natgillin/translations-raw huggingface dataset:
Zelo omejen dostop javnosti in neodvisnih strokovnjakov do podatkovne baze Eudravigilance.
The very limited access to the Eudravigilance database for the public and independent experts.
Podatki o farmakovigilanci morajo biti pregledni, da bi državljani zopet pridobili zaupanje v zdravstvene organe.
Transparency with regard to pharmacovigilance data is essential in order to restore public confidence in the health authorities.
Več predlogov je še vedno preveč nedorečenih in jih je treba okrepiti:
Several proposals are still too cautious and should be strengthened.
Ustanovitev evropskega svetovalnega odbora za obvladovanje tveganja, ki dejansko nima več moči in samostojnosti kot sedanja delovna skupina za farmakovigilanco, ne ustvarja pomembne dodatne vrednosti.
The formal establishment of a European risk management advisory committee (PRAAC), without any more genuine authority or autonomy than the current Pharmacovigilance Working Party, does not contribute any significant added value.
Ta poročila in vsa poročila o oceni zdravil morajo nujno postati javna.
PSURs and all assessment reports should be published immediately.
Iz tega sledi, da je treba:
To conclude:
· okrepiti merila, ki bodo omogočila izdajanje zanesljivejših dovoljenj za promet z zdravili, iz česar bo razvidno tudi, da bodo morala nova zdravila prinesti dejanski napredek v zdravljenju; uporaba hitrega postopka ne bi smela biti splošno pravilo;
· Strengthen the criteria to enable marketing authorisation to be granted on surer grounds , entailing the requirement for new medicinal products to bring genuine therapeutic advances; no widespread use of the fast-track procedure
· zagotoviti kakovostne podatke o farmakovigilanci;
· Ensure the quality of pharmacovigilance data
· zagotoviti sredstva za učinkovito javno farmakovigilanco;
· Provide the resources to ensure effective public pharmacovigilance
okrepiti preglednost.
Increase transparency
(5) Zaradi jasnosti je treba opredelitev neželenega učinka spremeniti, da se zagotovi, da ne zajema samo škodljivih in nenamernih učinkov, ki izhajajo iz dovoljene uporabe zdravila v običajnih odmerkih, ampak tudi napake pri zdravilih in uporabe zunaj odobrenega povzetka glavnih značilnosti zdravila, vključno z nepravilno uporabo in zlorabo zdravil.
(5) For the sake of clarity, the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived from the authorised use of a medicinal product at the normal doses, but also medication errors and uses outside the authorised summary of the product characteristics, including the misuse and abuse of the product.
(5) Zaradi jasnosti je treba opredelitev neželenega učinka spremeniti, da se zagotovi, da ne zajema samo škodljivih in nenamernih učinkov, ki izhajajo iz dovoljene uporabe zdravila v običajnih odmerkih, ampak tudi škodljive in nenamerne učinke zaradi napak pri zdravilih in uporabe zunaj odobrenega povzetka glavnih značilnosti zdravila, vključno z nepravilno uporabo in zlorabo zdravil.
(5) For the sake of clarity, the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived from the authorised use of a medicinal product at the normal doses, but also noxious and unintended effects derived from medication errors and uses outside the authorised summary of the product characteristics, including the misuse and abuse of the product.
Opredelitev pojma „neželeni učinki“ obsega vse nenamerne učinke zaradi nepravilne uporabe, vključno z napakami pri zdravilu.
The definition of adverse reaction covers all unintended effects derived from misuse, including medication errors.
Namen direktive ni podajanje splošnih informacij o napakah pri zdravilu, temveč zgolj v povezavi z nenamernimi učinki.
The directive does not, however, aim to give information on medication errors in general, but only on medication errors leading to unintended effects.
(7) Imetnik dovoljenja za promet mora farmakovigilanco za vsako zdravilo načrtovati v okviru sistema obvladovanja tveganja, farmakovigilanca pa mora biti sorazmerna z ugotovljenimi tveganji, možnimi tveganji in potrebo po dodatnih informacijah o zdravilu.
