FrancophonIA/ELRC3.0 huggingface dataset:
English: • evaluate medical devices.
Maltese: • tevalwax apparat mediku.
English: • National competent authorities (veterinary)
Maltese: • awtoritajiet nazzjonali kompetenti (veterinarji)
English: This policy entered into force on 1 May 2016 and was subsequently updated in October 2016 to clarify restrictions for positions in a governing body of a professional organisation and to align the rules on grants or other funding with those for committee members and experts.
Maltese: Din il-politika daħlet fis-seħħ fl-1 ta' Mejju 2016 u ġiet sussegwentament aġġornata f'Ottubru 2016 biex tiċċara restrizzjonijiet għall-pożizzjonijiet f'korp ta' governanza ta' organizzazzjoni professjonali u biex tallinja r-regoli dwar l-għoti jew finanzjament ieħor ma' dawk għall-membri tal-kumitat u għall-esperti.
English: • advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines;
Maltese: • mediċini ta' terapija avvanzata bħal terapija ġenetika, terapija ċellulari somatika jew mediċini mill inġinerija tat-tessuti;
English: • suspected side effects reported with medicines;
Maltese: • effetti sekondarji suspettati rrapportati bil-mediċini;
English: This restriction is reflected in the guidance document.
Maltese: Din ir-restrizzjoni hija riflessa fiddokument ta' gwida.
English: Scientific experts
Maltese: Esperti xjentifiċi
English: • paediatric procedures;
Maltese: • proċeduri pedjatriċi;
English: Pooling information
Maltese: Skambju ta' informazzjoni
English: • one representative of each of the EU Member States;
Maltese: • rappreżentant minn kull Stat Membru tal-UE;
English: EMA's Management Board adopted the current version of the policy and trust of-breach procedure in December 2015.
Maltese: Il-Bord ta' Tmexxija tal-EMA adotta l-verżjoni attwali tal-politika u tal-proċedura ta' ksur tal-fiduċja f'Diċembru 2015.
English: Some of the data are supplied by the Member States and centrally managed by EMA.
Maltese: Parti mid-data tiġi pprovduta mill-Istati Membri u tiġi ġestita ċentralment mill-EMA.
English: For more information see Pharmacovigilance.
Maltese: Għal aktar informazzjoni, ara Farmakoviġilanza.
English: For more information, see Transparency.
Maltese: Għal aktar informazzjoni, ara Trasparenza.
English: The revised rules are similar to the principles adopted for committee members and experts.
Maltese: Ir-regoli riveduti huma simili għall-prinċipji adottati għall-membri tal-kumitat u għall-esperti.
English: • orphan medicines (medicines for rare diseases);
Maltese: • mediċini orfni (mediċini għal mard rari);
English: Multinational assessment teams
Maltese: Timijiet ta' valutazzjoni multinazzjonali
English: The revised policy takes into account input from stakeholders at the Agency's September 2013 public workshop Best expertise vs conflicts of interests: striking the right balance.
Maltese: Il-politika riveduta tqis l-input mill-partijiet ikkonċernati mill-workshop pubbliku tal-Aġenzija li sar f'Settembru 2013.
English: • coordinating the monitoring of pharmaceutical companies' compliance with their pharmacovigilance obligations;
Maltese: • tikkoordina l-monitoraġġ tal-konformità ta' kumpaniji farmaċewtiċi mal-obbligi ta' farmakoviġilanza tagħhom;
English: • Search veterinary medicines
Maltese: • Fittex mediċini veterinarji
English: EMA does not:
Maltese: L-EMA ma
English: From April 2017, multinational teams can also evaluate certain post-authorisation applications to extend existing marketing authorisations.
Maltese: Minn April 2017, it-timijiet multinazzjonali jistgħu jevalwaw ukoll ċerti applikazzjonijiet ta' wara ttqegħid fis-suq sabiex jiġu estiżi awtorizzazzjonijiet għat-tqegħid fis-suq eżistenti.
English: The Agency updated the procedure in April 2015 to align it with the current version of the policy on handling competing interests and to take into account experience gained since it was first endorsed by EMA's Management Board in 2012.
