natgillin/translations-raw huggingface dataset:
The new pharmaceutical legislation also gives the Executive Director, in liaison with the Committee for Medicinal Products for Human Use (CHMP), the responsibility of setting up the administrative structures and procedures allowing the development of scientific advice for companies and sponsors.
Na podlagi nove farmacevtske zakonodaje je izvršni direktor pristojen, da skupaj z Odborom za zdravila za uporabo v humani medicini (CHMP) vzpostavi upravno organiziranost in postopke, ki bodo omogočali razvoj svetovanja za podjetja in sponzorje.
• Rare metabolic diseases affecting the blood or the cardiovascular system in neonates (5 products)
• redke bolezni presnove, ki vplivajo na kri ali kardiovaskularni sistem novorojenčkov (5
The Board elected Hannes Wahlroos as its chairman and re-elected Jytte Lyngvig as vice-chairman.
Odbor je izvolil Hannesa Wahlroosa kot predsednika ter ponovno izvolil Jytte Lyngvig kot podpredsednico.
Seventy-eight GMP inspections were requested in 2004; 40 % of these related to requests for reinspection of sites already inspected two to three years previously.
V letu 2004 je bilo oddanih 78 prošenj za inšpekcijske preglede za dobro proizvodno prakso; 40 % jih je bilo za ponovni pregled lokacij, ki so bile že pregledale dve ali tri leta pred tem.
• Domenica TARUSCIO (Italy)
• Domenica TARUSCIO (Italija)
The EMEA checks compliance of such products distributed in parallel with the appropriate terms of the Community marketing authorisation.
EMEA preverja skladnost takšnih izdelkov, ki so v vzporedni distribuciji, z ustreznimi pogoji Skupnosti za izdajo dovoljenja za promet z zdravilom.
The programme focuses primarily on important breakthrough drugs, and includes a mechanism for the EMEA, FDA and companies to exchange views on scientific issues during the development phase of new medicinal products.
Program je usmerjen predvsem na pomembna zdravila, ki prodirajo na trg, in vključuje mehanizem za izmenjavo mnenj o znanstvenih vprašanjih med EMEA, FDA in podjetji med razvojem novih zdravil.
The EMEA continually supported the Commission and the Member States with the implementation of Directive 2001/20/EC on clinical trials through the activities of the ad hoc meetings of GCP and GMP inspection services, through participation in working groups of the Commission, and through support to the implementation of European databases for clinical trials.
EMEA je nenehno podpirala Komisijo in države članice pri izvajanju Direktive 2001/20/ES o kliničnem preizkušanju z dejavnostmi ad hoc sestankov inšpekcijskih služb za dobro klinično prakso in dobro proizvodno prakso, sodelovanjem v delovnih skupinah Komisije in podporo pri izvajanju evropskih zbirk podatkov o kliničnih preizkušanjih.
Regulatory affairs and organisational support
Zakonske zadeve in organizacijska podpora
Major tasks of the HMPC: preparatory work for the establishment of a draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products; the elaboration of Community herbal monographs for herbal medicinal products with a well-established use and for traditional herbal medicinal products.
Glavne naloge HMPC: priprave za določitev osnutka seznama zeliščnih snovi, pripravkov in njihovih kombinacij za uporabo v tradicionalnih zeliščnih zdravilih; izdelava zeliščnih monografij Skupnosti za zeliščna zdravila, katerih uporaba je dobro uveljavljena, in za tradicionalna zeliščna zdravila.
Systems and procedures are fully in place for the timely back-up and archiving of the EMEA data
V celoti so vpeljani sistemi in postopki za pravočasno varnostno kopiranje in arhiviranje podatkov EMEA.
It became the first product approved by the Agency that plays a role in the treatment of malignant pleural mesothelioma, a rare form of cancer
To je prvi izdelek z odobritvijo Agencije, ki igra vlogo v zdravljenju malignega plevralnega mezotelioma, redke oblike raka;
Initiatives
Pobude
Activities in relation to new and emerging therapies
Dejavnosti, povezane z novimi terapijami
• Inspections of blood establishments to support certification of plasma master files (PMF) were initiated in the second half of 2004 and a new procedure was developed and published.
