FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: ][3: http://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_en.pdf][4: http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52010DC0003][5: http://ec.europa.eu/health/ph_threats/human_substance/documents/blood_com_0217_en.pdf][6: http://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_en.pdf]
Maltese: ][3: http://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_mt.pdf][4: http://eur-lex.europa.eu/legal-content/MT/ALL/?uri=CELEX:52010DC0003][5: http://ec.europa.eu/health/ph_threats/human_substance/documents/blood_com_0217_en.pdf][6: http://ec.europa.eu/health/blood_tissues_organs/docs/blood_reportdonation_mt.pdf]
English: They reported conducting additional tests for syphilis, malaria, hepatitis A, hepatitis E and Parvovirus B19.
Maltese: Huma rrapportaw li wettqu testijiet addizzjonali għas-sifilide, il-malarja, l-epatite A, l-epatite E u l-Parvovirus
English: 3.2 Obligations of blood competent authorities
Maltese: 3.2 Obbligi tal-awtoritajiet kompetenti tad-demm
English: In 2012, 22 countries reported having performed 760 on-site inspections.
Maltese: Fl-2012, 22 pajjiż irrapportaw li wettqu 760 spezzjoni fuq il-post.
English: While many countries report having data on imported volumes, it is difficult to draw conclusions in the absence of a harmonised data collection system on import and export volumes.
Maltese: Filwaqt li ħafna pajjiżi jirrapportaw li għandhom data fuq volumi importati, huwa diffiċli li tinstilet konklużjoni fin-nuqqas ta' sistema ta' ġbir ta' data armonizzata dwar il-volumi tal-importazzjoni u l-esportazzjoni.
English: EU legislation defines the minimum serological testing for human immunodeficiency virus (HIV) 1/2, hepatitis B and hepatitis C to be carried out for every whole blood and apheresis donation.
Maltese: Il-leġiżlazzjoni tal-UE tiddefinixxi l-ittestjar seroloġiku minimu għal virus tal-immunodefiċjenza umana (HIV) 1/2, epatite B u epatite Ċ sabiex jitwettaq għal kull donazzjoni ta' demm sħiħ u afereżi.
English: Donor screening for eligibility.
Maltese: Skrinjar tad-donatur għall-eliġibilità.
English: Sixteen reported discouraging such donations by requiring a local ID document or a proof or local residence.
Maltese: Sittax irrapportaw li jiskoraġġixxu dawn id-donazzjonijiet billi jitolbu dokument tal-identità lokali, prova ta' residenza jew residenza lokali.
English: This topic is intrinsically linked with the promotion and success of the principle of VUD, as highlighted in recital 23 of Directive 2002/98/EC.
Maltese: Dan is-suġġett huma marbut intrinsikament mal-promozzjoni u s-suċċess tal-prinċipju ta' VUD, kif enfasizzat fil-premessa 23 tad-Direttiva 2002/98/KE.
English: While all countries report having recall procedures in place, only 14 reported recalls (1867 in total).
Maltese: Filwaqt li l-pajjiżi kollha jirrapportaw li għandhom proċeduri ta' sejħiet lura fis-seħħ, 14 biss irrapportaw (1867 b'kollox).
English: The global growth of utilisation of plasma derivatives, particularly intravenous immunoglobulin (IVIG), requires a growing number of donations.
Maltese: Iż-żieda globali fl-użu tad-derivattivi tal-plażma, b'mod partikolari tal-immunoglobulina intravenuża (IVIG), tirrikjedi għadd dejjem ikbar ta' donazzjonijiet.
English: The UK and Ireland apply this policy as part of their risk mitigation strategy for transmission of variant Creutzfeldt Jacob disease.
Maltese: Ir-Renju Unit u l-Irlanda japplikaw din il-politika bħala parti mill-istrateġija għat-tnaqqis tar-riskju tagħhom għat-trażmissjoni ta' mard varjant ta' Creutzfeldt Jacob.
English: Fig. 3: Percentage of reporting blood establishments/country
Maltese: 3: Perċentwal tal-istabbilimenti tad-demm/pajjiżi rapportanti
English: Projects such as EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP and the on-going joint action VISTART provide strong support to Member States in their efforts to implement the requirements of the blood directives.