Maltese: F'April 2015 l-Aġenzija aġġornat il-proċedura biex tallinjaha mal-verżjoni attwali tal-politika dwar lindirizzar ta' interessi ta' kompetizzjoni u biex tqis l-esperjenza miksuba peress li din l-ewwel kienet ġiet approvata mill-Bord ta' Tmexxija tal-EMA fl-2012.
English: • Single evaluation by European experts.
Maltese: • Valutazzjoni unika minn esperti Ewropej.
English: • medicines derived from biotechnology processes, such as genetic engineering;
Maltese: • mediċini derivati minn proċessi bijoteknoloġiċi, bħall-inġinerija ġenetika;
English: • orphan designation of medicines for rare diseases;
Maltese: • klassifikazzjoni orfni ta' mediċini għal mard rari;
English: The Board's operational tasks range from adopting legally binding implementing rules, to setting strategic directions for scientific networks, to reporting on the use of European Union (EU) contributions for the Agency's activities:
Maltese: Il-kompiti operattivi tal-Bord ivarjaw mill-adozzjoni ta' regoli ta' implimentazzjoni legalment vinkolanti, għall-istabbiliment ta' direzzjonijiet strateġiċi għal netwerks xjentifiċi, għar-rappurtar dwar l-użu ta' kontribuzzjonijiet tal-Unjoni Ewropea (UE) għall-attivitajiet tal-Aġenzija:
English: For more information, see Health-technology-assessment bodies;
Maltese: Għal aktar informazzjoni, ara Korpi responsabbli għall-valutazzjoni tat-teknoloġija tas-saħħa;
English: The Management Board consists of 35 members, appointed to act in the public interest, who do not represent any government, organisation or sector.
Maltese: Il-Bord ta' Tmexxija huwa magħmul minn 35 membru, maħtura biex jaġixxu fl-interess pubbliku, li ma jirrappreżentaw ebda gvern, organizzazzjoni jew settur.
English: Handling competing interests
Maltese: L-immaniġġjar ta' kunflitti ta' kompetizzjoni
English: The diversity of the experts involved in the regulation of medicines in the EU encourages the exchange of knowledge, ideas and best practices between scientists striving for the highest standards for medicines regulation.
Maltese: Id-diversità tal-esperti involuti fir-regolamentazzjoni tal-mediċini fl-UE tinkoraġġixxi l-iskambju ta' għarfien, ideat u tal-aħjar prattiki bejn ix-xjenzjati fl-isforz tagħhom biex jintlaħqu l-ogħla standards għar-regolamentazzjoni tal-mediċini.
English: • control the advertising of medicines.
Maltese: • tikkontrollax ir-reklamar ta' mediċini.
English: EMA is a decentralised agency of the European Union (EU), located in Amsterdam.
Maltese: L-EMA hija aġenzija deċentralizzata tal-Unjoni Ewropea (UE), li tinsab f'Amsterdam.
English: The scheme began with co-rapporteur assessment teams for human medicines (CHMP and CAT), then expanded to rapporteur assessment teams, veterinary medicines (CVMP) and scientific advice procedures.
Maltese: L-iskema bdiet b'timijiet ta' valutazzjoni ta' ko-rapporteurs għal mediċini għall-użu mill-bniedem (CHMP u CAT), imbagħad espandiet għal timijiet ta' valutazzjoni ta' rapporteurs, mediċini veterinarji (CVMP) u proċeduri ta' parir xjentifiku.
English: For more information on the IT systems EMA manages together with the EU Member States, see EU Telematics.
Maltese: Għal aktar informazzjoni dwar is-sistemi tal-IT li l-EMA timmaniġġja flimkien mal-Istati Membri tal-UE, ara t-Telematika tal-UE.
English: For more information on the authorisation routes of medicines in the EU, see Chapter 2 of this document on the Authorisation of medicines;
Maltese: Għal aktar informazzjoni dwar ir-rotot ta' awtorizzazzjoni ta' mediċini fl-UE, ara lKapitolu 2 ta' dan id-dokument dwar l-Awtorizzazzjoni ta' mediċini;
English: In addition to the members, the Management Board also has one observer each from Iceland, Liechtenstein and Norway.
Maltese: Minbarra l-membri, il-Bord ta' Tmexxija għandu wkoll osservatur mill-Iżlanda, mil-Liechtenstein u min-Norveġja.
English: For more information, see Medical devices.
Maltese: Għal aktar informazzjoni, ara Tagħmir mediku.
