natgillin/translations-raw huggingface dataset:
Any budgetary requirements concerning the implementation of the pharmacovigilance legislation were only provisionally adopted, and need to be made fully plausible in the following months.
Vse proračunske zahteve v zvezi z izvajanjem zakonodaje o farmakovigilanci so bile sprejete samo začasno in morajo v naslednjih mesecih postati v celoti izvedljive.
• The legislative proposal on information to patients (the discussions will restart at the Council level).
• zakonodajni predlog o informiranju bolnikov (razprave se bodo ponovno začele na ravni Sveta);
With regard to the structural problems of the budget, Commissioner Dalli was of the opinion that the Agency should be allowed to retain the surplus revenue from fees.
Glede strukturnih težav s proračunom je komisar Dalli menil, da bi agenciji moralo biti dovoljeno, da zadrži presežek prihodkov od pristojbin.
The Acting Executive Director has also informed the Commissioner about 'project 2014'.
Vršilec dolžnosti izvršnega direktorja je komisarja obvestil tudi o „projektu 2014“.
There has been a significant increase in the numbers of paediatric procedures (around 20% higher than in 2009) and inspections (a 30% increase), and a very high increase in veterinary scientific advice applications (21 applications received, which is a 90% increase).
Do pomembnega povečanja delovanja je prišlo na področju pediatričnih postopkov (okoli 20 % več v primerjavi z letom 2009) in inšpekcijskih pregledov (30-odstotno povečanje), izrazito pa se je povečalo tudi število vlog za veterinarsko znanstveno svetovanje (prejetih je bilo 21 vlog oziroma 90 % več).
The Board was also informed that the Agency is reviewing the efficiency of its procedures and is introducing changes in other areas where savings can be made.
Odbor je bil tudi seznanjen, da agencija pregleduje učinkovitost svojih postopkov in uvaja nekatere spremembe na področjih, kjer so mogoči prihranki.
Mary G. Baker (morning session) Mike O'Donovan
Mary G. Baker (dopoldansko zasedanje) Mike O'Donovan
• The meeting with the European Commission to discuss principles of a future fee regulation (including the issue of non-remunerated tasks).
• srečanje z Evropsko komisijo za razpravo o načelih prihodnje uredbe o pristojbinah (vključno z vprašanjem o nalogah, ki se ne plačujejo);
The Board supported the proposed transitional measures for the pharmaceutical industry to comply with the 2 July 2011 deadline for the electronic submission of information on medicinal products for human use.
Odbor je podprl predlagane prehodne ukrepe za farmacevtsko industrijo, da bo delovala v skladu z rokom 2. julija 2011 za elektronsko predložitev informacij o zdravilih za uporabo v humani medicini.
The two-day meeting of the Management Board of the European Medicines Agency (EMA) started on 16 March 2011 with presentations and an exchange of views on the following topics:
Dvodnevna seja upravnega odbora Evropske agencije za zdravila (EMA) se je začela dne 16. marca 2011 s predstavitvijo in izmenjavo stališč o naslednjih temah:
It was also agreed that chairs may ask for the possibility to sit as observers in the meetings of the boards of other agencies.
Dogovorjeno je bilo tudi, da lahko predsedniki zaprosijo za možnost, da na sejah odborov drugih agencij sodelujejo kot opazovalci.
• Presentation: The EMA in 2010 - highlights.
• Predstavitev: EMA v letu 2010 - najpomembnejši dogodki.
[EMA/MB/19969/2011] The agenda was adopted.
[EMA/MB/19969/2011] Dnevni red je bil sprejet.
The Agency has not received new posts for 2011 and has difficulty recruiting scientific staff as contract agents, due to the short term of the contracts and lower remuneration level.
Agencija, ki ji za leto 2011 niso odobrili novih delovnih mest, se srečuje s težavami pri zaposlovanju znanstvenega osebja kot pogodbenih sodelavcev zaradi kratkoročnosti pogodb in nižje ravni nadomestil.
