natgillin/translations-raw huggingface dataset:
Vse domnevne neželene učinke je treba sporočiti <ime , spletni naslov , naslov in telefonska številka pristojnega nacionalnega organa> ali neposredno lekarni .“ ;
All suspected adverse reactions should be reported to name , web-address , postal address and telephone number of the national competent authority , or reported directly to the pharmacy. " ;
Člen 1 – točka 20
Article 1 — point 20
Člen 65 – točka g
Article 65 - point g
V členu 65 se doda naslednja točka (g):
In Article 65, the following point (g) is added:
„(g) Povzetek osnovnih informacij, potrebnih za varno in učinkovito uporabo zdravila, predpisan v členu 11(3a) in členu 59(1)(aa).“
“(g) the summary of the essential information necessary to use the medicine safely and effectively provided for in Article 11(3a) and Article 59(1)(aa).”
Člen 1 – točka 21
Article 1 — point 21
Člen 102
Article 102
Države članice:
The Member States shall:
(1) sprejmejo vse ustrezne ukrepe za spodbujanje bolnikov, zdravnikov, farmacevtov in drugih zdravstvenih delavcev, da nacionalnim pristojnim organom poročajo o domnevnih neželenih učinkih.
(1) take all appropriate measures to encourage patients, doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority .
Ti ukrepi zajemajo usposabljanje za zdravstvene delavce in bolnike ter javne informacijske kampanje za bolnike.
Those measures shall include training for healthcare professionals and for patients, and a public information campaign for patients.
Združenja bolnikov je treba vključiti v obveščanje in usposabljanje bolnikov;
Patient organisations should be involved in providing information and training to patients ;
(1a) izvajajo kampanje za ozaveščanje javnosti o tem, kako pomembno je poročati o neželenih učinkih, in o možnih načinih poročanja;
(1a) conduct public awareness campaigns on the importance of reporting adverse reactions and possible ways of doing so;
(1b) olajšajo neposredno poročanje bolnikov, s tem da poleg spletnih oblik v navodila za uporabo vključijo odstranljiv del, ki ga bolnik lahko posreduje zdravnikom, farmacevtom ali nacionalnemu pristojnemu organu;
(1b) facilitate direct patient reporting, in addition to web-based formats, through the provision on the patient information leaflet of a detachable portion that can be reported to the doctors, pharmacists or the national competent authority;
(2) zagotovijo, da poročila in zbirke podatkov o neželenih učinkih vsebujejo čim bolj kakovostne informacije;
(2) ensure that adverse reaction reports and the databases contain the highest quality information possible;
(3) zagotovijo, da je vsako biološko zdravilo, ki se predpiše, razdeli ali prodaja na njihovem ozemlju in je predmet domnevnih neželenih učinkov, prepoznavno , če je le mogoče, po imenu imetnika dovoljenja za promet, mednarodnem nelastniškem imenu (INN), imenu zdravila in številki serije, pri tem pa se uporabljajo standardni obrazci in postopki, razviti v skladu s členom 25 Uredbe (ES) št. 726/2004, ter se upošteva razvoj v okviru sistema EudraVigilance ; izvajajo potrebne ukrepe za zagotavljanje sledljivosti bioloških zdravil, razdeljenih bolnikom;
(3) ensure that any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of a suspected adverse reaction report is identifiable by, as far as available, the name of the marketing authorisation holder, the International Non-proprietary Name (INN), the name of the medicinal product and the batch number, using the standard forms and procedures developed in accordance with Article 25 of Regulation (EC) No 726/2004, taking due account of the developments within the EudraVigilance system ; and implement the necessary measures to ensure the traceability of biological medicinal products dispensed to patients ;
(3a) zagotovijo, da javnost pravočasno dobi informacije o vprašanjih farmakovigilance glede uporabe zdravila in da ima vedno dostop do podatkov;
(3a) ensure that the public is given important information in good time on pharmacovigilance concerns relating to the use of a medicinal product and that data is permanently accessible to the public;
(3b) storijo vse potrebno, da se javnosti omogoči poročanje o neželenih učinkih, zlasti s tem, da zagotovijo, da so v lekarnah na voljo ustrezni obrazci, pripravljeni v skladu s tehničnimi merili ter z načeli enostavnega jezika in strukture, ki sta dostopna splošni javnosti; te obrazce farmacevti pošljejo pristojnim organom;
(3b) take the necessary steps to enable the public to report adverse reactions, in particular by ensuring that appropriate forms are available at pharmacies, drawn up in line with technical criteria and complying with the principles of simplified language and structure, accessible to the general public; these forms shall be sent by the pharmacists to the competent authorities;
(4) sprejmejo potrebne ukrepe za zagotovitev, da za imetnika dovoljenja za promet, ki ne izpolnjuje obveznosti iz tega naslova, veljajo učinkovite, sorazmerne in odvračalne sankcije.
