natgillin/translations-raw huggingface dataset:
(9) Da se v vsej Skupnosti zagotovi usklajen odziv na pomisleke glede varnosti zdravil za humano uporabo, morata Odbor za zdravila za uporabo v humani medicini in koordinacijska skupina , ustanovljena z Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini upoštevati priporočilo Svetovalnega odbora za oceno tveganja na področju farmakovigilance pri vseh vprašanjih , povezanih s farmakovigilanco zdravil za humano uporabo.
(9) In order to ensure harmonised responses across the Community to safety concerns regarding medicinal products for human use, the Committee for Medicinal Products for Human Use and the coordination group established by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use should rely on the recommendation of the Pharmacovigilance Risk Assessment Committee on any question relating to the pharmacovigilance of medicinal products for human use.
Če naj bo Odbor za oceno tveganja na področju farmakovigilance predstavniški odbor, bi bilo treba njegove pristojnosti v primerjavi z Odborom za zdravila za uporabo v humani medicini in skupino za usklajevanje povečati.
If the Pharmacovigilance Risk Assessment Committee (PRAC) is to be a representative committee, its powers should be increased in relation to the CHMP and the coordination group.
Ne Odbor za zdravila za uporabo v humani medicini ne koordinacijska skupina nista strokovna organa za farmakovigilanco – njuna naloga je na splošno usklajevati tveganja in koristi.
Neither the CHMP nor the coordination group is a specialist body on pharmacovigilance – their job is to balance overall the risks with benefits.
Odbor za oceno tveganja bi moral biti edini organ, odgovoren za farmakovigilanco in ocenjevanje tveganj, da te vloge ne bi po nepotrebnem podvajali.
The PRAC should be the only body in charge of pharmacovigilance and risk assessment, in order to avoid undue duplication of roles.
(15) Kadar je za zdravilo izdano dovoljenje za promet pod pogojem, da je treba opraviti študijo varnosti po pridobitvi dovoljenja za promet, oziroma pod pogoji ali na podlagi omejitev v zvezi z varno in učinkovito uporabo zdravila, je treba zdravilo intenzivno spremljati na trgu.
(15) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or subject to 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.
Bolnike in zdravstvene delavce je treba spodbujati, da poročajo o vseh domnevnih neželenih učinkih takih zdravil, Agencija pa mora sproti dopolnjevati javno dostopen seznam takih zdravil.
Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be kept up to date by the Agency.
Bolnike in zdravstvene delavce je treba spodbujati, da poročajo o vseh domnevnih neželenih učinkih takih zdravil, ki so označena s simbolom in ustrezno kratko obrazložitvijo v povzetku značilnosti zdravila in navodilih za uporabo , Agencija pa mora sproti dopolnjevati javno dostopen seznam takih zdravil.
Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, identified by a symbol and a corresponding explanatory sentence on the summary of product characteristics and on the patient information leaflet , and a publicly available list of such medicinal products should be kept up to date by the Agency.
(20a) 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 podatkov¹ 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 podatkov².
(20a) 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 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 .
Za odkrivanje, oceno, razumevanje in preprečevanje neželenih učinkov ter za prepoznavanje in izvajanje ukrepov za zmanjšanje tveganj in povečanje koristi zdravil z namenom varovanja javnega zdravja, bi morala obstajati možnost obdelave osebnih podatkov v okviru sistema Eudravigilance, ob spoštovanju zakonodaje EU o varstvu osebnih podatkov.
In order to detect, assess, understand and prevent adverse reactions, and to identify and take action to reduce risks and increase 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.
Predlog zajema zelo občutljive osebne podatke, ki bi morali biti popolnoma zaščiteni.
The proposal covers highly sensitive personal information which should be fully protected.
Glej tudi mnenje Evropskega nadzornika za varstvo podatkov iz aprila 2009.
See also the opinion of the European Data Protection Supervisor of April 2009.
(21a) Namen varstva javnega zdravja je pomemben javni interes, kar opravičuje obdelavo določljivih zdravstvenih podatkov, pod pogojem, da se obdelujejo samo po potrebi in udeležene strani to potrebo ocenijo na vsaki stopnji procesa farmakovigilance.
(21a) The purpose of safeguarding public health constitutes a substantial public interest which justifies the processing of identifiable health data as long as it is processed only when necessary and the parties involved assess th e necessity of processing such data at every stage of the pharmacovigilance process.
