natgillin/translations-raw huggingface dataset:
Precedens za to so Odbor za zdravila sirote, Odbor za pediatrijo in Odbor za napredno zdravljenje pri Evropski agenciji za zdravila.
This follows the precedent set by the following EMEA committees: the Committee on Orphan Medicinal Products, the Paediatric Committee and the Committee for Advanced Therapies.
Člen 61a – odstavek 1 – točka (b a) (novo)
Article 61a – paragraph 1 – point (ba) (new)
(ba) en predstavnik in en namestnik iz delovne skupine bolnikov in potrošnikov Evropske agencije za zdravila ter en predstavnik in en namestnik iz delovne skupine zdravstvenih delavcev Evropske agencije za zdravila .
(ba) one representative and one alternate belonging to the EMEA working party of patients and consumers and one representative and one alternate belonging to the EMEA working party of healthcare professionals.
Da bi omogočili lažje izvajanje tega predloga, je pomembno, da se uporabi vse obstoječe strokovno znanje v okviru Evropske agencije za zdravila.
It is important to make use of all the experts who exist at EMEA in order to facilitate the practical implementation of the proposal.
Udeležba vseh sogovornikov tako odraža izpolnitev zahtev po jamstvu in preglednosti, ki jih terjata skrb za zdravje in dobro počutje državljanov.
The presence of representatives of all parties involved thus reflects the requirements with regard to safeguards and transparency which protecting the health and welfare of citizens requires.
Člen 61a – odstavek 6
Article 61a – paragraph 6
Predstavniki pristojnih nacionalnih organov se lahko udeležijo vseh sestankov Svetovalnega odbora za oceno tveganja na področju farmakovigilance, da se tako omogoči ustrezna koordinacija med nalogami Agencije in delom pristojnih nacionalnih organov.
Representatives of the national competent authorities shall be entitled to attend all meetings of the Pharmacovigilance Risk Assessment Advisory Committee to facilitate appropriate coordination between the tasks of the Agency and the work of national competent authorities.
Če so povabljeni, lahko predložijo pojasnila ali informacije, ne smejo pa poskušati vplivati na razprave.“
They may provide clarification or information if invited to do so but shall not seek to influence discussions.”
Predstavniki pristojnih nacionalnih organov se lahko udeležijo vseh sestankov Odbora za oceno tveganja na področju farmakovigilance in sodelujejo v razpravah , da se tako omogoči ustrezna koordinacija med nalogami Agencije in delom pristojnih nacionalnih organov.
Representatives of the national competent authorities shall be entitled to attend all meetings of the Pharmacovigilance Risk Assessment Committee and to participate in discussions in order to facilitate appropriate coordination between the tasks of the Agency and the work of national competent authorities.
Glej obrazložitev predloga spremembe člena 61a – odstavka 1.
See justification to amendment to Article 61a - paragraph 1.
Člen 62 – odstavek 2 – pododstavek 1
Article 62 – paragraph 2 – subparagraph 1
„Države članice posredujejo Agenciji imena nacionalnih strokovnjakov z dokazanimi izkušnjami pri vrednotenju zdravil, ki bi bili na voljo za delo v delovnih skupinah ali znanstvenih svetovalnih skupinah katerega koli odbora iz člena 56(1), skupaj z navedbo kvalifikacij in posebnih strokovnih področjih.“
"Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who would be available to serve on working parties or scientific advisory groups of any of the committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise."
„Države članice posredujejo Agenciji imena nacionalnih strokovnjakov z dokazanimi izkušnjami pri vrednotenju zdravil, ki bi bili na voljo za delo v delovnih skupinah ali znanstvenih svetovalnih skupinah katerega koli odbora iz člena 56(1), skupaj z navedbo kvalifikacij in posebnih strokovnih področjih, pa tudi njihovo stopnjo neodvisnosti od farmacevtskih družb .“
"Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who would be available to serve on working parties or scientific advisory groups of any of the committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise , and also of their degree of independence from pharmaceutical firms ."
Več primerov odločitev, ki so bile spremenjene po ustanovitvi novih skupin strokovnjakov, narekuje previdnost glede interesov, ki povezujejo te strokovnjake in farmacevtske družbe.
