natgillin/translations-raw huggingface dataset:
Za člen 102 so bili vloženi številni predlogi sprememb o spontanem poročanju o neželenih učinkih.
Many amendments were tabled to article 102, on spontaneous reporting of ADRs.
Poročevalka je večino bistvenih elementov teh predlogov sprememb vključila v kompromisni predlog.
The rapporteur has incorporated most of the key elements of these amendments into a compromise.
V zadnjem odstavku ni vključila tega, da bi moralo poročanje o napakah pri zdravilih potekati anonimno (predlog spremembe 183), saj bi to lahko privedlo do zlonamernega poročanja, je pa ohranila koncept poročanja brez iskanja krivca.
On the last paragraph, she did not include that the reporting of medication errors should be done anonymously (amendment 183), as this could lead to malicious reporting, but has accepted the concept of no-blame reporting.
Zaupna narava pomeni, da poročil o neželenih učinkih ne bi bilo mogoče predstaviti v pravnih postopkih proti zadevnim zdravstvenim delavcem.
"Legally privileged" means that the ADR reports would not be presentable in legal proceedings against the health professional involved.
Člen 102 – odstavek 1 – točka 1 a (novo)
Article 102 - paragraph 1- point 1 a (new)
(1a) omogočijo neposredno poročanje bolnikov z zagotovitvijo alternativnih načinov poročanja poleg spletnih oblik;
(1a) facilitate direct patient reporting through the provision of alternative reporting formats in addition to web-based formats;
Glej obrazložitev pri predlogu spremembe za člen 1, odstavek 1, točko 1.
see justification to am to Article 1 - paragraph 1 - point 1.
Člen 102 – odstavek 1 – točka 2
Article 102 - paragraph 1- point 2
(2) zagotovijo, da poročila o neželenih učinkih vsebujejo čim bolj kakovostne informacije;
(2) ensure that adverse reaction reports contain the highest quality information possible;
(2) zagotovijo, da poročila in podatkovne baze o neželenih učinkih vsebujejo čim bolj kakovostne informacije;
(2) ensure that adverse reaction reports and databases contain the highest quality information possible;
Člen 102 – odstavek 1 – točka 2 a (novo)
Article 102 - paragraph 1- point 2 a (new)
(2a) zagotovijo, da javnost pravočasno dobi pomembne informacije o vprašanjih farmakovigilance glede uporabe zdravila prek spletnega portala in drugih sredstev obveščanja javnosti, če je to potrebno;
(2a) ensure that the public is given important information in good time on pharmacovigilance concerns relating to the use of a medicinal product through publication on the web portal and through other means of public information as necessary;
Člen 102 – odstavek 1 – točka 3
Article 102 – paragraph 1 – point 3
(3) z načini zbiranja informacij in po potrebi nadaljnjim spremljanjem poročil o neželenih učinkih zagotovijo, da je vsako biološko zdravilo, ki se predpiše, razdeli ali prodaja na njihovem ozemlju in je predmet neželenih učinkov, prepoznavno;
(3) through the methods of collecting information and where necessary through the follow up of adverse reaction reports , ensure that any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of an adverse reaction report is identifiable;
(3) zagotovijo, da je vsako biološko zdravilo, ki se predpiše, razdeli ali prodaja na njihovem ozemlju in je predmet poročila o domnevnih neželenih učinkih, prepoznavno, če je le mogoče, po imenu imetnika dovoljenja za promet (MAH), mednarodnem nelastniškem imenu (INN), imenu zdravila in številki serije, pri tem pa se uporabljajo standardni obrazci in postopki, razviti v skladu s členom 25(1) Uredbe (ES) št. 726/2004, ter se upošteva razvoj v okviru sistema EudraVigilance.
(3) ensure that any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of a report on a suspected adverse reaction is identifiable by , where available , the name of the MAH, the INN, the name of the medicinal product and the batch number, using the standard forms and procedures developed in accordance with Article 25(1) of the Regulation (EC) No 726/2004 and taking due account of the developments within the EudraVigilance system .
Za namene točke (1) prvega odstavka lahko države članice uvedejo posebne zahteve do zdravnikov, farmacevtov in drugih zdravstvenih delavcev v zvezi s poročanjem o domnevnih resnih ali nepričakovanih neželenih učinkih .