The Board noted the oral report on the activities of the Agency in 2010.
Upravni odbor se je seznanil z ustnim poročilom o dejavnostih agencije v letu 2010.
22 March 2011
22. marec 2011
The main set of new activities for the Agency derives from the implementation of the pharmacovigilance legislation, which comes into effect in July 2012.
Večji del novih dejavnosti agencije izhaja iz izvajanja zakonodaje o farmakovigilanci, ki bo začela veljati julija 2012.
The Agency will receive a list of questions to which the Agency will reply in order to receive the discharge in June.
Agencija bo prejela seznam vprašanj in odgovorila nanje ter bo razrešnico prejela v juniju.
• The public consultation on the Transparency Directive (a proposal for the review of the Directive may be made by the end of 2011).
• javno posvetovanje o direktivi o preglednosti (predlog za pregled direktive bo izdan do konca leta 2011).
The Agency will provide national competent authorities with individual line listings to enable them to review their own performance.
Agencija bo pristojnim nacionalnim organom posredovala posamezne sezname, s katerimi bodo lahko pregledali uspešnost svojega delovanja.
The Board adopted the establishment plan of 612 posts, which represents an increase of 45 posts required for the preparation and implementation of the pharmacovigilance legislation.
Odbor je sprejel načrt za 612 delovnih mest, kar pomeni 45 novih delovnih mest, potrebnih za pripravo in izvajanje zakonodaje o farmakovigilanci.
• The procedure for the appointment of the Executive Director (the 5 May 2011 meeting of the Board will be maintained as planned).
• postopek za imenovanje izvršnega direktorja (seja odbora bo potekala 5. maja 2011, kot je bilo načrtovano);
Work programme and preliminary draft budget 2012
Delovni program in predhodni predlog proračuna za leto 2012
Update from the meeting of Chairs of the EU agencies
Posodobljene informacije s seje predsednikov agencij EU
Revision of 'Charter of tasks and responsibilities of the Agency's accounting officer'
Revizija „Listine nalog in odgovornosti računovodij agencije“
Annual report 2010
Letno poročilo za leto 2010
This may be due to the decrease in the number of applications and to fluctuations in submission of applications during the year.
To je morda posledica manjšega števila vlog in nihanj v številu predloženih vlog med letom.
Request of the former Executive Director for authorisation of external activities after leaving the service
Prošnja nekdanjega izvršnega direktorja za odobritev zunanjih dejavnosti po odhodu s položaja
Report on the performance of the Agency's scientific procedures: key performance indicators (KPIs) for medicinal products for human and veterinary use
Poročilo o uspešnosti znanstvenih postopkov agencije: glavni kazalniki uspešnosti za zdravila za humano in veterinarsko uporabo
A smaller number of generic medicines in the centralised procedure comes as a result of the European Commission's policy on multiple applications for centrally authorised products.
Manjše število generičnih zdravil v centraliziranih postopkih je posledica politike Evropske komisije o več vlogah za zdravila, odobrena po centraliziranem postopku.
• The progress on the five calls within the process on corporate responsibility in the field of pharmaceuticals: coordinated access to orphan medicinal products, capacity building on contractual agreements for innovative medicines, market access for biosimilars, facilitating supply in small markets and promoting a good governance for non-prescription medicines.
• napredek v zvezi s petimi pozivi v okviru postopka za družbeno odgovornost na področju farmacevtskih izdelkov: usklajen dostop do zdravil sirot, povečevanje zmogljivosti na podlagi pogodbenih sporazumov za inovativna zdravila, vstop biološko podobnih zdravil na tržišče, zagotavljanje oskrbe majhnih trgov in spodbujanje dobrega upravljanja na področju zdravil brez recepta;
The Board noted the paper providing more detail about the ICT projects and budget for 2012.
