FrancophonIA/ELRC3.0 huggingface dataset:
English: Key messages:
Maltese: Messaġġi importanti:
English: Treatment of epilepsy
Maltese: Trattament tal-epilessija
English: • It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have problems with early childhood development.
Maltese: • Huwa stmat li sa 30-40% tat-tfal f'età qabel jidħlu l-iskola li ommijiethom jkunu ħadu valproate waqt it-tqala jista' jkollhom problemi bl-iżvilupp bikri tat-tfulija.
English: Bipolar disorder <and> <migraine>
Maltese: Disturb bipolari <u> <emigranja>
English: [Quick Response (QR) code: A QR code should be included in the packaging material and/or the package leaflet, and its location should take into account the overall readability.]
Maltese: [Kodiċi Quick Response (QR): Kodiċi QR għandu jiġi inkluż fil-materjal tal-ippakkjar u/jew fil-fuljett ta' tagħrif, u l-lok tiegħu għandu jikkunsidra kemm jista' jinqara kumplessivament.]
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni tal-prodott tista' sussegwentement tiġi aġġornata mill-awtoritajiet kompetenti tal-Istat Membru, bi ftehim mal-Istat Membru ta' Riferenza, kif xieraq, skont il-proċeduri mniżżla f'Kapitlu 4 tatTitolu III tad-Direttiva 2001/83/KE.
English: Treatment of bipolar disorder <and prophylaxis of migraine attacks>
Maltese: Trattament ta' disturb bipolari <u profilassi ta' attakki tal-emigranja>
English: • in pregnancy (see section 4.4 and 4.6).
Maltese: • fit-tqala (ara sezzjoni 4.4 u 4.6).
English: Birth defects which have been reported include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations; heart, kidney, urinary tract and sexual organ malformations; limb defects.
Maltese: Difetti tat-twelid li ġew irrappurtati jinkludu spina bifida (fejn l-għadam tas-sinsla ma jkunx żviluppat kif suppost)); mankamenti fil-wiċċ u fil-qafas għadmi tar-ras; mankamenti fil-qalb, fil-kliewi, fl-apparat tal-awrina u fl-organi sesswali; difetti fid-dirgħajn u rriġlejn.
English: Pregnancy test
Maltese: Test tat-tqala
English: This compares to 2 to 3 babies in every 100 born to women who don't have epilepsy.
Maltese: Dan jikkumpara ma' 2 sa 3 trabi minn kull 100 li jitwieldu lil nisa li m'għandhomx epilessija.
English: • in pregnancy (see sections 4.3 and 4.6).
Maltese: • fit-tqala (ara sezzjoni 4.3 u 4.6).
English: Pregnancy Prevention Programme Valproate has a high teratogenic potential and children exposed in utero to valproate have a high risk for congenital malformations and neurodevelopmental disorders (see section 4.6).
Maltese: Valproate għandu potenzjal kbir ta' teratoġeniċità u tfal esposti fil-ġuf għal valproate jkollhom riskju kbir ta' malformazzjonijiet konġenitali u disturbi fl-iżvilupp newoloġiku (ara sezzjoni 4.6).
English: Section 4.2 Posology and method of administration
Maltese: Sezzjoni 4.2 Pożoloġija u metodu ta' kif għandu jingħata
English: • Valproate carries a risk if taken during pregnancy.
Maltese: • Valproate għandu riskju jekk jittieħed waqt it-tqala.
English: Ask your doctor about taking folic acid.
Maltese: Staqsi lit-tabib tiegħek dwar it-teħid ta' folic acid.
English: Valproate should preferably be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation.
Maltese: Valproate għandu preferibbliment jiġi ordnat bħala monoterapija bl-inqas doża effettiva, jekk possibbli bħala formulazzjoni li tintreħa bil-mod.
English: Valproate as treatment for epilepsy is contraindicated in pregnancy unless there is no suitable alternative treatment (see sections 4.3 and 4.4).
Maltese: Valproate bħala trattament għall-epilessija huwa kontraindikat fit-tqala ħlief meta ma jkunx hemm trattament alternattiv adattat (ara sezzjonijiet 4.3 u 4.4).