(7) The planning of pharmacovigilance for each individual medicinal product by the marketing authorisation holder should take place in the context of a risk management system and should be proportionate to the identified risks, potential risks, and the need for additional information on the medicinal product.
Treba je tudi predvideti, da so morebitni ključni ukrepi iz sistema obvladovanja tveganja vključeni v dovoljenje za promet z zdravilom kot pogoji.
It should also be foreseen that any key measures contained in a risk management system are included in the marketing authorisation as conditions.
Če pogoji iz dovoljenja za promet z zdravilom niso izpolnjeni v ustreznem roku, morajo imeti nacionalni pristojni organi pooblastila in sredstva za takojšnji začasni preklic ali ukinitev tega dovoljenja.
If the conditions included in the marketing authorisation are not fulfilled within the corresponding deadline, the competent authorities should have the power and appropriate resources to immediately suspend or revoke the marketing authorisation.
Izkušnje kažejo, da podjetja pogosto niso izvedla študij o varnosti, ki naj bi jih opravila po odobritvi.
Experience shows that in many cases where companies were required to conduct post-authorisation safety studies they failed to do so.
Posledica je, da ostajajo zdravniki in bolniki negotovi glede tega, ali so nekatera ključna zdravila za zdravljenje bolezni, kakršne so rak in srčna obolenja, dejansko koristna.
The result is that doctors and patients remain unsure whether some critical medicines used to treat illnesses like cancer and heart disease are actually beneficial.
Zaradi tega je pomembno, da se v zakonodajo uvedejo strožje zahteve in s tem zagotovi, da bodo farmacevtska podjetja res izvedla obljubljene študije.
That is why it is essential to introduce stricter requirements in the legislation in order to ensure that pharmaceutical companies complete their promised studies.
(8) Da se zagotovi zbiranje morebitnih potrebnih dodatnih informacij o varnosti odobrenih zdravil, morajo imeti pristojni organi pooblastilo, da v času izdaje dovoljenja za promet ali pozneje zahtevajo študije o varnosti zdravila po pridobitvi dovoljenja za promet, ta zahteva pa mora biti vključena kot pogoj v dovoljenju za promet z zdravilom.
(8) In order to ensure the collection of any necessary additional data about the safety of authorised medicinal products, competent authorities should be empowered to require post-authorisation safety studies at the time of the granting of the marketing authorisation or later, and this requirement should be included as a condition of the marketing authorisation.
Če pogoji iz dovoljenja za promet niso izpolnjeni v določenem roku, morajo imeti nacionalni pristojni organi pooblastila in ustrezna sredstva za takojšnji začasni preklic ali ukinitev tega dovoljenja.
If the conditions included in the marketing authorisation are not fulfilled within the deadline set, the competent authorities should have the power and appropriate resources to immediately suspend or revoke the marketing authorisation.
(9) Kadar obstaja zdravstvena potreba, ki ni izpolnjena, in 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 intenzivno spremljati.
(9) Where , in the case of an unmet medical need, 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 intensively monitored on the market.
Treba je zagotoviti, da strožji sistem farmakovigilance ne bo povzročil preuranjenega izdajanja dovoljenj za promet.
Steps must be taken to ensure that tightening up the pharmacovigilance system does not result in marketing authorisations being issued prematurely.
Bolnike in zdravstvene delavce je treba spodbujati, da poročajo o vseh domnevnih neželenih učinkih takih zdravil, ki bi morala biti prepoznavna po posebnem simbolu na zunanji embalaži in ustrezni kratki obrazložitvi v navodilih, Evropska agencija za zdravila, ustanovljena z Uredbo (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 (v nadaljnjem besedilu: Agencija), pa mora hraniti ažuren javno dostopen seznam takih zdravil.
Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, which should be identified by a specific symbol on the outer packaging and by a corresponding explanatory sentence in the leaflet , and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by 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 (hereinafter referred to as the ‘Agency’).
Posebna opozorila za zdravila, ki se intenzivno spremljajo, bodo v pomoč tako zdravstvenim delavcem kot bolnikom pri prepoznavanju novih zdravil pod intenzivnim nadzorom in bi lahko povečala njihovo ozaveščenost glede poročanja o neželenih učinkih, ki bi se lahko pojavili, kakor je bilo že priporočeno v poročilu Ameriškega medicinskega inštituta za leto 2006.