Odbor se je seznanil z dokumentom, ki vsebuje podrobnosti o projektih IKT in proračun za leto 2012.
These comprised six consultations on new membership in the CHMP and CVMP, the adoption of the non-automatic carryover of appropriations from 2010 to 2011, and the adoption of the minutes of the 69th meeting of the Management Board from 16 December, as indicated below:
To vključuje šest posvetovanj o novem članstvu v odborih CHMP in CVMP, potrditev nesamodejnega prenosa proračunskih sredstev iz leta 2010 v leto 2011 ter potrditev zapisnika 69. seje upravnega odbora z dne 16. decembra, kot je navedeno v nadaljevanju:
The Board asked for information on the management of procurement and recruitment procedures, and on its work in the area of the management of conflicts of interests, to be included in the final work programme.
Odbor je zaprosil za informacije o vodenju postopkov naročanja in zaposlovanja ter o njegovem delu na področju obvladovanja navzkrižja interesov, kar naj bi bilo vključeno v končni delovni program.
Two new agencies joined the meeting.
Seje sta se udeležili dve novi agenciji.
Currently, the Agency provides annual reports drawn up by the internal audit capability and by the Audit Advisory Committee (AAC), as well as final reports from the European Court of Auditors, with the Agency's replies.
Trenutno agencija posreduje letna poročila, ki so bila pripravljena na službi za notranjo revizijo in v Odboru za presojo in svetovanje, ter končna poročila Evropskega računskega sodišča z odgovori agencije.
The Board stressed that the increase in pharmacovigilance and other activities at the Agency's level will mean a higher workload for the national authorities.
Odbor je poudaril, da se bo zaradi večjega obsega dejavnosti na področju farmakovigilance in drugih dejavnosti na ravni agencije povečala delovna obremenitev nacionalnih organov.
A gradual shift from chemical to biological products, and from general to more specialised types of medicines, has also been observed, as has an increase in the number of applications from small and medium-sized enterprises.
Opažen je bil tudi postopen premik od kemičnih k biološkim zdravilom in od splošnih k bolj specializiranim vrstam zdravil ter večje število vlog malih in srednje velikih podjetij.
The group is currently working on a set of documents, including one on the role of the chairs of management boards, to set out best practice in the area.
Skupina trenutno pripravlja sklop dokumentov, vključno z dokumentom, ki bo urejal vlogo predsednikov upravnih odborov, s čimer želi oblikovati najboljšo prakso na tem področju.
This increase is mainly due to the increase in requested EU contribution to finance the implementation of the pharmacovigilance legislation in 2012, as well as an increase in fee income due to the expected increases in workload.
To povečanje je predvsem posledica prošnje za povečanje prispevkov EU za financiranje izvajanja zakonodaje o farmakovigilanci v letu 2012 in povečanja prihodkov iz pristojbin zaradi pričakovanega povečanja delovne obremenitve.
• A meeting with the medical device authorities.
• srečanje z organi za medicinske pripomočke;
The Board noted that the number of new chemical entities and the number of opinions were lower than those received in the previous three years.
Odbor je ugotovil, da je bilo število novih kemičnih sestavin in število mnenj manjše v primerjavi s številom kemičnih sestavin in mnenj, prejetih v preteklih treh letih.
With regard to the transparency of application dossiers, the Board repeated the need to reach an agreement at the EU level among the stakeholders as to what information is considered commercially confidential or constitutes personal data.
Glede preglednosti dokumentacije vlog je odbor ponovno poudaril potrebo po sporazumu med zainteresiranimi stranmi na ravni EU o tem, katere informacije se štejejo za poslovno zaupne ali vsebujejo osebne podatke.
Management Board consultation procedure for CHMP and CVMP nominations: follow-up from December 2010 discussion
Postopek posvetovanja v upravnem odboru za imenovanja v odbora CHMP in CVMP: nadaljevanje razprave iz decembra 2010
The discussion was held behind closed doors and focused on two areas of potential conflict of interests: firstly, whether any activity risked the misuse of confidential or privileged information gained during his leadership of the Agency; and secondly, whether any activity risked improper influence on decisions taken by the Agency.
