natgillin/translations-raw huggingface dataset:
C. ker je bilo še posebej poudarjeno, da prvotno sprejeti proračun Parlamenta, ki znaša 19,87 % dovoljenih odhodkov v razdelku 5 (upravni odhodki) večletnega finančnega okvira, ne vključuje nobenih popravkov zaradi Lizbonske pogodbe, zlasti na zakonodajnem področju,
C. whereas it was particularly stressed that the adopted original level of its budget amounting to 19,87 % of the authorised expenditure under heading 5 (administrative appropriations) of the MFF did not include any adaptations in the light of the Treaty of Lisbon, particularly in the legislative area,
o predlogu direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini glede farmakovigilance
on the proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
MNENJE Odbora za industrijo, raziskave in energetiko .............................53
OPINION of the Committee on Industry, Research and Energy ...............56
MNENJE Odbora za notranji trg in varstvo potrošnikov .........................85
OPINION of the Committee on the Internal Market and Consumer Protection 90
– ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2008)0665 ),
– having regard to the Commission proposal to the European Parliament and the Council ( COM(2008)0665 ),
– ob upoštevanju člena 251(2) in člena 95 Pogodbe ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C7‑0514/2008 ),
– having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C7‑0514/2008 ),
– ob upoštevanju sporočila Komisije Evropskemu Parlamentu in Svetu „Posledice začetka veljavnosti Lizbonske pogodbe za še nedokončane medinstitucionalne postopke odločanja“ ( KOM(2009)0665 ),
– having regard to the Communication from the Commission to the European Parliament and the Council entitled "Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures" ( COM(2009)0665 ),
– ob upoštevanju členov 294(3) ter 114 in 168(4)(c) Pogodbe o delovanju EU,
– having regard to Article 294(3) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the EU,
– ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane in mnenj Odbora za industrijo, raziskave in energetiko ter Odbora za notranji trg in varstvo potrošnikov ( A7‑0159/2010 ),
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection ( A7‑0159/2010 ),
(5) Zaradi jasnosti je treba opredelitev neželenega učinka spremeniti , da se zagotovi, da ne zajema samo škodljivih in nenamernih učinkov , ki izhajajo iz dovoljene uporabe zdravila v običajnih odmerkih, ampak tudi napake pri zdravilih in uporabe zunaj odobrenega povzetka glavnih značilnosti zdravila, vključno z nepravilno uporabo in zlorabo zdravil .
(5) For the sake of clarity, the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived from the authorised use of a medicinal product at the normal doses, but also medication errors and uses outside the authorised summary of the product characteristics, including the misuse and abuse of the product.
(5) Zaradi jasnosti je treba vstaviti opredelitev napake pri zdravilih , da se zagotovi, da so nenamerni in neustrezni dogodki, ki jih je mogoče preprečiti in imajo neželene učinke , ki izhajajo iz dovoljene uporabe zdravila v običajnih odmerkih, pa tudi tisti, ki izhajajo iz napake pri zdravilih in iz uporabe zunaj odobrenega povzetka glavnih značilnosti zdravila , vključeni v to direktivo .
(5) For the sake of clarity, the definition of “medication error” should be introduced, to ensure that preventable non-intentional and inappropriate incidents, resulting in an adverse reaction, derived from the authorised use of a medicinal product at the normal doses, but also those derived from medication errors and from uses outside the authorised summary of the product characteristics, are covered by this Directive.
(5a) Onesnaževanje voda in tal s farmacevtskimi ostanki je vse večji okoljski problem in vedno večji problem javnega zdravja.
(5a) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem and an emerging public health concern.
Komisija bi morala na podlagi podatkov, prejetih od Evropske agencije za zdravila, Agencije za okolje in držav članic, pripraviti poročilo o razsežnosti problema, obenem pa oceniti, ali so potrebne spremembe zakonodaje EU o zdravilih ali druge zadevne zakonodaje.
The Commission should, based on data received from the European Medicines Agency, the Environment Agency, and Member States, produce a report on the scale of the problem, along with an assessment on whether amendments to EU legislation on medicinal products or to other relevant EU legislation are required.
(6) Imetnik dovoljenja za promet z zdravilom vzpostavi sistem farmakovigilance, s katerim zagotovi spremljanje in nadzor enega ali več svojih odobrenih zdravil, vpisanih v glavni dokumentaciji sistema farmakovigilance, ki je stalno dostopna za pregled.
(6) The marketing authorisation holder should establish a pharmacovigilance system to ensure the monitoring and supervision of one or more of its authorised medicinal products, recorded in a Pharmacovigilance System Master File permanently accessible for inspection.
Navedene sisteme nadzirajo pristojni organi.
The competent authorities should undertake the supervision of those systems.
