natgillin/translations-raw huggingface dataset:
Za namene tega člena in člena 102(3) Komisija v sodelovanju z Agencijo, državami članicami in zainteresiranimi stranmi pripravi natančne smernice o dobrem vodenju evidence za lekarne in druge, ki izdajajo zdravila ali jih dodeljujejo, da se zagotovi hranjenje evidenc, ki so potrebne za vložitev farmakovigilančnega poročila ali zagotovitev informacij, ki jih potrebuje imetnik dovoljenja za promet, ki pripravlja vrednotenje neželenega učinka, ter da se imetniku dovoljenja za promet in nacionalnim pristojnim organom olajšajo nadaljnje preiskave.
For the purposes of this Article and Article 102(3), the Commission, in cooperation with the Agency, Member States and stakeholders, shall prepare detailed guidelines on good record-keeping practices for pharmacies and others that dispense or administer medicinal products, to ensure retention of records necessary for filing a pharmacovigilance report or to provide information needed by a marketing authorisation holder conducting an evaluation of an adverse event and to facilitate follow-up investigations by the marketing authorisation holder and national competent authorities.
Sistem farmakovigilance je učinkovit zgolj toliko, kot so ustrezni podatki v posameznih poročilih.
A pharmacovigilance system is only as good as the details in individual reports.
Predlagano dodatno besedilo k členu 108 bi zagotovilo skladnost vsebine za obrazce poročanja, ki jih zdravstveni delavci in bolniki uporabljajo za poročanje o neželenih učinkih neposredno sistemu Skupnosti Eudravigilance.
The proposed addition to Article 108 would ensure uniformity between the content for reporting forms used for reporting adverse events directly to the Community Eudravigilance system from healthcare professionals and patients.
Člen 108a
Article 108a
Komisija sprejme vse morebitne spremembe, ki so lahko potrebne za posodobitev določb tega naslova zaradi upoštevanja znanstvenega in tehničnega napredka.
The Commission shall adopt any amendments which may be necessary to update the provisions of this Title to take account of scientific and technical progress.
Navedeni ukrepi, katerih namen je sprememba nebistvenih elementov te direktive, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 121(2a).
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121(2a).
Člen 1 – točka 24 a (novo)
Article 1 – point 24 a (new)
Člen 119 a (novo)
Article 119 a (new)
Vstavi se naslednji člen:
The following Article is inserted:
„Člen 119a
“Article 119a
Spremljanje in varstvo okolja
Environmental supervision and protection
Države članice imenujejo enega ali več nacionalnih organov, da spremljajo škodljive vplive zdravil na okolje za javno zdravje ali okolje.
Member States shall appoint one or several national authorities to monitor adverse environmental effects of medicinal products on public health or the environment.
Če kateri koli izmed teh organov ugotovi okoljsko tveganje, ki je večje od tveganja, navedenega pri vrednotenju v skladu s členom 8(3)(ca), ali če najde nove škodljive vplive na okolje, te ugotovitve nemudoma predloži Evropski agenciji za vrednotenje zdravil in pristojnim organom.
If one of these authorities identifies an environmental risk that is higher than that indicated in the evaluation pursuant to Article 8(3)(ca), or if it finds new adverse environmental effects, it shall forthwith transmit all findings to the European Medicines Evaluation Agency and to the competent authority.
Agencija po prejemu takšnih informacij presodi, ali razmerje med tveganjem in koristmi še naprej ostaja ugodno ob upoštevanju novih dognanj.
The Agency shall, upon receiving such information, assess whether the risk-benefit balance remains favourable when taking into account the new findings.
To ne sme imeti za posledico odvzema dovoljenja za zdravila, ki so potrebna za zdravljenje življenjsko nevarnih ali hudih bolezni.“
This must not lead to the withdrawal of the authorisation for drugs necessary for treating life-threatening or serious diseases.”
Farmacevtski ostanki so prisotni v pitni vodi in površinskih vodah v skoraj vseh državah članicah.
Pharmaceutical residues are present in drinking water and surface water in most member countries.
Ker so svetovni viri pitne vode omejeni, je treba izvire pitne vode zaščititi pred onesnaženjem.
Since global water resources are limited, wells for tap water need to be protected from pollution.
Če tega ne bomo storili, se bo neizogibna in neprostovoljna izpostavljenost nosečnic farmacevtskim snovem povečala, s tem pa se bo povečalo tudi tveganje za nepravilno rast zarodkov.
If not, the involuntary and unavoidable exposure of pregnant women to pharmaceuticals will increase, thereby increasing the risk for foetal malformation.