Maltese: Proġetti bħal EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP u l-azzjoni konġunta kontinwa VISTART jipprovdu appoġġ b'saħħtu lill-Istati Membri fl-isforzi tagħhom sabiex jimplimentaw ir-rekwiżiti tad-direttivi dwar id-demm.
English: The maximum reported values of compensation and incentives are around EUR 25-30 per donation while the reported values of refreshments and small tokens are between EUR 1 and EUR 10 per donation.
Maltese: Il-valuri massimi ta' kumpens u ta' inċentivi rrapportati huma ta' madwar EUR 25-30 għal kull donazzjoni, filwaqt li l-valuri tal-ikel u x-xorb u ta' tokens żgħar irrapportati huma ta' bejn EUR 1 u EUR 10 għal kull donazzjoni.
English: Other eligibility criteria that several countries would wish to reflect on relate to the history of malignancy, donor risk behaviour and haemoglobin levels.
Maltese: Kriterji ta' eliġibilità oħrajn li diversi pajjiżi jixtiequ li jirriflettu fuqhom huma relatati mal-istorja ta' tumuri malinni, imġiba ta' riskju tad-donatur u livelli tal-emoglobina.
English: Since the survey was conducted, changes in national policies have been reported by some countries during the bi-annual meetings of Competent Authorities; the trend is to move from permanent to temporary (usually 12 months) deferral for MSM.
Maltese: Minn mindu sar l-istħarriġ, ġew irrapportati bidliet fil-politiki nazzjonali minn xi pajjiżi waqt il-laqgħat biannwali tal-Awtoritajiet kompetenti; ix-xejra hija ta' qlib minn differiment permanenti għal wieħed temporanju (ġeneralment 12-il xahar) fir-rigward ta' MSM.
English: Fig. 1: Additional fields of competence for national blood competent authorities
Maltese: 1: Oqsma addizzjonali ta' kompetenza għall-awtoritajiet kompetenti nazzjonali tad-demm
English: There is diversity between Member States in organisation (e.g. desk-based versus on-site), and outcome (i.e. classification and follow-up of deficiencies) of inspections.
Maltese: Hemm diversità bejn l-Istati Membri fl-organizzazzjoni (eż. minn ġewwa uffiċċju kontra fuq il-post), u fir-riżultat (jiġifieri klassifikazzjoni u segwitu tad-defiċjenzi) tal-ispezzjonijiet.
English: Safety and quality of blood depends on the implementation of a combination of three pillars: donor screening for deferral criteria, donor testing and, where possible, pathogen inactivation techniques.
Maltese: Is-sigurtà u l-kwalità tad-demm jiddependu fuq l-implimentazzjoni ta' kombinament ta' tliet pilastri: skrinjar tad-donatur għal kriterji tad-differiment, ittestjar tad-donatur u, fejn possibbli, tekniki ta' inattivazzjoni tal-patoġenu.
English: Shortages, surpluses and self-sufficiency.
Maltese: Skarsezzi, eċċessi u awto-suffiċjenza.
English: Additionally, the distinction between import/export from/to third countries and distribution from/to other EU Member States is not consistently applied.
Maltese: Barra minn hekk, id-distinzjoni bejn importazzjoni/esportazzjoni minn/għal pajjiżi terzi u d-distribuzzjoni minn/għal Stati Membri tal-UE oħrajn mhijiex applikata b'mod konsistenti.
English: The EU is significantly reliant on importation of plasma for the manufacture of plasma derived medicinal products, mainly from the United States.
Maltese: L-UE tiddependi b'mod sinifikanti fuq l-importazzjoni tal-plażma għall-manifattura ta' plażma li ġejja minn prodotti mediċinali, prinċipalment mill-Istati Uniti.
English: These shortages often occur in summer/holiday seasons when the number of donors is reduced and the risk of epidemiological outbreaks, such as West Nile Virus, can temporarily reduce the number of eligible donors.
Maltese: Dawn l-iskarsezzi ta' sikwit iseħħu fis-sajf/staġuni tal-vaganzi meta n-numru ta' donaturi jonqos u r-riskju ta' tifqigħat epidemjoloġiċi, bħall-virus tal-West Nile, jistgħu jnaqqsu n-numru ta' donaturi eliġibbli b'mod temporanju.
English: Legend: ART = assisted reproductive technologies
Maltese: ART = teknoloġiji riproduttivi assistiti
English: (Total POs = 4825; 2011 data)
Maltese: (POs totali = 4825; data tal-2011)
English: Penalties.