Several instances of decisions which have been changed following the establishment of new groups of experts prompt a cautious approach with regard to the existence of interests linking such experts and pharmaceutical firms.
Izjave o interesih ne zadoščajo za odpravo pritiska na strokovnjake.
Declarations of such links are not enough to free experts from pressure.
Člen 1 – točka 18 – točka (b)
Article 1 - point 18 - point b
Člen 67 – odstavek 4
Article 67 - paragraph 4
Dejavnosti v zvezi s farmakovigilanco, delovanjem komunikacijskih mrež in nadzorom trga so pod stalnim nadzorom uprave, da se zagotovi neodvisnost Agencije.
Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency.
To ne izključuje zbiranja pristojbin, ki jih morajo plačati imetniki dovoljenj za promet za dejavnosti, ki jih izvaja Agencija.“
This shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of these activities by the Agency.
To ne izključuje zbiranja pristojbin, ki jih morajo plačati imetniki dovoljenj za promet za dejavnosti, ki jih izvaja Agencija , pod pogojem, da je njihova neodvisnost strogo zagotovljena. .
This shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of these activities by the Agency , on condition that its independence is strictly guaranteed.
poročevalka lahko podpre del predloga spremembe 81 – da se farmakovigilanca lahko financira le s pristojbinami, ki so zagotovljeno neodvisne od nacionalnih pristojnih oblasti.
The rapporteur can support part of amendment 81 - that pharmacovigilance can only be financed by fees if the independence of national competent authorities is guaranteed.
Zahteva za vključitev povzetka osnovnih informacij za varno in učinkovito uporabo zdravila v povzetek glavnih značilnosti zdravila in navodilo za uporabo, določena v točki 3a člena 11 in točki (aa) člena 59(1) Direktive 2001/83/ES, kakor je bila spremenjena z Direktivo …/…/ES, ki se uporablja za zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004 na podlagi člena 9(4)(a) in (d) Uredbe, se uporablja za dovoljenje za promet, izdano pred datumom, določenim v drugem odstavku člena 3 te uredbe, od podaljšanja navedenega dovoljenja ali od izteka treh let od navedenega datuma, odvisno od tega, kaj nastopi prej.
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 Directive …/…/EC, which applies to medicinal products authorised pursuant to Regulation (EC) No 726/2004 by virtue of its Article 9(4)(a) and (d), shall apply to a marketing authorisation granted before the date set out in the second paragraph of Article 3 of this Regulation from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.
Predlog spremembe je v skladu s poročevalkinim predlogom spremembe k točki 3a člena 11 in k točki (aa) člena 59(1) Direktive 2001/83/ES.
This amendment is consistent with the rapporteur's amendment to the point 3a of Article 11 and to the point (aa) of Article 59(1) of Directive 2001/83/EC.
Farmakovigilanca je sistem, ki se uporablja za nadzorovanje varnosti zdravil po njihovi odobritvi za javno uporabo.
Pharmacovigilance is the system used to monitor the safety of medicines after they have been authorised for public use.
Ima pomembno vlogo v javnem zdravju.
Pharmacovigilance plays an important role in public health.
V EU je po ocenah mogoče 197.000 primerov smrti letno pripisati neželenim učinkom zdravila.
An estimated 197,000 deaths per year are caused by Adverse Drug Reactions (ADRs) in the EU).
Pri kliničnih preskušanjih se lahko zgodi, da neželenih učinkov zdravil ne zaznajo, če so redki, če se pojavijo šele po dolgotrajni uporabi ali ob interakciji z drugimi zdravili.
Clinical trials can miss side effects from drugs if they are rare, only appear after long-term use or involve interaction with other drugs.
Večina se nas spomni katastrofalnih posledic talidomida v 60. letih 20. stoletja in nedavno vioxa.
Most of us will be aware of the tragedy of the drugs Thalidomide in the 1960s and Viox more recently.
Zato ni dvoma, da so sistemi za sledenje uporabe zdravil, poročanje o neželenih učinkih in iskanje vzorcev („odkrivanje signalov“) prednostna naloga za evropsko politiko javnega zdravja.
There can therefore be no doubt that systems for tracking drug use, reporting on ADRs and looking for patterns (“signal detection”) are a priority for European public health policy.
