natgillin/translations-raw huggingface dataset:
(28a) Ta direktiva se mora uporabljati brez poseganja v Direktivo Evropskega parlamenta in Sveta 95/46/ES z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov 1 in v 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 .
(28a) 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, opredelili in izvajali ukrepe za zmanjšanje tveganja in povečanje koristi zdravil za namene varovanja javnega zdravja, bi morala biti v sistemu Eudravigilance omogočena obdelava osebnih podatkov, ki bi bila v skladu z veljavno zakonodajo 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.
Obdelava osebnih podatkov uporabnikov zdravil, ki poteka na različnih stopnjah procesa farmakovigilance, bi morala biti v skladu z načelom varstva podatkov, določenim v Direktivi 95/46/ES.
The processing of personal data of users of medication taking place at several stages of the pharmacovigilance process, should take place in accordance with the data protection principles laid down by Directive 95/46/EC.
„Za namene točke (3a) prvega pododstavka za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 povzetek vključuje izjavo:
For the purposes of point 3(a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of the Regulation (EC) No 726/2004, the summary shall include the statement:
„To zdravilo se intenzivno spremlja.
"This medicinal product is under intensive monitoring.
Vse domnevne neželene učinke je treba sporočiti <ime in spletni naslov nacionalnega pristojnega organa>.“
All suspected adverse reactions should be reported to name and web-address of the national competent authority."
„To novo odobreno zdravilo se obširno spremlja.
"This newly authorised medicinal product is subject to extended monitoring.
Vse domnevne neželene učinke je treba sporočiti zdravniku, farmacevtu ali <ime in spletni naslov nacionalnega pristojnega organa>.“
All suspected adverse reactions should be reported to your doctor, pharmacist or name and web-address of the national competent authority."
Pristojni nacionalni organi nemudoma javno objavijo dovoljenje za promet skupaj z navodilom za uporabo, povzetkom glavnih značilnosti in pogoji, določenimi v skladu s členi 21a, 22 in 22a, skupaj z roki za izpolnitev pogojev, za vsako zdravilo, za katero so izdali dovoljenje za promet.
The national competent authorities shall make publicly available without delay the marketing authorisation together with the package leaflet, 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, for each medicinal product which they have authorised.
Člen 21a – uvodni del
Article 21a – introductory part
Dovoljenje za promet se lahko izda ne glede na določbe člena 19 in če je izpolnjen eden ali več naslednjih pogojev:
Without prejudice to the provisions of Article 19, marketing authorisation may be granted subject to one or more of the following conditions:
Novi člen ne sme omogočiti lažjega pridobivanja dovoljenj za promet, kot to velja za pogojna in natančno opredeljena dovoljenja za promet iz člena 22.
This new article must not open the door to ‘easy’ marketing authorisations similar to the conditional – and strictly limited – authorisations laid down in Article 22.
Člen 22 – pododstavek 3
Article 22 – subparagraph 3
Nadaljevanje dovoljenja za promet je vezano na vsakoletno ponovno oceno teh pogojev.“
Continuation of the authorisation shall be linked to the annual reassessment of these conditions.
Nadaljevanje dovoljenja za promet je vezano na vsakoletno ponovno oceno teh pogojev.
Continuation of the authorisation shall be linked to the annual reassessment of these conditions.
Seznam pogojev je treba nemudoma javno objaviti skupaj s končnimi roki in datumi izpolnitve.
The list of these conditions shall be made accessible to the public without delay, together with deadlines and dates of fulfilment.
Zahteva je pisna 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.
Objavi se nemudoma.
It shall be made public without delay.
Pristojni nacionalni organ imetniku dovoljenja za promet z zdravilom da možnost, da predloži pojasnila o zahtevi v roku, ki ga določi organ, če imetnik dovoljenja za promet z zdravilom to zahteva v 30 dneh od prejema pisne zahteve.
The national competent authority shall provide the marketing authorisation holder with an opportunity to present explanations on the requirement within a time limit which it shall specify, if the marketing authorisation holder requests this within 30-days of receipt of the written requirement.
Pristojni nacionalni organ imetniku dovoljenja za promet z zdravilom da možnost, da predloži pojasnila o zahtevi v roku, ki ga določi organ, če imetnik dovoljenja za promet z zdravilom to zahteva s podrobno pisno utemeljitvijo v 30 dneh od prejema pisne zahteve.
The national competent authority shall provide the marketing authorisation holder with an opportunity to present explanations on the requirement within a time limit which it shall specify, if the marketing authorisation holder requests this in writing and with a detailed justification within 30 days of receipt of the written requirement.
Ta zahteva se nemudoma objavi.