English: • Autistic spectrum disorders are more often diagnosed in children exposed to valproate and there is some evidence children may be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
Maltese: • Disturbi tal-ispettru awtistiku jiġu dijanjostikati iżjed ta' spiss fi tfal esposti għal valproate u hemm xi xhieda li t-tfal għandhom aktar mnejn jiżviluppaw sintomi ta' Disturb ta' Nuqqas ta' Attenzjon u Iperattività (ADHD, Attention Deficit Hyperactivity Disorder).
English: [*For the printed material, please refer to the guidance of the annotated QRD template.]
Maltese: [*Għall-materjal mitbugħ, jekk jogħġbok irreferi għall-gwida tal-mudell annotat tal-QRD.]
English: Valproate is prescribed and dispensed according to the Valproate Pregnancy Prevention Programme (sections 4.3 and 4.4).
Maltese: Valproate jiġi ordnat b'riċetta u jingħata b'riċetta skont il-Programm ta' Prevenzjoni tat-Tqala għal Valproate (sezzjonijiet 4.3 u 4.4).
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V*.
English: During pregnancy, maternal tonic clonic seizures and status epilepticus with hypoxia may carry a particular risk of death for mother and the unborn child.
Maltese: Matul it-tqala, aċċessjonijiet tonic clonic u status epilepticus b'ipoksja fl-omm jista' jkollhom riskju partikulari ta' mewt għall-omm u għat-tarbija mhux imwielda.
English: For the indication(s) <bipolar disorder> <and> < migraine> if a woman is planning to become pregnant a specialist experienced in the management of <bipolar disorder> <migraine> must be consulted and treatment with valproate should be discontinued and if needed switched to an alternative treatment prior to conception, and before contraception is discontinued.
Maltese: Għall-indikazzjoni(jiet)) <disturb bipolari> <u> <emigranja> jekk mara tkun qed tippjana li toħroġ tqila għandu jiġi kkonsultat speċjalista b'esperjenza fl-immaniġġjar ta' <disturb bipolari> <emigranja> u t-trattament b'valproate għandu jitwaqqaf u jekk ikun meħtieġ jinbidel ma trattament alternattiv qabel il-konċepiment, u qabel mal-kontraċezzjoni titwaqqaf.
English: • You must use an effective method of birth control (contraception) during your entire treatment with <Invented name>.
Maltese: • Inti għandek tuża metodu effettiv ta' kontroll tat-tqala (kontraċezzjoni) matul it-trattament kollu tiegħek b'<Isem ivvintat>.
English: In order to assist healthcare professionals and patients in avoiding exposure to valproate during pregnancy, the Marketing Authorisation Holder has provided educational materials to reinforce the warnings and provide guidance regarding use of valproate in women of childbearing potential and the details of the pregnancy prevention programmeme.
Maltese: Sabiex tgħin lill-professjonisti fil-qasam tas-saħħa u l-pazjenti jevitaw esponiment għal valproate waqt it-tqala, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda materjal edukattiv biex jirrinforza t-twissijiet u jipprovdi gwida dwar l-użu ta' valproate f'nisa f'età li jista' jkollhom it-tfal u d-dettalji tal-proqramm ta' prevenzjoni tat-tqala.
English: How to take <invented name>
Maltese: JIENA TQILA U QED NIEĦU <ISEM
English: Annex III Amendments to relevant sections of the Product Information
Maltese: Anness III Emendi f'sezzjonijiet rilevanti tal-Informazzjoni tal-Prodott
English: Do not pass it on to others.
Maltese: F'każ ta' tqala
English: • The prescriber must ensure that parents/caregivers of female children who have experienced menarche are provided with comprehensive information about the risks of congenital malformations and neurodevelopmental disorders including the magnitude of these risks for children exposed to valproate in utero.
Maltese: • l-pazjenta tkun fehmet u tagħraf ir-riskji ta' malformazzjonijiet konġenitali u disturbi fliżvilupp newroloġiku inkluż il-kobor ta' dawn ir-riskji għal tfal esposti għal valproate filġuf.
English: Valproate is contraindicated as treatment for epilepsy during pregnancy unless there is no suitable alternative to treat epilepsy.
Maltese: Valproate huwa kontraindikat bħala trattament għall-epilessija waqt it-tqala ħlief meta ma jkunx hemm alternattiva adattata biex titratta l-epilessija.