Special warnings for intensively monitored medicines will help both the health professionals and the patients to identify new medicines under intensive surveillance and would increase their awareness to report any adverse reaction that might appear as already recommended by the US Institute of Medicine in its 2006 report .
Ta ukrep bi lahko še izboljšali, če bi dodali slikovno oznako, na primer črni trikotnik, ki ga v nekaterih državah članicah že uporabljajo.
This measure could be further improved by adding on the box a pictogram like for example the black triangle ( ) already well known and used in some Member States.
(10) Da se zdravstvenim delavcem in bolnikom omogoči, da brez težav ugotovijo najpomembnejše informacije o zdravilih, ki jih uporabljajo, morata povzetek glavnih značilnosti zdravila in navodilo za uporabo vključevati kratek in jedrnat del s ključnimi informacijami o zdravilu in informacijami, kako čim bolj zmanjšati tveganja in čim bolj povečati koristi.
(10) In order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about the medicines they use, the summary of the product characteristics and the package leaflet should include a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefits.
(10) Pet let po začetku veljavnosti te direktive mora Komisija po posvetovanju z organizacijami bolnikov in potrošnikov, strokovnimi organizacijami zdravstvenih delavcev, državami članicami in drugimi zainteresiranimi stranmi predstaviti Evropskemu parlamentu in Svetu ocenjevalno poročilo o razumljivosti povzetkov značilnosti zdravil in navodil za uporabo.
(10) Within five years of the entry into force of this Directive, the Commission should, following consultations with patient and consumer organisations, healthcare professional 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.
Po analizi teh podatkov naj Komisija po potrebi predstavi predloge za izboljšanje oblike in vsebine povzetkov glavnih značilnosti zdravila in navodil za uporabo, da bi zagotovila, da bodo dragocen vir informacij za splošno javnost in zdravstvene delavce.
Following an analysis of such 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.
Pojem povzetek je problematičen.
The notion of a summary poses a problem.
Pomembneje je, da je navodilo za uporabo čitljivo, s čimer se zagotovi, da bo bolnik prebral vse potrebne informacije.
It is more important for the report to be drawn up legibly to ensure that the patient reads all the necessary information.
(17) Za boljše usklajevanje virov med državami članicami mora biti država članica pooblaščena, da prenese nekatere naloge farmakovigilance na drugo državo članico.
(17) To further increase the coordination of resources between the Member States, Member State should be authorised to delegate certain pharmacovigilance tasks to another Member State .
(17) Vsaka država članica mora biti odgovorna za pregled nad neželenimi učinki, ki se pojavijo na njenem ozemlju.
(17) Each Member State should be responsible for the oversight of the adverse reactions occurring in its territory.
Da bi zvišali raven strokovnosti v farmakovigilanci, je treba države članice spodbujati, naj organizirajo usposabljanje ter redno izmenjujejo informacije in strokovno znanje.
To further increase the level of expertise in pharmacovigilance, Member States should be encouraged to organise training and to regularly exchange information and expertise .
Vsaka država članica mora biti v celoti odgovorna za odkrivanje in spremljanje vseh neželenih učinkov, povezanih z zdravilom, ki se trži na njenem ozemlju.
Each member state should be fully responsible for the detection and the follow up of any adverse event related to a medicine marketed within its territory.
(19) Za večjo raven preglednosti o procesih farmakovigilance morajo države članice oblikovati in vzdrževati spletne portale o varnosti zdravil.
(19) In order to increase the level of transparency on the processes of pharmacovigilance, the Member States should create and maintain medicines safety web-portals.
Iz istega razloga morajo imetniki dovoljenja za promet organom posredovati predhodno opozorilo o varnostnih sporočilih, organi pa si morajo taka opozorila izmenjavati .
To the same end, the marketing authorisation holders should provide the authorities with prior warning about safety announcements and the authorities should provide each other with such a warning .
