which were fatal) permitted to raise awareness about the need to strengthen pharmacovigilance.
Farmakovigilanca je postopek spremljanja varnosti zdravil in znanost o tem spremljanju, ki vključuje zbiranje in obdelavo podatkov o varnosti zdravil, oceno teh podatkov, s katero se ugotovi, ali je varnost ogrožena, ukrepanje za rešitev morebitnega vprašanja glede varnosti in poročanje o njem ter vrednotenje uporabljenega postopka in dobljenih rezultatov.
Pharmacovigilance is the process and science of monitoring the safety of medicines, including the collection and management of data on the safety of medicines, the assessment of that data to detect whether there is a safety issue, action to address the possible safety issue including informing on this issue, and the evaluation of the procedure followed and results obtained.
Postopek za zdravila, ki pridobijo dovoljenje za promet po centraliziranem postopku, je določen v Uredbi (ES) 726/2004.
As regards centrally authorised medicines the pharmacovigilance procedure is laid down in Regulation 726/2004.
To mnenje zadeva predloge sprememb Direktive 2001/83/ES, ki jih je predlagala Komisija.
This opinion concerns the Commission's proposed amendments to Directive 2001/83.
Komisija želi izboljšati sedanji sistem farmakovigilance tako, da bi pojasnila vlogo različnih sodelujočih subjektov, poenostavila postopke, povečala preglednost in sporazumevanje, izboljšala zbiranje podatkov in postopke vrednotenja, povečala sodelovanje zainteresiranih strani ter opredelila najboljšo prakso.
The Commission wishes to improve the current system of pharmacovigilance by clarifying the roles of the various actors involved, simplifying procedures, enhanced transparency and communication, better data collection and evaluation procedures, more involvement of stakeholders and the establishment of best practices.
Čeprav pripravljavec mnenja pozdravlja predlog, meni, da ga je mogoče še izboljšati, zlasti pri vprašanjih varstva potrošnikov, preglednosti in varstva podatkov.
Though the rapporteur for opinion welcomes the proposal, he is of the view that there is a room for further improvements, mainly with regard to consumer protection issues, transparency and data protection .
Zato predlaga nekatere spremembe v skladu z naslednjimi smernicami:
He therefore proposes amendments along the following lines:
· Poročanje bolnikov lahko na nov način prispeva k poznavanju neželenih učinkov zdravil, kot v primeru sredstva proti depresiji paroksetin (Deroxat/Seroxat), za katerega je bilo po poročanju bolnikov ugotovljeno, da povečuje tveganje za samomor in povzroča odtegnitveni sindrom („električna glava“), če želijo bolniki prekiniti zdravljenje.
· Patient reports can bring a new contribution to the understanding of adverse drug reactions (ADR) as it was the case for paroxetine (Deroxat/Seroxat), an antidepressant which was found, thanks to patient reports, to increase the risk of suicides and to cause a deprivation syndrome (“electric head”) if the patients wished to stop their treatment.
Zaradi decentraliziranih sistemov poročanja, pri katerih se sporočanje vseh neželenih učinkov zdravil (o katerih poročajo bodisi bolniki, bolnišnice, zdravstveni strokovnjaki ali farmacevtska podjetja) v evropsko bazo podatkov usklajuje na nacionalni ravni, je varstvo podatkov boljše in kakovost podatkov, zabeleženih na evropski ravni, zagotovljena.
Decentralised reporting systems whereby communication of all adverse drug reactions (reported whether by patients, hospitals, health professionals and pharmaceutical companies) to the European database is coordinated at a national level, increase the safety for data protection and guarantees the quality of the data which are registered at the European level.
Bližina omogoča nacionalnim zdravstvenim organom tudi, da:
Proximity also allows national health authorities to:
- izvajajo preiskave, s katerimi prispevajo dragocene informacije in uporabijo svoje posebno strokovno znanje in izkušnje,
- investigate the reports to add valuable information whereby they apply their particular expertise,
- imajo jasen pregled nad neželenimi učinki, ki se pojavljajo na njihovem ozemlju, in
- to have a clear view of the adverse effects occurring on their territory,
- omogočijo prebivalcem svoje države dostop do teh informacij v lastnem jeziku (kot že počneta Združeno kraljestvo in Nizozemska).
- and to make this information accessible to their country’s population in its own language (as the UK and the Netherlands already do).
· Potrošniki in zdravstveni strokovnjaki bi morali imeti popoln dostop do osrednje evropske baze podatkov EUDRAVigilance, s čimer bi preprečili ponavljanje neželenih učinkov zdravil, ki jih je mogoče preprečiti, saj bi bile potrjene informacije lahko dostopne.