Člen 1 – točka 24 b (novo)
Article 1 - point 24 b (new)
Člen 121a (novo)
Article 121 a (new)
(24b) Vstavi se naslednji člen:
(24 b ) The following Article is inserted:
Pooblastila za sprejemanje delegiranih aktov iz člena 11(3a) in 59(1)(aa) ter 108 se Komisiji podelijo za nedoločen čas.
The powers to adopt the delegated acts referred to in Article 11(3 a ) ,and 59(1)(aa) and 108 shall be conferred on the Commission for an indeterminate period of time.
Pooblastila za sprejemanje delegiranih aktov se Komisiji dodelijo pod pogoji iz členov 121b in 121c.
The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 121b and 121c
Člen 1 – točka (24 c) (novo)
Article 1 - point 24 c (new)
Člen 121b (novo)
Article 121 b (new)
(24c) Vstavi se naslednji člen:
(24 c ) The following Article is inserted:
Preklic prenesenih pooblastil
Revocation of the delegation
Prenos pooblastil iz člena 11(3a), 59(1)(aa) in 108 lahko Evropski parlament ali Svet kadar koli prekliče.
The delegation of power referred to in Article 11(3 a ) , 59(1)(aa ) and 108 may be revoked at any time by the European Parliament or by the Council.
Institucija, ki je začela notranji postopek o morebitnem preklicu pooblastila, si o tem prizadeva obvestiti drugo institucijo in Komisijo v razumnem času pred sprejetjem končne odločitve, pri čemer navede pooblastilo, ki bi lahko bilo preklicano, ter razloge za preklic.
The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation.
Z odločitvijo o preklicu pooblastil prenehajo veljati prenesena pooblastila, navedena v tej odločitvi.
The decision of revocation shall put an end to the delegation of the powers specified in that decision.
Člen 1 – točka (24d) (novo)
Article 1 - point 24 d (new)
Člen 121c (novo)
Article 121 c (new)
(24d) Vstavi se naslednji člen 121c:
(24 d ) The following Article 121c is inserted:
Evropski parlament ali Svet lahko nasprotuje delegiranemu aktu v dveh mesecih od datuma uradnega obvestila.
The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification.
Če niti Evropski parlament niti Svet ne nasprotuje delegiranemu aktu, se ta objavi v Uradnem listu Evropske unije in začne veljati na datum, naveden v tem aktu.
If neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and enter into force at the date stated therein.
Če Evropski parlament ali Svet nasprotuje sprejetemu delegiranemu aktu, ta ne začne veljati.
If the European Parliament or the Council objects to the adopted delegated act, it shall not enter into force.
Člen 1 – točka 28
Article 1 – point 28
Glede zahteve po vključitvi povzetka osnovnih informacij, potrebnih za varno in učinkovito uporabo zdravila, v povzetek glavnih značilnosti zdravila in navodilo za uporabo iz točke 3a člena 11 in točke (aa) člena 59(1) Direktive 2001/83/ES, kakor je bila spremenjena s to direktivo, države članice zagotovijo, da se zahteva uporablja za dovoljenje za promet, izdano pred datumom, določenim v drugem pododstavku člena 3(1) te direktive, od podaljšanja navedenega dovoljenja za promet ali po izteku triletnega obdobja, ki se začne na navedeni datum, kar nastopi prej.
With regard to the requirement for the inclusion of a summary of the essential information necessary to use the medicine safely and effectively in the summary of the product characteristics and the package leaflet provided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by this Directive, the Member States shall ensure that the requirement applies to a marketing authorisation granted before the date set out in the second subparagraph of Article 3(1) of this Directive from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.
Vstavitev povzetka osnovnih informacij je odveč (ker je povzetek glavnih značilnosti proizvoda (PGZP) že sam po sebi povzetek pomembnih informacij) ter lahko povzroča zmedo pri bolnikih (ti lahko spregledajo pomembne informacije, vpisane v PGZP, ne pa v povzetek ključnih informacij) in težave z berljivostjo (npr. navodilo za uporabo, objavljeno v več jezikih).
The inclusion of a summary of essential information is superfluous (the summary of product characteristics already gives the main information), may be a source of confusion for patients (who may overlook important information given in the summary of product characteristics but not in the summary of essential information) and could create problems of legibility (if package leaflets are published in several languages, for example).
Dokler lahko Agencija zagotovi funkcionalnost podatkovne baze Eudravigilance, se vsa redna poročila o varnosti zdravila predložijo tudi pristojnim organom držav, v katerih je zdravilo odobreno.