Maltese: Penali.
English: Reproductive cells (ART sector).
Maltese: Ċelloli riproduttivi (settur tal-ART).
English: [11: Case C-29/14, judgment pronounced on 11 June 2015.
Maltese: [11: Kawża C-29/14, sentenza mogħtija fil-11 ta' Ġunju 2015.
English: Diverse practices related to the implementation of the requirements of Article 4 of Directive 2006/86/EC were reported.
Maltese: Ġew irrapportati prattiki diversi relatati mal-implimentazzjoni tar-rekwiżiti tal-Artikolu 4 tad-Direttiva 2006/86/KE.
English: Donor testing.
Maltese: Ittestjar tad-donatur.
English: Total inspections = 549; data reported by 22 Member States
Maltese: Spezzjonijiet totali = 549; data rrapportata minn 22 Stat Membru
English: Legend: HSC = haematopietic stem cells
Maltese: HSC = ċelloli staminali ematopojetiċi
English: Total inspections = 443; data reported by 21 Member States
Maltese: Spezzjonijiet totali = 443; data rrapportata minn 21 Stat Membru
English: ][4: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0708:FIN:EN:PDF ][5: http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1422283594361&uri=CELEX:52006DC0593 ][6: http://ec.europa.eu/health/blood_tissues_organs/docs/tissues_voluntary_report_en.pdf ]
Maltese: ][4: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0708:FIN:MT:PDF ][5: http://eur-lex.europa.eu/legal-content/MT/TXT/?qid=1422283594361&uri=CELEX:52006DC0593 ][6: http://ec.europa.eu/health/blood_tissues_organs/docs/tissues_voluntary_report_en.pdf]
English: Quality and safety of tissues and cells
Maltese: Kwalità u sigurtà tat-tessuti u ċ-ċelloli
English: Quality management, responsible person and personnel.
Maltese: Ġestjoni tal-kwalità, persuna responsabbli u persunal.
English: Designation of competent authority or authorities responsible for the implementation of Directive 2004/23/EC
Maltese: Ħatra ta' awtorità jew awtoritajiet kompetenti responsabbli għall-implimentazzjoni tad-Direttiva 2004/23/KE
English: [22: Commission Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (OJ L 93, 9.4.2015, p. 56). ]
Maltese: [22: Direttiva tal-Kummissjoni (UE) 2015/566 li timplimenta d-Direttiva 2004/23/KE dwar il-proċeduri għall-verifika tal-istandards ekwivalenti ta' kwalità u sikurezza ta' tessuti u ċelloli importati (ĠU L 93, 9.4.2015, p. 56). ]
English: Tissue establishments' status (public vs. private)/type of tissue (2011 data; data submitted by 25 Member States and one EEA country)
Maltese: Status tal-istabbilimenti tat-tessuti (pubbliċi vs. privati)/tip ta' tessuti (data tal-2011; data ppreżentata minn 25 Stat Membru u pajjiż wieħed taż-ŻEE)
English: [23: http://ec.europa.eu/chafea/documents/health/leaflet/transplantation-transfusion.pdf][24: http://ec.europa.eu/health/blood_tissues_organs/projects/index_en.htm]
Maltese: [23: http://ec.europa.eu/chafea/documents/health/leaflet/transplantation-transfusion.pdf][24: http://ec.europa.eu/health/blood_tissues_organs/projects/index_mt.htm]
English: At the end of 2011, 2047 tissue establishments were authorised in the EU, showing an almost 20% increase compared to the 2008 data (Fig. 4).
Maltese: Fl-aħħar tal-2011, 2047 stabbiliment tat-tessuti kienu awtorizzati fl-UE, fejn dehret żieda ta' kważi 20% meta mqabbla mad-data tal-2008 (Fig. 4).
English: Consent, data protection and confidentiality.
Maltese: Kunsens, protezzjoni tad-data u kunfidenzjalità.
English: Obligations of Member State competent authorities
Maltese: Obbligi tal-awtoritajiet kompetenti tal-Istat Membru
English: As a consequence, pursuant to Article 258 TFEU, the Commission has brought action against one Member State to the Court of Justice, and launched an infringement proceeding against another Member State, which is ongoing.