Vseeno pa bi morala biti omogočena obdelava osebnih podatkov v sistemu Eudravigilance, pri tem pa bi bilo treba spoštovati zakonodajo EU o varstvu podatkov.
However, it should be possible to process personal data within the Eudravigilance system whilst also respecting EU data protection legislation.
Pri izpolnjevanju nalog v zvezi s farmakovigilanco mu pomaga Svetovalni odbor za oceno tveganja na področju farmakovigilance iz člena 56(1)(aa).
For the fulfilment of its pharmacovigilance tasks, it shall be assisted by the Pharmacovigilance Risk Assessment Advisory Committee referred to in Article 56(1)(aa).
Pri izpolnjevanju nalog v zvezi s farmakovigilanco upošteva priporočilo odbora za oceno tveganja na področju farmakovigilance iz člena 56(1)(aa).
For the fulfilment of its pharmacovigilance tasks, it shall rely on the recommendation of the Pharmacovigilance Risk Assessment Committee referred to in Article 56(1)(aa).
Beseda „Svetovalni“ se izbriše iz naziva Odbora za ocenjevanje tveganja farmakovigilance, tako da bo njegovo ime bolje odražalo njegove pristojnosti.
The word « Advisory » should be removed from the title of the Pharmacovigilance Risk Assessment Committee so that it better reflects the powers of the committee.
Če bo sprememba sprejeta, se bo naziv popravil v vsem besedilu.
If adopted the name will be changed throughout the text.
Če naj bo Odbor za oceno tveganja na področju farmakovigilance predstavniški odbor, bi bilo treba njegove pristojnosti v primerjavi z Odborom za zdravila za uporabo v humani medicini povečati.
If the Pharmacovigilance Risk Assessment Committee (PRAC) is to be a representative committee, its powers should be increased in relation to the CHMP.
Ta namreč ni specializirani organ za farmakovigilanco – njegova naloga je na splošno usklajevati tveganja in koristi.
The CHMP is not a specialist body on pharmacovigilance – its job is to balance overall the risks with benefits.
Po izdaji dovoljenja za promet lahko Agencija zahteva, da imetnik dovoljenja za promet izvede študijo varnosti po pridobitvi dovoljenja za promet, če obstajajo pomisleki glede tveganj v zvezi z odobrenim zdravilom .
After the granting of a marketing authorisation, the Agency may require a marketing authorisation holder to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product.
Zahteva se sestavi v pisni obliki in vsebuje podrobno utemeljitev ter cilje in časovni okvir za predložitev in izvedbo študije.
The requirement shall be made in writing, provide a detailed justification and include the objectives and timeframe for submission and conduct of the study.
Po izdaji dovoljenja za promet lahko Agencija zahteva, da imetnik dovoljenja za promet izvede študijo varnosti po pridobitvi dovoljenja za promet, ali študije varnosti in učinkovitosti po pridobitvi dovoljenja za promet, kjer ostajajo odprta vprašanja glede učinkovitosti proizvoda , ali ko bi znanstvena spoznanja glede razumevanju bolezni ali klinične metodologije bistveno spremenila prejšnje ocene učinkovitosti.
After the granting of a marketing authorisation, the Agency may require a marketing authorisation holder to conduct a post-authorisation safety study, or post - authorisation safety and efficacy studies where important questions relating to the efficacy of a product remain; or when scientific advances in the understanding of the disease or in the clinical methodology would significantly change previous efficacy evaluations.
V ta namen Komisija zagotovi smernice.
For this purpose the Commission shall provide guidelines .
Komisija na podlagi podatkov, prejetih od Agencije in držav članic, pripravi poročilo, osredinjeno na pojem klinične učinkovitosti, študije in zahtevane podatke ter metodologije za njihovo oceno.
The Commission shall also, based on data received from the Agency and Member States , produce a report focusing on the concept of Clinical Effectiveness, studies and data required and methodologies for assessing it.
Sedaj za večino zdravil veljajo neke vrste študije o varnosti zdravila po pridobitvi dovoljenja za promet kot poseben varnostni ukrep.
At the moment, most drugs are subject to some kind of PASS as an extra safety precaution.