English: It includes a number of measures which take into account the nature of the declared interest before determining the length of time any restrictions may apply:
Maltese: Din tinkludi numru ta' miżuri li jikkunsidraw in-natura tal-interess iddikjarat qabel jiġi ddeterminat ittul ta' żmien li tista' tapplika xi restrizzjoni:
English: The European medicines regulatory network gives EMA access to experts from across the EU, allowing it to bring together the best-available scientific expertise in the EU for the regulation of medicines.
Maltese: In-netwerk regolatorju Ewropew tal-mediċini jagħti lill-EMA aċċess għal esperti minn madwar l-UE, u dan jippermettilha tlaqqa' flimkien l-aħjar għarfien espert xjentifiku disponibbli fl-UE għarregolamentazzjoni tal-mediċini.
English: • two representatives of the European Parliament;
Maltese: • żewġ rappreżentanti tal-Parlament Ewropew;
English: EMA is governed by an independent Management Board.
Maltese: L-EMA hija regolata minn Bord ta' Tmexxija indipendenti.
English: • evaluate applications for the authorisation of clinical trials.
Maltese: • tevalwax applikazzjonijiet għall-awtorizzazzjoni ta' provi kliniċi.
English: The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMA) hija aġenzija deċentralizzata tal-Unjoni Ewropea (UE) responsabbli għall-valutazzjoni xjentifika, għas-sorveljanza u għall-monitoraġġ tas-sigurtà ta' mediċini żviluppati minn kumpaniji farmaċewtiċi għall-użu fl-UE.
English: • the Innovation Task Force, a forum for early dialogue with applicants.
Maltese: • it-Task Force dwar l-Innovazzjoni, forum għal djalogu bikri mal-applikanti.
English: EMA brings together scientific experts from across Europe by working closely with the national regulatory authorities in European Union (EU) Member States, in a partnership known as the European medicines regulatory network (For more information, see Chapter 5).
Maltese: L-EMA tiġbor fiha esperti xjentifiċi minn madwar l-Ewropa permezz ta' ħidma mill-qrib mal-awtoritajiet regolatorji nazzjonali fl-Istati Membri tal-Unjoni Ewropea (UE), fi sħubija magħrufa bħala n-netwerk regolatorju Ewropew tal-mediċini (Għal aktar informazzjoni, ara l-Kapitolu 5).
English: For more information, see:
Maltese: Għal aktar informazzjoni, ara:
English: By working closely together, this network ensures that safe, effective and high-quality medicines are authorised throughout the European Union (EU), and that patients, healthcare professionals and citizens are provided with adequate and consistent information about medicines.
Maltese: Permezz ta' ħidma flimkien mill-qrib, dan in-netwerk jiżgura l-awtorizzazzjoni ta' mediċini siguri, effettivi u ta' kwalità għolja fl-Unjoni Ewropea (UE), u li l-pazjenti, il-professjonisti fil-qasam tal-kura tas-saħħa u ċ-ċittadini jiġu pprovduti b'informazzjoni adegwata u konsistenti dwar il-mediċini.
English: The system for regulating medicines in Europe is unique in the world.
Maltese: Is-sistema għar-regolamentazzjoni tal-mediċini fl-Ewropa hija unika fid-dinja.
English: The policy on handling competing interests for Management Board members and breach-of-trust procedure aligns with the policy on handling competing interests and breach-of-trust procedure for scientific committee members and experts.
Maltese: Il-politika dwar l-indirizzar ta' interessi kunfliġġenti għall-membri tal-Bord ta' Tmexxija u l-proċedura ta' ksur tal-fiduċja tallinja mal-politika dwar l-immaniġġjar ta' interessi kunfliġġenti u l-proċedura ta' ksur tal-fiduċja għall-membri tal-kumitat xjentifiku u għall-esperti.
English: • to clarify the restrictions if an expert takes up a job in industry and to align the rules on close family members for committee and working party members interests with those for Management Board members in October 2016.
Maltese: • sabiex tiċċara r-restrizzjonijiet jekk espert jiħux impjieg fl-industrija u biex tallinja r-regoli dwar membri tal-familja mill-qrib għal interessi tal-kumitat u tal-grupp ta' ħidma ma' dawk għall-membri tal-Bord ta' Tmexxija f'Otturbu 2016.