Od imetnikov dovoljenja za promet je treba zahtevati, da organom posredujejo varnostna sporočila, ki jih nameravajo objaviti za predhodno odobritev .
The marketing authorisation holders should be required to submit to the authorities the safety announcements which they plan to disseminate for prior authorisation.
Organi morajo po tej zahtevi nemudoma izmenjati predhodna opozorila o teh varnostnih sporočilih .
Without delay following such a request, the authorities should provide each other with a prior warning about these safety announcements .
Pomembno je zagotoviti, da informacije o zdravilih, ki jih podjetja izdajo za javnost, niso oglaševalske narave.
It is important to ensure that any information on medicines provided by companies to the general public is non promotional.
Načelo predhodne potrditve informacij že velja za navodila v embalaži in javne kampanje ter se o njem razpravlja v predlogu o informacijah o zdravilih na recept za širšo javnost; zaradi doslednosti bi bilo treba to načelo uporabljati tudi za informacije s področja farmakovigilance.
The principle of prior validation of the information is already applied for package leaflets, public campaigns and also in the proposal on information to the general public on prescription medicines currently under discussion and for consistency it should be applied to pharmacovigilance information.
(28) Pristojni nacionalni organi morajo za varovanje javnega zdravja zagotoviti ustrezno financiranje dejavnosti v zvezi s farmakovigilanco.
(28) In order to protect public health, there should be adequate funding of activities related to pharmacovigilance by the national competent authorities.
Treba je zagotoviti ustrezno financiranje farmakovigilančnih dejavnosti s pobiranjem pristojbin.
It should be possible to ensure adequate funding for pharmacovigilance activities through the collection of fees.
Upravljanje navedenih zbranih sredstev pa mora biti pod stalnim nadzorom pristojnih nacionalnih organov, da se zagotovi njihova neodvisnost.
However, the management of those collected funds should be under the permanent control of the national competent authorities in order to guarantee their independence.
Dejavnosti farmakovigilance bi se morale financirati iz javnih sredstev, da bi zagotovili njihovo neodvisnost, pa tudi da bi bile države članice popolnoma odgovorne za farmakovigilanco (tudi glede financiranja), saj ravno one krijejo stroške, povezane s stranskimi učinki, tako glede obolevnosti kot smrtnosti.
Pharmacovigilance activities should be publicly financed not only to ensure their independence but also because the Member States should be fully responsible for pharmacovigilance (also in terms of funding) as they are those who bear the costs associated with side effects both in terms of morbidity and in terms of mortality.
Po navedbah Evropske komisije je 5 % vseh hospitalizacij posledica neželenih učinkov zdravil, 5 % vseh bolnikov v bolnišnicah trpi zaradi neželenih učinkov zdravil, poleg tega pa so neželeni učinki zdravil peti najpogostejši vzrok smrti v bolnišnicah.
According to the European Commission “it is estimated that 5% of all hospital admissions are due to an adverse drug reaction, 5% of all hospital patients suffer an adverse reaction and adverse reactions are the fifth most common cause of hospital death.
(29a) Ta direktiva se mora uporabljati ne glede na 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 1 in ne glede na 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 2 .
(29a) This Directive should 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 1 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 2 .
Da bi odkrili, ocenili, razumeli in preprečili neželene učinke, prepoznali tveganja in ukrepali za njihovo zmanjšanje ter povečali koristi zdravil pri varovanju javnega zdravja, mora biti omogočena obdelava osebnih podatkov v sistemu Eudravigilance, pri čemer se spoštuje zakonodaja EU o varstvu podatkov.
In order to detect, assess, understand and prevent adverse reactions, identify and take action to reduce the risks and increase the benefits of medicinal products for the purpose of safeguarding public health, it should be possible to process personal data within the Eudravigilance system while complying with EU data protection legislation.
Ta namen pomeni pomemben javni interes, ki ga lahko upravičimo, če se določljivi zdravstveni podatki obdelajo samo po potrebi in udeležene strani to potrebo ocenijo na vsaki stopnji procesa farmakovigilance.