Maltese: Bħala konsegwenza, skont l-Artikolu 258 TFUE, il-Kummissjoni ressqet azzjoni kontra Stat Membru wieħed fil-Qorti tal-Ġustizzja, u nediet proċediment ta' ksur kontra Stat Membru ieħor, li għadha għaddejja.
English: Non-reproductive tissues and cells.
Maltese: Tessuti u ċelloli mhux riproduttivi.
English: Only 15 Member States reported putting in place additional measures like examination/inspection/approval of advertising materials, training of professionals to spot illegal and fraudulent activities, verification that the VUD principle is also respected for imported tissues and cells.
Maltese: 15-il Stat Membru biss irrapportaw it-tqegħid fis-seħħ ta' miżuri addizzjonali bħall-eżaminazzjoni/spezzjoni/approvazzjoni ta' materjal tar-reklamar, taħriġ ta' professjonisti sabiex jidentifikaw attivitajiet illegali u ta' frodi, verifika li l-prinċipju ta' VUD huwa rispettat ukoll għal tessuti u ċelloli importati.
English: Most Member States allow compensation to be offered to living donors (22 countries for living donors of non-reproductive tissues and cells; 17 countries for donors of reproductive cells).
Maltese: Ħafna mill-Istati Membri jippermettu kumpens li għandu jiġi offrut lil donaturi ħajjin (22 pajjiż għal donaturi ħajjin ta' tessuti u ċelloli mhux riproduttivi; 17-il pajjiż għal donaturi ta' ċelloli riproduttivi).
English: [12: http://ec.europa.eu/health/blood_tissues_organs/docs/manual_en.pdf ]
Maltese: [12: http://ec.europa.eu/health/blood_tissues_organs/docs/manual_mt.pdf ]
English: In some Member States the sector is fully controlled by public organisations, whilst in others private operators make a significant contribution (Fig. 5).
Maltese: F'xi Stati Membri s-settur huwa kkontrollat b'mod sħiħ minn organizzazzjonijiet pubbliċi, filwaqt li f'oħrajn operaturi privati jagħtu kontribut sinifikanti (Fig. 5).
English: [13: Commission Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (OJ L 93, 9.4.2015, p.
Maltese: [13: Direttiva tal-Kummissjoni (UE) 2015/565 li temenda d-Direttiva 2006(86/KE fir-rigward ta' ċerti rekwiżiti tekniċi għall-kodifikazzjoni tat-tessuti u ċ-ċelloli tal-bniedem (ĠU L 93, 9.4.2015, p. 43).]
English: Several countries have introduced more stringent testing requirements such as nucleic acid testing (NAT) for hepatitis B (HBV), hepatitis C (HCV) and/or human immunodeficiency virus (HIV) for non-reproductive and/or reproductive tissue and cells, whereas in most Member States and EEA countries the use of this type of testing is not required on the basis of a cost-benefit analysis and/or the epidemiological context.
Maltese: Diversi pajjiżi introduċew rekwiżiti aktar stretti għall-ittestjar bħall-ittestjar tal-aċidu nuklejku (NAT) għall-epatite B (HBV), epatite Ċ (HCV) u/jew virus tal-immunodefiċjenza umana (HIV) għal tessuti u ċelloli mhux riproduttivi u/jew riproduttivi, mentri f'ħafna mill-Istati Membri u pajjiżi taż-ŻEE l-użu ta' dan it-tip ta' ttestjar mhuwiex meħtieġ abbażi tal-analiżi tal-ispiża u l-benefiċċju u/jew il-kuntest epidemjoloġiku.
English: Relations between tissue establishments and third parties.
Maltese: Relazzjonijiet bejn stabbilimenti tat-tessuti u partijiet terzi.
English: EN EN
Maltese: a.
English: Additional screening and testing may reduce, but cannot completely eliminate, the possibility of a transmission from donor to recipient.
Maltese: Skrining u ttestjar addizzjonali jistgħu jnaqqsu, imma ma jistgħux jeliminaw kompletament, il-possibilità ta' trażmissjoni mid-donatur għar-reċipjent.
English: Outcome of tissue establishment inspections performed in 2011
Maltese: Riżultat ta' spezzjonijiet tal-istabbilimenti tat-tessuti mwettqa fl-2011
English: [41: OJ L 123, 12.5.2016, p.