· Consumers and Healthcare professionals should also have full access to the central European EUDRAVigilance database in order to prevent the repetition of preventable adverse drug reactions by making validated information easily available.
Gre za učinkovit način obravnave različnih informacij o neželenih učinkih med državami članicami.
It is an effective way to tackle inequalities of information on adverse drug reactions among Member States.
Javni dostop do Eudravigilance je potreben, da bi državljanom povrnili zaupanje v zmožnost zdravstvenih organov, da zavarujejo javno zdravje.
This public access to Eudravigilance is needed to restore citizens’ trust in health authorities’ capacity to protect public health.
· Uporabo spletnega formata poročanja bi bilo treba (tako kot v ZDA in Združenem kraljestvu) dopolniti z drugimi načini, kot so pošta, faks in telefon, da ne bi bili izključeni tisti, ki nimajo dostopa do interneta ali ga ne morejo uporabljati, ter da bi izboljšali poročanje bolnikov.
· The use of a web format for reporting should be supplemented by other means, such as mail, fax and phone as it is the case in the US and in the UK, in order to not exclude those who do not have access to or cannot use the internet and to improve patient reporting.
· Vsa poročila o oceni, ki zadevajo zdravljenje v okviru nacionalnih in evropskih sistemov farmakovigilance, bi morala biti dostopna javnosti.
· All assessment reports concerning a medication in the framework of the national and European pharmacovigilance systems should be available to the public.
Ko gre za prevladujoči javni interes, kot v primeru podatkov farmakovigilance, je treba vedno zagotoviti njihovo popolno razkritje.
When an overriding public interest is at stake, as it is the case concerning pharmacovigilance data, full disclosure has always to be guaranteed.
· Financiranje sistemov farmakovigilance mora ostati javno, saj so javni organi odgovorni, da zavarujejo svoje prebivalstvo, ter da se zagotovi njihova neodvisnost.
· The funding of the pharmacovigilance systems should remain public as recognition of the public authorities’ responsibility to protect their populations, and in order to guarantee their independency.
(9) Kadar je zdravilo odobreno pod pogojem, da se izvedejo študije o varnosti zdravila po pridobitvi dovoljenja za promet, ali kadar v zvezi z varnostjo in učinkovito uporabo zdravil obstajajo pogoji ali omejitve, je treba zdravilo na trgu obširno spremljati.
(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be subject to extended monitoring on the market.
(10a) V treh letih po začetku veljavnosti te direktive naj Komisija po posvetovanju z organizacijami bolnikov, potrošnikov, zdravnikov in farmacevtov, državami članicami in drugimi zainteresiranimi stranmi predstavi Evropskemu parlamentu in Svetu poročilo o oceni berljivosti povzetkov glavnih značilnosti zdravila in navodila za uporabo ter njihove pomembnosti za splošno javnost in zdravstvene strokovnjake.
(10a) Within three years of the entry into force of this Directive, the Commission should, following consultations with patient and consumer organisations, doctor and pharmacist organisations, Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability of the summaries of product characteristics and the packaging leaflets and their value to the general public and healthcare professionals.
Po analizi navedenih podatkov naj Komisija po potrebi predstavi predloge za izboljšanje oblike in vsebine povzetkov glavnih značilnosti zdravila in navodil za uporabo, da bi zagotovila, da so dragocen vir informacij za splošno javnost in zdravstvene strokovnjake.
Following an analysis of the above data, the Commission should, if appropriate, put forward proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.
Navodila za zdravila so pogosto še vedno nejasna in težko razumljiva za potrošnike.
Medication leaflets are still often not clear and easy understandable for consumers.
Naloga Evropske komisije je, da predstavi premišljene predloge, o katerih je razpravljala z vsemi zadevnimi zainteresiranimi stranmi.
It is the duty of the European Commission to come up with reflected proposals discussed with all relevant stakeholders.
(13) Zaradi zagotavljanja enake ravni znanstvenega znanja in izkušenj na področju odločanja o farmakovigilanci na ravni Skupnosti in na državni ravni pri izvajanju nalog farmakovigilance, mora imeti skupina za usklajevanje možnost, da se opira na nasvete Svetovalnega odbora Agencije za ocenjevanje tveganja farmakovigilance .
(13) With a view to ensuring that the same level of scientific expertise in the area of pharmacovigilance decision-making at both Community and national level, when fulfilling pharmacovigilance tasks the coordination group should be able to rely on the advice of the Pharmacovigilance Risk Assessment Advisory Committee of the Agency .