Until the Agency can ensure the functionalities of the Eudravigilance database, all the periodic safety update reports shall also be submitted to the National Competent Authorities where the product is authorised.
Države članice morajo poskrbeti, da se zahteva iz člena 107(3) te direktive, da imetniki dovoljenj za promet po elektronski poti predložijo informacije o domnevnih neželenih učinkih, ki bodo vključene v podatkovno bazo Eudravigilance, uvede, ko bo funkcionalnost podatkovne baze omogočala popolna poročila o neželenih učinkih ustrezne kakovosti z nujnimi podatki o zdravju, kodificiranimi podatki o zdravilih, primernim razlikovanjem poročil o spremljanju in izločitvijo podvojenih primerov.
Member States shall ensure that the requirement for the marketing authorisation holder to submit information on adverse reactions electronically to the Eudravigilance database, as laid down in Article 107(3) of this Directive, is applied once the functionalities of the database make it possible to provide information on adverse reactions that is complete and of proper quality and that includes essential health data, codified data on the medicinal products, proper differentiation of follow-up reports and the elimination of duplicate cases.
Upravni odbor Agencije mora na podlagi rezultatov neodvisne revizije potrditi delovanje v prejšnjem odstavku omenjene funkcionalnosti.
The Agency’s Management Board shall confirm, on the basis of an independent inquiry, that the functionalities referred to in paragraph 1 are operational.
Po veljavni zakonodaji EU je zdravila mogoče odobriti na dva načina: a) po centraliziranem postopku, kjer farmacevtsko podjetje agenciji EMEA (Evropska agencija za zdravila) predloži eno vlogo ali b) po sistemu vzajemnega priznavanja, kjer ena država prevzame vodilno vlogo pri oceni novega zdravila in usklajevanju z drugimi državami članicami na podlagi vzajemnega priznavanja.
Under current EU legislation, medicines can be authorised in two ways: a) through a central procedure where one application is made by a pharmaceutical company to the EMEA (European Medicines Agency) or b) through a system of mutual recognition where one country leads on the assessment of the new drug and coordinates with other Member States through mutual recognition.
Za nekatere vrste novih zdravil je obvezna uporaba centraliziranega sistema, npr. za biotehnološka zdravila, zdravila proti raku, zdravila proti virusu HIV, nevrodegenerativna zdravila.
There is an obligation for certain kinds of new products to go through the centralised system e.g. Biotech, cancer, HIV, neurodegenerative drugs.
Predlog Komisije o posodobitvi predpisov o farmakovigilanci zato zahteva spremembo obeh zakonodajnih aktov.
The Commission proposal to update the rules on pharmacovigilance therefore requires amendment of both pieces of legislation.
Poročevalka je podobno pripravila predloge sprememb uredbe in direktive, vendar zaradi prekrivanja obeh zakonodajnih aktov spodnje besedilo velja za oba zakonodajna akta.
Your rapporteur has similarly drafted amendments to both the Regulation and the Directive, but given the overlapping nature of the two pieces of legislation, the narrative below refers to both.
Bistvo dobrega sistema farmakovigilance je, da zdravstveno osebje, podjetja in tudi bolniki sami pravilno poročajo o neželenih učinkih ter da jih javni organi pravilno beležijo, tako da je mogoče odkriti „signale“, ki kažejo na morebitne težave.
The essence of a good pharmacovigilance system is proper reporting of ADRs by healthcare professionals, companies and patients themselves and proper recording of these ADRs by the public authorities so that “signals” pointing to potential problems can be detected.
Tem signalom morajo nato slediti ukrepi, ki lahko vključujejo spremembe načina predpisovanja zdravila, boljše informacije o njegovi uporabi ali, če so neželeni učinki hujši, o popolnem umiku zdravila.
These signals must then be followed up with action which can include changes to the way a medicine is prescribed, better information on how it is used or, where the nature of the ADR is severe, the withdrawal of the medicine altogether.
Veljavni sistem farmakovigilance v EU zaradi razvoja v preteklih letih omogoča boljše usklajevanje dela med državami članicami.
The current system of pharmacovigilance in the EU has evolved in recent years to better coordinate work between Member States.
Poročevalka se strinja s Komisijo glede zamenjave sedanje delovne skupine za farmakovigilanco s Svetovalnim odborom za oceno tveganja na področju farmakovigilance.
The rapporteur believes the Commission is right to replace the existing Pharmacovigilance working party with the Pharmacovigilance Risk Assessment Advisory Committee (PRAAC).