English: <Invented name> treatment must be started and supervised by a doctor specialised in the treatment of <epilepsy> <or> <bipolar disorders> <or> <migraine>.
Maltese: It-trattament b'<Isem ivvintat> għandu jinbeda u jiġi sorveljat minn tabib speċjalizzat fit-trattament <tal-epilessija> <jew> <ta' disturbi bipolari> <jew> <tal-emigranja>.
English: Valproate is contraindicated as treatment for bipolar disorder <and migraine> during pregnancy.
Maltese: Valproate huwa kontraindikat bħala trattament għal disturb bipolari <u emigranja> waqt it-tqala.
English: Valproate as treatment for bipolar disorder <and prophylaxis of migraine attacks> is contraindicated for use during pregnancy.
Maltese: Valproate bħala trattament għal disturb bipolari <u profilassi ta' attakki tal-emigranja> huwa kontraindikat biex jintuża waqt it-tqala.
English: If, despite the known risks of valproate in pregnancy and after careful consideration of alternative treatment, in exceptional circumstances a pregnant woman must receive valproate for epilepsy, it is recommended to:
Maltese: Jekk, minkejja r-riskji magħrufa ta' valproate fit-tqala u wara kunsiderazzjoni b'attenzjoni ta' trattament alternattiv, f'ċirkostanzi eċċezzjonali mara tqila jkollha tirċievi valproate għall-epilessija, huwa rrakkomandat li:
English: Because valproate has been used for many years we know that in women who take valproate around 10 babies in every 100 will have birth defects.
Maltese: Minħabba li valproate ilu jintuża għal ħafna snin nafu li f'nisa li jieħdu valproate madwar 10 trabi minn kull 100 se jkollhom difetti tat-twelid.
English: • the patient understands the need for regular (at least annual) review of treatment by a specialist experienced in the management of epilepsy, or bipolar disorders <or migraine>.
Maltese: • Inti irid ikollok appuntamenti regolari (mill-inqas darba fis-sena) ma' speċjalista b'esperjenza fl-immaniġġjar ta' disturbi bipolari jew epilessija <jew> <emigranja>.
English: • You must discuss the appropriate methods of birth control (contraception) with your doctor.
Maltese: • Inti għandek tiddiskuti l-metodi adattati ta' kontroll tat-tqala (kontraċezzjoni) mat-tabib tiegħek.
English: • in pregnancy unless there is no suitable alternative treatment (see sections 4.3 and 4.6).
Maltese: • fit-tqala ħlief meta ma jkun hemm l-ebda trattament alternattiv adattat (ara sezzjoni 4.3 u
English: Your doctor will refer you to a specialist experienced in the management of bipolar disorder <or>< migraine> or epilepsy, so that alternative treatment options can be evaluated early on.
Maltese: Inti se tintbagħat għand speċjalista b'esperjenza fl-immaniġġjar ta' disturb bipolari, <emigranja> jew epilessija, sabiex jiġu stmati għażliet alternattivi ta' trattament.
English: For the indication epilepsy, if a woman is planning to become pregnant, a specialist experienced in the management of epilepsy, must reassess valproate therapy and consider alternative treatment options.
Maltese: Għall-indikazzjoni tal-epilessija, jekk mara tkun qed tippjana li toħroġ tqila, speċjalista b'esperjenza fl-immaniggjar tal-epilessija, għandu jevalwa mill-ġdid it-terapija ta' valproate u jqis għażliet alternattivi oħra ta' trattament.
English: The use of a prolonged release formulation may be preferable to other treatment formulations in order to avoid high peak plasma concentrations (see section
Maltese: L-użu ta' formulazzjoni li terħi l-mediċina bil-mod jista' jkun ppreferut aktar minn formulazzjonijiet oħra tat-trattament sabiex jiġi evitat li jkun hemm logħla konċentrazzjonijiet fil-plażma għoljin (ara sezzjoni 4.2).