Predpisi za centralizirani postopek so določeni v uredbi (ES) št. 726/2004, predpisi za decentralizirani sistem pa v direktivi 2001/83/ES.
Rules governing the centralised procedure are set out in EU Regulation 726/2004 and for the decentralised system in Directive 2001/83/EC.
Prednost okrepitve sodelovanja na področju farmakovigilance na ravni EU je povečanje nabora sporočenih neželenih učinkov, kar pomeni, da bo redkejše vzorce mogoče hitreje odkriti, da se bo mogoče izogniti podvajanju dela pri spremljanju istih neželenih učinkov v različnih državah članicah ter da bo mogoče nevarna zdravila hitro umakniti, kadar bo potrebno. „Signali“ so vzeti iz spontanih poročil o neželenih učinkih pristojnim nacionalnim organom, iz rednih posodobljenih poročil o varnosti, ki jih morajo podjetja posredovati, ko je zdravilo na trgu, in iz strokovnih pregledov zdravstvenih raziskovalnih dokumentov.
The advantage of strengthening cooperation on pharmacovigilanvce at EU level is that the “pool” of reported ADRs is larger, meaning rarer patterns can be picked up more quickly, duplicate work on following up the same ADRs in different Member States can be avoided and unsafe medicines can be withdrawn quickly when required.
Veljavni sistem farmakovigilance v EU zaradi razvoja v preteklih letih omogoča boljše usklajevanje dela med državami članicami.
“Signals” are picked up from spontaneous reports of ADRs to national competent authorities, from the periodic safety update reports (PSURs) that companies are required to present once a product is on the market and from expert review of medical research papers.The current system of pharmacovigilance in the EU has evolved in recent years to better coordinate work between Member States.
Enotna podatkovna baza Eudravigilance za zbiranje podatkov je vzpostavljena in se izvaja, delovna skupina pa se sestaja, da razpravlja o odprtih vprašanjih.
A single Eudravigilance database which collects data is up and running and a working party meets to discuss issues.
Vendar pa vrzeli v veljavni zakonodaji pomenijo, da je pristop v določeni meri priložnosten in nedosleden.
However, gaps in the current legislation mean that the approach is somewhat ad hoc and inconsistent.
Komisija zato predlaga spremembe za okrepitev farmakovigilanco v EU in racionalizacijo postopkov.
The Commission therefore proposes changes to strengthen EU pharmacovigilance and rationalise procedures.
Poročevalka v splošnem pozdravlja pristop Komisije, vendar je okrepila njene predloge na nekaterih področjih.
Your rapporteur generally welcomes the Commission’s approach but has strengthened its proposals in some areas.
V nadaljevanju so predstavljene točke, ki so po mnenju poročevalke ključne.
The following are, your rapporteur believes, the main points.
Okrepitev vloge odbora EU za farmakovigilanco:
Strengthened EU Committee on Pharmacovigilance:
Poročevalka se strinja s Komisijo glede zamenjave sedanje delovne skupine za farmakovigilanco s Svetovalnim odborom za oceno tveganj na področju farmakovigilance.
The rapporteur believes the Commission is right to replace the existing Phamacovigilance working party with the Pharmacovigilance Risk Assessment Advisory Committee (PRAAC).
Večina strokovnjakov meni, da veljavni sistem delovnih skupin deluje dokaj ad hoc in daje poudarek le zdravilom, odobrenim po centraliziranem postopku, ter nima ustreznega statusa, da bi Odbor za zdravila za uporabo v humani medicini (CHMP), ki nadzoruje ves sistem, upošteval njegove rezultate.
Most experts agree that the existing working party system works in a rather ad hoc manner, focusing only on drugs authorised through the central procedure and lacking the status to ensure its findings are acted on by the Committee for Medicinal Products for Human Use (CHMP) which oversees the whole system.
Vloga držav članic v sistemu:
The role of Member States in the system:
Po mnenju poročevalke morajo države članice ostati osrednji akterji v evropskem sistemu farmakovigilance.
Your rapporteur believes that Member States must remain key players in the EU pharmacovigilance system.
Komisija je predlagala, da mora pristojni organ vsake posamezne države članice še naprej delovati kot center za vsa spontana poročanja o neželenih učinkih ter da morajo zdravstveno osebje in bolniki še naprej poročati o neželenih učinkih svojim pristojnim organom in ne neposredno bazi Eudravigilance (bazi podatkov EU o neželenih učinkih).