For the purposes of point (1) of the first paragraph the Member States may impose specific requirements on doctors, pharmacists and other health-care professionals in respect of the reporting of suspected serious or unexpected adverse reactions .
Za namene točk (1) in (3) prvega odstavka lahko države članice uvedejo posebne zahteve do zdravnikov, farmacevtov in drugih zdravstvenih delavcev.
For the purposes of point s (1) and ( 3 ) of the first paragraph the Member States may impose specific requirements on doctors, pharmacists and other health-care professionals.
Sporočanje domnevnih neželenih učinkov zaradi napak pri zdravilih bi moralo potekati brez iskanja krivca in biti zaupno.
Reporting of suspected adverse reactions due to medication errors should be on a 'no blame' basis, and should be legally privileged.
Člen 104 – odstavek 2 – pododstavek 2
Article 104 – paragraph 2 – subparagraph 2
Od imetnika dovoljenja za promet se zahteva redna presoja njegovega sistema farmakovigilance.
The marketing authorisation holder shall be required to perform a regular audit of his pharmacovigilance system.
V glavno dokumentacijo sistema farmakovigilance vpiše opombo o glavnih ugotovitvah presoje in na podlagi teh ugotovitev zagotovi pripravo in izvedbo ustreznega načrta popravnih ukrepov.
He shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and, based on the audit findings, ensure that an appropriate corrective action plan is prepared and followed.
Zagotovi pripravo in izvedbo ustreznega načrta korektivnih ukrepov.
He shall ensure that an appropriate corrective action plan is prepared and followed.
Revizije so instrumenti za izboljšanje notranjih sistemov podjetja.
Audits are instruments to improve the internal systems of a company.
Če je ugotovitve treba razkriti, lahko ima to za posledico spremenjena revizijska poročila.
If findings have to be disclosed, this could lead to a tampered audit reports.
Člen 104a – odstavek 2 – pododstavek 2
Article 104a – paragraph 2 – subparagraph 2
Zahteva je pisna, 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 je pisna, vsebuje podrobno utemeljitev na podlagi znanstvenih argumentov in časovni okvir za predložitev podrobnega opisa sistema obvladovanja tveganja.
The requirement shall be made in writing, provide a detailed scientific justification and include the timeframe for submission of the detailed description of the risk-management system.
Zahteva za podroben opis sistema obvladovanja tveganja mora temeljiti na znanstvenih razlogih.
Requests for a detailed description of the risk management system should be scientifically justified.
Člen 105 – pododstavek 2
Article 105 - subparagraph 2
Prvi odstavek ne izključuje pobiranja pristojbin, ki jih plačajo imetniki dovoljenja za promet za navedene dejavnosti, ki jih opravljajo pristojni nacionalni organi.
The first paragraph shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of those activities by the national competent authorities.
Prvi odstavek ne izključuje pobiranja pristojbin, ki jih plačajo imetniki dovoljenja za promet za navedene dejavnosti, ki jih opravljajo pristojni nacionalni organi, če je njihova neodvisnost strogo zajamčena.
The first paragraph shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of those activities by the national competent authorities to the extent that their independence is strictly guaranteed .
Poročevalka lahko podpre del predlogov spremembe 204 in 205, da se farmakovigilanca lahko financira s pristojbinami le, če je zagotovljena neodvisnost Agencije.
The rapporteur can support part of amendments 204 and 205 - that pharmacovigilance can only be financed by fees if the independence of the Agency is guaranteed.
Člen 106 – uvodni del
Article 106 - introductory part
Vsaka država članica vzpostavi in vzdržuje nacionalni spletni portal o varnosti zdravil , ki je povezan z evropskim spletnim portalom o varnosti zdravil , vzpostavljenim v skladu s členom 26 Uredbe (ES) št. 726/2004.
Each Member State shall set up and maintain a national medicines safety web-portal which shall be linked to the European medicines safety web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004.
Na nacionalnih spletnih portalih o varnosti zdravil države članice objavijo najmanj naslednje:
By means of the national medicines safety web-portals, the Member States shall make public at least the following:
Vsaka država članica vzpostavi in vzdržuje nacionalni spletni portal o zdravilih , ki vključuje tudi posebno spletno stran o varnosti zdravil in je povezan z evropskim spletnim portalom o zdravilih , vzpostavljenim v skladu s členom 26 Uredbe (ES) št. 726/2004.