Povzetek sistema farmakovigilance je zato treba predložiti z vlogo za dovoljenje za promet in vključiti sklic na spletno stran, kjer se vzdržuje glavna dokumentacija sistema farmakovigilance za zadevno zdravilo, ki je stalno dostopna za pregled.
A summary of the pharmacovigilance system should be therefore submitted with the marketing authorisation application and include a reference to the site where the Pharmacovigilance System Master File for the medicinal product concerned is maintained and accessible for inspection.
Povzetek sistema farmakovigilance je zato treba predložiti z vlogo za dovoljenje za promet in vključiti sklic na spletno stran, kjer se vzdržuje glavna dokumentacija sistema farmakovigilance za zadevno zdravilo, ki je pristojnim organom stalno dostopna za pregled.
A summary of the pharmacovigilance system should be therefore submitted with the marketing authorisation application and include a reference to the site where the Pharmacovigilance System Master File for the medicinal product concerned is maintained and accessible for inspection by the competent authorities.
Pristojni organi morajo imeti možnost pregledati glavno dokumentacijo farmakovigilance, kar je treba jasno določiti.
It is the competent authorities who should be able to check the permanent pharmacovigilance file, and this should be clearly stated.
(9) Kadar je zdravilo odobreno pod pogojem, da se izvedejo študije o varnosti zdravila po pridobitvi dovoljenja za promet, ali kadar v zvezi z varnostjo in učinkovito uporabo zdravil obstajajo pogoji ali omejitve, je treba zdravilo na trgu intenzivno spremljati.
(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market.
Bolnike in zdravstvene delavce je treba spodbujati, da poročajo o vseh domnevnih neželenih učinkih takih zdravil, Evropska agencija za zdravila, ustanovljena z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila (v nadaljnjem besedilu: Agencija), pa mora vzdrževati ažuren 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 maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).
(9) Pomembno je, da utrditev sistema farmakovigilance ne bo povzročila prezgodnje odobritve dovoljenj za promet.
(9) It is essential that a strengthened system of pharmacovigilance does not lead to the premature granting of market authorisations .
Toda kadar je zdravilo odobreno pod pogojem, da se izvedejo študije o varnosti zdravila po pridobitvi dovoljenja za promet, ali kadar v zvezi z varnostjo in učinkovito uporabo zdravil obstajajo pogoji ali omejitve, je treba zdravilo na trgu intenzivno spremljati.
However, where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market.
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 , Evropska agencija za zdravila, ustanovljena z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila (v nadaljnjem besedilu: Agencija), pa mora vzdrževati ažuren javno dostopen seznam takih zdravil.
Patients and healthcare professionals should be encouraged to report all suspect ed adverse reactions to such medicinal products, identified by a symbol and a corresponding explanatory sentence on the summary of product characteristics on the patient information leaflet , and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).
(10) Da se zdravstvenim delavcem in bolnikom omogoči , da brez težav ugotovijo najpomembnejše informacije o zdravilih, ki jih uporabljajo, morata povzetek glavnih značilnosti zdravila in navodilo za uporabo vključevati kratek in jedrnat del s ključnimi informacijami o zdravilu in informacijami, kako čim bolj zmanjšati tveganja in čim bolj povečati koristi .
(10) In order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about the medicines they use, the summary of the product characteristics and the package leaflet should include a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefits.
(10) Pomembno je, da zdravstveni delavci in bolniki brez težav ugotovijo najpomembnejše informacije o zdravilih, ki jih uporabljajo.
(10) It is important for healthcare professionals and patients to identify easily the most relevant information about the medicines they use.
Da bi Komisija omogočila takšno lažje prepoznavanje, bi morala v 18 mesecih pregledati povzetek glavnih značilnosti zdravila in navodilo za uporabo.
In order to facilitate such identification , the Commission should review the summary of the product characteristics and the package leaflet within 18 months.
Poročevalka se strinja z večinskim mnenjem, da so težave s predlaganim povzetkom osnovnih informacij.
The rapporteur accepts the majority view that there are problems with the proposed Summary of Essential Information.
(10a) Komisija bi morala v sodelovanju z Agencijo takoj po posvetovanju z združenji bolnikov in potrošnikov, združenji zdravnikov in farmacevtov, organizacijami socialnega in zdravstvenega zavarovanja, državami članicami ter drugimi zainteresiranimi stranmi Evropskemu parlamentu in Svetu predstaviti poročilo o oceni berljivosti povzetkov glavnih značilnosti zdravila in navodil za uporabo ter njihove pomembnosti za splošno javnost in zdravstvene delavce.
(10a) Without any delay, the Commission shall, in collaboration with the Agency , and following consultations with organisations representing patients, consumers, doctors and pharmacists, social health insurers, and Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability of the summaries of product characteristics and the packaging leaflets and their value to the general public and healthcare professionals.