• Inšpekcijski pregledi zavodov za kri v okviru certificiranja glavnega dosjeja plazme (PMF) so se začeli izvajati v drugi polovici leta 2004 in razvit in objavljen je bil nov postopek.
Eight applications were received in 2004 for PMFs.
Za PMF-je je bilo v letu 2004 prejetih osem vlog.
Each Committee member has an alternate.
Vsak član odbora ima namestnika.
• (Invented) Name Review Group
• Skupina za presojo (izmišljenih) imen
The use of a pneumococcal vaccine was extended to include the age range 2 to 5 years and a new treatment option for children under 6 suffering from haemophilia A was made available.
Uporaba pnevmokoknih cepiv se je razširila tako, da zajema otroke od 2 do 5 let starosti, na voljo pa je tudi nova možnost zdravljenja za otroke s hemofilijo A, mlajše od 6 let.
• The EMEA/CHMP Working Group with Patients Organisations finalised its Recommendations and proposals for action after extensive consultation.
• Delovna skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov je po obsežnem posvetovanju dokončala "Priporočila in predloge za ukrepanje".
Environmental Risk Assessment (temporary working party)
Ocena tveganja za okolje (začasna delovna skupina)
• Margarita ARBOIX (Spain) Alternate: Ricardo de la FUENTE LÓPEZ
• Margarita ARBOIX (Španija) Namestnik: Ricardo de la FUENTE LÓPEZ
• Assessment report templates to harmonise and facilitate the assessment review by the CHMP during the evaluation of the dossier pre-/post-authorisation were updated to take into consideration the changes of the European pharmaceutical legislation, especially Annex 1 of Directive 2001/83/EC.
• Vzorci poročil o oceni so bili posodobljeni, da se uskladi in omogoči revizija vrednotenja, ki jo izvaja CHMP, med presojo dokumentacije pred izdajo dovoljenja za promet in po njej, glede na spremembe v evropski farmacevtski zakonodaji, zlasti Prilogo 1 k Direktivi 2001/83/ES.
The referral was initiated because of safety concerns relating to potential risk of emotional changes and withdrawal reactions associated with the use of paroxetine.
Predložitev se je uvedla zaradi varnostnih vprašanj v zvezi z možnim tveganjem, da bi uporaba paroksetina lahko povzročila čustvene spremembe in zapiranje vase.
To ensure that the help and support available to EMEA staff, delegates and users of EU telematics systems is in line with the Agency s operating requirements
Zagotoviti, da sta pomoč in podpora, ki sta na voljo osebju EMEA, delegatom in uporabnikom telematskih sistemov EU, skladni z obratovalnimi zahtevami Agencije
IT training was provided to all EMEA staff on a regular basis.
Zagotovljeno je bilo redno usposabljanje o IT za vse osebje EMEA.
EMEA contact points and reference documents
Kontaktne osebe in referenčni dokumenti EMEA
This included class labellings for all antiretroviral medicinal products with regard to liver impairment and immune reactivation syndrome, and a statement on mitochondrial toxicity in children with postnatal or in utero exposure to nucleotide and nucleoside analogues.
Te zajemajo "označevanje razreda" za vsa protiretrovirusna zdravila glede poškodbe jeter in sindroma imunske reaktivacije ter izjavo o mitohondrijski toksičnosti pri otrocih, ki so bili postnatalno ali in utero izpostavljeni nukleotidom in nukleosidnim analogom.
4 Inspections
4 Inšpekcijski nadzor
Mutual recognition procedure
Postopek medsebojnega priznavanja
The Agency also began, in July 2004, publishing the name of the active substance (international non-proprietary name, or INN), the orphan condition and the name of the sponsor for all designated orphan drugs submitted for marketing authorisation, in order to improve transparency with regard to orphan medicinal products.
Agencija je julija 2004 začela objavljati tudi naziv zdravilnih učinkovin (mednarodno nelastniško ime, oziroma INN), stanje sirote in ime sponzorja za vsa zdravila, določena za zdravila sirote, za katera je predložena vloga za izdajo dovoljenja za promet z zdravili, da bi izboljšala preglednost, kar zadeva zdravila sirote.