English: It is based on a closelycoordinated regulatory network of national competent authorities in the Member States of the EEA working together with the EMA and the European Commission.
Maltese: Hija bbażata fuq netwerk regolatorju koordinat mill-qrib ta' awtoritajiet nazzjonali kompetenti fl-Istati Membri taż-ŻEE li jaħdmu flimkien mal-EMA u mal-Kummissjoni Ewropea.
English: The Agency's staff support the Executive Director in carrying out his responsibilities, including administrative and procedural aspects of EU law related to the evaluation and safety-monitoring of medicines in the EU.
Maltese: Il-persunal tal-Aġenzija jappoġġja lid-Direttur Eżekuttiv fit-twettiq tar-responsabbiltajiet tiegħu, inklużi l-aspetti amministrattivi u proċedurali tad-dritt tal-UE relatati mal-valutazzjoni u l-monitoraġġ tassigurtà tal-mediċini fl-UE.
English: As of 2015, EMA reviews all of its policies on independence and rules for handling competing interests and their implementation on an annual basis and publishes an annual report.
Maltese: Mill-2015, l-EMA tirrevedi l-politiki kollha tagħha dwar l-indipendenza u r-regoli għall-indirizzar ta' interessi kunfliġġenti u l-implimentazzjoni tagħhom fuq bażi annwali u tippubblika rapport annwali.
English: EMA is involved in the assessment of certain categories of medical devices.
Maltese: L-EMA hija involuta fil-valutazzjoni ta' ċerti kategoriji ta' tagħmir mediku.
English: In the EU, there are two main routes for authorising medicines: a centralised route and a national route.
Maltese: Fl-UE, hemm żewġ rotot ewlenin għall-awtorizzazzjoni ta' mediċini: rotta ċentralizzata u rotta nazzjonali.
English: • scientific advice and protocol assistance;
Maltese: • konsulenza xjentifika u għajnuna fuq il-protokoll;
English: Centralised authorisation procedure
Maltese: Il-proċedura ta' awtorizzazzjoni ċentralizzata
English: • provide medical advice.
Maltese: • tipprovdix parir mediku.
English: The control of the advertising of non-prescription medicines in the EU is primarily conducted on a self-regulatory basis by industry bodies, supported by the statutory role of the national regulatory authorities in the Member States;
Maltese: Il-kontroll tar-reklamar ta' mediċini li jinxtraw mingħajr riċetta fl-UE jsir primarament fuq bażi ta' awtoregolamentazzjoni minn korpi tal-industrija, appoġġjat mill-irwol statutorju tal-awtoritajiet regolatorji nazzjonali fl-Istati Membri;
English: As part of this process, the Board conducts an analysis and assessment of the Executive Director's annual activity report.
Maltese: Bħala parti minn dan il-proċess, il-Bord iwettaq analiżi u valutazzjoni tar-rapport annwali ta' attività tad-Direttur Eżekuttiv.
English: Breach-of-trust procedure
Maltese: Il-persunal tal-Aġenzija
English: The current revised policy reflects a balanced approach to handling competing interests that aims to effectively restrict the involvement of experts with possible competing interests in the Agency's work while maintaining EMA's ability to access the best available expertise.
Maltese: Il-politika attwali riveduta tirrifletti approċċ ibbilanċjat ta' kif jiġu ġestiti kunflitti ta' interess li għandha l-għan li b'mod effettiv tillimita l-involviment ta' esperti b'kunflitti ta' interess possibbli fil-ħidma talAġenzija waqt li żżomm l-abbiltà tal-EMA li taċċessa l-aħjar għarfien disponibbli.
English: • National competent authorities (human)
Maltese: • awtoritajiet nazzjonali kompetenti (bniedem)
English: EMA has encouraged the formation of multinational assessment teams since 2013 for initial marketing authorisation applications.
Maltese: L-EMA ħeġġet il-formazzjoni ta' timijiet ta' valutazzjoni multinazzjonali mill-2013 għal applikazzjonijiet inizjali ta' awtorizzazzjoni għat-tqegħid fis-suq.
English: EMA's scientific committees provide independent recommendations on medicines for human and veterinary use, based on a comprehensive scientific evaluation of data.