Po analizi navedenih podatkov Komisija po potrebi predstavi predloge za izboljšanje oblike in vsebine povzetkov glavnih značilnosti zdravila in navodil za uporabo, da bi zagotovila, da so dragocen vir informacij za širšo javnost in zdravstvene delavce.
Following an analysis of the above data, the Commission shall, if appropriate, put forward proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.
(13) Zaradi zagotavljanja enake ravni znanstvenega znanja in izkušenj na področju odločanja o farmakovigilanci na ravni Skupnosti in na državni ravni pri izvajanju nalog farmakovigilance, mora imeti skupina za usklajevanje možnost, da se opira na nasvete Svetovalnega odbora Agencije za ocenjevanje tveganja farmakovigilance.
(13) With a view to ensuring that the same level of scientific expertise in the area of pharmacovigilance decision-making at both Community and national level, when fulfilling pharmacovigilance tasks the coordination group should be able to rely on the advice of the Pharmacovigilance Risk Assessment Advisory Committee of the Agency.
(13) Zaradi zagotavljanja enake ravni znanstvenega znanja in izkušenj na področju odločanja o farmakovigilanci na ravni Skupnosti in na državni ravni pri izvajanju nalog farmakovigilance se mora skupina za usklajevanje opirati na priporočilo odbora Agencije za oceno tveganja na področju farmakovigilance.
(13) With a view to ensuring that the same level of scientific expertise in the area of pharmacovigilance decision-making at both Community and national level, when fulfilling pharmacovigilance tasks the coordination group should rely on the recommendation of the Pharmacovigilance Risk Assessment Committee of the Agency.
Pristojnosti odbora za oceno tveganja na področju farmakovigilance bi bilo treba povečati glede na skupino za usklajevanje.
The powers of the Pharmacovigilance Risk Assessment Committee (PRAC) should be increased in relation to the coordination group.
Ta namreč ni specializirani organ za farmakovigilanco – njena naloga je na splošno usklajevati tveganja in koristi.
The coordination group is not a specialist body on pharmacovigilance – its job is to balance overall the risks with benefits.
(16) Države članice morajo izvajati sistem farmakovigilance za zbiranje informacij, uporabnih za nadzor zdravil, vključno z informacijami o domnevnih neželenih učinkih zdravil, o nepravilni uporabi, zlorabi in napakah pri zdravilih, in zagotoviti kakovost z nadaljnjim spremljanjem primerov domnevnih neželenih učinkov zdravil.
(16) Member States should operate a pharmacovigilance system to collect information useful in the surveillance of medicinal products including information on suspected adverse drug reactions, on misuse, abuse and medication errors, and ensure its quality through the follow up of suspected adverse drug reaction cases.
(16) Države članice morajo izvajati sistem farmakovigilance za zbiranje informacij, uporabnih za nadzor zdravil, vključno z informacijami o domnevnih neželenih učinkih zdravil, ki jih povzročijo običajni pogoji uporabe, uporaba, ki ni v skladu s povzetkom značilnosti zdravila, nepravilna uporaba, zloraba in napake pri zdravilih, in zagotoviti kakovost z nadaljnjim spremljanjem primerov domnevnih neželenih učinkov zdravil.
(16) Member States should operate a pharmacovigilance system to collect information useful in the surveillance of medicinal products including information on suspected adverse drug reactions resulting from normal conditions of use, off-label use, misuse, abuse and medication errors, and ensure its quality through the follow up of suspected adverse drug reaction cases.
Predlog Komisije je nejasen, razjasniti pa bi ga bilo mogoče z opredelitvijo, da je treba sistem farmakovigilance uporabljati za zbiranje informacij o vseh domnevnih neželenih učinkih zdravil in ne samo tistih, ki jih povzročijo nepravilna uporaba, zloraba in napake pri zdravilih.
The Commission's proposal is confusing and could be clarified to confirm that the pharmacovigilance system should be used to collect information on all suspected adverse drug reactions - not just those occurring through misuse, abuse and medication errors.
(18) Za poenostavitev poročanja o domnevnih neželenih učinkih morajo imetniki dovoljenja za promet in države članice te učinke sporočati samo v podatkovno bazo farmakovigilance Skupnosti in omrežje za obdelavo podatkov iz člena 57(1)(d) Uredbe (ES) št. 726/2004 (v nadaljnjem besedilu: podatkovna baza Eudravigilance).
(18) In order to simplify the reporting of suspected adverse reactions the marketing authorisation holders and the Member States should report those reactions only to the Community pharmacovigilance database and data-processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (hereinafter ‘the Eudravigilance database’).
(18) Za poenostavitev poročanja o domnevnih neželenih učinkih in zagotovitev, da lahko države članice hkrati dostopajo do iste informacije , morajo imetniki dovoljenja za promet in države članice te učinke sporočati samo v podatkovno bazo farmakovigilance Skupnosti in omrežje za obdelavo podatkov iz člena 57(1)(d) Uredbe (ES) št. 726/2004 (v nadaljnjem besedilu: podatkovna baza Eudravigilance).