Razprava je bila zaprta za javnost, v njej pa sta bili izpostavljeni dve morebitni področji navzkrižja interesov: prvič, ali bi se pri opravljanju katere koli dejavnosti pojavilo tveganje za zlorabo zaupnih ali zaščitenih informacij, pridobljenih med njegovim vodenjem agencije; in drugič, ali bi katera koli dejavnost lahko pomenila tveganje za neprimerno vplivanje na sprejete odločitve agencije.
Agenda for 17 March 2011 meeting
Dnevni red za sejo dne 17. marca 2011
The Board also supported the proposals for maintaining the EudraVigilance system until the new functionalities are implemented (in relation to data-quality management, support of EVDAS and the revised implementation of the EudraVigilance Access Policy).
Odbor je podprl tudi predloge za ohranitev sistema EudraVigilance, dokler ne bodo uvedene vse funkcionalnosti (v zvezi z upravljanjem kakovosti podatkov, podporo sistemu EVDAS in pregledanim izvajanjem politike dostopa do sistema EudraVigilance).
• Plans for limited and targeted amendement to the Penalties Regulation (focusing on the scope of the Regulation; a public consultation will be launched in spring 2011).
• načrti za omejeno in ciljno usmerjeno spremembo uredbe o kaznih (s poudarkom na področju uporabe uredbe; javna razprava se bo začela spomladi leta 2011);
At the last meeting, the EMA Chair handed over the chairmanship for the group to the Chair of EFSA.
Na zadnji seji je predsednik agencije EMA predsedovanje skupine predal predsedniku agencije EFSA.
The Chair invited the Board members to volunteer as topic coordinators for the analysis and assessment of the Acting Executive Director's Annual Activity Report 2010.
Predsedujoči je člane odbora pozval, naj prostovoljno prevzamejo mesta tematskih koordinatorjev za analizo in oceno Letnega poročila o dejavnostih za leto 2010 vršilca dolžnosti izvršnega direktorja.
The European Commission drew the attention of the Board to the fact that the EU contribution is still under discussion in the Commission, and that any increase in budget or staff needs to be duly substantiated, particularly in crisis periods.
Evropska komisija je odbor opozorila, da v Komisiji še vedno poteka razprava o prispevku EU ter da je treba zahteve po povečanju proračunskih sredstev ali števila zaposlenih ustrezno utemeljiti, še posebno v obdobju krize.
The conditions set by the Board also require that Mr Lönngren should neither have contact with Agency staff or committee members in the context of his professional activities, nor represent or accompany third parties at meetings with the Agency.
Pogoji, ki jih je sprejel odbor, določajo tudi, da gospod Lönngren pri svojem poslovnem delovanju ne sme biti v stiku z zaposlenimi agencije ali člani odborov, prav tako pa ne sme predstavljati ali spremljati tretjih strank na srečanjih z agencijo.
Held in London on 16-17 March 2011
V Londonu, 16. in 17. marca 2011
The Board was informed that the Director-General for DG SANCO has written to remind the Agency that audit reports need to be provided to the Board.
Odbor je bil seznanjen, da je generalni direktor GD SANCO z dopisom opomnil agencijo, da je treba odboru predložiti revizijska poročila.
Budget 2011
Proračun za leto 2011
Following such a uniform position at the EU level, a proposal can be made at the level of te International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), with a view to changing the format of the dossier to enable automatic publication of application information without releasing information that is commercially confidential or contains personal data.
Po oblikovanju enotnega stališča na ravni EU se lahko pripravi predlog na ravni Mednarodne konference o usklajevanju tehničnih zahtev za registracijo zdravil za uporabo v humani medicini (ICH) z namenom, da se oblika dokumentacije spremeni tako, da bo mogoče samodejno objavljanje informacij o vlogi, ne da bi bile pri tem objavljene informacije, ki so poslovno zaupne ali vsebujejo osebne podatke.