Maltese: Il-kumitati xjentifiċi tal-EMA jipprovdu rakkomandazzjonijiet indipendenti dwar mediċini għall-użu millbniedem u veterinarju, abbażi ta' valutazzjoni xjentifika u komprensiva tad-data.
English: The centralised procedure is compulsory for:
Maltese: Din il-proċedura ċentralizzata hija obbligatorja għal:
English: • contributing to international pharmacovigilance activities with authorities outside the EU;
Maltese: • tikkontribwixxi għal attivitajiet internazzjonali ta' farmakoviġilanza ma' awtoritajiet barra mill-UE;
English: It is responsible for adopting the implementing provisions for the practical application of the rules and regulations applicable to officials and other EU staff.
Maltese: Huwa responsabbli għall-adozzjoni tad-dispożizzjonijiet ta' implimentazzjoni għall-applikazzjoni prattika tar-regoli u tar-regolamenti applikabbli għall-uffiċjali u għal persunal ieħor tal-UE.
English: • the nature of the interests declared;
Maltese: • in-natura tal-interessi ddikjarati;
English: Tthe Management Board revised its rules on how the Agency handles potential competing interests of staff members in October 2016.
Maltese: F'Ottubru 2016, il-Bord ta' Tmexxija rreveda r-regoli dwar kif l-Aġenzija timmaniġġja kunflitti ta' kompetizzjoni potenzjali tal-membri tal-persunal kollu.
English: Requirements for experts who are members of scientific committees are stricter than for those participating in advisory bodies and ad-hoc expert groups.
Maltese: Ir-rekwiżiti għall-esperti li huma membri ta' kumitati xjentifiċi jibqgħu aktar stretti milli għal dawk li jkunu qed jipparteċipaw f'korpi konsultattivi u fi gruppi ta' esperti ad-hoc.
English: This supports an exchange of information on a number of issues, including:
Maltese: Dan jappoġġja skambju ta' informazzjoni dwar għadd ta' kwistjonijiet, fosthom:
English: The Agency's policy on the handling of competing interests of scientific experts, including committee members allows the Agency to identify cases where the potential involvement of an expert as a member of a committee, working party or other group or in any other Agency activity needs to be restricted or excluded due to interests in the pharmaceutical industry.
Maltese: Il-politika dwar l-immaniġġjar ta' kunflitti ta' kompetizzjoni tal-Aġenzija, inkluż il-membri tal-kumitat, tippermetti lill-Aġenzija li tidentifika każijiet fejn l-involviment potenzjali ta' espert bħala membru ta' kumitat, grupp ta' ħidma jew grupp ieħor jew fi kwalunkwe attività tal-Aġenzija jeħtieġ li jiġi ristrett jew eskluż minħabba interessi fl-industrija farmaċewtika.
English: They are selected to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographical spread within the EU.
Maltese: Jintgħażlu biex jiġu ggarantiti l-ogħla livelli ta' kwalifiki speċjalizzati, spettru wiesgħa ta' kompetenza rilevanti u l-aktar firxa ġeografika wiesgħa possibbli fi ħdan l-UE.
English: Board members are appointed for a three-year term, which may be renewed.
Maltese: Il-membri tal-Bord jinħatru għal terminu ta' tliet snin, li jista' jiġġedded.
English: Benefits of the network for EU citizens
Maltese: Benefiċċji għaċ-ċittadini tal-UE
English: These bodies are composed of European experts made available by national competent authorities of the EU Member States, which work closely with EMA in the European medicines regulatory network.
Maltese: Dawn il-korpi huma magħmula minn esperti Ewropej magħmula disponibbli minn awtoritajiet nazzjonali kompetenti tal-Istati Membri tal-UE, li jaħdmu mill-qrib mal-EMA fin-netwerk regolatorju Ewropew talmediċini.
English: Healthcare professionals can provide individual patients advice on medical conditions, treatments or side effects with a medicine;
Maltese: Il-professjonisti tal-kura tas-saħħa jistgħu jipprovdu parir lil pazjenti individwali dwar kundizzjonijiet mediċi, kuri jew effetti sekondarji b'mediċina;
English: Under the centralised authorisation procedure, pharmaceutical companies submit a single marketingauthorisation application to EMA.
Maltese: Taħt il-proċedura ta' awtorizzazzjoni ċentralizzata, il-kumpaniji farmaċewtiċi jippreżentaw applikazzjoni unika għal awtorizzazzjoni għat-tqegħid fis-suq lill-EMA.