Maltese: [41: ĠU L 123, 12.5.2016, p. 1.]
English: GRAND TOTAL 34 60 85 85 85
Maltese: TOTAL FINALI 34 60 85 85 85
English: Standard data formats
Maltese: Formats standard ta' data
English: Title 2: Infrastructure and operating expenditure Commitments (1a)
Maltese: Titolu 2: Infiq operazzjonali u infrastrutturali Impenji (1a)
English: "(m) a summary of the dossier in a standardised form.
Maltese: "(m) sommarju tad-dossier f'forma standardizzata.";
English: [23: https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf.]
Maltese: [23: https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_mt.pdf.]
English: [4: C(2017) 8414 final.]
Maltese: ĠU C(2017) 8414 finali.]
English: Appeals 8.4 FTEs 450/ dossier10% =45 appeals 10% confid.
Maltese: Appelli 8,4 FTEs 450/ dossier10 % =45 appell 10 % talbiet għal kunfid.
English: [Body]: <EFSA.> Year
Maltese: [Test]: <EFSA.> Sena
English: Regulatory fitness and simplification
Maltese: Idoneità regolatorja u simplifikazzjoni
English: of the multiannual financial framework (Total commitments = Total payments)
Maltese: tal-qafas finanzjarju pluriennali (Impenji totali = Pagamenti totali)
English: Transparency and confidentiality
Maltese: Trasparenza u kunfidenzjalità
English: (4) the following Articles 32a, 32b, 32c, 32d and 32e are inserted:
Maltese: (4) jiddaħħlu l-Artikoli 32a, 32b, 32c, 32d u 32e li ġejjin:
English: EUR million (to three decimal places)
Maltese: EUR miljun (sa tliet punti deċimali)
English: [19: OJ C , , p.
Maltese: ĠU C , , p. .]
English: [43: Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx.]
Maltese: [43: Id-dettalji tal-modi ta' ġestjoni u r-referenzi għar-Regolament Finanzjarju jistgħu jinsabu fis-sit BudgWeb: https://myintracomm.ec.europa.eu/budgweb/MT/man/budgmanag/Pages/budgmanag.aspx.]
English: "Article 57a
Maltese: "Artikolu 57a
English: TOTAL appropriations co-financed
Maltese: Approprjazzjonijiet TOTALI kofinanzjati
English: Protection of personal data
Maltese: Protezzjoni tad-data personali
English: claims/dossier 0.432 0.757 1.081
Maltese: /dossier 0,432 0,757 1,081
English: X Proposal/initiative of unlimited duration
Maltese: X Proposta/inizjattiva ta' durata mhux limitata
English: […] [XX.YY.YY.YY] […] […] YES/
Maltese: […] [XX.SS.SS.SS] […] […] IVA/
English: Capacity building 2.4 FTEs 0.124 0.217 0.310
Maltese: Bini ta' kapaċità 2,4 FTEs 0,124 0,217 0,310
English: A public consultation on the initiative in all Union official languages was launched on 23 January 2018 and ran until 20 March 2018; 471 replies were received (318 from individuals and 153 from organisations).
Maltese: Konsultazzjoni pubblika dwar l-inizjattiva fil-lingwi uffiċjali kollha tal-Unjoni tnediet fit-23 ta' Jannar 2018 u baqgħet għaddejja sal-20 ta' Marzu 2018; daħlu 471 tweġiba (318 mingħand individwi u 153 mingħand organizzazzjonijiet).
English: Ex-post evaluations/fitness checks of existing legislation
Maltese: Evalwazzjonijiet ex post/kontrolli tal-idoneità tal-leġiżlazzjoni eżistenti
English: X bodies referred to in Articles 208 and 209;
Maltese: X lill-korpi msemmija fl-Artikoli 208 u 209;
English: Each Member State shall nominate at least 12 scientific experts.
Maltese: Kull Stat Membru għandu jinnomina tal-anqas 12-il espert xjentifiku.