Vendar se – čeprav se varnost zdravila preverja skozi vso njegovo življenjsko dobo – učinkovitost preveri le enkrat, ko se izda dovoljenje.
However, although safety monitoring happens throughout the life of a drug, efficacy is only checked once, at the time of authorisation.
Obstajati mora tudi možnost spremljanja učinkovitosti zdravila po pridobitvi dovoljenja za promet – pri dejanskem svetovnem prebivalstvu in v dejanski življenjskih razmerah.
There should be the possibility to monitor drug efficacy post-authorisation as well - in real world populations and real-life conditions.
Na podlagi obrazložitev, ki jih predloži imetnik dovoljenja za promet, Komisija prekliče ali potrdi zahtevo.
On the basis of explanations submitted by the marketing authorisation holder, the Commission shall withdraw or confirm the requirement.
Kadar Komisija potrdi zahtevo, se dovoljenje za promet spremeni tako, da se zahteva vključi kot pogoj za izdajo dovoljenja za promet, sistem obvladovanja tveganja pa se ustrezno dopolni z novimi podatki.
Where the Commission confirms the requirement, the marketing authorisation shall be varied to include the requirement as a condition of the marketing authorisation and the risk management system shall be updated accordingly.
Ne glede na to, ali je bila zahteva odobrena ali zavrnjena, mora Komisija natančno obrazložiti odločitev, ki se ustrezno zabeleži.“
Irrespective of whether the requirement is confirmed or withdrawn, the Commission must state the grounds for its decision in detail, and the decision shall be duly recorded.
Člen 1 – točka 5 b
Article 1 – point 5 b
Ko je dovoljenje za promet obnovljeno, je veljavno za nedoločen čas, razen če se pristojni nacionalni organ iz upravičenih razlogov v zvezi s farmakovigilanco ali nezadostno izpostavljenostjo zdravila odloči, da nadaljuje z dodatnim petletnim obnovitvenim obdobjem v skladu z odstavkom 2.“
Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the national competent authority decides, on justified grounds relating to pharmacovigilance or to insufficient exposure to the product , to proceed with one additional five-year renewal in accordance with paragraph 2.”
Ko je dovoljenje za promet obnovljeno, je veljavno za nedoločen čas, razen če se pristojni organ iz upravičenih razlogov v zvezi s farmakovigilanco odloči, da nadaljuje z dodatnim petletnim obnovitvenim obdobjem v skladu z odstavkom 2.“
Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal in accordance with paragraph 2.”
Koristi usklajenega in poenostavljenega pristopa iz sedanjega predloga bi bilo treba ohraniti.
The benefits of a harmonised and simplified approach pursued in the current proposal should be preserved.
Novi predlog ne bi smel postaviti pod vprašaj izboljšav, uvedenih pri prejšnji reviziji zakonodaje o zdravilih, katere cilj je bilo zmanjšati število postopkov podaljšanja.
The new proposal should not regress on improvements introduced by the previous revision of the medicines legislation which aimed at reducing the number of renewal procedures.
Ohraniti je treba izvirno besedilo glede organov za odločanje.
The original wording regarding the deciding authority should be maintained.
Člen 21 – odstavek 2 – pododstavek 2
Article 21 – paragraph 2 – subparagraph 2
Zahteva se sestavi v pisni obliki ter vsebuje podrobno utemeljitev in časovni okvir za predložitev podrobnega opisa sistema obvladovanja tveganja.
The requirement shall be made in writing, provide a detailed justification , and include the timeframe for submission of the detailed description of the risk-management system.
Zahteva se sestavi v pisni obliki ter vsebuje podrobno znanstveno utemeljitev na podlagi znanstvenih utemeljitev in časovni okvir za predložitev podrobnega opisa sistema obvladovanja tveganja.
The requirement shall be made in writing, provide a detailed justification on the basis of scientific arguments and include the timeframe for submission of the detailed description of the risk-management system.
Zahteva za podroben opis sistema obvladovanja tveganja mora biti znanstveno utemeljena.
Where a detailed description of the risk-management system is requested, it should be based on scientific reasons.
Predlog Komisije v zvezi s tem ni dovolj natančen.
The Commission proposal is not sufficiently precise on this point.