Vendar je po mnenju poročevalke vlogo Svetovalnega odbora za oceno tveganj na področju farmakovigilance še vedno mogoče okrepiti, če se mu dodeli pristojnost priporočanja ukrepov odboru CHMP, ne le da ima zgolj svetovalno vlogo, ter da se članstvo v njem razširi na predstavnika iz vsake države članice.
However, the rapporteur believes that the PRAAC ‘s role can be strengthened still by giving it the power to recommend action to the CHMP rather than simply providing advice to it and be extending its membership to one representative per Member State.
Za izboljšanje preglednosti dela Svetovalnega odbora za oceno tveganja na področju farmakovigilance predlaga imenovanje dveh dodatnih predstavnikov, ki bosta zastopala bolnike in zdravstveno osebje, kot je praksa v drugih odborih agencije EMEA.
To reinforce the transparency of the work of the PRAAC, your rapporteur also proposes that two additional representatives be appointed to represent patients and healthcare professionals, as is the case with other EMEA Committees.
Trenutno le nekaj držav članic omogoča neposredno poročanje, kjer pa se izvaja, sistem ni povzročil preobremenitve pristojnega organa.
At present, only a few Member States accept direct reporting but where it exists, the system has not overburdened the competent authority.
Mnoge zainteresirane strani se ne strinjajo s predlogom Evropske komisije za vključitev „črnih okenc“ s pomembnimi informacijami v navodilo za uporabo.
A number of stakeholders are unhappy with the proposal by the European Commission to include the “black box” with essential information on the PIL.
Poročevalka razume te pomisleke, zlasti ker to, kar je pomembno za enega bolnika, ni nujno pomembno za vse.
Your rapporteur understands those concerns, in particular that what is essential to one patient may not be essential to all patients.
Zaveda pa se tudi, da sedanja navodila za uporabo za bolnike niso zadovoljiva in da bi morala vključevati jasnejšo navedbo glavnih značilnosti zdravila.
However, she also feels that the current PIL is not satisfactory from a patient point of view and that there needs to be a clearer indication of the main features of the drug for patients .
Če se bodo v bazi Eudravigilance zabeležili vsi neželeni učinki, se poročevalki zdi logično, da se zmanjša zahteva po poročanju podjetij o neželenih učinkih v rednih poročilih o varnosti.
If all ADRs are recorded on Eudravigilance, the rapporteur sees the logic of cutting back on the requirement by companies to provide line by line reporting of ADRs in PSURs .
Poročevalka si zato prizadeva za vključitev določb za zagotovitev boljših mehanizmov za skladnost.
The Rapporteur has therefore sought to include provisions to ensure better compliance mechanisms.
Nujno ukrepanje ali postopek Skupnosti:
Urgent action or “Community procedure” :
o predlogu direktive Evropskega parlamenta in Sveta o spremembi Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini glede farmakoviligance
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
Predloga (uredbe in direktive) o farmakovigilanci nas postavljata v središče aktualnih vprašanj.
These two proposals (a regulation and a directive) on pharmacovigilance place us right at the heart of current issues.
Polemika o cepivu proti virusu gripe AH1N1, ki je bilo dano v promet po zelo hitrem postopku, kaže na to, da so državljani izgubili zaupanje v sposobnost pristojnih organov, da jim zagotovijo zaščito.
The arguments surrounding the vaccine against AH1N1 influenza, which was put on the market following a very quick procedure, illustrate the public's loss of confidence in the ability of the authorities to guarantee their protection.
Nedavna študija je pokazala, da se 61 % francoskih zdravnikov ne namerava cepiti.
A recent study shows that 61% of French doctors do not intend to have themselves vaccinated.
To samo še bolj poudarja, da mora imeti Evropska unija učinkovito politiko farmakovigilance, s katero bo pomirila in zaščitila svoje državljane.
This context further highlights (if it were necessary to do so) the need for the European Union to have an effective pharmacovigilance policy, to reassure and protect its citizens.