English: MAHs of all valproate and related substances containing products authorised in the EU should amend the product information (insertion, replacement or deletion of the text, as appropriate) to reflect the wording as provided below, and in conjunction to the Scientific conclusions:
Maltese: L-MAHs tal-prodotti kollha li fihom valproate u sustanzi relatati awtorizzati fl-UE għandhom jemendaw l-informazzjoni tal-prodott (b'kitba mdaħħla ġdida, mibdula jew imneħħija, kif xieraq) biex tirrifletti lkliem kif mogħti hawn taħt, u flimkien mal-Konklużjonijiet xjentifiċi:
English: Pregnancy planning.
Maltese: Ippjanar tat-tqala.
English: • For bipolar disorder <and> <migraine>, you must not use <Invented name> if you are pregnant.
Maltese: • Għal disturb bipolari <u> <emigranja>, inti m'għandekx tuża <Isem ivvintat> jekk inti tqila.
English: • the patient understands the need to consult her physician as soon as she is planning pregnancy to ensure timely discussion and switching to alternative treatment options prior to conception, and before contraception is discontinued.
Maltese: • l-pazjenta tifhem il-bżonn li tikkonsulta t-tabib tagħha malli tibda tippjana tqala biex tiġi aċċertata diskussjoni f'waqtha u bidla għal għażliet alternattivi ta' trattament qabel ilkonċepiment, u qabel titwaqqaf il-kontraċezzjoni.
English: Folic acid can lower the general risk of spina bifida and early miscarriage that exists with all pregnancies.
Maltese: Folic acid jista' jbaxxi r-riskju ġenerali ta' spina bifida u korriment bikri li jeżisti fit-tqaliet kollha.
English: The risks of valproate when taken during pregnancy (irrespective of the disease for which valproate is used)
Maltese: Ir-riskji ta' valproate meta jittieħed waqt it-tqala (irrispettivament għal-liema marda jintuża valproate)
English: The daily dose should be divided into at least two single doses (see section 4.6).
Maltese: Id-doża ta' kuljum għandha tinqasam f'mill-inqas żewġ dożi singoli (ara sezzjoni 4.6).
English: Your doctor will discuss the Annual Risk Acknowledgement Form and will ask you to sign it and keep it. You will also receive a Patient Card from your pharmacist to remind you of valproate risks in pregnancy.
Maltese: Ittabib tiegħek se jiddiskuti miegħek il-Formola Annwali ta' Konferma tar-Riskju u se jistaqsik tiffirmaha u żżommha.
English: Women of childbearing potential who are prescribed valproate must use effective contraception, without interruption during the entire duration of treatment with valproate.
Maltese: Nisa f'età li jista' jkollhom it-tfal li jiġi ordnat lilhom valproate għandhom jużaw kontraċezzjoni effettiva, mingħajr interruzzjoni matul it-tul ta' żmien kollu ta' trattament b'valproate.
English: Conditions of Pregnancy Prevention Programme: The prescriber must ensure that
Maltese: Kondizzjonijiet tal-Programm ta' Prevenzjoni tat-Tqala:
English: Female children
Maltese: SE NIBDA TRATTAMENT
English: • Ask your doctor about taking folic acid when trying for a baby.
Maltese: • Staqsi lit-tabib tiegħek dwar it-teħid ta' folic acid meta tkun qed tipprova għal tarbija.
English: Talk to your doctor or family planning clinic if you need advice on contraception.
Maltese: Kellem lit-tabib tiegħek jew lill-klinika tal-ippjanar tal-familja jekk teħtieġ parir dwar kontraċezzjoni.
English: • For bipolar disorder <and> <migraine>, if you are a woman able to have a baby, you must not take <Invented name>, unless you use effective method of birth control (contraception) during your entire treatment with <Invented name>).
Maltese: • Għal disturb bipolari <u> <emigranja>, jekk inti mara li jista' jkollok tarbija, inti m'għandekx tieħu <Isem ivvintat>, ħlief jekk inti tuża metodu effettiv ta' kontroll tat-tqala (kontraċezzjoni) matul it-trattament kollu tiegħek b'<Isem ivvintat>).
English: • the patient is counselled regarding contraception, and that the patient is capable of complying with the need to use effective contraception (for further details please refer to subsection contraception of this boxed warning), without interruption during the entire duration of treatment with valproate.