Each Member State shall set up and maintain a national medicines web-portal, including a dedicated medicine safety web page, which shall be linked to the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004.
Člen 106 – točka 1
Article 106 - point 1
(1) sisteme obvladovanja tveganja za zdravila, odobrena v skladu s to direktivo;
(1) risk management systems for medicinal products authorised in accordance with this Directive;
(1) sisteme obvladovanja tveganja in uporabniku prijazen povzetek teh sistemov za zdravila, odobrena v skladu s to direktivo;
(1) risk management systems and a user-friendly summary of these systems, for medicinal products authorised in accordance with this Directive;
Glej obrazložitev k členu 106 – uvodni del.
see justification to Article 106 - introductory part
Člen 106 – točka 1 a (novo)
Article 106 - point 1 a (new)
(1a) najnovejšo elektronsko različico navodil za uporabo zdravil, ki so na voljo na nacionalnem trgu, v nacionalnem jeziku (in po potrebi povezavo do podatkovne baze Agencije EudraPharm);
(1a) the most up-to-date electronic version of the leaflets of the medicines available on the national market in the national language (and where applicable the link to the Agency's EudraPharm database);
Člen 106 – točka 1 b (novo)
Article 106 - point 1 b (new)
(1b) za vsako zdravilo, ki so ga odobrile države članice, najnovejšo elektronsko različico povzetka značilnosti zdravila in vse druge pogoje v skladu s členi 21a, 22 in 22a skupaj z roki za njihovo izpolnitev;
(1b) for each medicinal product which Member States have authorised, the most up-to-date electronic version of the summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for their fulfilment ; ;
Člen 106 – točka (1 c) (novo)
Article 106 - point 1 c (new)
(1c) poročila o oceni za zdravila, odobrena v skladu s to direktivo (in po potrebi povezavo na povzetek evropskega javnega poročila o oceni zdravila);
(1c) assessment reports for medicinal products authorised in accordance with this Directive (and where applicable the link to the EPAR summary);
Člen 106 – točka 2
Article 106 - point 2
(2) seznam zdravil, ki so predmet intenzivnega spremljanja iz člena 23 Uredbe (ES) št. 726/2004;
(2) the list of medicinal products under intensive monitoring referred to in Article 23 of Regulation (EC) No 726/2004;
(2) seznam zdravil iz člena 23 Uredbe (ES) št. 726/2004;
(2) the list of medicinal products referred to in Article 23 of Regulation (EC) No 726/2004;
Člen 106 – točka 3
Article 106 - point 3
(3) spletne strukturirane obrazce za poročanje o domnevnih neželenih učinkih s strani zdravstvenih delavcev in bolnikov na podlagi obrazcev iz člena 25 Uredbe (ES) št. 726/2004.
(3) web-based structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients based on the forms referred to in Article 25 of Regulation (EC) No 726/2004.
(3) strukturirane obrazce za poročanje o domnevnih neželenih učinkih s strani zdravstvenih delavcev in bolnikov na podlagi obrazcev iz člena 25 Uredbe (ES) št. 726/2004.
(3) structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients based on the forms referred to in Article 25 of Regulation (EC) No 726/2004.
Člen 107 – odstavek 2
Article 107 – paragraph 2
Imetnik dovoljenja za promet ne sme zavrniti poročil o domnevnih neželenih učinkih, ki jih od bolnikov in zdravstvenih delavcev prejme elektronsko.
The marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically from patients and health-care professionals.
Imetnik dovoljenja za promet ne sme zavrniti poročil o domnevnih neželenih učinkih, ki jih zdravstvenih delavcev prejme elektronsko ali na kateri koli drug ustrezen način .
The marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically or by any other appropriate means from health-care professionals.
Pomembno je, da se poročanje o neželenih učinkih ne prepreči s postavljanjem tehnoloških omejitev.
It is important not to prevent the reporting of adverse reactions by creating technological barriers.
Nekatere osebe namreč nimajo dostopa do interneta ali pa imajo težave pri njegovi uporabi.
Some people do not necessarily have access to the Internet or have difficulty using it.
Člen 107 – odstavek 2 a (novo)
Article 107 – paragraph 2 a (new)
Posamezne države članice imetnikom dovoljenja za promet ne nalagajo nobenih dodatnih zahtev glede poročanja, razen iz utemeljenih razlogov v zvezi s farmakovigilanco.