V zadnjih letih je bilo žal nekaj primerov zdravil, ki so povzročila veliko neželenih učinkov, čeprav so bila dana v promet po klasičnem postopku:
We are unfortunately able to point to several cases of medicinal products in recent years which, despite having been placed on the market upon completion of a traditional procedure, have produced substantial side-effects:
– rofekoksib (Vioxx®, Ceox®, Ceeoxx®): protivnetno zdravilo, ki ni učinkovitejše od ibuprofena, povzročilo pa je na tisoče smrtnih primerov zaradi srčnega napada; odobreno je bilo leta 1999, leta 2004 pa umaknjeno s trga;
- rofecoxib (Vioxx®, Ceox®, Ceeoxx®): an anti-inflammatory which is no more effective than ibuprofene and which triggered thousands of fatal heart attacks; authorised in 1999 and withdrawn from the market in 2004;
– paroksetin: zdravilo proti depresiji (Deroxat, Seroxat), ki je povečalo tveganje samomorov;
- paroxetine: an anti-depressant (Deroxat®, Seroxat®) which increased the risk of suicide;
– rimonabant (Acomplia®): zdravilo proti debelosti, ki je bilo dano v promet brez zadostne ocene, leto in pol kasneje pa umaknjeno z evropskega trga.
- rimonabant (Acomplia®): an anti-obesity medicine, which was put on the market without adequate assessment and withdrawn from the European market a year and a half later.
Več sodnih procesov je pokazalo, da farmacevtska podjetja težijo k temu, da bi čim dlje prikrivala informacije o neželenih učinkih svojih zdravil, ki bi lahko škodile prodaji.
Several court cases have shown that pharmaceutical companies have a tendency to conceal information about adverse reactions to their medicinal products, which might damage sales, for as long as possible.
Pri vseh teh primerih smo lahko videli, da sta dolgotrajnost postopka odločanja in zadrževanje informacij o neželenih učinkih škodila bolnikom.
In each of these cases we were able to see that the length of the decision-making process and the withholding of information about adverse reactions were harmful to patients.
Človeški davek teh stranskih učinkov je nesprejemljiv, finančni stroški pa ogromni, poleg tega jih krije družba kot celota, saj se nanašajo na 5 % hospitalizacij in 5 % smrti v bolnišnicah.
The human cost of such side-effects is unacceptable; as for the financial costs, these are massive, and it is society as a whole which bears them, because they account for 5% of hospital admissions and 5% of the causes of hospital deaths.
Ocenjevanje in nadzorovanje zdravila, informiranje o njem in dajanje v promet
From assessment, via supervision and information relating to medicinal products, to placing them on the market
Vloga farmakovigilance je, da nas nato seznani z neželenimi učinki, da bi omejila škodo, ki jo povzročajo pri ljudeh.
Pharmacovigilance's role is subsequently to extend our knowledge of adverse reactions, so as to limit the harm caused to the public.
Pripravljavka mnenja se boji, da direktiva ne bi oslabila sistema farmakovigilance, namesto da bi ga okrepila, iz naslednjih razlogov:
Your rapporteur fears that the Directive will weaken the pharmacovigilance system, instead of strengthening it, for the reasons given below.
S prenehanjem obveznosti javnega financiranja obstaja nevarnost, da se bo sistem farmakovigilance skrčil na raven izvajanja storitev za farmacevtska podjetja.
The ending of the requirement for funding to be public threatens to reduce the pharmacovigilance system to the status of service provider to pharmaceutical firms.
Pripravljavka mnenja pa nasprotno predlaga, naj se nacionalni in regionalni neodvisni sistemi farmakovigilance okrepijo.
The rapporteur proposes, instead, to strengthen the independent national and regional pharmacovigilance systems.
Podjetja bi se z okrepitvijo svojega vpliva na zbiranje, analiziranje in razlaganje podatkov znašla v nevzdržnem navzkrižju interesov.
Companies' increased control over the collection, analysis and interpretation of the data places them in an untenable situation regarding conflicts of interest.
Pri preučevanju neželenih učinkov bi morala sodelovati le pod nadzorom organov oblasti in nikakor ne bi smela imeti monopola.
Firms should be able to take part in the study of adverse reactions, but under the control of the authorities, and in no circumstances in a monopoly position.
Organiziranje redčenja podatkov, shranjenih neposredno v podatkovni megazbirki Eudravigilance, brez postopka, ki bi zagotavljal kakovost njene vsebine.
The organisation of dilution of the data, which are stored directly in Eudravigilance, a mega-database, without any procedure to ensure that the quality of the content of Eudravigilance is safeguarded.
Pripravljavka mnenja predlaga, naj podatke vanjo vnašajo le organi držav članic, pristojni za farmakovigilanco (ne smejo jih neposredno vnašati bolniki in farmacevtska podjetja, da ne bi bilo preveč informacij, zaradi katerih pomembnih podatkov ne bi mogli več uporabljati).
Your rapporteur proposes that input to Eudravigilance be restricted to the Member States' relevant pharmacovigilance authorities (no direct input by patients, nor by pharmaceutical firms, with the risk of creating too much background noise and thus making the relevant data unusable).