With regard to the staffing for 2011, the Commissioner indicated that the Agency may receive some of the posts requested for 2011.
Komisar je glede zaposlovanja v letu 2011 dejal, da bodo agenciji morda odobrena nekatera delovna mesta, za katera je zaprosila za leto 2011.
The Board concluded that none of the activities as communicated presented a conflict of interests.
Odbor je sklenil, da nobena predstavljena dejavnost ne predstavlja možnega navzkrižja interesov.
The Management Board adopted the preliminary work programme and the preliminary draft budget 2012.
Upravni odbor je sprejel predhodni delovni program in predhodni predlog proračuna za leto 2012.
Following the appointment of Marcus Müllner as Heads of Medicines Agencies (HMA) representative to the Management Board Telematics Committee (MBTC), the Chair invited members to express their interest to represent the Management Board at the MBTC.
Po imenovanju Marcusa Müllnerja kot predstavnika vodij agencij za zdravila v Odbor za telematiko pri upravnem odboru (Management Board Telematics Committee, MBTC) je predsedujoči pozval člane, naj se prijavijo za mesto predstavnika upravnega odbora v odboru MBTC.
If five or more members express their reservations, the chair of the committee concerned will be approached and his/her views sought before finalising the procedure.
Če pet ali več članov izrazi zadržek, bo predsednik zadevnega odbora 1 naprošen, da pred zaključkom postopka izrazi svoje stališče.
The Board indicated that it expects the next Executive Director to inform it of their intentions before the end of their mandate.
Odbor je nakazal, da od prihodnjega izvršnega direktorja pričakuje, da ga bo o svojih namenih obvestil pravočasno in pred koncem mandata.
In case the review will be completed later than the implementation work is due, the Agency requested the European Commission to provide for additional financial resources in the interim period.
Če bo pregled zaključen kasneje, kot je predvideno dokončanje del za izvajanje zakonodaje, je agencija Evropsko komisijo zaprosila, da za vmesno obdobje zagotovi dodatna finančna sredstva.
With regard to financing the implementation of the new pharmacovigilance legislation, the Agency requires significant financial and human resources to accomplish the work.
Za financiranje izvajanja nove zakonodaje o farmakovigilanci agencija potrebuje znatna finančna sredstva in človeške vire za dokončanje dela.
Chair: Pat O'Mahony
Predsedujoči: Pat O'Mahony
The Board agreed on the following strategic steer, allowing for the preparation of the implementation to proceed without delay, while asking the Agency to monitor the situation on an ongoing basis as the implementation of the legislation progresses.
Odbor je potrdil naslednjo strateško usmeritev, ki omogoča, da priprave za izvajanje potekajo brez zamud, agencijo pa je zaprosil, da nenehno spremlja dogajanje med izvajanjem zakonodaje.
In adopting its decision, the Board imposed a set of limitations on these and any future activities for a period of two years after leaving the Agency, including prohibitions on taking managerial and executive positions in the pharmaceutical industry, and on providing product-related advice with regard to activities falling within the remit of the Agency.
Pri sprejemanju odločitev je odbor določil nekatere omejitve teh in morebitnih prihodnjih dejavnosti za obdobje dveh let po odhodu iz agencije, vključno s prepovedjo opravljanja menedžerskih ali izvršnih funkcij v farmacevtski industriji ter prepovedjo svetovanja v zvezi z zdravili na področjih, ki sodijo v pristojnosti delovanja agencije.
• The Mediator case (a stress test was conducted in the context of the new pharmacovigilance legislation).
• primer Mediator (v okviru nove zakonodaje o farmakovigilanci je bilo izvedeno testiranje izjemnih situacij);
The KPIs enable the performance of the newly established cooperation agreements with national competent authorities to be monitored.