Such requests shall be made public without delay.
Pristojni nacionalni organ na podlagi pojasnil, ki jih predloži imetnik dovoljenja za promet, umakne ali potrdi zahtevo.
On the basis of explanations submitted by the marketing authorisation holder, the national competent authority shall withdraw or confirm the requirement.
Kadar pristojni nacionalni organ potrdi zahtevo, se dovoljenje za promet z zdravilom spremeni, da se zahteva vključi kot pogoj dovoljenja za promet z zdravilom, sistem obvladovanja tveganja pa se ustrezno posodobi.
Where the national competent authority 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.
Ta odločitev se nemudoma objavi.
That decision shall be made public without delay.
Kadar pristojni nacionalni organ potrdi zahtevo, se dovoljenje za promet z zdravilom spremeni, da se zahteva vključi kot pogoj dovoljenja za promet z zdravilom, sistem obvladovanja tveganja pa se ustrezno posodobi.
Where the national competent authority confirms the requirement, the marketing authorisation shall be modified to include the requirement as a condition of the marketing authorisation and the risk management system shall be updated accordingly.
Pri izdajanju dovoljenj pod izrednimi pogoji bi morala biti zagotovljena popolna preglednost.
Authorisation in exceptional circumstances should be granted with in a fully transparent manner.
Člen 1 – točka 14 – podtočka a
Article 1 – point 14 – subpoint a
Člen 27 – odstavek 1– pododstavek 3
Article 27 – paragraph 1 – subparagraph 3
Skupini za usklajevanje pri izvajanju nalog farmakovigilance pomaga Svetovalni odbor za ocenjevanje tveganja farmakovigilance iz člena 56(1)(aa) Uredbe (ES) št. 726/2004.“
For the fulfilment of its pharmacovigilance tasks, the coordination group shall be assisted by the Pharmacovigilance Risk Assessment Advisory Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004.”
Odbor pa je pristojen za vsa vprašanja v zvezi s farmakovigilanco (predlog uredbe, člen 1(14)).
But the Committee’s remit is for ‘questions related to … pharmacovigilance’ (proposed regulation, Article 1, point 14).
Ta predlog spremembe se mora uporabljati v celotnem besedilu predloga direktive.
This amendment applies throughout the text of the proposed directive.
Člen 1 – točka 14 – podtočka c
Article 1 – point 14 – subpoint c
Člen 27 – odstavek 7
Article 27 – paragraph 7
Od članov skupine za usklajevanje se tudi po prenehanju njihovih dolžnosti zahteva, da ne razkrijejo podatkov, ki jih zajema obveznost varovanja poslovne skrivnosti.“
Members of the coordination group shall be required, even after their duties have ceased, not to disclose information of the kind covered by the obligation of professional secrecy.”
Podrobni dnevni redi srečanj usklajevalnih skupin se objavijo najkasneje dan pred srečanji.
Detailed agendas of coordination group meetings shall be made public not later than one day before the meeting concerned.
Podrobni zapisniki teh srečanj s sprejetimi odločitvami, podrobnostmi in razlago glasovanja, vključno z manjšinskimi mnenji, se objavijo najkasneje mesec po srečanju.“
Detailed minutes of coordination group meetings, containing the decisions taken, details of votes and explanations of votes, including minority opinions, shall be made public not later than one month following the meeting.”
Uskladitev z novo strukturo agencije, po kateri so farmakovigilanca in dovoljenja za promet strogo ločeni.
Consistency with the Agency’s new structure, strictly separating pharmacovigilance from marketing authorisation.
Člen 59 – odstavek 1 – pododstavek 2 a (novo)
Article 59 – paragraph 1 – subparagraph 2 a (new)
Vse domnevne neželene učinke je treba sporočiti <ime in spletni naslov nacionalnega pristojnega organa>.“
All suspected adverse reactions should be reported to name and web-address of the national competent authority.”
Za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 se vključi naslednja dodatna izjava: „To novo odobreno zdravilo se obširno spremlja.
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This newly authorised medicinal product is subject to extended monitoring.
Vse domnevne neželene učinke je treba sporočiti zdravniku, farmacevtu ali <ime in spletni naslov nacionalnega pristojnega organa>.“
All suspected adverse reactions should be reported to your doctor, pharmacist or name and web-address of the national competent authority".”
Člen 65 – točka g
Article 65 – point g
“(g) „(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).”
Treba je zavrniti predlagani povzetek osnovnih informacij o varni in učinkoviti uporabi zdravil, saj je pojem „osnovne informacije“ zavajajoč in bi utegnil biti napačno razumljen.