(4) take the necessary measures to ensure that a marketing authorisation holder who fails to discharge the obligations laid down in this Title is subject to effective, proportionate and dissuasive penalties.
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.
Bolnike in zdravstvene delavce je ustrezneje spodbujati, naj poročila pošiljajo pristojnim nacionalnim organom kot farmacevtskim podjetjem.
It is more appropriate to encourage patients & health professionals to submit their reports to the competent authorities rather than to pharmaceutical companies.
Neposredno poročanje podjetjem je vprašljivo tako glede varovanja zasebnosti uporabnikov kot glede povratnih zdravstvenih informacij.
Direct reporting to companies raises concerns both in terms of privacy of users and in terms of medical feedback.
Poleg tega bodo lahko odločali o tem, ali gre v poročilu za neželeni učinek, napako pri zdravilu ali kaj drugega.
In addition they will be in the position to decide if the report is an “adverse reaction”, a medication error, or else.
Poročanje bolnikov bi morale spremljati tudi informacijske kampanje o pomembnosti poročanja.
Patient reporting should be accompanied by information campaigns about the importance of reporting.
Država članica lahko prenese katero koli od nalog, ki ji je zaupana na podlagi tega naslova, drugi državi članici na podlagi pisnega soglasja slednje.
A Member State may delegate any of the tasks entrusted to it under this Title to another Member State subject to a written agreement of the latter.
Država članica, ki prenese naloge, o tem pisno obvesti Komisijo, Agencijo in druge države članice.
The delegating Member State shall inform the Commission, the Agency and all other Member States of the delegation in writing.
Država članica, ki prenese naloge, in Agencija tako informacijo javno objavita.
The delegating Member State and the Agency shall make that information public.
Člen 105 – odstavek 2
Article 105 – paragraph 2
Prvi odstavek ne izključuje pobiranja pristojbin, ki jih plačajo imetniki dovoljenja za promet kot dopolnilni prispevek 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 as a complementary contribution to the carrying out of those activities by the national competent authorities.
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.
- (1) navodila za uporabo zdravil, ki so na voljo na nacionalnem trgu, v nacionalnem jeziku (in po potrebi povezavo do zbirke podatkov agencije EMEA EudraPharm);
- (1) the leaflets for the medicines available on the national market in the national language (and where applicable the link to the EMEA EudraPharm database);
(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 ;
(4) dnevne rede sej odbora za farmakovigilanco in usklajevalne skupine ter posnetke njunih sej, ob tem pa tudi sprejete sklepe ter podatke o glasovanju in obrazložitve glasov, vključno z manjšinskimi mnenji;
(4) agendas for meetings of the Pharmacovigilance Committee and of the coordination group and records of their meetings, accompanied by the decisions taken and by details and explanations of the votes, including minority opinions;
(5) zahteve nacionalnega pristojnega organa, naj imetnik dovoljenja za promet vodi sistem za obvladovanje tveganja ali opravi študijo po odobritvi, po potrebi skupaj z obrazložitvami imetnika, poslanimi nacionalnemu pristojnemu organu, in končno odločitvijo slednjega.
(5) requests from the national competent authority to the marketing authorisation holder to operate a risk management system or to conduct a post-authorisation study, together with the explanations provided by the marketing authorisation holder to the national competent authority where necessary, and the final decision of the competent authority .
Vse države članice bi morale imeti portal nacionalne agencije za zdravila, da bi javnosti zagotovile visokokakovostne informacije o zdravilih.
Each member states should have a national medicine agency portal to provide high quality information on medicines to the general public.
Spletni portal bi moral imeti poseben prostor za vse informacije o vprašanjih varnosti in farmakovigilance.
The web portal should include a dedicated area for all information related to safety issues and pharmacovigilance.
Imetniki dovoljenja za promet vodijo dokumentacijo o vseh domnevnih neželenih učinkih v Skupnosti ali v tretjih državah, na katere jih opozorijo bolniki sami ali zdravstveni delavci ali pa se pojavijo v okviru študije o varnosti zdravila po pridobitvi dovoljenja za promet.
Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community or in third countries which are brought to their attention, whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post-authorisation safety study.
Imetniki dovoljenja za promet vodijo dokumentacijo o vseh domnevnih neželenih učinkih v Skupnosti ali v tretjih državah, na katere jih opozorijo bolniki sami ali zdravstveni delavci ali pa se pojavijo v okviru kliničnega preskušanja ali študije o varnosti zdravila po pridobitvi dovoljenja za promet.
Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community or in third countries which are brought to their attention, whether reported spontaneously by patients or healthcare professionals or occurring in the context of a clinical trial or a post-authorisation safety study.
Od imetnika dovoljenja za promet se zahteva, da zagotovi dostopnost navedenih poročil na eni sami točki v Skupnosti.
Marketing authorisation holders shall be required to ensure that those reports are accessible at a single point within the Community.
Z odstopanjem od prvega pododstavka se domnevni neželeni učinki, ki se pojavijo v okviru kliničnih preskušanj, evidentirajo in poročajo v skladu z Direktivo 2001/20/ES.
By way of derogation to the first subparagraph, suspected adverse reactions occurring in the context of a clinical trial shall be recorded and reported in accordance with Directive 2001/20/EC.
Domnevni neželeni učinki, ki se pojavijo v okviru kliničnih preskušanj, se tudi evidentirajo in poročajo v skladu z Direktivo 2001/20/ES
Suspected adverse reactions occurring in the context of a clinical trial shall also be recorded and reported in accordance with Directive 2001/20/EC.
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 nacionalnemu pristojnemu organu posreduje vsa poročila o domnevnih neželenih učinkih, ki jih prejme od bolnikov in zdravstvenih delavcev , v sedmih dneh po prejetju poročila .
The marketing authorisation holder shall forward to the national competent authorities any reports of suspected adverse reactions received from patients and health-care professionals within 7 days of receiving the reports .
Bolnike in zdravstvene delavce obvesti, da so bila njihova poročila posredovana pristojnim organom, ki bodo odgovorni za nadaljnje ukrepanje.
The marketing authorization holder shall inform the patient and healthcare professional that their report has been forwarded to the competent authorities who will be in charge of following it up.
Nacionalni pristojni organi ne smejo zavrniti poročil o domnevnih neželenih učinkih, ki jih od bolnikov in zdravstvenih delavcev prejmejo po pošti, telefonu, telefaksu ali v elektronski obliki.
The national competent authorities may not refuse any reports of suspected adverse reactions received by post, telephone, facsimile transmission or in electronic format from patients and healthcare professionals.
Imetniki dovoljenja za promet morajo podatke o vseh resnih neželenih učinkih, ki se pojavijo v Skupnosti in tretjih državah, posredovati nacionalnim pristojnim organom 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 national competent authorities 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.
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 morajo podatke o vseh neželenih učinkih, ki niso resni in se pojavijo na trgih, kjer delujejo, posredovati elektronsko nacionalnim pristojnim organom 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 national competent authorities information on all non-serious suspected adverse reactions that occur on the markets in which they operate , 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.
Za zdravila, ki vsebujejo zdravilne učinkovine s seznama publikacij, ki jih spremlja Agencija na podlagi člena 27 Uredbe (ES) št. 726/2004, imetnikom dovoljenja za promet v podatkovno bazo Eudravigilance ni treba sporočati domnevnih neželenih učinkov, vpisanih v navedeni medicinski literaturi, vendar spremljajo vso ostalo medicinsko literaturo in poročajo o morebitnih domnevnih neželenih učinkih.
For medicinal products containing the active substances referred to in the list of publications monitored by the Agency pursuant to Article 27 of Regulation (EC) No 726/2004, marketing authorisation holders shall not be required to report to the Eudravigilance database the suspected adverse reactions recorded in the listed medical literature, but they shall monitor all other medical literature and report any suspected adverse reactions.
Države članice imajo dostop do poročil o neželenih učinkih preko podatkovne baze Eudravigilance in ocenijo kakovost podatkov, prejetih od imetnikov dovoljenja za promet z zdravilom.
Member States shall access reports on adverse reactions through the Eudravigilance database and shall assess the quality of the data received from marketing authorisation holders.
Če je to primerno, v spremljanje poročil, ki jih prejmejo, vključijo bolnike in zdravstvene delavce , in zahtevajo, da taka poročila spremljajo imetniki dovoljenja za promet .
They shall, as appropriate, involve patients and health-care professionals in the follow up of any reports they receive and request follow up of such reports to be conducted by the marketing authorisation holders .
Od imetnikov dovoljenja za promet z zdravilom se zahteva, da poročajo o vseh informacijah o spremljanju, prejetih v podatkovni bazi Eudravigilance.
The marketing authorisation holders shall be required to report any follow up information received to the Eudravigilance database.
Države članice ocenijo kakovost podatkov, prejetih od imetnikov dovoljenja za promet z zdravilom.
Member States shall assess the quality of the data received from marketing authorisation holders.