(13) Zaradi zagotavljanja enake ravni znanstvenega znanja in izkušenj na področju odločanja o farmakovigilanci na ravni Skupnosti in na državni ravni pri izvajanju nalog farmakovigilance, mora imeti skupina za usklajevanje možnost, da se opira na nasvete Svetovalnega odbora Agencije za ocenjevanje razmerja med tveganjem in koristmi zdravil na področju farmakovigilance .
(13) With a view to ensuring the same level of scientific expertise in the area of pharmacovigilance decision-making at both Community and national level, when fulfilling pharmacovigilance tasks the coordination group should be able to rely on the advice of the Agency’s Pharmacovigilance Risk-Benefit Balance Assessment Advisory Committee .
Poimenovanje „Svetovalni odbor za ocenjevanje tveganja na področju farmakovigilance“ je preveč omejujoče in ne vključuje potrebe po analizi razmerja med tveganjem in koristmi zdravila, temveč poudarja le analizo tveganja.
The designation ‘Pharmacovigilance Risk Assessment Advisory Committee’ is too restrictive and ignores the need for analysis of a drug’s risk-benefit balance by insisting on risk assessment as a separate issue.
Odbor pa je pristojen za vsa vprašanja v zvezi s farmakovigilanco (predlog direktive, člen 1(14)).
But the Committee’s remit is for ‘questions related to … pharmacovigilance’ (proposal for a directive, Article 1, point 14).
(18) Za poenostavitev poročanja o domnevnih neželenih učinkih morajo imetniki dovoljenja za promet te učinke sporočati samo v podatkovno bazo farmakovigilance Skupnosti in omrežje za obdelavo podatkov iz člena 57(1)(d) Uredbe (ES) št. 726/2004 (v nadaljnjem besedilu: podatkovna baza Eudravigilance) ter hkrati pristojnim nacionalnim organom .
(18) In order to simplify the reporting of suspected adverse reactions the marketing authorisation holders should report those reactions to the Community pharmacovigilance database and data-processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (hereinafter ‘the Eudravigilance database’) and simultaneously to competent national authorities.
Vse spremembe v nacionalnih podatkovnih bazah se morajo nemudoma in samodejno pokazati v podatkovni bazi Eudravigilance.
Any change in the national database should be immediately and automatically reflected in the Eudravigilance database.
Podatkovna baza Eudravigilance in nacionalne podatkovne baze morajo biti popolnoma medobratovalne.
The Eudravigilance database and the national database should be fully interoperable.
Samo neposredno poročanje bolnikov, zdravstvenih strokovnjakov in imetnikov dovoljenja za promet o neželenih učinkih pristojnim nacionalnim organom zagotavlja kakovostne podatke v sistemu Eudravigilance.
Only indirect reporting of adverse reactions from patients, health professionals, and marketing authorization holders to national competent authorities guarantees quality data in the Eudravigilance system.
To omogoča, da se izkoristijo njihovo strokovno znanje in izkušnje ter prizna njihova odgovornost, kar zadeva varstvo javnega zdravja na nacionalni in evropski ravni.
It allows benefiting from their expertise and recognises their responsibility in terms of public health protection, at both national and European levels.
Nujno pa je, da imajo bolniki neposreden dostop do podatkov v podatkovni bazi Eudravigilance.
It is however essential that patients have a direct access to the data on the Eudravigilance database.
To zagotavlja, da so kakovostne informacije v javnem interesu lahko dostopne in se hitro razširijo.
This guarantees that good quality information of public interest is easily accessible and rapidly spread.
Zato je treba redno poročanje o varnosti zdravila povezati s sistemom obvladovanja tveganja za novo odobrena zdravila, obdobja poročanja pa podaljšati za generična zdravila, zdravila z dobro uveljavljeno uporabo, prostovoljnim soglasjem, homeopatska zdravila ali registrirana zdravila rastlinskega izvora s tradicionalno uporabo.
Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and the intervals between reports should be extended for generic, well-established use, informed consent, homeopathic, or traditional use registered herbal medicinal products.
Vendar morajo organi v interesu javnega zdravja zahtevati poročila o varnosti takih zdravil v določenih časovnih presledkih , kadar je treba oceniti tveganje ali pregledati ustreznost informacij o zdravilu.
However, in the interest of public health the authorities should require safety update reports for such products at specific intervals when there is a need to assess their risk or review the adequacy of product information.