Unless justifiable on grounds related to pharmacovigilance, individual Member States shall not impose any additional reporting requirements on marketing authorisation holders.
Eden izmed ciljen predloga Komisije in kot je navedeno v uvodni izjavi 5 uredbe je, da njeno izvajanje ne bo imelo za posledico nobenih dodatnih nacionalnih zahtev.
One of the objectives of the Commission’s proposal, and as stated in recital 5 of the Regulation, is that no additional national requirements result from its implementation.
Za dodatne nacionalne zahteve je potrebnih veliko virov in časa tako s strani oblasti, kot tudi s strani imetnika dovoljenja za promet, lahko pa tudi onemogočajo usklajeno odkrivanje signalov.
Additional national requirements require lots of resources and time for both authorities and marketing authorisation holders and may even disable harmonised signal detection.
Člen 107 – odstavek 3 – pododstavek 1
Article 107 - paragraph 3 - subparagraph 1
Imetniki dovoljenja za promet morajo podatke o vseh resnih neželenih učinkih, ki se pojavijo v Skupnosti in v tretjih državah, posredovati elektronsko v podatkovno bazo in omrežje za obdelavo podatkov iz člena 24 Uredbe (ES) št. 726/2004 (v nadaljnjem besedilu: podatkovna baza Eudravigilance) v 15 dneh od prejema poročila, ob odsotnosti poročila pa na dan, ki sledi dnevu, ko je zadevni imetnik izvedel za dogodek.
Marketing authorisation holders shall be required to submit electronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’) information on all serious suspected adverse reactions that occur in the Community and in third countries within 15 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event.
Vzpostavi se sistem, ki samodejno obvešča države članice o vloženih poročilih.
A system shall be established to simultaneously notify the relevant Member States of these submitted reports.
Člen 107 – odstavek 3 – pododstavek 2
Article 107 – paragraph 3 – subparagraph 2
Imetniki dovoljenja za promet morajo podatke o vseh neželenih učinkih, ki niso resni in se pojavijo v Skupnosti, posredovati elektronsko v podatkovno bazo Eudravigilance v 90 dneh od prejema poročila, ob odsotnosti poročila pa na dan, ki sledi dnevu, ko je zadevni imetnik izvedel za dogodek.
Marketing authorisation holders shall be required to submit electronically to the Eudravigilance database information on all non-serious suspected adverse reactions that occur in the Community, within 90 days following the receipt of the report or, in the absence of a report, following the day on which the holder concerned gained knowledge of the event.
Imetniki dovoljenja za promet z zdravili, odobrenimi na podlagi člena 10a, in imetniki registracij za zdravila, navedena v členih 14 do 16a, so izključeni iz zgornje zahteve.
Marketing authorisation holders of medicines authorised on the basis of Article 10a and holders of registrations for medicinal products referred to in Articles 14 to 16a shall be exempted from the above requirement.
Predlagana nova zahteva, da naj bi farmacevtska podjetja poročala o vseh neželenih učinkih, ki niso resni (vključno z zdravstveno nepotrjenimi poročili potrošnikov), bo imela zelo velik vpliv na delovno obremenitev industrije in regulativne organe, saj gre v večini primerov za nepotrjena poročila potrošnikov, ki niso resna.
The proposed new requirement for pharmaceutical companies to report all non serious suspected adverse reactions (including non-medically confirmed consumer reports) will have a massive impact on the workload of both the industry and regulatory authorities since the majority of cases are non-serious unconfirmed consumer reports.
Zbiranje takšnih podatkov, razen velike obremenitve virov za farmakovigilanco, za stara zdravila ne bo imelo nobene dodane vrednosti z vidika javnega zdravja; prav nasprotno, ogrozi lahko odkrivanje morebitnih novih varnostnih signalov.
Apart from the huge drain of pharmacovigilance resources, collection of such data will not add any value from a public health perspective for old medicines; it may on the contrary impair detection of potential new safety signals.
Člen 107a – odstavek 1 – pododstavek 1
Article 107a – paragraph 1 – subparagraph 1
Države članice vodijo dokumentacijo o vseh domnevnih neželenih učinkih, ki se pojavijo na njihovem ozemlju, na katere jih opozorijo zdravstveni delavci in bolniki .