Integrated quality management / audit
Integrirano upravljanje kakovosti /pregledovanje
Other activities in 2004 focused on the quality and consistency of CVMP assessments for centrally authorised products.
Druge dejavnosti v letu 2004 so bile usmerjene na kakovost in skladnost vrednotenja CVMP za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku.
In line with this new responsibility, the CVMP adopted the position paper Procedure to be followed to facilitate communication and dialogue between the CVMP and interested parties .
Glede na to novo nalogo je CVMP sprejel dokument o stališču z naslovom "Postopek za pospešitev obveščanja in dialoga med CVMP in zainteresiranimi stranmi".
Applications are submitted directly to the EMEA.
Vloge se vložijo neposredno na EMEA.
Rui SANTOS IVO Presidente
PORTUGALSKA Rui SANTOS IVO Presidente
In addition to the standing and temporary working parties, the CHMP has created scientific advisory groups (SAGs).
Poleg stalnih in začasnih delovnih skupin je CHMP oblikoval tudi znanstveno-svetovalne skupine.
All variation procedures were handled within the legal timeframes.
Vsi postopki v zvezi s spremembami so bili opravljeni v zakonskih časovnih okvirih.
Assessment phase
Faza vrednotenja
This total includes 3 applications for biosimilar products and 6 multiple applications.
Skupno število vlog zajema 3 vloge za biološko podobne izdelke in 6 večnamenskih vlog.
• Creation of a new EMEA scientific committee: the Committee on Herbal Medicinal Products (HMPC)
• oblikovanje novega znanstvenega odbora EMEA: Odbor za zeliščna zdravila (HMPC);
This reflects the upward trend in the number of applications that has been experienced since the shortfall in 2002, with the highest number of active substances in the past five years.
Iz tega je razvidna tendenca zviševanja števila zahtevkov, ki je prisotna od upada v letu 2002, število zdravilnih učinkovin pa je bilo najvišje v zadnjih petih letih.
Project management
Upravljanje projektov
Often, such guidelines are developed as a result of the EU s cooperation with Japan, the US and other international partners on the harmonisation of regulatory requirements for medicinal products, particularly through the VICH conference, and thus reflect a harmonised approach.
Take smernice se pogosto razvijejo na podlagi sodelovanja EU z Japonsko, ZDA in drugimi mednarodnimi partnerji za uskladitev regulativnih zahtev za zdravila, zlasti konference VICH, in zato odsevajo usklajen pristop.
Three of the orphan product designation applications received in 2004 were from sponsors established in the new Member States.
Izmed vlog za določitev zdravil sirot, prejetih v letu 2004, so bile tri prejete od sponzorjev s sedežem v novih državah članicah.
• John O BRIEN (United Kingdom) Alternate: Martin ILOTT
• John O'BRIEN (Združeno kraljestvo) Namestnik: Martin ILOTT
As part of this, the Board and committees agreed to the publication of the declarations of interests of the members of the Agency s scientific committees on the EMEA website.
V tem okviru so se upravni odbor in znanstveni odbori dogovorili o objavi izjav o interesih članov znanstvenih odborov Agencije na spletni strani EMEA.
ADMINISTRATION
ADMINISTRACIJA
• Emmanuel HÉRON (France)
• Emmanuel HÉRON (Francija)
Applications for extension/modification of maximum residue limits 2002-2004
Vloge za razširitev/spremembo mejnih vrednosti ostankov v obdobju 2002-2004
To implement a new data centre at the EMEA with full switched back-up capability to the existing computer room
Uvesti nov podatkovni center v EMEA z možnostjo popolnega varnostnega kopiranja v obstoječo računalniško sobo
Emiel VAN GALEN (Netherlands) Alternate: Burt H KROES
￭ Emiel VAN GALEN (Nizozemska) Namestnik: Burt H KROES
3.11 Veterinary mutual recognition facilitation group
3.11 Veterinarska skupina za poenostavitev medsebojnega priznavanja
• Ivo CLAASEN (Netherlands) (co-opted)
• Ivo CLAASEN (Nizozemska) (sporazumno izbran)
The EMEA coordinates the verification of compliance with the principles of good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP), and with certain aspects of the supervision of authorised medicinal products in use in the EU, through inspections requested by the CHMP or CVMP in connection with the assessment of marketing authorisation applications and/or the assessment of matters referred to these committees in accordance with Community legislation.