The proposed summary of essential information about the safe and effective use of medicines should be rejected since the concept of 'essential information' is misleading and might be misunderstood
Člen 65 – točka g a (novo)
Article 65 – point g a (new)
(ga) postopek Skupnosti, ki določa časovni potek postopka, jasno strukturo in opredeljene vloge za vse sodelujoče strani, tudi za izvajanje javnih obravnav.
(ga) the Community procedure defining a procedural timeline, a clear structure and defined roles for all the stakeholders involved, including for the conduct of public hearings.
Treba je razviti smernice, da bi pojasnili postopke in časovni potek postopkov Skupnosti, tudi za javne obravnave.
Guidance should be developed to clarify the procedures and timelines for the community procedure, including public hearings.
Člen 102 – odstavek 1 – točka 1
Article 102 – paragraph 1 – point 1
(1) sprejmejo vse ustrezne ukrepe za spodbujanje bolnikov, zdravnikov, bolnišnic, farmacevtov in drugih zdravstvenih delavcev, da nacionalnim pristojnim organom poročajo o domnevnih neželenih učinkih;
(1) take all appropriate measures to encourage patients , doctors, hospitals , pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority;
Zagotovitev kakovostnega in kritičnega nadaljnjega spremljanja vseh pomembnih podatkov je naloga nacionalnih organov.
It is the duty of national authorities to guarantee the quality and the critical follow up of all relevant data.
Člen 102 – odstavek 1 – točka 3 a (novo)
Article 102 – paragraph 1 – point 3 a (new)
(3a) zagotovijo, da je javnost pravočasno obveščena o zadevah farmakovigilance glede uporabe zdravila;
(3a) ensure that the public are informed in good time about pharmacovigilance concerns relating to the use of a medicinal product;
Da bi bilo upoštevano previdnostno načelo, je treba podatke o farmakovigilanci čim prej posredovati zdravstvenim strokovnjakom in bolnikom.
Pharmacovigilance data should reach health care professionals and patients as quickly as possible in order to apply the precautionary principle.
Člen 102 – odstavek 1 – točka 4 a (novo)
Article 102 – paragraph 1 – point 4 a (new)
(4a) zagotovijo, da so informacije o nezaželenih učinkih zdravil hitro javno dostopne.
(4a) ensure that information about adverse reactions to medicines is rapidly made publicly accessible.
Člen 105 – odstavek -1 (novo)
Article 105 – paragraph -1 (new)
Dejavnosti, povezane s farmakovigilanco, delovanjem komunikacijskih mrež in tržnim nadzorom prejmejo javna sredstva.
The a ctivities connected with pharma covigilance, the operation of communication networks and market surveillance shall receive public funding.
Člen 106 – točka 2
Article 106 – point 2
(2) seznam novo odobrenih zdravil, ki so predmet obširnega spremljanja iz člena 23 Uredbe (ES) št. 726/2004;
(2) the list of newly authorised of medicinal products subject to extended monitoring referred to in Article 23 of Regulation (EC) No 726/2004;
Člen 106 – točka 3 a (novo)
Article 106 – point 3 a (new)
Sistem farmakovigilance mora biti povsem pregleden, da bi se zagotovila popolna obveščenost vseh zainteresiranih strani, še posebej zaradi povrnitve zaupanja bolnikov in državljanov v odgovornost zdravstvenih organov.
The Pharmacovigilance system should be entirely transparent in order to guarantee full information of all stakeholders, notably in order to restore patients' and citizens' trust in health authorities' accountability.
Člen 106 – točka 3 b (novo) in točka 3 c (novo)
Article 106 – point 3 b (new) and point 3 c (new)
(3b) najsodobnejšo elektronsko verzijo navodil za uporabo in povzetek glavnih značilnosti zdravila za vsa obstoječa in nova zdravila;
(3b) the most up-to-date electronic version of the package leaflet and summary of product characteristics for all existing and new medicinal products;
(3c) kratko zgodovino dokumenta s spremembami informacij o proizvodu
(3c) a brief document history of changes made to the product information.
Vse informacije na spletnih portalih o varnosti zdravil, tudi tiste iz točk od 1 do 3b, se predstavijo v obliki, ki bo razumljiva širši javnosti.
All information on the medicine safety web-portals, including all of the information set out in points 1 to 3b, shall be presented in a manner that is comprehensible to the general public.
Člen 107 – odstavek 1– pododstavek 1
Article 107 – paragraph 1 – subparagraph 1
Države članice 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; pri tem države članice navedejo, ali so se domnevni neželeni učinki pojavili pri odmerkih, ki se običajno uporabljajo pri ljudeh za preprečevanje, diagnosticiranje ali zdravljenje bolezni ali za ponovno vzpostavitev, izboljšanje ali spremembo fiziološke funkcije, ali so se pojavili zaradi napake pri uporabi zdravila ali zaradi uporabe, ki ni v skladu z odobrenim povzetkom glavnih značilnosti zdravila .