The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals and patients .
Države članice vodijo dokumentacijo o vseh domnevnih neželenih učinkih, ki se pojavijo na njihovem ozemlju, na katere jih opozorijo zdravstveni delavci.
The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals.
Države članice se lahko same odločijo, ali bodo domnevni neželeni učinki, o katerih poročajo bolniki, predstavljeni neposredno ali prek zdravstvenih delavcev.
Concerning suspected adverse reactions reported by patients, Member States may decide whether those are reported directly or via healthcare professionals .
Člen 107a – odstavek 1 – pododstavek 2
Article 107a - paragraph 1 - subparagraph 2
Države članice zagotovijo, da se poročila o takih učinkih predstavijo na nacionalnih spletnih portalih o varnosti zdravil.
Member States shall ensure that reports of such reactions are submitted by means of the national medicines safety web-portals.
Države članice zagotovijo, da se poročila o takih učinkih lahko predstavijo na nacionalnih spletnih portalih o varnosti zdravil ali na kateri koli drug ustrezen način .
Member States shall ensure that reports of such reactions may be submitted by means of the national medicines safety web-portals , or b y any other appropriate means.
S to spremembo se člen uskladi s predlogi sprememb 11, 12 in 14.
This change brings the article into line with amendments 11, 12 & 14.
Bolnikom mora biti omogočeno elektronsko vlaganje poročil, vendar ne bi smeli omejevati drugih oblik.
It must be possible for patients to submit reports electronically, however the provision of other formats should not be prevented.
Države članice pa so odgovorne za pretvorbo poročil v elektronsko obliko, skladno s podatkovno bazo Eudravigilance.
It is the responsibility of the Member State to put the report into an electronic format compatible with Eudravigilance.
Člen 107 e – odstavek 3
Article 107e - paragraph 3
Svetovalni odbor za ocenjevanje tveganja farmakovigilance na naslednjem srečanju po koncu obdobja, ki ga ima imetnik dovoljenja za promet za predložitev pripomb iz odstavka 2, sprejme poročilo o oceni s spremembami ali brez njih, ob upoštevanju pripomb, predloženih v skladu z navedenim odstavkom.
At its next meeting following the end of the period for comments by the marketing authorisation holder referred to in paragraph 2, the Pharmacovigilance Risk Assessment Advisory Committee shall adopt the assessment report with or without changes, taking into account any comments submitted in accordance with that paragraph.
Odbor za oceno tveganja na področju farmakovigilance na naslednjem srečanju po koncu obdobja, ki ga ima imetnik dovoljenja za promet za predložitev pripomb iz odstavka 2, sprejme poročilo o oceni s spremembami ali brez njih, ob upoštevanju pripomb, predloženih v skladu z navedenim odstavkom.
At its next meeting following the end of the period for comments by the marketing authorisation holder referred to in paragraph 2, the Pharmacovigilance Risk Assessment Committee shall adopt the assessment report with or without changes, taking into account any comments submitted in accordance with that paragraph.
Na podlagi ocenjevalnega poročila oblikuje priporočilo za skupino za usklajevanje.
It shall formulate a recommendation for the coordination group on the basis of the assessment report.
(Predlog spremembe se nanaša na celotno besedilo.)
This amendment concerns the whole text
Gl. predlog spremembe 3.
See amendment 3.
Člen 107g – odstavek 1
Article 107g - paragraph 1
V primeru enotne ocene rednih poročil o varnosti zdravila, ki zadevajo več kot eno dovoljenje za promet v skladu s členom 107e(1), ki ne vključuje nobenega dovoljenja za promet, izdanega v skladu z Uredbo (ES) št. 726/2004, skupina za usklajevanje v 30 dneh po prejemu poročila Svetovalnega odbora za ocenjevanje tveganja farmakovigilance preuči poročilo in sprejme mnenje o ohranitvi, spremembi, začasnem preklicu ali ukinitvi zadevnega dovoljenja za promet, vključno s časovnim razporedom za izvajanje mnenja.
In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 107e(1) which does not include any marketing authorisation granted in accordance with Regulation (EC) No 726/2004, the coordination group shall, within 30 days of receipt of the report of the Pharmacovigilance Risk Assessment Advisory Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned, including a timetable for the implementation of the opinion.