English: Additional ad hoc studies 4FTEs 0.207 0.362 0.517
Maltese: Studji ad hoc addizzjonali 4FTEs 0,207 0,362 0,517
English: Insourcing routine work 15 FTEs 0.775 1.357 1.938
Maltese: Ħidma ta' rutina b'sorsi interni 15-il FTE 0,775 1,357 1,938
English: (10) the following Article 57a is inserted after the title of Section 1 in Chapter V:
Maltese: (10) l-Artikolu 57a li ġej jiddaħħal wara t-titolu tat-Taqsima 1 fil-Kapitolu V:
English: Temporary staff 4.861 8.507 12.154 12.154 12.154 49.830
Maltese: Persunal temporanju 4,861 8,507 12,154 12,154 12,154 49,830
English: (b) results of production batches of the active substance including impurities; and,
Maltese: (b) ir-riżultati ta' lottijiet tal-produzzjoni tas-sustanza attiva inklużi l-impuritajiet; u,
English: Confidentiality checks 25.2 FTEs 12.600studies 450 dossiers 80%confid.studies 0.4day scrutiny Average No studies /dossier= 35 1.302 2.279 3.256
Maltese: Kontrolli ta' kunfidenzjalità 25,2 FTEs 12,600 studju 450 dossier 80 % studji kunfid. 0,4jum ta' skrutinju Nru medju ta' studji /dossier= 35 1,302 2,279 3,256
English: Subtotal for specific objective No 4 2.800 4.900 7.000 7.000 7.000 28.700
Maltese: Subtotal għall-objettiv speċifiku Nru 4 2,800 4,900 7,000 7,000 7,000 28,700
English: Contract staff 0.629 1.101 1.572 1.572 1.572 6.446
Maltese: Aġenti kuntrattwali 0,629 1,101 1,572 1,572 1,572 6,446
English: (ii) Independence and absence of conflict of interests in accordance with Article 37(2) and the Authority's independence policy and implementing rules on the independence of the Scientific Panels' members;
Maltese: (ii) Indipendenza u nuqqas ta' kunflitt ta' interessi b'konformità mal-Artikolu 37(2) u l-politika dwar l-indipendenza tal-Awtorità u r-regoli ta' implimentazzjoni dwar l-indipendenza tal-membri tal-Bordijiet Xjentifiċi;
English: "Article 39
Maltese: "Artikolu 39
English: MB with MSs & observers 0.2 FTEs 0.010 0.018 0.025
Maltese: MB mal-SM u ma' osservaturi 0,2 FTEs 0,010 0,018 0,025
English: (a) Article 1(2) shall apply from 1st July 2022.
Maltese: (a) L-Artikolu 1(2) għandu japplika mill-1 ta' Lulju 2022.
English: The proposal is based on Articles 43, 114, and 168(4)(b) of the Treaty on the Functioning of the European Union.
Maltese: Il-proposta hi bbażata fuq l-Artikoli 43, 114, u 168(4)(b) tat-Trattat dwar il-Funzjonament tal-Unjoni Ewropea.
English: The proposal/initiative requires application of the flexibility instrument or revision of the multiannual financial framework.
Maltese: Il-proposta/L-inizjattiva teħtieġ applikazzjoni tal-istrument ta' flessibbiltà jew reviżjoni tal-qafas finanzjarju pluriennali.
English: Subtotal for specific objective No 1 1.120 1.960 2.800 2.800 2.800 11.480
Maltese: Subtotal għall-objettiv speċifiku Nru 1 1,120 1,960 2,800 2,800 2,800 11,480
English: Additional ad hoc studies 16 ad hoc studies 6.000 10.500 15.000 15.000 15.000 61.500
Maltese: Studji ad hoc addizzjonali 16-il studju ad hoc 6,000 10,500 15,000 15,000 15,000 61,500
English: EFSA Single Programming Document (SPD), EFSA Management Board meeting (responsible for Authority's governance), EFSA Annual report activities.
Maltese: Id-Dokument Uniku ta' Programmazzjoni (SPD) tal-EFSA, il-laqgħa tal-Bord ta' Ġestjoni tal-EFSA (responsabbli għall-governanza tal-Awtorità), l-attivitajiet tar-Rapport annwali tal-EFSA.
