natgillin/translations-raw huggingface dataset:
• The EMEA, together with the Inspections Telematics Implementation Group, began to work on the deployment of an inspections database which comprises information about all inspections activities carried out in the European system
• EMEA je skupaj s skupino za izvedbo telematike pri inšpekcijskih pregledih začela razvijati zbirko podatkov o inšpekcijskih pregledih, ki zajema podatke o vseh dejavnostih inšpekcijskega nadzora, izvajajočih se v evropskem sistemu.
Time (days)
Čas (v dnevih)
Observers Iceland
Opazovalci Islandija
• Approved nominations from Member States for new composition of the CHMP and CVMP
• odobritev imenovanih članov iz držav članic za novo sestavo CHMP in CVMP
2.8 Management and organisation of EMEA scientific committees for human medicines
2.8 Upravljanje in organizacija znanstvenih odborov EMEA za zdravila za uporabo v humani medicini
The standard operating procedure (SOP) and web guidance document were revised considerably, taking into account comments received from interested parties.
Standardni operativni postopek in spletni usmeritveni dokument sta bila precej spremenjena glede na pripombe, prejete od zainteresiranih strani.
Since July 2004, additional details of COMP opinions have been published in the COMP press release.
Od julija 2004 se objavljajo dodatne podrobnosti mnenj COMP v njegovem sporočilu za javnost.
In May 2004, the composition of the COMP increased to 31 members as the Committee welcomed members from the 10 new EU Member States.
Maja 2004 se je sestava COMP povečala na 31 članov, saj so se Odboru pridružili člani iz 10 novih držav članic.
This figure includes 6 positive opinions for designated orphan medicinal products, and relates to a total of 29 new active substances.
Od tega je bilo 6 pozitivnih mnenj za zdravila, določena za zdravila sirote, obravnavano pa je bilo skupaj 29 novih zdravilnih učinkovin.
The CVMP nominated additional members as follows: one expert on quality aspects of biotechnology products; three experts on clinical medicine (one for companion animals, one for large animals and one for intensive production, with a focus on poultry); and one expert on safety and risk assessment.
CVMP je izbral naslednje dodatne člane: enega strokovnjaka za kakovost biotehnoloških zdravil, tri strokovnjake za klinično medicino (en za hišne živali, en za velike živali in en za intenzivno proizvodnjo s poudarkom na perutnini) ter enega strokovnjaka za oceno varnosti in tveganja.
• The CHMP reviewed and gave a positive opinion for the first proteosome inhibitor, which is indicated for the treatment of a form of cancer of the blood
• CHMP je pregledal in dal pozitivno mnenje za prvi inhibitor proteaze, ki je indiciran za zdravljenje oblike raka krvi;
The Committee for Medicinal Products for Human Use (CHMP), the Committee on Orphan Medicinal Products (COMP) and the Committee on Herbal Medicinal Products (HMPC) are responsible for formulating the Agency's opinions on all questions concerning medicinal products for human use.
Odbor za zdravila za uporabo v humani medicini (CHMP), Odbor za zdravila sirote (COMP) in Odbor za zeliščna zdravila (HMPC) so odgovorni za oblikovanje mnenj Agencije o vseh vprašanjih v zvezi z zdravili za uporabo v humani medicini.
A new data centre was constructed in 2004 with storage mirroring capability and critical redundant services deployed, combined with the implementation of a new LAN with sophisticated data switching equipment at the EMEA.
V letu 2004 je bil zgrajen nov podatkovni center z uvedeno možnostjo zrcalnega shranjevanja in pomembnimi storitvami odvečnih podatkov skupaj z izvedbo novega LAN z visoko razvito opremo za prehod podatkov v EMEA.
The EMEA contributed to the further development of the European risk management strategy and further developed the Agency s component thereof.
EMEA je prispevala k nadaljnjemu razvoju evropske strategije obvladovanja tveganja in je še naprej razvijala sodelovanje Agencije v tej strategiji.
To obtain a marketing authorisation for a veterinary medicinal product intended for use in food-producing species, so-called maximum residue limits (MRLs) for all pharmacologically active substances must be established in advance for the animal species concerned and for its relevant tissues or products, e.g. meat, milk, honey etc. An MRL is the safe level of residue in food that can be consumed by a person every day over a lifetime without it causing a harmful effect.
Za pridobitev dovoljenja za promet z veterinarski zdravilom za uporabo pri vrstah, namenjenih proizvodnji hrane, je treba vnaprej določiti tako imenovane mejne vrednosti ostankov (maximum residue limits, MLR) vseh farmakološko zdravilnih učinkovin za zadevne živalske vrste in njihova tkiva ali proizvode, kot so meso, mleko, med itd. MRL je varna raven ostankov v hrani, ki jih lahko oseba vse življenje uživa vsak dan, ne da bi to imelo škodljive učinke.
• The EMEA provided support for the implementation of the Clinical Trials Directive, ensuring the successful rollout of the European clinical trials database (EudraCT) in line with the legal deadline of 1 May 2004.
• EMEA je zagotovila podporo za izvajanje Direktive o kliničnem preizkušanju ter uspešno uvajanje zbirke podatkov evropskih kliničnih preizkušanj (EudraCT) v skladu z zakonskim rokom - 1. maj 2004.
The CHMP can request the involvement of the Pharmacovigilance Working Party and, in cases where specialised scientific input is needed, it can draw additional expertise from a pool of pharmacovigilance experts.
CHMP lahko zahteva sodelovanje delovne skupine za farmakovigilanco, kadar so potrebni specializirani znanstveni prispevki, pa lahko črpa dodatno strokovno znanje iz skupine strokovnjakov za farmakovigilanco.
As part of the Agency s efforts to improve its structures and procedures, and as a follow-up to an audit of the former CPMP held in 2003, an EMEA action plan for the improvement of the Agency s core procedures and CHMP activities was developed.
V okviru prizadevanj Agencije, da bi izboljšala svoje strukture in postopke, je bil kot nadaljnji ukrep po reviziji nekdanjega CPMP, ki je bila opravljena v letu 2003, razvit akcijski načrt EMEA za izboljšanje osnovnih postopkov Agencije in dejavnosti CHMP.
The composition of the Management Board changed in May 2004 with the entry into force of Regulation (EC) No 726/20041.
Sestava upravnega odbora se je spremenila maja 2004, ko je začela veljati Uredba (ES) št. 726/20041.
New applications (by medicinal product) New applications (by active substance) Orphan medicinal products (included in total applications)
Nove vloge (po zdravilih) Nove vloge (po zdravilnih učinkovinah) Zdravila sirote (vključena v celotno število vlog)
In addition, the EMEA contributed to the work undertaken at the level of the Heads of Medicines Agencies on further development of the European Risk Management Strategy.
EMEA je poleg tega prispevala k prizadevanjem na ravni vodij agencij za zdravila za nadaljnji razvoj evropske strategije obvladovanja tveganja.
The smooth operation of EMEA internal information technology systems is critical to the Agency s ability to perform its tasks.
Nemoteno delovanje interne informacijske tehnologije v EMEA je nujno za opravljanje nalog Agencije.
IT deployed a support team to prepare for the handover of EDMS into production.
IT je s pomočjo podporne skupine pripravila prenos EDMS v proizvodnjo.
A USR procedure is a rapid, 24-hour regulatory process used to change the product information provided to prescribers and users of a medicine.
USR je hiter 24-urni regulativni postopek, ki se uporablja za spremembo informacij o zdravilu, namenjenih tistim, ki zdravilo predpisujejo in uporabljajo.
Following entry into force of Title IV of Regulation (EC) No 726/2004 on 20 May 2004, a new Committee structure came into effect from June 2004 with one member per country.
Po uveljavitvi naslova IV Uredbe (ES) št. 726/2004 20. maja 2004 je od junija 2004 začela veljati nova sestava Odbora s po enim članom iz vsake države.
• Harrie J J SEEVERENS (Netherlands)
• Harrie J J Seeverens (Nizozemska)
This evaluation process determines whether a product for which a marketing authorisation is sought satisfies the quality, safety and efficacy requirements set out in EU legislation.
S takim postopkom vrednotenja se ugotovi, ali zdravilo, za katerega je vložena vloga za izdajo dovoljenja za promet z zdravili, izpolnjuje zahteve po kakovosti, varnosti in učinkovitosti, določene v zakonodaji EU.
The Agency also participated in international activities of the Codex Alimentarius, the World Organisation for Animal Health (OIE) and the European Directorate for the Quality of Medicines (EDQM)/European Pharmacopoeia.
Agencija je sodelovala tudi v mednarodnih dejavnostih Codexa Alimentariusa, Mednarodnega urada za živalske kužne bolezni (OIE) in Evropskega direktorata za kakovost zdravil (EDQM)/Evropska farmakopeja.
This rapid USR procedure is followed by a formal variation to the marketing authorisation of the medicine.
Temu hitremu postopku USR sledi uradna sprememba dovoljenja za promet z zdravilom.
Regulatory and procedural guidance or advice is provided to the pharmaceutical industry during the lifecycle of medicinal products, starting from pre-submission meetings with applicants through to annual meetings with marketing authorisation holders (MAHs).
Regulativne in postopkovne smernice ali svetovanje se farmacevtski industriji zagotavljajo med življenjskim ciklom zdravil, od sestankov z vlagatelji pred oddajo vloge do letnih sestankov z imetniki dovoljenja za promet.
The EMEA also works closely with the DirectoratesGeneral for Health and Consumer Protection and for Research.
EMEA tesno sodeluje tudi z Generalnim direktoratom za zdravje in varstvo potrošnikom ter Generalnim direktoratom za raziskave.
Official batch release excluded
Izključena sprostitev uradne serije
Pat O MAHONY (Alternate: Joan GILVARRY)
Pat O'MAHONY (namestnik: Joan GILVARRY)
Forty-five periodic safety update reports (PSURs) were received as forecast and were reviewed by the CVMP based on in-depth reviews provided by the rapporteur.
Kot je bilo predvideno, je bilo prejetih 45 periodično dopolnjenih poročil o varnosti (periodic safety update reports, PSUR), ki jih je CVMP pregledal na podlagi poglobljenih revizij, ki jih je zagotovil poročevalec.
One product can now be used to treat children over 3 years of age suffering from hepatitis C, in combination with an antiviral medicine.
Eno zdravilo se zdaj lahko uporablja za zdravljenje otrok, starejših od 3 let, ki so zboleli za hepatitisom C, v kombinaciji s protivirusnim zdravilom.
It held a public consultation exercise relating to the EMEA Road Map to 2010 discussion paper and a consultation on recommendations for better provision of information to patients.
Opravila je tudi javno posvetovanje v zvezi s posvetovalnim dokumentom o usmeritvenem načrtu EMEA do leta 2010 in posvetovanje o priporočilih za boljše zagotavljanje informacij bolnikom.
Delegates and meetings
Delegati in srečanja
An oral report on the activities of the VMRFG was provided at each CVMP meeting in 2004.
Na vsakem sestanku CVMP v letu 2004 je bilo predstavljeno ustno poročilo o dejavnostih VMRFG.
In the EMEA Road Map, the Agency has developed a strategy that will help to stimulate innovation and research in the EU pharmaceutical, biotechnology and healthcare industries for the development of medicinal products.
Agencija je v usmeritvenem načrtu EMEA razvila strategijo, ki bo spodbudila inovacije in raziskave v farmacevtskem, biotehnološkem in zdravstvenem sektorju EU za razvoj zdravil.
In 2004, further assistance to sponsors was provided in a number of cases by conducting presubmission teleconferences to spare them the travel costs associated with pre-submission meetings.
V letu 2004 je sponzorjem večkrat pomagala tudi z izvedbo telekonferenc pred oddajo vloge, da bi jim prihranila stroške potovanja, povezane s sestanki pred oddajo vloge.
Of all type-II variation opinions adopted in 2004, 5.3 % related to extension of indication, 46.3 % related to changes in the SPC and 48.4 % related to quality.
Od vseh mnenj glede sprememb tipa II, sprejetih v letu 2004, se jih je 5,3 % nanašalo na razširitev terapevtskih indikacij, 46,3 % na spremembe povzetka glavnih značilnosti zdravila (SPC) in 48,4 % na kakovost.
The provision of scientific advice is a priority area for the EMEA as it benefits companies developing new medicinal products and thus contributes to the availability of innovative medicines for EU citizens.
Znanstveno svetovanje je za EMEA prednostno področje, saj je koristno za podjetja, ki razvijajo nova zdravila, in tako prispeva k razpoložljivosti inovativnih zdravil za državljane EU.
Of the requests for scientific advice and protocol assistance finalised in 2004, two thirds related to clinical aspects of the development of medicinal products.
Dve tretjini zahtevkov za znanstveno svetovanje in pomoč pri protokolu, ki so bili dokončno obravnavani v letu 2004, se je nanašalo na klinične vidike razvoja zdravil.
The report also summarises the operation of the decentralised (mutual recognition) procedure in accordance with Article 38(1) of Council Directive 2001/83/EC on the Community code relating to medicinal products for human use as amended by Directive 2004/27/EC and Article 42(1) of Council Directive 2001/82/EC as amended by Directive 2004/28/EC.
Poročilo povzema tudi delovanje decentraliziranega postopka (medsebojno priznavanje) v skladu s členom 38(1) Direktive Sveta 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini, kakor je bila spremenjena z Direktivo 2004/27/ES, in členom 42(1) Direktive Sveta 2001/82/ES, kakor je bila spremenjena z Direktivo 2004/28/ES.
A total of 27 recruitment procedures were carried out in 2004.
V letu 2004 je bilo opravljenih skupaj 27 postopkov zaposlovanja.
In addition, guidance documents on how to further improve the centralised procedure and the functioning of the CHMP and its working parties have been drafted, finalised or are still being discussed at Committee level.
Usmeritveni dokumenti za nadaljnje izboljšanje centraliziranega postopka in delovanja CHMP in njegovih delovnih skupin so pripravljeni, dokončani ali pa se o njih še vedno razpravlja na ravni Odbora.
• Adopted new policy on the handling of declarations of interests, and agreed to the publication of the declarations of interests of scientific committee members on the EMEA website
• sprejetje nove politike glede obravnave izjav o interesih in odobritev objave izjav o interesih članov znanstvenih odborov na spletni strani EMEA
In 2004, the Management Board focused on the preparation of the EMEA Road Map to 2010.
V letu 2004 se je upravni odbor osredotočil na pripravo usmeritvenega načrta ("Road Map") EMEA do leta 2010.
Important responsibilities of the CVMP include the preparation of regulatory guidelines for the veterinary pharmaceuticals industry as well as the provision of assistance to companies researching and developing new veterinary medicines.
Med pomembne naloge CVMP sodi priprava regulativnih smernic za veterinarske farmacevtske izdelke ter zagotavljanje pomoči podjetjem, ki raziskujejo in razvijajo nova veterinarska zdravila.
Of these, phase-I clinical trials represented 15 %, compared to 18 % the year before, and 68 % related to phase-III trials.
Izmed teh jih je bilo 15 % povezanih s kliničnimi preizkušanji I. faze (v primerjavi z 18 % v preteklem letu), 68 % pa se jih je nanašalo na preizkušanja III. faze.
The CVMP Pharmacovigilance Working Party continues to advise the Committee on pharmacovigilance issues and, in 2004, reviewed even more issues relating to the safety of nationally approved products, underlining the benefits of the good working relationship that exists between the EMEA, CVMP and Member States with regard to ensuring adequate safety monitoring of products in the market place.
Delovna skupina CVMP za farmakovigilanco še naprej svetuje Odboru glede vprašanj farmakovigilance in v letu 2004 je pregledala še več vprašanj glede varnosti nacionalno odobrenih izdelkov, s čimer poudarja koristi dobrega delovnega odnosa med EMEA, CVMP in državami članicami, kar zadeva zagotavljanje ustreznega spremljanja varnosti izdelkov na trgu.
• Sigurður B THORSTEINSSON (Iceland)
• Sigurður B Thorsteinsson (Islandija)
In 2004, the CVMP met 11 times and held 2 informal meetings.
V letu 2004 je imel CVMP 11 zasedanj in 2 neformalna sestanka.
PAT is a system for designing, analysing and controlling manufacturing through the timely measurement (i.e. during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality (= identifying and monitoring factors that affect product quality).
PAT je sistem načrtovanja, analiziranja in nadzorovanja proizvodnje s pravočasnim merjenjem (to je med predelavo) pomembnih značilnosti glede kakovosti in učinkovitosti surovin in vmesnih materialov ter procesov z namenom, da se zagotovi kakovost končnega izdelka (ugotavljanje in spremljanje dejavnikov, ki vplivajo na kakovost izdelka).
One application involved collaboration with the Food and Drug Administration (FDA) on a parallel protocol assistance procedure, which was also subject to a follow-up procedure.
Pri enem zahtevku je šlo za sodelovanje z Upravo ZDA za hrano in zdravila (FDA) glede postopka vzporedne pomoči pri protokolu, za katerega se je opravil tudi nadaljnji postopek.
All relevant staff were trained on the changes introduced.
Usposabljanje glede uvedenih sprememb je bilo opravljeno za vse zadevno osebje.
The safety of medicines was once again in the spotlight in 2004, with two major classes of nationally authorised medicinal products causing serious public concern COX-2s and SSRIs both of which the EMEA conducted safety reviews of.
Varnost zdravil je bila v letu 2004 ponovno v središču pozornosti, saj sta dva pomembna razreda nacionalno odobrenih zdravil povzročila javno zaskrbljenost, in sicer COX-2 in SSRI, za katera je EMEA opravila preglede varnosti.
These details include the name of the medicinal product, the orphan indication and the name of the sponsor.
Te podrobnost zajemajo ime zdravila, navedbo sirota in ime sponzorja.
The workload arising from the handling of periodic safety updates, follow-up measures and specific obligations decreased slightly compared to 2003, owing partly to a decrease in the number of marketing authorisation applications received at the EMEA in the years 2002 and 2003.
Delovna obremenitev glede obravnave periodično dopolnjenih poročil o varnosti, nadaljnjih ukrepov in posebnih obveznosti se je v primerjavi z letom 2003 nekoliko zmanjšala, kar je delno posledica manjšega števila vlog za izdajo dovoljenja za promet z zdravili, ki jih je EMEA prejela v letih 2002 in 2003.
• New scientific advisory groups were set up to replace the former therapeutic advisory groups as a result of the entry into force of Title IV of Regulation (EC) No 726/2004.
• Ustanovljene so bile nove znanstvenosvetovalne skupine, ki so nadomestile prejšnje svetovalne skupine za terapevtsko področje, kar je posledica začetka veljavnosti naslova IV Uredbe (ES) št. 726/2004.
The CHMP gave 2 opinions on referrals under Article 29 and 2 opinions on referrals under Article 30.
CHMP je sprejel 2 mnenji o predložitvah v skladu s členom 29 in 2 mnenji o predložitvah v skladu s členom 30.
Hannes Wahlroos (Alternate: Pekka JÄRVINEN)
Hannes Wahlroos (namestnik: Pekka JÄRVINEN)
This brings the total to 5 national competent authorities and 39 pharmaceutical companies in production with EudraVigilance at the end of 2004.
Ob koncu leta 2004 je tako z EudraVigilance sodelovalo skupaj 5 pristojnih nacionalnih organov in 39 farmacevtskih podjetij.
As expected, the workload in dealing with product defects and deviations increased, mainly due to the greater number of centrally authorised products on the market and a growing awareness of Industry s responsibilities to keep the EMEA informed.
Kot je bilo pričakovano, se je delovna obremenitev pri obravnavi pomanjkljivosti in odstopanj povečala predvsem zaradi večjega števila zdravil na trgu, za katera je bilo izdano dovoljenje po centraliziranem postopku, in vse večje ozaveščenosti o odgovornosti industrije za obveščanje EMEA.
• Yann LE CAM (patients organisation representative) (vice-chairman)
• Yann LE CAM (predstavnik organizacije bolnikov) (podpredsednik)
Method transfer problems occur in particular when the description of testing procedures by the companies is not sufficiently detailed.
Težave pri prenosu metode se pojavijo zlasti, kadar podjetja ne opišejo
Almost half of the orphan medicinal products designated in 2004 are indicated for conditions that affect children.
Skoraj polovica zdravil sirot, določenih v letu 2004, je namenjenih zdravljenju bolezni, ki prizadenejo otroke.
This more than triples the number requested in 2003 and results from an increase in the number of applications, the impact of applications for biosimilar medicinal products, and a number of inspections for pharmacovigilance purposes.
To več kot trikrat presega število prošenj iz leta 2003, kar je posledica povečanja števila vlog, učinka vlog za biološko podobna zdravila in številnih inšpekcijskih pregledov za namene farmakovigilance.
• The organisational and structural changes to the Agency and its scientific committees following the entry into force of Title IV of Regulation (EC) No 726/2004 were successfully implemented.
• Uspešno so bile izvedene organizacijske in strukturne spremembe v Agenciji in njenih znanstvenih odborih, ki so sledile, ko je začel veljati Naslov IV Uredbe (ES) št. 726/2004.
The Agency also provides secretarial support to the Joint CHMP/CVMP Quality Working Party (QWP) that continued with the development of EU quality guidelines, support to ICH, and cooperation with the European Directorate for the Quality of Medicines (EDQM).
Agencija zagotavlja tudi podporo sekretariata Skupni delovni skupini CHMP/CVMP za kakovost (Quality Working Party, QWP), ki je še naprej razvijala smernice kakovosti EU, zagotavljala podporo za ICH in sodelovala z Evropskim direktoratom za kakovost zdravil (EDQM).
For example, within the EMEA, the implementation of an extensive firewall combined with the segmented 3-tier architecture ensures high levels of protection
Na primer izvedba obsežnega požarnega zidu v kombinaciji s segmentirano triplastno strukturo znotraj EMEA zagotavlja visoke ravni zaščite.
This represents an increase of 10 % over 2003.
To je 10 % več kot v letu 2003.
Those applications for which a pre-submission meeting was held were of higher quality, as measured by time to validation, which was 30 % shorter on average than for applications for which no presubmission discussion took place.
Vloge, za katere je bil opravljen sestanek pred oddajo vloge, so bile višje kakovosti, kar se lahko izmeri s časom do potrditve, ki je bil povprečno za 30 % krajši kot za vloge, za katere ni bil opravljen sestanek pred oddajo vloge.
Including validation time, the overall procedure took 102 days on average.
Vključno s časom odobritve je celoten postopek trajal povprečno 102 dneva.
The EMEA is responsible for the implementation and the operational aspects of these MRAs.
EMEA je odgovorna za izvajanje in operativne vidike sporazumov.
In addition, the notification of the parallel distribution of centrally authorised medicinal products to the EMEA became mandatory on 20 May 2004, in accordance with Title IV of Regulation (EC) No 726/2004.
Drugič, obveščanje EMEA o vzporedni distribuciji zdravil, za katera je bilo izdano dovoljenje po centraliziranem postopku, je od 20. maja 2004 obvezno v skladu z naslovom IV Uredbe (ES) št. 726/2004.
EudraVigilance version 7.0 was launched in May 2004, including a Clinical Trial module (EVCTM) to support the electronic reporting of suspected unexpected serious adverse reactions (SUSARs) occurring during clinical trials.
Maja 2004 se je začela izvajati različica EudraVigilance 7.0, ki vključuje modul kliničnih preizkušanj (EVCTM) kot podporo za elektronsko poročanje sumov na resne nepričakovane neželene učinke (suspected unexpected serious adverse reactions, SUSAR), ki se pojavijo med kliničnim preizkušanjem.