English: • scientific support for advanced-therapy medicines;
Maltese: • appoġġ xjentifiku għal mediċini ta' terapija avvanzata;
English: Its day-to-day operations are carried out by the EMA staff, based inAmsterdam, overseen by EMA's Executive Director.
Maltese: L-operazzjonijiet ta' kuljum tagħha jsiru millpersunal tal-EMA, ibbażati f'Amsterdam, taħt is-sorveljanza tad-Direttur Eżekuttiv tal-EMA.
English: − auto-immune and other immune dysfunctions;
Maltese: − mard awtoimmuni u disfunzjonijiet immuni oħrajn;
English: The legal decision to grant, suspend or revoke a marketing authorisation for any medicine falls under the remit of the European Commission for centrally authorised products, and the national competent authorities of the EU Member States for nationally authorised products.
Maltese: Id-deċiżjoni legali għall-għoti, għassospensjoni jew għar-revoka ta' awtorizzazzjoni għat-tqegħid fis-suq għal kwalunkwe mediċina taqa' taħt il-kompetenza tal-Kummissjoni Ewropea għal prodotti awtorizzati skont il-proċedura ċentralizzata, u tal-awtoritajiet nazzjonali kompetenti tal-Istati Membri tal-UE għal prodotti awtorizzati fuq livell nazzjonali.
English: It is based on the ‘About us' section of EMA's corporate website.
Maltese: Huwa bbażat fuq is-sezzjoni ‘Dwarna' tas-sit elettroniku korporattiv tal-EMA.
English: Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the EEA countries Iceland, Liechtenstein and Norway.
Maltese: Ladarba l-Kummissjoni Ewropea tagħti l-awtorizzazzjoni ċentralizzata għat-tqegħid fis-suq, din tkun valida fl-Istati Membri kollha tal-UE kif ukoll fil-pajjiżi taż-ŻEE l-Iżlanda, il-Liechtenstein u nNorveġja.
English: EMA and its regulatory network partners run a scheme to enable multinational teams to assess applications for human and veterinary medicines.
Maltese: L-EMA u s-sħab tan-netwerk regolatorji tagħha għandhom skema li tippermetti lil timijiet multinazzjonali biex jivvalutaw applikazzjonijiet għal mediċini għall-użu mill-bniedem u dawk veterinarji.
English: • inspections to check compliance with good practice in the clinical development, manufacturing and distribution, and safety monitoring of medicines.
Maltese: • spezzjonijiet biex tiġi ċċekkjata l-konformità mal-prattika tajba fl-iżvilupp kliniku, fil-manifattura u d-distribuzzjoni u fil-monitoraġġ tas-sigurtà tal-mediċini.
English: The European Commission also develops EU policies in the field of human or veterinary medicines and public health.
Maltese: IlKummissjoni Ewropea tiżviluppa wkoll politiki tal-UE fil-qasam tal-mediċini tal-bniedem jew veterinarji u tas-saħħa pubblika.
English: The Agency screens each expert's declaration of interests (DoI) and assigns each DoI an interest level based on whether the expert has any interests, and whether these are direct or indirect.
Maltese: L-Aġenzija tiskrinja d-dikjarazzjoni ta' interessi (DoI, declaration of interests) ta' kull espert u tassenja kull DoI, livell ta' interess abbażi ta' jekk l-espert għandux xi interess, u jekk dan huwiex dirett jew indirett.
English: All Management Board members must submit a DoI every year.
Maltese: Il-membri kollha tal-Bord ta' Tmexxija għandhom jippreżentaw DoI kull sena.
English: • informing the public on the safety of medicines and cooperating with external parties, in particular representatives of patients and healthcare professionals.
Maltese: • tinforma lill-pubbliku dwar is-sigurtà tal-mediċini u tikkoopera ma' partijiet esterni, b'mod partikolari ma' rappreżentanti tal-pazjenti u tal-professjonisti fil-qasam tal-kura tas-saħħa.
English: • evaluate the initial marketing authorisation application of all medicines in the EU.
Maltese: • tevalwax l-applikazzjoni inizjali għal awtorizzazzjoni għat-tqegħid fis-suq tal-mediċini kollha fl-UE.