EMEA usklajuje preverjanje skladnosti z načeli dobre proizvodne prakse, dobre klinične prakse in dobre laboratorijske prakse ter z določenimi vidiki nadzorovanja zdravil, za katera je bilo izdano dovoljenje za promet in se uporabljajo v Evropski uniji, z inšpekcijskimi pregledi, ki jih zahtevata CHMP ali CVMP v zvezi z oceno vlog za izdajo dovoljenja za promet in/ali oceno zadev, ki so bile tema odboroma predložene v skladu z zakonodajo Skupnosti.
• André LHOIR (Belgium)
• André LHOIR (Belgija)
After two years of decline, 2004 saw a recovery in the number of applications submitted to the EMEA for products containing new active substances.
Po dveh leti upadanja se je v letu 2004 število vlog, predloženih EMEA za izdelke, ki vsebujejo nove zdravilne učinkovine, povečalo.
EPARs were made public in all official languages within four weeks of the European Commission adopting its decision.
Evropska javna poročila o oceni zdravila (EPARs) so bili objavljeni v vseh uradnih jezikih v štirih tednih po tem, ko je Evropska komisija sprejela odločitev.
Scientific advice (SA) activity increased in 2004.
Dejavnost znanstvenega svetovanja se je v letu 2004 povečala.
One of these related to SSRI (serotonin selective reuptake inhibitor) and SNRI (serotonin-norepinephrine reuptake inhibitor) products, in particular regarding the use of these products in children and adolescents.
Prva presoja varnosti je obravnavala zdravila SSRI (selektivni inhibitorji ponovnega privzema serotonina) in SNRI (inhibitorji ponovnega privzema serotonin-norepinefrina), zlasti glede uporabe teh zdravil pri otrocih in mladostnikih.
IT projects and operational activities
Projekti IT in operativne dejavnosti
Following the paroxetine referral, the Committee conducted a review of data available for the whole class of SSRI (serotonin selective reuptake inhibitor) and SNRI (serotonin-norepinephrine reuptake inhibitor) products at the request of the European Commission.
Po predložitvi paroksetina je Odbor na zahtevo Evropske komisije pregledal podatke, ki so na voljo za ves razred zdravil SSRI (selektivni inhibitorji ponovnega privzema serotonina) in SNRI (inhibitorji
• Markku TOIVONEN (Finland) Alternate: Riita TOKOLA8
• Markku TOIVONEN (Finska) Namestnik: Riita TOKOLA8
Piotr BLASZCZYK (Alternate: Jacek SPLAWINSKI)
Piotr BLASZCZYK (namestnik: Jacek SPLAWINSKI)
Electronic submission
Elektronsko pošiljanje
The EMEA, through its Committee for Medicinal Products for Human Use (CHMP), conducts a thorough scientific evaluation of all new applications for marketing authorisation concerning medicinal products for human use submitted through the Community or centralised procedure.
EMEA prek Odbora za zdravila za uporabo v humani medicini (CHMP) opravi temeljito znanstveno vrednotenje vseh novih vlog za izdajo dovoljenja za promet za zdravila za uporabo v humani medicini, ki so vložene prek Skupnosti ali po "centraliziranem" postopku.
Sponsors of designated orphan medicinal products are entitled to reductions on fees levied by the EMEA for protocol assistance, marketing authorisation applications and other regulatory procedures.
Sponzorji zdravil, določenih za zdravila sirote, so upravičeni do znižanj pristojbin, ki jih EMEA zaračunava za pomoč pri protokolu, vloge za dovoljenje za promet z zdravili in druge regulativne postopke.
In 2004, a total of 51 new applications for marketing authorisation were received under the centralised procedure.
V letu 2004 je bilo prejetih skupaj 51 novih vlog za izdajo dovoljenja po centraliziranem postopku.