As proposed by the Commission, the competent authority(CA) in each Member State should continue to act as the clearing house for all spontaneous reporting of ADRs and healthcare professionals and patients should continue to report ADRs to their CA and not directly to Eudravigilance (the EU database of ADRs).
Poročevalka razume pomisleke držav članic v zvezi s predlogom Komisije, da bi se podjetju dovolilo, da pripravi eno samo poročilo bazi Eudravigilance o neželenem učinku namesto vsem državam članicam (gl. točko 2).
The rapporteur understands the concerns of Member States at the Commission proposal to allow a company to make a single report to Eudravigilance on an ADR rather than to every Member State (see point 2).
Meni, da morajo biti države članice takoj obveščene, če podjetje podatkovni bazi Eudravigilance poroča o neželenem učinku, do katerega je prišlo na njihovem ozemlju, ter predlaga vzpostavitev sistema za hkratno obveščanje držav članic.
She believes that Member States must be immediately informed if a company reports an ADR which happened on its territory to the Eudravigilance database and suggests that a system to alert relevant Member States simultaneously be established.
Vloga podjetij v sistemu:
The role of companies in the system:
Predlaganih je nekaj koristnih sprememb, ki zadevajo podjetja.
Several useful changes are proposed which affect companies.
Poročevalka zlasti pozdravlja predloge, ki zagotavljajo boljše nadaljnje spremljanje in usklajevanje ocen neželenih učinkov s preprečevanjem podvajanja dela v različnih državah članicah.
The rapporteur particularly welcomes proposals which ensure better follow up and coordination of the assessments of ADRs by preventing duplicate work in different Member States.
V ta namen predlaga neposredno poročanje podjetij bazi Eudravigilance (z zaščitnimi ukrepi iz točke 3) in mehanizme za delitev dela pri nadaljnjem spremljanju periodičnih poročil o varnosti, ki jih usklajuje Svetovalni odbor za oceno tveganja na področju farmakovigilance.
She therefore supports direct reporting to Eudravigilance by companies (with the safeguards in point 3) and the work-sharing mechanisms for follow-up to Periodic Safety Reports coordinated through the PRAAC.
Vloga zdravstvenega osebja:
The role of Healthcare professionals:
Poročevalka predlaga ukrepe za spodbujanje zdravstvenih delavcev k prostovoljnemu poročanju o neželenih učinkih svojemu pristojnemu organu ter se zavzema za okrepitev njihove vloge pri obveščanju in spodbujanju bolnikov k poročanju.
Your rapporteur supports measures to encourage healthcare professionals to voluntarily report ADRs to their competent authority and wants to strengthen their role in informing and encouraging patients to report.
Vloga bolnikov:
The role of patients:
Bolniki imajo ključno vlogo pri „odkrivanju signalov“ neželenih učinkov.
Patients are key to “signal detection” of ADRs.
Poročevalka podpira predloge za spodbujanje „obveščenega bolnika“ in močno podpira nove določbe, ki omogočajo neposredno poročanje bolnikov o neželenih učinkih, meni pa, da bi morali poročati pristojnim organom in ne podjetjem.
Your rapporteur supports proposals to encourage the “informed patient” and strongly supports the new provisions to allow direct patient reporting of ADRs, though she believes this should be to competent authorities and not companies.
Poročevalka zato tudi podpira predlog za zdravila, ki se intenzivno spremljajo, in meni, da bi moral sistem poleg obveščanja bolnikov, katerim se predpiše novo zdravilo, bolnike tudi spodbujati, da poročajo o neželenih učinkih.
The rapporteur therefore also supports the proposal for Intensively Monitored Products and believes the system should not only inform patients who are prescribed a new product but encourage them to report ADRs.
V ta namen je vložila številne predloge sprememb za izboljšanje informacij v navodilih za uporabo.
She has tabled a number of amendments to improve information on the Patient Information Leaflet (PIL) to that effect.
Navodila za uporabo:
The Patient Information Leaflet (PIL):
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.
Verjetno bi bila najboljša rešitev te težave ob splošnem pregledu navodil za uporabo.
It is possible that the best solution would be to remit this problem to a general review of the PIL.