Maltese: • l-pazjenta tingħatalha għajnuna professjonali ta' pariri dwar kontraċezzjoni, u li lpazjenta tkun kapaċi tikkonforma mal-ħtieġa li tuża kontraċezzjoni effettiva (għal aktar dettalji jekk jogħġbok irreferi għas-sottosezzjoni kontraċezzjoni ta' din it-twissija f'kaxxa), mingħajr interruzzjoni matul iż-żmien kollu li jdum it-trattament b'valproate.
English: • the patient card is provided with every valproate dispensing and that the patients understand its content.
Maltese: • Qabel jordnalek din il-mediċina, it-tabib tiegħek ikun spjegalek x'jista' jiġri lit-tarbija tiegħek jekk tinqabad tqila waqt li tkun qed tieħu valproate.
English: Strength Pharmaceutical Form
Maltese: Għamla farmaċewtikaf
English: Veterinary medicines
Maltese: Medicini veterinarji
English: Programming of human and financial resources for decentralised agencies 2014-2020; http://ec.europa.eu/budget/library/biblio/documents/fin_fwk1420/COM_2013_519_en.pdf
Maltese: Programmar ta' riżorsi umani u finanzjarji għal aġenziji deċentralizzati 2014-2020; http://ec.europa.eu/budget/library/biblio/documents/fin_fwk1420/COM_2013_519_en.pdf
English: Planned FTE
Maltese: Direttur Eżekuttiv
English: Timely access to promising medicines
Maltese: Aċċess f'waqtu għal mediċini promettenti
English: Stakeholder involvement and transparency
Maltese: L-involviment tal-partijiet ikkonċernati u t-trasparenza
English: The EMA, like other EU agencies, is required to reduce the number of posts by 10% during 2014-20202.
Maltese: L-EMA, bħal aġenziji oħrajn tal-UE, hija mitluba tnaqqas in-numru ta' karigi b'10 % waqt l-2014-20201.
English: Emerging new technologies, personalised medicines, new advanced therapies, combination and borderline products all contribute to the increasing complexity of medicines.
Maltese: Teknoloġiji ġodda emerġenti, mediċini personalizzati, terapiji ġodda avvanzati, prodotti ta' kombinazzjoni u borderline kollha jikkontribwixxu għall-kumplessità dejjem tikber talmediċini.
English: The Agency is finalising implementation of the pharmacovigilance legislation in 2016-2017.
Maltese: L-Aġenzija qiegħda tiffinalizza l-implimentazzjoni tal-leġiżlazzjoni tal-farmakoviġilanza fl-2016-2017.
English: Among these are the introduction of single assessment for nationally authorised products (PSUSA) in 2015, the upcoming implementation of public hearings, and management of signals submitted by the pharmaceutical industry from 2017.
Maltese: Fosthom hemm l-introduzzjoni ta' valutazzjoni unika għal prodotti awtorizzati nazzjonalment (PSUSA) fl-2015, l-implimentazzjoni li ġejja ta' seduti pubbliċi, l-ġestjoni ta' sinjali ppreżentati mill-industrija tal-farmaċewtika mill-2017.
English: Q3 2016 2018
Maltese: 8 ta' Frar 2016
English: EMA/92499/2016 Rev. 11 Executive Director
Maltese: EMA/171288/2016
English: Addressing public-health priorities
Maltese: L-indirizzar tal-prijoritajiet tas-saħħa pubblika
English: • Discussions on transition approach eCollaboration programme eSubmission Gateway v3 Q4 2013 Q2 2016 • Delivery of functionality to provide and process metadata delivery files required to process all submissions via the eSubmission Gateway
Maltese: L-implimentazzjoni tal-politika dwar il-pubblikazzjoni u l-aċċess għal data klinika sejra tkun aspett sinifikanti tal-inizjattivi ta' trasparenza tal-Aġenzija fl-2016.
English: Alongside old problems such as antimicrobial resistance, new diseases and issues emerge.
Maltese: Flimkien ma' problemi antiki bħar-reżistenza antimikrobika jitfaċċaw mard u problemi ġodda.
English: The globalisation of pharmaceutical activities results in an increasing number of manufacturing and clinical-trial activities being conducted outside the EU.
Maltese: Il-globalizzazzjoni tal-attivitajiet tal-farmaċewtika tirriżulta fit-twettiq ta' numru dejjem jikber ta' attivitajiet ta' manifattura u provi kliniċi barra l-UE.