Agencija v sodelovanju z državami članicami in Komisijo ustanovi in vodi podatkovno bazo in mrežo za obdelavo podatkov (v nadaljnjem besedilu „podatkovna baza Eudravigilance“), v katerih se zbirajo informacije o farmakovigilanci zdravil, odobrenih v Skupnosti, ter ki omogočajo pristojnim organom hkraten dostop do informacij in njihovo skupno uporabo.
The Agency, in collaboration with the Member States and the Commission, shall set up and maintain a database and data processing network (hereinafter ‘the Eudravigilance database’) to collate pharmacovigilance information regarding medicinal products authorised in the Community and to allow competent authorities to access the information at the same time and to share it.
Države članice podprejo razvoj strokovnega znanja nacionalnih in regionalnih centrov farmakovigilance.
Member States shall support the development of the expertise of national and regional pharmacovigilance centres.
Pristojni nacionalni organi morajo zbirati poročila teh centrov in prenesti podatke v podatkovno zbirko Eudravigilance.
National competent authorities should collect the reports from those centres and should then transfer data to the Eudravigilance database.
Člen 24 – odstavek 2 – pododstavek 2
Article 24 - paragraph 2 - subparagraph 2
Agencija zagotovi ustrezen dostop do podatkovne baze Eudravigilance tudi zdravstvenim delavcem in javnosti, pri čemer zagotovi varstvo osebnih podatkov.
The Agency shall ensure that health-care professionals and the public have appropriate levels of access to the Eudravigilance database, with personal data protection being guaranteed.
Agencija sodeluje z vsemi interesnimi skupinami, raziskovalnimi ustanovami, zdravstvenimi delavci ter organizacijami bolnikov in potrošnikov, da se določi „ustrezna raven dostopa“ do podatkovne baze Eudravigilance.
The Agency shall work together with all stakeholders, including research institutions, health care professionals, and patient and consumer organisations, in order to define the "appropriate level of access" to the Eudravigilance database.
Poročevalka se strinja, da se ne sme dovoliti, da bi Evropska agencija za vrednotenje zdravil sama določila ustrezno raven javnega dostopa do Eudravigilance – treba je vključiti interesne skupine.
The rapporteur agrees that EMEA should not be left to define itself the "appropriate level" of public access to Eudravigilance - but should involve stakeholders.
Vendar pa ne podpira, da bi bili na spletu dostopni vsi podatki, ne samo zbirni, saj bo baza podatkov vsebovala številna še nepotrjena poročila o neželenih učinkih.
However, she does not support full data being publically available online instead of aggregate data, as the database will contain many ADR reports which are unconfirmed.
Opozarja tudi, da člen 24 uredbe določa, da so posamezna poročila o neželenih učinkih javno dostopna na zahtevo.
She also notes that article 24 of the Regulation specifies that individual ADR reports are publically available on request.
Agencija v sodelovanju z državami članicami razvije standardne spletne oblike, prek katerih lahko zdravstveni delavci in bolniki poročajo o domnevnih neželenih učinkih.
The Agency, in collaboration with the Member States, shall develop standard web-based structured forms for the reporting of suspected adverse reactions by health-care professionals and patients.
Agencija v sodelovanju z državami članicami in ustreznimi interesnimi skupinami razvije standardne oblike in postopke, vključno s spletnimi oblikami, prek katerih lahko zdravstveni delavci in bolniki poročajo o domnevnih neželenih učinkih.
The Agency, in collaboration with the Member States and all relevant stakeholders , shall develop standard structured forms and procedures, including web-based forms, for the reporting of suspected adverse reactions by health-care professionals and patients.
Za zagotovitev istovetnosti bioloških zdravil, ki se predpisujejo, razdeljujejo ali prodajajo na ozemlju Unije, morajo standardne oblike in postopki vsebovati ime imetnika dovoljenja za promet (MAH), mednarodno nelastniško ime (INN), ime zdravila, kot je določeno v členu 1(2), in serijsko številko.
To ensure the identification of biological medicinal products prescribed, dispensed or sold in the territory of the Union , the standard forms and procedures shall include the name of the MAH (marketing authorisation holder) , the INN (international non-proprietary name) , the name of the medicinal product as defined in Article 1(2) and the batch number.
Agencija daje na voljo javnosti tudi druga sredstva, s katerimi lahko bolniki poročajo o neželenih učinkih, med drugim tudi namensko telefonsko številko ali posebno elektronsko pošto.