That purpose constitutes a substantial public interest which can be justified if identifiable health data are processed only when necessary and the parties involved assess such necessity at every stage of the pharmacovigilance process.
V predlogu so omenjeni zelo občutljivi osebni podatki, ki bi morali biti popolnoma zaščiteni.
The proposal covers highly sensitive personal information which should be fully protected.
Gl. tudi mnenje evropskega nadzornika za varstvo podatkov iz aprila 2009.
See also opinion of the European data protection supervisor of April 2009.
Člen 1 – točka 1 – točka (a)
Article 1 – point 1 – point a
(a) točka 11 se nadomesti z naslednjim:
(a) point 11 is replaced by the following:
„(11) Neželen učinek: Neželen učinek zdravila je škodljiva in nenamerna reakcija.“
´(11) Adverse reaction: A response to a medicinal product which is noxious and unintended´
Predlagana je uporaba prvotnega besedila (člen 1(11) prečiščene Direktive 2001/83/ES), ki natančno pojasnjuje, da gre za običajne pogoje uporabe, in zlasti preprečuje zamenjavo z nepravilno uporabo ali zlorabo zdravila.
The initial wording (Article 1, point 11, of consolidated Directive 2001/83/EC), which clearly states that it refers to normal conditions of use and avoids confusion with cases involving misuse or abuse, should be reinstated.
(14) Domnevni neželen učinek: Neželeni učinek, pri katerem ni mogoče izključiti vzročnega odnosa med dogodkom in zdravilom.
(14) Suspected adverse reaction: An adverse reaction in respect of which a causal relationship between the event and the medicinal product cannot be excluded.
(14) Domnevni neželen učinek zdravila : nenamerni dogodek , pri katerem ni mogoče izključiti vzročnega odnosa med dogodkom in zdravilom.
(14) Suspected adverse drug reaction: An unintended event in respect of which a causal relationship between the event and the medicinal product cannot be excluded.
Redakcijska opomba: če bo predlog spremembe sprejet, bo treba ustrezno spremeniti ostalo besedilo direktive in Uredbe (ES) št. 726/2004.
Drafting note: The remaining text of the directive and of Regulation (EC) No 726/2004 will have to be changed accordingly if this amendment is adopted.
Člen 1 – točka 1 – točka (c)
Article 1 – point 1 – point c
(15) Študija o varnosti zdravila po pridobitvi dovoljenja za promet: Vsaka študija o odobrenem zdravilu, katere cilj je opredelitev, ugotovitev značilnosti ali količinska določitev tveganja , ki potrjuje varnostne lastnosti zdravila , ali merjenje učinkovitosti ukrepov za obvladovanje tveganj.
(15) Post-authorisation safety study: Any study with 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.
(15) Študija o farmakovigilanci po pridobitvi dovoljenja za promet: vsaka študija o predčasno odobrenem zdravilu zaradi javnega zdravja, če ni drugih možnosti zdravljenja, ali ki je izvedena na zahtevo zdravstvenih organov potem, ko je zdravilo dano v promet , katere cilj je opredelitev, ugotovitev značilnosti ali količinska določitev tveganja neželenih učinkov ali ocenitev lastnosti neželenih učinkov zdravila in njegovo razmerje med tveganji in koristmi ali merjenje učinkovitosti ukrepov za obvladovanje tveganj.
(15) Post-authorisation pharmacovigilance study: Any study with a medicinal product authorised early for reasons of public health in the absence of a therapeutic alternative, or carried out at the request of the health authorities once a medicinal product has been placed on the market, with the aim of identifying, characterising or quantifying an adverse reaction risk or of assessing the adverse reaction profile of the medicinal product and its risk/benefit balance , or of measuring the effectiveness of risk management measures.
Cilj študije po pridobitvi dovoljenja za promet je nadzorovanje neželenih učinkov zdravil na človeka, ne pa varnosti zdravil.
The aim of a post-authorisation study is to monitor the adverse reactions of medicinal products in human beings.
Ni namenjena nadzorovanju „varnosti zdravila po pridobitvi dovoljenja za promet“.
It is not intended to monitor ‘post-authorisation safety’.