(18) In order to simplify the reporting of suspected adverse reactions : and to enable Member States to access the same information simultaneously, the marketing authorisation holders and the Member States should report those reactions only to the Community pharmacovigilance database and data-processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (hereinafter ‘the Eudravigilance database’).
Podatkovna baza Eudravigilance mora zadevne države članice sočasno elektronsko obvestiti o poročilih, ki jih vložijo imetniki dovoljenja za promet.
The Eudravigilance database should simultaneously and electronically notify the relevant Member States of reports submitted by market authorisation holders.
S tega vidika in za doseganje zgoraj navedenih ciljev države članice imetnikom dovoljenja za promet z zdravilom ne bi smele postavljati dodatnih zahtev glede hitrega in rednega prijavljanja domnevnih neželenih učinkov.
From this perspective, and in order to achieve the objectives referred to above, Member States should not impose any further requirements on marketing authorisation holders in respect of the prompt and regular reporting of suspected adverse reactions.
Podatkovna baza Eudravigilance in nacionalne podatkovne baze morajo biti popolnoma povezljive.
The Eudravigilance database and the national database should be fully interoperable.
(20a) Poročanje zdravstvenih delavcev je treba spodbujati zlasti, kadar je njihov prispevek bistven za razumevanje pomena neželenega učinka in neželenih učinkov, ki so posledica napak pri zdravilih.
(20a) Reporting by healthcare professionals should be particularly encouraged in cases where their contribution is essential in order to understand the significance of the adverse reaction and of adverse reactions derived from medication errors.
Za lažje tovrstno poročanje in zaradi zaščite državljanov bi morali zdravstvenim delavcem zagotoviti dostop do podatkov v zdravstvenih kartotekah bolnikov.
To facilitate this type of reporting and to protect the citizen, access to data contained in patients’ medical files should be accessible to healthcare professionals.
Pomembno je poudariti aktivno vlogo zdravstvenega delavca pri poročanju na področju farmakovigilance.
It is important to emphasise the active role of healthcare professionals in pharmacovigilance reporting.
Poleg tega je bistvenega pomena, da imajo tako zdravniki kot farmacevti dostop do zdravstvenih kartotek bolnikov, ob popolnem upoštevanju zakona o zasebnosti in varstvu osebnih podatkov, v ozračju vzajemnega sodelovanja, ki je že pokazalo spodbudne rezultate, da se olajša pravilnejšo opredelitev mogočih napak pri zdravilih, ki povzročajo domnevne neželene učinke.
Furthermore, in order to facilitate more accurate identification of potential medication errors resulting in suspect adverse reactions, it is essential that doctors and pharmacists share access to patients’ medical files – while fully respecting the law on privacy and data protection – in a climate of mutual cooperation that has proven results.
(22) Zahteve za redna poročila o varnosti zdravila morajo biti sorazmerne s tveganji, ki jih predstavljajo zdravila.
(22) Requirements for periodic safety update reports should be proportional to the risks posed by medicinal products.
Zato je treba redno poročanje o varnosti zdravila povezati s sistemom obvladovanja tveganja za novo odobrena zdravila, običajno poročanje pa ne sme biti več potrebno za generična zdravila, zdravila z dobro uveljavljeno uporabo, prostovoljnim soglasjem, homeopatska zdravila ali registrirana zdravila rastlinskega izvora s tradicionalno uporabo.
Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and routine reporting should not be necessary for generic, well-established use, informed consent, homeopathic, or traditional use registered herbal medicinal products.
Vendar morajo organi v interesu javnega zdravja zahtevati redna poročila o varnosti takih zdravil, kadar je treba oceniti tveganje ali pregledati ustreznost informacij o zdravilu.
However, in the interest of public health the authorities should require periodic safety update reports for such products when there is a need to assess their risk or review the adequacy of product information.
Zato je treba redno poročanje o varnosti zdravila povezati s sistemom obvladovanja tveganja za novo odobrena zdravila, običajno poročanje pa bi se moralo zahtevati za generična zdravila, zdravila z dobro uveljavljeno uporabo, prostovoljnim soglasjem, homeopatska zdravila ali registrirana zdravila rastlinskega izvora s tradicionalno uporabo.
Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and routine reporting should be required for generic, well-established use, informed consent, homeopathic, or traditional use registered herbal medicinal products.
Učinki zdravila se lahko spreminjajo glede na njegovo sestavo in postopek izdelave, zato je treba za vsa zdravila objavljati redna poročila o varnosti zdravil.
The effects of a medicinal product can vary according to its composition or its method of manufacture, and for this reason all medicinal products should be subject to the publication of periodic safety update reports.