• A first iteration forming the basis of the first production system restricted to data on products that have been approved using the centralised procedure was completed and demonstrated at the end of 2004
• ob koncu leta 2004 je bila končana in predstavljena prva ponovitev, ki je podlaga za prvi proizvodni sistem, omejen na podatke o izdelkih, za katere je bilo izdano dovoljenje po centraliziranem postopku.
Documentation services
Dokumentacijske službe
• Ioannis MALEMIS (Greece) Alternate: Orestis PAPADOPOULOS
• Ioannis MALEMIS (Grčija) Namestnik: Orestis PAPADOPOULOS
The Agency finalised the procedures well within the defined time limits.
Agencija je dokončno oblikovala postopke v za to določenih rokih.
• A CVMP audit was completed in October 2004 and four opportunities for improvement resulted; action plans addressing the concerns highlighted were finalised and submitted to the EMEA IQM team.
• oktobra 2004 je bila opravljena revizija CVMP, ki je pokazala "štiri priložnosti za izboljšanje"; akcijski načrti glede glavnih vprašanj so bili zaključeni in predloženi skupini EMEA za integrirano upravljanje kakovosti.
The Internal Audit Function of the Agency was formalised in 2004.
V letu 2004 je bila uradno oblikovana funkcija notranje revizije.
Ingolf J PETERSEN (Alternate: Rannveig GUNNARSDÓTTIR)
Ingolf J PETERSEN (namestnik: Rannveig GUNNARSDÓTTIR)
A new Procedure for coordinating pre-approval inspections in the context of plasma master file certification (SOP/INSP/2009) was developed, agreed and published on the EMEA website.
Razvit in dogovorjen je bil nov "Postopek za usklajevanje inšpekcijskih pregledov pred odobritvijo v okviru certificiranja glavnega dosjeja plazme" (SOP/INSP/2009), ki je bil objavljen na spletnih straneh EMEA.
• Pekka KURKI1 (Finland) (co-opted)
• Pekka KURKI1 (Finland) (sporazumno izbran)
Robert SCHLÖGEL (Alternate: Christian KALCHER)
Robert SCHLÖGEL (namestnik: Christian KALCHER)
The Committee on Herbal Medicinal Products (HMPC) held its inaugural meeting on 23 September 2004.
Ustanovitveno zasedanje Odbora za zeliščna zdravila (HMPC) je bilo 23. septembra 2004.
EMEA and WHO representatives participated in each other s meetings to discuss matters of global significance, such as tropical diseases, influenza pandemics, pharmacovigilance and consultations on international non-proprietary names (INNs).
Predstavniki EMEA in WHO so sodelovali na sestankih obeh strani, na katerih so razpravljali o vprašanjih svetovnega pomena, kot so tropske bolezni, pandemija influence, farmakovigilanca in posvetovanja o mednarodnih nelastniških imenih (INN).
Neurology/CNS
Nevrologija/CŽS
• Gabriel BEECHINOR (Ireland)
• Gabriel BEECHINOR (Irska)
Data centre
Podatkovni center
In total, 61 518 ICSRs were reported electronically to EudraVigilance in 2004, referring both to reports for centrally authorised medicinal products as well as those authorised through the mutual recognition and national procedures.
V letu 2004 je bilo v EudraVigilance prijavljenih skupaj 61.518 ICSR-jev, ki so se nanašali na poročila za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku, kot tudi na zdravila, za katera je bilo izdano dovoljenje po medsebojnem priznanju in nacionalnih postopkih.
• Provision for the CHMP to give scientific opinions in the context of cooperation with the WHO for the use of medicines outside the EU
• določitev, da CHMP daje znanstvena mnenja v okviru sodelovanja z WHO za uporabo zdravil zunaj EU.
Per CLAESON (Sweden) Alternate: Ubonwan CLAESON
￭ Per CLAESON (Švedska) Namestnik: Ubonwan CLAESON
Other medicinal products were approved for use in combination with other chemotherapy to treat metastatic breast cancer, non-Hodgkins lymphoma and metastatic prostate cancer.
Druga zdravila so bila odobrena za uporabo v kombinaciji z drugo kemoterapijo za zdravljenje metastatičnega raka dojk, nehodgkinovega limfona in metastatičnega raka prostate.
• Giuseppe NISTICÒ (Italy) Alternate: Pasqualino ROSSI
• Giuseppe NISTICÒ (Italija) Namestnik: Pasqualino ROSSI
The EMEA s ten years of operations have proven that both EU citizens and the pharmaceutical industry benefit from centralised medicines control and supervision.
EMEA je v desetih letih delovanja dokazala, da centraliziran nadzor in spremljanje zdravil koristita državljanom EU in tudi farmacevtski industriji.
Use of EU special contribution for orphan medicines 2004
Poraba posebnega prispevka EU za zdravila sirote v letu 2004
In the anti-HIV area, several variations were implemented in 2004 to add important safety information to relevant SPCs.
Na področju boja proti HIV je bilo v letu 2004 uvedenih več sprememb, s katerimi so se dodale pomembne informacije o varnosti v ustrezne povzetke glavnih značilnosti zdravil (SPC).
• Kerstin WESTERMARK (Sweden)
• Kerstin WESTERMARK (Švedska)
• All requests for GMP, GCP (including pharmacovigilance) and GLP inspections relating to applications for products through the centralised procedure were successfully coordinated and managed within the timeframes laid down in Community law and to the standards required in the Agency s quality management system.
• Vse zahteve za inšpekcijski nadzor za dobro proizvodno prakso, dobro klinično prakso (vključno s farmakovigilanco) in dobro laboratorijsko prakso glede vlog za zdravila po centraliziranem postopku so bile uspešno usklajene in obravnavane v časovnih okvirih, ki jih določa zakonodaja Skupnosti, in v skladu s standardi, ki jih zahteva sistem Agencije za upravljanje kakovosti.
• A new non-steroidal anti-inflammatory medicinal product (NSAID) belonging to the coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) medicated protaglandin synthesis, for relief of pain and inflammation associated with osteoarthritis in dogs
• novo nesteroidno protivnetno zdravilo (non-steroidal anti-inflammatory medicinal product, NSAID) iz skupine koksibov, ki deluje na podlagi selektivne inhibicije ciklooksigenaze-2 (COX-2) zdravilne sinteze prostaglandina, za lajšanje bolečine in vnetja pri osteoartritisu psov;
This includes: ensuring best practice in document and records management; verifying the quality of all published documents; and verifying the accuracy of translations.
dokumentov in poročil, preverjanje kakovosti vseh objavljenih dokumentov ter preverjanje točnosti prevodov.
Pre-submission meetings are offered to companies before they submit requests for SA/PA, during which the EMEA can provide regulatory information and scientific support on how to submit their requests, the required information and the most suitable format.
Pred vložitvijo zahtevka za znanstveno svetovanje ali pomoč pri protokolu so podjetjem na voljo sestanki pred oddajo vloge, na katerih lahko EMEA zagotovi regulativne informacije in znanstveno podporo glede vložitve zahtevka ter zagotovi zahtevane informacije in najprimernejšo obliko.
4.2 Mutual recognition agreements
4.2 Sporazumi o medsebojnem priznavanju
• Neuropsychiatric disorders, such as epilepsy, depression, Parkinsons disease or severe pain (7 products)
• nevropsihiatrične motnje, kot so epilepsija, depresija, parkinsonova bolezen ali huda bolečina
A further new transparency initiative started in September 2004: COMP press releases and CHMP monthly reports now list all designated orphan medicinal products that have been the subject of a marketing authorisation application submitted since July 2003.
Septembra 2004 se je začela izvajati nova pobuda za večjo preglednost: v sporočilih za javnost COMP in mesečnih poročilih CHMP je zdaj objavljen seznam vseh zdravil, določenih za zdravila sirote, za katere je bila vložena vloga za dovoljenje za promet z zdravili od julija 2003.
The objective of introducing greater consistency in the triggering of investigations following receipt of pharmacovigilance reporting has been progressed by the release for consultation of a guideline by the CVMP on this topic in June 2004.
Dosežen je bil napredek glede cilja uvedbe večje skladnosti pri uvedbi preiskav po prejemu poročil o farmakovigilanci, ko je CVMP junija 2004 predstavil smernice o tej temi za posvetovanje.