Iz tega razloga ni vložila svojih predlogov sprememb k predlogom Komisije.
For this reason, she has not tabled any amendments herself to the Commission proposals .
Poročanje o neželenih učinkih:
The reporting of ADRs:
Novi sistem predlaga poročanje pristojnih organov in podjetij o vseh neželenih učinkih (ne le o resnih) podatkovni bazi Eudravigilance.
The new system proposes that all ADRs (and not just serious ones) are reported to the Eudravigilance database by Competent Authorities and Companies.
To pomeni, da bodo informacije o vseh neželenih učinkih prvič centralizirane na enem mestu v EU.
This means that information on all ADRs will, for the first time, be centralised in one place in the EU.
To utegne biti dragoceno raziskovalno orodje za vse.
This can be a valuable research tool for all.
Vendar Komisija mora zagotoviti, da bo baza Eudravigilance zmožna obvladati velik obseg informacij, in vzpostaviti sisteme, tako da so najresnejši neželeni učinki jasno označeni.
The Commission needs to ensure, however, that Eudravigilance is able to cope with the surge of information and by putting systems in place so that the most serious ADRs are clearly flagged up.
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.
Namesto zgolj predložitve neobdelanih podatkov bodo podjetja morala analizirati neželene učinke in posredovati povzetke svojih rezultatov.
Instead of just presenting raw data, companies will be required instead to analyse the ADRs and present summaries of their findings.
To je smiselno, zlasti ker je poročevalka ugotovila, da so pristojni organi pogosto preobremenjeni že s količino rednih poročil o varnosti, ki so jih prejeli, kar pomeni, da mnogih niso uspeli prebrati.
This makes sense, particularly since the rapporteur has learned that competent authorities have often been overwhelmed by the sheer volume of PSURS they have received in the past, with the result that many have gone unread.
Hitrost poročanja o neželenih učinkih bazi Eudravigilance je za varnost bolnikov poglavitna.
The speed with which ADRs are reported to Eudravigilance is of paramount importance for patient safety.
Poročevalka je zato zaskrbljena zaradi novice, da tako podjetja kot tudi države članice niso uspele izpolniti sedanje zahteve po poročanju o neželenih učinkih v 15 dneh.
The rapporteur is therefore concerned to hear that both companies and Member States have failed to meet the current requirement to report ADRs within 15 days.
Vendar so države članice bistveno večji kršitelji: v primerjavi s 5 % prepoznih poročili podjetij je bilo prepoznih 50 % poročil držav članic.
However, Member States are by far the worst “offenders”: 5% of company reports were late compared with 50% of Member State reports.
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”:
Poročevalka pozdravlja vključitev jasnejših določb o tem, kdaj je potreben nujni postopek.
Your rapporteur welcomes the inclusion of clearer provisions for when an urgent procedure is triggered.
Države članice morajo hitro in povezano ukrepati, kadar pride do resnih neželenih učinkov.
Member States need to work quickly together to act when a serious ADR occurs.
Poročevalka pozdravlja predloge za povečanje preglednosti sistema farmakovigilance v EU.
Your rapporteur welcomes the proposals to bring more transparency to the EU pharmacovigilance system.
Pozdravlja razširitev spletnega portala in uporabo javnih predstavitev za zbiranje dokazov o neželenih učinkih.
She welcomes the expansion of the web portal and the use of public hearings to gather evidence about ADRs.
Meni, da bi javne predstavitve poleg uporabe v primerih nujnega ukrepanja utegnile biti uporabno orodje za običajno farmakovigilanco, zato je predlagala spremembo.
She believes public hearings should not only be used in the case of urgent action, but could also be useful tools for normal pharmacovigilance and has therefore proposed an amendment along these lines.
o predlogu Uredbe Evropskega parlamenta in Sveta o spremembi Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila, kar zadeva farmakovigilanco zdravil za humano uporabo
on the proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Pripravljavka mnenja: Michèle Rivasi
Rapporteur: Michèle Rivasi
S tema dvema predlogoma (uredbe in direktive) o farmakovigilanci smo v središču 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 gripi AH1N1, ki je prišlo na trg po zelo hitrem postopku, kaže na zmanjšano zaupanje državljanov v sposobnost oblasti, da jih obvarujejo.
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.