Po potrebi v spremljanje poročil, ki jih prejmejo, vključijo bolnike in zdravstvene delavce.
They shall, as appropriate, involve patients and health-care professionals in the follow up of any reports they receive.
Člen 107a
Article 107a
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 , bolniki , imetniki dovoljenja za promet ali programi za zbiranje in preprečevanje napak pri zdravilih .
The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention by healthcare professionals , patients , marketing authorisation holders and programmes for the reporting and prevention of medication errors .
Države članice zagotovijo, da se poročila o takih učinkih lahko predstavijo na nacionalnih spletnih portalih o varnosti zdravil ter po pošti, telefonu in faksu .
Member States shall ensure that reports of such reactions can be submitted by means of the national medicines safety web-portals , as well as by post, telephone and fax .
Države članice v 15 dneh od prejema poročil iz odstavka 1 poročila elektronsko posredujejo v podatkovno bazo Eudravigilance.
Member States shall, within 15 days following the receipt of the reports referred to in paragraph 1, submit the reports electronically to the Eudravigilance database.
Države članice v 15 dneh od prejema poročil iz odstavka 1 informacije o vseh neželenih učinkih, ki so se pojavili na njihovem ozemlju, elektronsko posredujejo v podatkovno bazo in omrežje za obdelavo podatkov iz člena 24 Uredbe (ES) št. 726/2004 (v nadaljevanju: podatkovna baza Eudravigilance ), ob odsotnosti takšnega poročila pa v 15 dneh od dneva, ko je pristojni organ izvedel za dogodek .
Member States shall, within 15 days following the receipt of the reports referred to in paragraph 1, 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 adverse reactions that occur within their territory within 15 days following receipt of the report or, in the absence of a report, following the day on which the competent authority acquired knowledge of the event .
Imetniki dovoljenja za promet imajo dostop do teh poročil preko podatkovne baze Eudravigilance.
Marketing authorisation holders shall access those reports through the Eudravigilance database.
Imetniki dovoljenja za promet , zdravstveno osebje in javnost imajo dostop do teh poročil preko podatkovne baze Eudravigilance , ki mora biti vedno in nemudoma na voljo .
Marketing authorisation holders , healthcare professionals and the public shall access those reports through the Eudravigilance database , which must be made permanently accessible without delay .
Države članice zagotovijo, da so poročila o napakah pri zdravilih, na katera so opozorjene v okviru poročanja o domnevnih neželenih učinkih za zdravila, na voljo podatkovni bazi Eudravigilance in vsem organom, odgovornim za varnost bolnikov v navedeni državi članici.
The Member States shall ensure that reports of medication errors brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database and to any authorities responsible for patient safety within that Member State.
Zagotovijo tudi, da so organi, odgovorni za zdravila v navedeni državi članici, obveščeni o vseh domnevnih neželenih učinkih, na katere so bili opozorjeni organi, odgovorni za varnost bolnikov v tej državi članici.
They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that Member State.
Države članice zagotovijo, da so poročila o napakah pri zdravilih ali o neželenih učinkih zdravil pri uporabi, ki ni v skladu z navedbami v dovoljenju za promet, na katera so opozorjene v okviru poročanja o domnevnih neželenih učinkih za zdravila, na voljo podatkovni bazi Eudravigilance , vsem organom, odgovornim za varnost bolnikov v navedeni državi članici , ter neodvisnim programom za zbiranje in preprečevanje napak pri zdravilih .
The Member States shall ensure that reports of medication errors , or of the unintended effects of medicinal products used contrary to the indications covered by the authorisation, brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database , to any authorities responsible for patient safety within that Member State and to independent programmes for the reporting and prevention of medication errors .
Člen 107a – odstavek 3 a (novo)
Article 107a – paragraph 3 a (new)
Države članice zagotovijo, da lahko imetniki dovoljenja za promet informacije o neželenih učinkih zdravila elektronsko posredujejo tudi nacionalnim podatkovnim bazam, da bi tako učinkoviteje in hitreje opredelili težave glede varnosti, specifične za posamezno državo.
The Member States shall ensure that marketing authorisation holders may electronically transmit information on unintended effects of medicinal products to national databases so that country-specific safety problems can be identified more effectively and more promptly.
Člen 107i – odstavek 1 – točke a, b in c
Article 107i – paragraph 1 – points a, b, c
(a) razmišlja o začasnem preklicu ali ukinitvi dovoljenja za promet;
(a) it considers suspending or revoking of a marketing authorisation;
(a) na podlagi ocene podatkov o farmakovigilanci razmisli o :
(a) it considers , as a result of the evaluation of pharmacovigilance data: