natgillin/translations-raw huggingface dataset:
The company presented results of two main studies involving a total of around 1,000 non-small cell lung cancer patients with cachexia. 
Družba je predložila rezultate dveh glavnih študij, ki sta skupaj vključevali približno 1 000 bolnikov z nedrobnoceličnim rakom pljuč in kaheksijo.
In addition, following an inspection at clinical study sites, CHMP considered that the safety data on the medicine had not been recorded adequately. 
Poleg tega je odbor CHMP po inšpekcijskem pregledu na lokacijah klinične študije presodil, da podatki o varnosti zdravila niso bili pravilno zabeleženi.
Adlumiz is a medicine that contains the active substance anamorelin hydrochloride. 
Adlumiz je zdravilo, ki vsebuje zdravilno učinkovino anamorelinijev hidroklorid.
Refusal of the marketing authorisation for Adlumiz (anamorelin hydrochloride) EMA/599030/2017 
Zavrnitev dovoljenja za promet z zdravilom Adlumiz (anamorelinijev hidroklorid) EMA/599030/2017
What is Adlumiz? 
Kaj je zdravilo Adlumiz?
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes in Europe with Adlumiz. 
Družba je odbor CHMP obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe zdravila Adlumiz v Evropi.
What was Adlumiz expected to be used for? 
Za kaj naj bi se zdravilo Adlumiz uporabljalo?
On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Adlumiz, intended for the treatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 18. maja 2017 priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Adlumiz, namenjenim zdravljenju anoreksije, kaheksije ali nenamernega hujšanja pri bolnikih z nedrobnoceličnim rakom pljuč.
Therefore the CHMP was of the opinion that the benefits of Adlumiz did not outweigh its risks and recommended that it be refused marketing authorisation. 
Posledično je odbor CHMP tedaj menil, da koristi zdravila Adlumiz ne odtehtajo z njim povezanih tveganj, in priporočil, da se dovoljenje za promet z njim zavrne.
The company that applied for authorisation is Helsinn Birex Pharmaceuticals Ltd. 
Vlogo za pridobitev dovoljenja za promet z zdravilom je predložila družba Helsinn Birex Pharmaceuticals Ltd.
The CHMP concluded that the studies show a marginal effect of Adlumiz on lean body mass and no proven effect on hand grip strength or patients' quality of life. 
Odbor CHMP je zaključil, da študije kažejo neznaten vpliv zdravila Adlumiz na mršavo telesno maso in odsotnost vpliva na moč stiska pesti ali kakovost življenja bolnikov.
Patients were given either Adlumiz or placebo (a dummy treatment) and the main measures of effectiveness were changes in lean body mass (body weight excluding fat) and hand grip strength. 
Bolniki so prejemali zdravilo Adlumiz ali placebo (zdravilo brez zdravilne učinkovine), glavni merili učinkovitosti pa sta bili sprememba mršave telesne mase (telesne mase brez maščobe) in moč stiska pesti.
Adlumiz was expected to be used to treat anorexia (loss of appetite), cachexia (a form of muscle wasting with significant weight loss) or unintended weight loss in patients with a type of lung cancer called non-small cell lung cancer. 
Zdravilo Adlumiz naj bi se uporabljalo za zdravljenje anoreksije (izgube apetita), kaheksije (oblike izgube mišic z znatno izgubo telesne mase) ali nenamernega hujšanja pri bolnikih z vrsto raka pljuč, imenovanega nedrobnocelični rak pljuč.
How does Adlumiz work? 
Kako zdravilo Adlumiz deluje?
Refusal of the marketing authorisation for Adlumiz (anamorelin hydrochloride) 
Zavrnitev dovoljenja za promet z zdravilom Adlumiz (anamorelinijev hidroklorid)
Adlumiz attaches to and activates a target on cells called a ghrelin receptor. 
Zdravilo Adlumiz se pritrdi na prijemališče na celicah, imenovano grelinski receptor, in ga aktivira.
7 ml (50 mg/ml) 1 vial 
EU/1/19/1376/001 LIBTAYO 350 mg koncentrat za raztopino za infundiranje intravenska uporaba viala (steklena) 7 ml (50 mg/ml) 1 viala
LIBTAYO 
Jakost
The Reference Member State was the Netherlands and the Concerned Member States were Estonia, Greece, Portugal and Spain. 
Referenčna država članica je bila Nizozemska, zadevne države članice pa so bile Estonija, Grčija, Portugalska in Španija.
London, 22 August 2007 EMEA/CHMP/248862/2007 
London, 22. avgust 2007 EMEA/CHMP/248862/2007
Cefuroximaxetil and associated names 
Cefuroximaxetil in povezana imena
The repeat-use Mutual Recognition Procedure started on 17 May 2006. 
Ponovljeni postopek medsebojnega priznavanja se je začel 17. maja 2006.
The arbitration procedure started on 18 October 2006 with the adoption of a list of questions. 
Arbitražni postopek se je začel 18. oktobra 2006 s sprejetjem seznama vprašanj.
The final opinion was converted into a Decision by the European Commission on 22 August 2007. 
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 22. avgusta 2007.
The Rapporteur was Dr Frits Lekkerkerker and Co-Rapporteur was Dr Gonzalo Calvo Rojas. 
Poročevalec je bil dr. Frits Lekkerkerker, soporočevalec pa dr. Gonzalo Calvo Rojas.
Spain referred the reasons for disagreement to the EMEA on 25 September 2006. 
Španija je agenciji EMEA dne 25. septembra 2006 predložila razloge za nestrinjanje.
These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. 
Omenjene države članice niso mogle doseči soglasja glede medsebojnega priznavanja dovoljenja za promet z zdravilom, ki ga je odobrila referenčna država članica.
An opinion was adopted by consensus on 26 April 2007. 
Mnenje je bilo soglasno sprejeto dne 26. aprila 2007.
The Marketing Authorisation Holder provided written explanations on 15 January 2007. 
Imetnik dovoljenja za promet z zdravilom je podal pisna pojasnila 15. januarja 2007.
International Non-Proprietary Name (INN): cefuroxime (as axetil) 
Mednarodno nelastniško ime (INN): cefuroksim (kot aksetil)
During their April 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections raised by Spain could be agreed and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. 
Na sestanku v aprilu 2007 je CHMP na podlagi vseh predloženih podatkov in znanstvene razprave znotraj Odbora podal mnenje, da se strinja z zadržki, ki jih je izrazila Španija, in da je treba spremeniti Povzetek glavnih značilnosti zdravila, označevanje in Navodilo za uporabo referenčne države članice.
This refers to the safety and efficacy of cefuroximaxetil in uncomplicated gonorrhoea and riskbenefit balance for this sought indication and this was considered to be a serious public health concern. 
Nanaša se na varnost in učinkovitost cefuroksimaksetila pri zdravljenju nezapletene gonoreje in na razmerje med tveganji in koristmi za to indikacijo, pri čemer je bilo ugotovljeno, da utegne to predstavljati resen zadržek glede javnega zdravja.
- upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis - acute bronchitis, acute exacerbations of chronic bronchitis - lower uncomplicated urinary tract infections: cystitis - skin and soft tissue infections: furunculosis, pyoderma and impetigo - uncomplicated gonorrhoea: urethritis and cervicitis - treatment of early stage Lyme disease (stadium I) and subsequent prevention of late complications in adults and children above 12 years of age. 
- okužbe zgornjih dihal: akutno vnetje srednjega ušesa, sinuzitis, tonzilitis in faringitis - akutni bronhitis, akutno poslabšanje kroničnega bronhitisa - nezapletene okužbe spodnjih sečil: cistitis - okužbe kože in mehkih tkiv: furunkuloza, piodermija in impetigo - nezapletena gonoreja: vnetje sečnice in vnetje sluznice materničnega vratu - zdravljenje zgodnjega stadija lymske bolezni (stadij I) in naknadno preprečevanje kasnejših zapletov pri odraslih in otrocih, starih več kot 12 let.
Existing Marketing Authorisations should be varied and pending Marketing Authorisation Applications should be granted to include these amendments. 
Obstoječa dovoljenja za promet z zdravilom je potrebno spremeniti, medtem ko je treba dovoljenja za promet z zdravilom, ki so trenutno v postopku odobritve, izdati le pod pogojem, da vključujejo omenjene spremembe.
Sandoz B.V. submitted applications for mutual recognition of Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets on the basis of the marketing authorisation granted by the Netherlands on 1 October 2004. 
je predložila vloge za medsebojno priznavanje zdravila Cefuroximaxetil in z njim povezanih imen 125 mg, 250 mg in 500 mg obložene tablete na podlagi dovoljenja za promet z zdravilom, ki ga je 1. oktobra 2004 odobrila Nizozemska.
Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets is a cephalosporin (βlactam group of antibiotics), indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as: 
Cefuroximaxetil in povezana imena 125 mg, 250 mg in 500 mg obložene tablete je cefalosporin (iz skupine β-laktamskih antibiotikov), indiciran za zdravljenje blagih do zmerno hudih okužb, ki jih povzročajo mikroorganizmi, občutljivi na cefuroksim, in sicer:
Significant difference was identified with regard to the indication “uncomplicated gonorrhoea: urethritis and cervicitis”. 
V zvezi z indikacijo "nezapletena gonoreja: vnetje sečnice in vnetje sluznice materničnega vratu" je bila ugotovljena pomembna razlika.
Czech Republic Roche s.r.o., Dukelských hrdinů 52 
Češka republika Roche s.r.o., Dukelských hrdinů 52
Slovak Republic F.Hoffmann-La Roche Ltd. Basel, Switzerland 
Slovaška republika F.Hoffmann-La Roche Ltd. Basel, Switzerland
Slovak Republic Roche Slovensko s.r.o. 
Slovaška republika Roche Slovensko s.r.o.
United Kingdom Roche Products Limited, 6 Falcon Way, Shire Park Welwyn Garden City 
Velika Britanija Roche Products Limited, 6 Falcon Way, Shire Park Welwyn Garden City
Concentrate for solution for infusion/injection 
koncentrat za raztopino za infundiranje/ injiciranje
5x1 ml and 5x3 ml 
02181 Espoo Finland intravenska uporaba 5x1 ml and 5x3 ml
5 x 1 ml 5 x 3 ml 
100 74 Stockholm Sweden intravenska uporaba 5 x 1 ml 5 x 3 ml
3ml contains 3mg granisetron (hydrochloride) 3ml contains 27mg sodium chloride = 10.62 mg sodium 
3ml contains 27mg sodium chloride =
3mg/3ml (1mg/ml) 
Romania intravenska uporaba 3mg/3ml (1mg/ml)
1ml contains 1mg granisetron (hydrochloride) 1mg contains 9mg sodium chloride = 3.54 mg sodium 
1mg contains 9mg sodium chloride =
1 ml (1 mg/ ml) 3 ml (1 mg/ ml) 
Bulgaria raztopina za injiciranje/infundira nje intravenska uporaba 1 ml (1 mg/ ml) 3 ml (1 mg/ ml)
Kevatril 3 mg/3 ml Injektionslösung 
Kevatril 3 mg/3 ml Injektionslösung intravenska uporaba 3 ml
Kevatril 1 mg/1 ml Injektionslösung 
Kevatril 1 mg/1 ml Injektionslösung intravenska uporaba 1 ml
Kytril 3 mgInjektionslösung 
Kytril 3 mgInjektionslösung intravenska uporaba 3 ml
1ml contains 1mg granisetron (hydrochloride 
Kytril Ampoule 1mg/1ml koncentrat za raztopino za infundiranje/ injiciranje intravenska uporaba 1ml contains 1mg granisetron (hydrochloride
Kytril Ampoules 1 mg/1 ml concentrate for solution for infusion or injection 
Kytril Ampoules 1 mg/1 ml concentrate for solution for infusion or injection koncentrat za raztopino za infundiranje/ injiciranje intravenska uporaba 1ml contains 1mg granisetron (hydrochloride)
The European Commission granted a marketing authorisation valid throughout the European Union for Valdoxan on 19 February 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Valdoxan, veljavno po vsej Evropski uniji, izdala 19. februarja 2009.
The full EPAR for Valdoxan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Valdoxan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Valdoxan? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Valdoxan?
This is a summary of the European public assessment report (EPAR) for Valdoxan. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Valdoxan.
Valdoxan is a medicine used to treat major depression in adults. 
Valdoxan je zdravilo, ki se uporablja za zdravljenje hude depresije pri odraslih.
Since dopamine and noradrenaline are involved in the control of mood, their increase between nerve cells in the brain is believed to help relieve the symptoms of depression. 
Dopamin in noradrenalin sodelujeta pri nadzoru razpoloženja, zato je verjetno, da povečanje njunih ravni med živčnimi celicami v možganih pomaga pri lajšanju simptomov depresije.
However, the second study showed that symptoms returned in 21% of the patients taking Valdoxan over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174). 
Vendar je druga študija pokazala, da so se simptomi ponovno pojavili pri 21 % (34 od 165) bolnikov, ki so 24 tednov jemali zdravilo Valdoxan, medtem ko je ta delež pri bolnikih, ki so jemali placebo, znašal 41 % (72 od 174) bolnikov.
Therefore, the CHMP decided that Valdoxan's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zato je zaključil, da so koristi zdravila Valdoxan večje od z njim povezanih tveganj in priporočil, da se zanj izda dovoljenje za promet.
Valdoxan has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression. 
Zdravilo Valdoxan so primerjali s placebom (zdravilom brez zdravilne učinkovine) v petih glavnih kratkoročnih študijah, ki so vključevale skupaj 1 893 odraslih s hudo obliko depresije.
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Valdoxan's benefits in terms of treating depression might be lower than seen with other antidepressants. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je menil, da so koristi zdravila Valdoxan pri zdravljenju depresije morda manjše kot pri drugih antidepresivih.
Valdoxan can only be obtained with a prescription and is available as tablets (25 mg). 
Predpisovanje in izdaja zdravila Valdoxan je le na recept, na voljo pa je v obliki tablet (25 mg).
In the first study, there was no difference between Valdoxan and placebo in preventing symptoms from returning during 26 weeks of treatment. 
V prvi študiji ni bilo razlik med zdravilom Valdoxan in placebom pri preprečevanju ponovnega pojava simptomov v 26 tednih zdravljenja.
The most common side effects with Valdoxan (seen in more than 1 patients in 100) are headache, nausea (feeling sick) and dizziness. 
Najpogostejši neželeni učinki zdravila Valdoxan (opaženi pri več kot 1 bolniku od 100) so glavobol, navzeja (slabost) in omotica.
The company also presented the results of a further study comparing Valdoxan with sertraline (another antidepressant), which showed that Valdoxan was more effective than sertraline, with a reduction in HAM D scores after six weeks.. 
Družba je predstavila tudi rezultate nadaljnje študije, v kateri so zdravilo Valdoxan primerjali s sertralinom (drugim antidepresivom) in ki je pokazala, da je zdravilo Valdoxan učinkovitejše od sertralina z zmanjšanjem rezultata HAM D po šestih tednih.
Valdoxan might also help to normalise the patient's sleep patterns. 
Zdravilo Valdoxan lahko pomaga tudi pri uravnavanju bolnikovega vzorca spanja.
Other information about Valdoxan 
Druge informacije o zdravilu Valdoxan
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Valdoxan have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Valdoxan upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Three of these studies included some patients treated with other antidepressants, either fluoxetine or paroxetine, as an ‘active comparator'. 
Tri študije so vključevale nekaj bolnikov, zdravljenih z drugimi antidepresivi, in sicer s fluoksetinom ali paroksetinom kot „aktivnim primerjalnim zdravilom“.
For more information about treatment with Valdoxan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Valdoxan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is Valdoxan and what is it used for? 
Kaj je zdravilo Valdoxan in za kaj se uporablja?
Valdoxan must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease, nor in patients whose level of transaminases (liver enzymes) in the blood is more than three times the normal level. 
Zdravilo Valdoxan se ne sme uporabljati pri bolnikih, ki imajo težave z jetri, kot sta ciroza (brazgotinjenje jeter) ali aktivna jetrna bolezen, in pri bolnikih, katerih ravni transaminaz (jetrnih encimov) v krvi so trikrat višje od običajnih.
A patient booklet will also be distributed to all patients who are prescribed Valdoxan so that they are aware of the risk to the liver, the importance of monitoring liver function and the signs of liver problems to look out for. 
Informativno knjižico bodo prav tako prejeli bolniki, katerim je bilo predpisano zdravilo Valdoxan, da bi se zavedali tveganj za jetra, pomena nadzora delovanja jeter ter prepoznavanja znakov, ki kažejo na težave z njimi.
It must also not be used in patients who are taking medicines that slow down the breakdown of Valdoxan in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic). 
Prav tako ga ne smejo uporabljati bolniki, ki jemljejo zdravila, ki upočasnjujejo presnovo zdravila Valdoxan v telesu, kot sta fluvoksamin (druga vrsta antidepresiva) in ciprofloksacin (antibiotik).
Two other main studies compared the ability of Valdoxan and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Valdoxan. 
V dveh drugih glavnih študijah so učinkovitost zdravila Valdoxan in placeba pri preprečevanju ponovnega pojava simptomov primerjali pri 706 bolnikih, pri katerih so depresijo že nadzorovali z zdravilom Valdoxan.
The company that markets Valdoxan will supply educational material for doctors prescribing Valdoxan. 
Družba, ki trži zdravilo Valdoxan, bo zdravnikom, ki ga predpisujejo, priskrbela izobraževalno gradivo.
The active substance in Valdoxan, agomelatine, is an antidepressant. 
Zdravilna učinkovina v zdravilu Valdoxan, agomelatin, je antidepresiv.
What benefits of Valdoxan have been shown in studies? 
Kakšne koristi je zdravilo Valdoxan izkazalo v študijah?
What are the risks associated with Valdoxan? 
Kakšna tveganja so povezana z zdravilom Valdoxan?
However, since the medicine has a different mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Valdoxan could be a valuable treatment for some patients as long as their liver function is tested frequently. 
Vendar je glede na drugačen način delovanja zdravila, majhno število neželenih učinkov in drugačen varnostni profil v primerjavi z obstoječimi antidepresivi zaključil, da bi lahko bilo pomembno za zdravljenje nekaterih bolnikov, pri čemer pa bi bilo treba redno preverjati delovanje jeter.
For practical information about using Valdoxan, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Valdoxan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
In the other three studies, which did include an active comparator, there were no differences in scores between the patients taking Valdoxan and those taking placebo. 
V drugih treh študijah, ki so vključevale aktivno primerjalno zdravilo, razlik v rezultatih med bolniki, ki so jemali zdravilo Valdoxan, in tistimi, ki so jemali placebo, ni bilo.
Why is Valdoxan approved? 
Zakaj je bilo zdravilo Valdoxan odobreno?
In the two studies where no active comparator was used Valdoxan was seen to be more effective than placebo. 
V dveh študijah, v katerih niso uporabili nobenega aktivnega primerjalnega zdravila, so opazili, da je bilo zdravilo Valdoxan učinkovitejše od placeba.
For the full list of all side effects reported with Valdoxan, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Valdoxan, glejte navodilo za uporabo.
It is not intended to provide practical advice on how to use Valdoxan. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The patient's liver function should be checked with blood tests before starting treatment and when the dose is increased, followed by further tests around 3, 6, 12 and 24 weeks later. 
Ob začetku zdravljenja, ob povečanju odmerka in nato ponovno po približno treh, šestih, 12 in 24 tednih zdravljenja je treba s krvnimi preiskavami preveriti delovanje bolnikovih jeter.
Valdoxan contains the active substance agomelatine. 
Zdravilo Valdoxan vsebuje zdravilno učinkovino agomelatin.
How does Valdoxan work? 
Kako zdravilo Valdoxan deluje?
How is Valdoxan used? 
Kako se zdravilo Valdoxan uporablja?
Treatment should not be started or should be stopped in patients with abnormal liver enzyme levels in the blood (more than three times the normal level). 
Pri bolnikih z nenormalno količino jetrnih encimov v krvi (za več kot trikratne običajne vrednosti) se zdravljenje ne sme začeti ali se mora prekiniti.
Annually, we also conduct a strategic risk-management review. 
Vsako leto izvedemo tudi strateški pregled upravljanja tveganj.
The business environment and priorities for 2013 
Poslovno okolje in prednostne naloge za leto 2013
The budget for 2013 does show an increase compared to 2012, but this is mainly due to fees being increased in line with inflation. 
Proračun za leto 2013 je v primerjavi z letom 2012 večji, čeprav je to predvsem posledica pristojbin, ki so se zaradi inflacije povišale.
At the same time, the Agency needs to find compensation for services that do not generate revenue (of which there have been an increasing number in recent years) and to finance new legislative tasks. 
Hkrati mora agencija najti sredstva za kritje storitev, ki ne ustvarjajo prihodkov (teh je v zadnjih letih čedalje več), in za financiranje novih projektov v zvezi z zakonodajo.
Increasing the efficiency of operations 
Povečevanje učinkovitosti dejavnosti
Guido Rasi 
Izvršni direktor Guido Rossi
Taking into account the strategy of the Agency and the analysis of its current business environment, we will focus on the following priority areas in 2013: 
V letu 2013 se bomo ob upoštevanju strategije agencije in analize trenutnega poslovnega okolja se osredotočili na naslednje prednostne naloge:
EMA/MB/945561/2011 Executive Director 
11 marec 2013 EMA/154461/2013 Direktorat
Improvements that would further contribute to the quality of the work carried out will be made. 
Uvedene bodo tudi izboljšave, ki bodo še dodatno pripomogle k izboljšanju kakovosti opravljenega dela.
Numerous detailed aspects will be discussed and agreed with national authorities to facilitate a harmonised implementation. 
O številnih podrobnih vidikih se bo treba pogovoriti in sporazumeti z nacionalnimi organi, kar bo olajšalo usklajeno izvajanje zakonodaje.
A number of provisions are yet to be implemented, in cooperation with national authorities, and depend on whether resources can be made available. 
Nekatere ukrepe je v sodelovanju z nacionalnimi organi še treba izvesti, odvisni pa so od sredstev, ki bodo na voljo.