The Agency shall also make available to the public other means for patients to report undesirable effects, such as a dedicated telephone number or special email address
Ta možnost poročanja prek spleta je vsem državljanom Unije na voljo v njihovem maternem jeziku .
: All citizens of the Union shall have the option of submitting online declarations in their mother tongue .
Natančna opredelitev zdravila, povezanega z domnevnimi neželenimi učinki, je zelo pomembna za dobro delujoč sistem farmakovigilance.
Accurate identification of the product associated with a suspected adverse event is fundamental to a sound pharmacovigilance system.
Glede na posebnost bioloških zdravil v primerjavi z zdravili malih molekul je torej treba zagotoviti več identifikatorjev, da bo razlikovanje med proizvodi, dostopnimi na trgu, jasno.
Due to the specificities of biological medicinal products compared to small molecule medicinal products it is thus necessary to provide a number of identifiers to clearly distinguish the products available on the market.
Zato predlagani predlog spremembe zahteva, da Evropska agencija za vrednotenje zdravil razvije standardne oblike in postopke, ki jih bodo strokovno zdravstveno osebje in bolniki uporabljali za poročanje o domnevnih neželenih učinkih, ki naj vključujejo sredstva za jasno prepoznavanje zdravil ter za okrepitev in uskladitev zahtev za poročanje o takih proizvodih.
Therefore the proposed amendment requires the EMEA to develop standard forms and procedures to be used by health-care professionals and patients in reporting suspected adverse events which shall include means to accurately identify biological medicinal products and both strengthen and harmonize reporting requirements for such products.
Člen 26 – odstavek 1 – točka 1
Article 26 - paragraph 1 - point 1
(1) člane odborov iz točk (a) in (aa) člena 56(1) te uredbe in člane koordinacijske skupine iz člena 27 Direktive 2001/83/ES (v nadaljnjem besedilu „koordinacijska skupina“), skupaj z njihovimi poklicnimi kvalifikacijami in izjavami v skladu s členom 63(2) te uredbe;
(1) the members of the committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and the members of the coordination group referred to in Article 27 of Directive 2001/83/EC (hereinafter ‘the coordination group’), together with their professional qualifications and with the declarations pursuant to Article 63(2) of this Regulation;
(1) člane odborov iz točk (a) in (aa) člena 56(1) te uredbe in člane koordinacijske skupine iz člena 27 Direktive 2001/83/ES (v nadaljnjem besedilu „koordinacijska skupina“), skupaj z njihovimi poklicnimi kvalifikacijami in njihovimi izjavami o interesih v skladu s členom 63(2) te uredbe;
(1) the members of the committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and the members of the coordination group referred to in Article 27 of Directive 2001/83/EC (hereinafter ‘the coordination group’), together with their professional qualifications and with their declarations of interest, pursuant to Article 63(2) of this Regulation;
Veliko kolegov podpira večjo stopnjo preglednosti, kot je zagotovljena v predlogu Komisije.
Many colleagues support a greater degree of transparency than is provided for in the Commission's proposal.
Poročevalka podpira skoraj vse predloge sprememb in posledično ne podpira nobenega poskusa, da bi spreminjali, kar Komisija predlaga, da bi bilo javno objavljeno.
The rapporteur supports nearly all of these amendments, and, by extension, does not support any attempt to dilute what the Commission proposes should be made public.
Poročevalka podpira, da se javno objavijo vse podrobnosti sej Odbora za oceno tveganja na področju farmakovigilance, Odbora za zdravila za uporabo v humani medicini in koordinacijske skupine, tudi podatke o glasovanju in manjšinska mnenja.
The rapporteur supports full details of every PRAC, CHMP and Coordination Group meeting to be made public, including details of votes and minority opinions.
To je že zahtevano v členu 126b iste direktive, vendar se ne izvaja. „Države članice zagotovijo, da pristojni organ javno objavi svoj poslovnik in poslovnik svojih odborov, dnevne rede za svoje sestanke in zapisnike sestankov, skupaj s sprejetimi sklepi, podrobnostmi glasovanja in razlage glasovanja, vključno z manjšinskimi mnenji“.
This is already required by Article126b of this same Directive, but is not implemented: “Member States shall ensure that the competent authority makes publicly accessible its rules of procedure and those of its committees, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions”.