English: electronic Curriculum Vitae
Maltese: Mid-Direttur Eżekuttiv, Guido Rasi
English: − EMA-FDA GCP initiative and EMA/EU MS/FDA initiative on inspections for generic applications
Maltese: Għaldaqstant, it-trasparenza hija waħda mill-prijoritajiet ewlenin talAġenzija.
English: Organization (WHO), thus highlighting AMR as a global health crisis of similar importance to infectiousdisease pandemics.
Maltese: Il-gravità tal-kwistjoni hija rikonoxxuta wkoll mill-iżvilupp ta' pjan ta' azzjoni globali dwar lAMR mill-Organizzazzjoni Dinjija tas-Saħħa (WHO), u dan jenfasizza l-AMR bħala kriżi globali tas-saħħa b'importanza simili għal pandemiji ta' mard infettiv.
English: Satisfaction level of partners/stakeholders with EMA communications n/a
Maltese: Il-prijoritajiet u l-influwenzi ewlenin tal-EMA
English: Joint CVMP/CHMP Ad-hoc Expert Group on the Application of the 3Rs in Regulatory Testing of Medicinal Products
Maltese: 1 Komunikazzjoni mill-Kummissjoni lill-Parlament Ewropew u l-Kunsill.
English: The Clinical Trials Regulation (EU) 536/2014 was published in May 2014, and requires the Agency, in collaboration with the European Commission (EC) and Member States, to develop the systems necessary for its implementation.
Maltese: Ir-Regolament dwar il-Provi Kliniċi (UE) 536/2014 kien ippubblikat f'Mejju 2014, u jeħtieġ li l-Aġenzija, f'kollaborazzjoni mal-Kummissjoni Ewropea (KE) u l-Istati Membri, tiżviluppa s-sistemi meħtieġa għallimplimentazzjoni tiegħu.
English: The European medicines regulatory network is based on a network of around 50 human and veterinary medicines regulatory authorities ('national competent authorities', or NCAs) from the 31 European Economic Area Member States, together with the European Medicines Agency (EMA).
Maltese: In-netwerk regolatorju tal-mediċini Ewropew huwa bbażat fuq netwerk ta' madwar 50 awtorità regolatorja tal-mediċini tal-bniedem u veterinarji (‘awtoritajiet nazzjonali kompetenti', jew NCAs) mill31 pajjiż taż-Żona Ekonomika Ewropea flimkien mill-Aġenzija Ewropea għall-Mediċini (EMA).
English: MRL extension and modification applications MRL extrapolations
Maltese: L-avvanz xjentifiku u x-xena tinbidel tal-iżvilupp tal-mediċini
English: Publish annual report on EMA's interaction with patients, consumers, healthcare professionals and their organisations Conduct a joint PCWP/HCPWP workshop on the use of social media to further engage with patients, consumers and healthcare professionals Publish 10 year report of PCWP operations Explore processes to capture patients' input on the value of evidence during benefit risk evaluation, based on the outcome of the pilot phase of patients involvement in benefit risk assessment Develop recommendations to promote GPs interactions with EMA Implement revised framework of EMA interaction with patients
Maltese: Meta jitqies ir-rwol tal-valutazzjoni tat-teknoloġija tas-saħħa (HTA)/korpi ta' pprezzar u ta' rimborż filkisba ta' mediċini innovattivi għall-pazjenti, l-esplorar ta' sinerġiji potenzjali u l-estensjoni u t-tisħiħ tal-kollaborazzjoni ma' korpi tal-HTA għall-iskambju tal-informazzjoni fiż-żmien ta' liċenzjar sejrin ikunu qasam tal-enfasi ewlieni ieħor għall-Aġenzija u l-NCAs.
English: This is particularly important with continued economic pressures on the Member States, and regulatory authorities being required to cut costs while delivering their responsibilities.
Maltese: Dan huwa partikolarment importanti bi pressjonijiet ekonomiċi kontinwi fuq l-Istati Membri, u bl-awtoritajiet regolatorji mitluba sabiex inaqqsu l-ispejjeż waqt li jwettqu r-responsabbiltajiet tagħhom.