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, specifying whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics , whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post-authorisation safety study.
Razširitev pojma „neželeni učinki“ na stranske učinke zaradi napak pri uporabi zdravila ali uporabe, ki ni v skladu z odobrenim povzetkom glavnih značilnosti zdravila (vključno z nepravilno uporabo in zlorabo zdravil), omogoča celovitejši pregled nad stranskimi učinki, ki bi lahko škodili bolniku.
Extending the concept of ‘adverse reaction’ to include secondary effects resulting from a medication error or use that is not consistent with the authorised summary of the product’s characteristics (including misuse and abuse of the medicine) will make it possible to ascertain more comprehensively the secondary effects that may be harmful to patients.
Treba pa je jasno razločevati stranske učinke v običajnih pogojih uporabe zdravil od drugih stranskih učinkov.
But it is still important to make a clear distinction between secondary effects that result from normal use and those that do not.
To razločevanje mora biti jasno navedeno v postopku poročanja.
This distinction should be clear in the reporting procedure.
Imetnik dovoljenja za promet ne sme zavrniti poročil o domnevnih neželenih učinkih, ki jih od bolnikov in zdravstvenih delavcev prejme po elektronski ali drugi ustrezni poti .
The marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically or by any other suitable means from patients and health-care professionals.
Člen 107 – odstavek 3 – pododstavka 1 in 2
Article 107 – paragraph 3 – subparagraph 1 and 2
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.
Imetniki dovoljenja za promet morajo vse podatke o vseh resnih neželenih učinkih posredovati elektronsko v podatkovno bazo in omrežje za obdelavo podatkov iz člena 24 Uredbe (ES) št. 726/2004 (v nadaljnjem besedilu: podatkovna baza Eudravigilance) ter hkrati pristojnim nacionalnim 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 database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as ‘the Eudravigilance database’), and simultaneously to national competent authorities, all information on all serious suspected adverse reactions that occur 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 vse podatke o vseh neželenih učinkih, ki niso resni in se pojavijo v Skupnosti, posredovati elektronsko v podatkovno bazo Eudravigilance in hkrati pristojnim nacionalnim 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 Eudravigilance database , and simultaneously to national competent authorities, all 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.
Člen 107 – odstavek 4 a (novo)
Article 107 – paragraph 4 a (new)
(4a) Države članice in javnost morajo imeti prek podatkovne baze Eudravigilance dostop do poročil o neželenih učinkih, ki se pojavljajo v drugih državah članicah.
(4a) Member States and the public shall be able to access reports on adverse reactions occurring in other Member States through the Eudravigilance database.
Evropska podatkovna baza farmakovigilance mora biti povsem pregledna, da bi lahko posredovala informacije zainteresiranim stranem, pa tudi bolnikom.
The European pharmacovigilance database should be entirely transparent in order to deliver information in due time to all stakeholders and also patients.
Gre za učinkovit način spoprijema z različnimi informacijami o neželenih učinkih med državami članicami.
It is also an effective way to tackle inequalities of information on adverse drug reactions among Member States.
Člen 107a – odstavek 1
Article 107a – paragraph 1
Države članice vodijo dokumentacijo o vseh domnevnih neželenih učinkih, ki se pojavijo na njihovem ozemlju, na katere jih opozorijo zdravstveni delavci , bolnišnice in bolniki, imetniki dovoljenja za promet in programi za zbiranje in preprečevanje napak pri zdravilih ter pri tem navedejo, ali so se neželeni učinki pojavili pri odmerkih, ki se običajno uporabljajo pri ljudeh za preprečevanje, diagnosticiranje ali zdravljenje bolezni ali za ponovno vzpostavitev, izboljšanje ali spremembo fiziološke funkcije, ali so se pojavili zaradi napake pri uporabi zdravila ali zaradi uporabe, ki ni v skladu z odobrenim povzetkom glavnih značilnosti zdravila .
The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals , hospitals and patients , marketing authorisation holders and medication error reporting and prevention programmes, specifying whether they have occurred at doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or for restoring, correcting or modifying a physiological function; following a medication error; or following use not consistent with the authorised summary of product characteristics .
Države članice zagotovijo, da se poročila o takih učinkih predstavijo na nacionalnih spletnih portalih o varnosti zdravil i n na vse druge ustrezne načine .
Member States shall ensure that reports of such reactions are submitted by means of the national medicines safety web-portals , and by any other appropriate means.