Glavni kazalniki uspešnosti omogočajo nadzorovanje izvajanja novih veljavnih sporazumov o sodelovanju s pristojnimi nacionalnimi organi.
• Non-automatic carryover of appropriations from 2010 to 2011, finalised on 13 January 2011.
• Nesamodejni prenos proračunskih sredstev iz leta 2010 v leto 2011, zaključeno 13. januarja 2011.
Apology received
Opravičilo
• The revision of the clinical trials legislation (target for the proposal is the second quarter of 2012).
• pregled zakonodaje o kliničnih preskušanjih (cilj je predlog v drugem četrtletju leta 2012);
Giulia Del Brenna Lenita Lindström Stefaan Van Der Spiegel
Giulia Del Brenna Lenita Lindstrom Stefaan Van Der Spiegel
The Board supported that the EudraVigilance audit should take place by Q4 2014 at the latest.
Odbor se je strinjal, da je treba revizijo sistema EudraVigilance izvesti najkasneje do zadnjega četrtletja leta 2014.
No conflict of interests was declared.
Nihče ni navedel, da obstaja navzkrižje interesov.
The Management Board also suggested considering how the training needs of regulators can be reflected in the projects undertaken under the Innovative Medicines Initiative (IMI).
Upravni odbor je tudi predlagal, da se preučijo potrebe regulativnih organov po usposabljanju in se nato upoštevajo pri projektih, ki se izvajajo v okviru pobude za inovativna zdravila (IMI).
Amendments to the delegate reimbursement rules
Spremembe pravil o povračilu stroškov delegatom
As regards pharmacovigilance implementation, the Commission is starting a review of the Fee Regulation in order for the Agency to charge fees for pharmacovigilance activities as foreseen in the pharmacovigilance legislation.
Glede izvajanja zakonodaje o farmakovigilanci pa je Komisija začela pregled uredbe o pristojbinah, da bi agencija lahko začela zaračunavati pristojbine za farmakovigilančne dejavnosti, kot je predvideno v zakonodaji o farmakovigilanci.
• The next cycle of the Benchmarking of the European Medicines Agencies (BEMA) exercise (the BEMA cycle will follow the five-year period of the HMA strategy and the EMA road map).
• naslednji cikel vaj primerjalnih analiz Evropske agencije za zdravila (BEMA) (cikel BEMA poteka v skladu s petletnim obdobjem strategije vodij agencij za zdravila in časovnega načrta agencije EMA);
• The continued work to clarify the tasks of the EMA and ECDC in the area of substances of human origin (a concept paper is under development; a proposal will be made at the June Management Board meeting).
• Nadaljevanje dela za podrobnejšo pojasnitev nalog agencij EMA in ECDC na področju snovi človeškega izvora (oblikuje se koncept; predlog bo oblikovan na junijski seji upravnega odbora);
The members noted the update report from the European Commission on a range of topics, including the following:
Člani so se seznanili s posodobljenim poročilom Evropske komisije o različnih temah:
The minutes have been published on the Agency's website.
Zapisnik je objavljen na spletni strani agencije.
It attaches great importance to transparency, and, acting in the public interest, requested the Acting Executive Director to publish its decision, together with supporting documents on the EMA website.
Posebej je poudaril pomen preglednosti in zaradi varovanja javnega interesa zaprosil vršilca dolžnosti izvršnega direktorja, da na spletni strani agencije EMA objavi njegovo odločitev, skupaj s podporno dokumentacijo.
However, it remains to be seen whether this is a temporary increase or the level of activity will remain high for a longer period.
Sčasoma se bo pokazalo, ali gre le za začasno ali dolgotrajno povečan obseg delovanja na tem področju.
List of participants
Seznam udeležencev
Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway)
Brigitte Batliner (Lihtenštajn) Gro Ramsten Wesenberg (Norveška)