English: Officials (AD Grades)
Maltese: Uffiċjali (Gradi AD)
English: Article 8a
Maltese: Artikolu 8a
English: 2021 Year
Maltese: 2021 Sena
English: "Article 61
Maltese: "Artikolu 61
English: (a) the name and address of the applicant;
Maltese: (a) l-isem u l-indirizz tal-applikant;
English: Seconded National Experts
Maltese: Esperti Nazzjonali Sekondati
English: Strengthen advocacy: targeted messages, narrative, translations etc 4.8 FTEs 0.248 0.434 0.620
Maltese: It-tisħiħ tar-rappreżentanza: messaġġi mmirati, narrattiva, traduzzjonijiet eċċ 4,8 FTEs 0,248 0,434 0,620
English: Stakeholders engagement in RA process 50 events/year 10 panels5event panel/y 0.600 1.050 1.500 1.500 1.500 6.150
Maltese: Involviment tal-partijiet ikkonċernati fil-proċess tal-RA 50 avveniment/sena 10 bordijiet5avvenimenti għal kull bord/sena 0,600 1,050 1,500 1,500 1,500 6,150
English: (c) take into account risk perceptions;
Maltese: (c) tikkunsidra l-perċezzjonijiet tar-riskju;
English: Function group IV
Maltese: Grupp ta' funzjonijiet IV
English: bodies governed by private law with a public service mission to the extent that they provide adequate financial guarantees;
Maltese: korpi rregolati bil-liġi privata b'missjoni ta' servizz pubbliku sa fejn jipprovdu garanziji finanzjarji adegwati;
English: Strengthen advocacy: targeted messages, narrative, translations, etc Increase targeted communication key topics Sc.literacy actions 1.700 2.975 4.250 4.250 4.250 17.425
Maltese: It-tisħiħ tar-rappreżentanza: messaġġi mmirati, narrattiva, traduzzjonijiet, eċċ Komunikazzjoni mmirata akbar tas-suġġetti ewlenin Azzjonijiet għal-litteriżmu xjentifiku 1,700 2,975 4,250 4,250 4,250 17,425
English: "SECTION 1a
Maltese: "TAQSIMA 1a
English: Risk(s) identified
Maltese: 2.2.1. Riskju/i identifikat/i
English: PC on all dossiers 8.5 FTEs 376dossiers for PC 0.5 effort/day+4 outcome 0.437 0.765 1.093
Maltese: PC fuq kull dossier 8,5 FTEs 376 dossier għall-PC 0,5 sforz/jum+4 eżitu 0,437 0,765 1,093
English: Subsidiarity (for non-exclusive competence)
Maltese: Sussidjarjetà (għal kompetenza mhux esklużiva)
English: Capacity building 10 panels/21 members 7 days/training /y 0.224 0.392 0.560 0.560 0.560 2.296
Maltese: Bini tal-kapaċità 10 bordijiet/21 membru 7 jiem/taħriġ /sena 0,224 0,392 0,560 0,560 0,560 2,296
English: (b) promote consistency and transparency in formulating risk management recommendations;
Maltese: (b) il-promozzjoni tal-konsistenza u tat-trasparenza fil-formulazzjoni ta' rakkomandazzjonijiet dwar l-amministrazzjoni tar-riskju;
English: Toxicological studies (H2020-FP9) 2FTEs 0.103 0.181 0.258
Maltese: Studji tossikoloġiċi (H2020-FP9) 2FTEs 0,103 0,181 0,258
English: Stakeholder consultations
Maltese: IMPLIKAZZJONIJIET BAĠITARJI
English: Article 8c
Maltese: Artikolu 8c
English: N° of requests for access to documents addressed to EFSA and the Commission.
Maltese: Nru ta' talbiet għal aċċess għal dokumenti indirizzati lill-EFSA u lill-Kummissjoni.
English: Stakeholders engagement in RA process 12.5 FTES 0.646 1.131 1.615
Maltese: Involviment tal-partijiet ikkonċernati fil-proċess tal-RA 12,5-il FTE 0,646 1,131 1,615
English: There are no negative impacts in the duration of authorisation procedures since this is a parallel activity.
Maltese: Ma hemm ebda impatt negattiv fuq id-durata tal-proċeduri ta' awtorizzazzjoni peress li din hi attività parallela.
English: "Article 39a
Maltese: "Artikolu 39a
English: However, the term of office of the members referred to in paragraph 1a(a) and (b) shall not be limited in duration.
Maltese: Madankollu, il-mandat tal-membri msemmija fil-paragrafu 1a(a) u (b) ma għandux ikun limitat fid-durata tiegħu.
English: Human Resources
Maltese: Riżorsi Umani
English: [13: Proposal for a Regulation of the European Parliament and of the Council adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union, COM(2016)799 final, dated 14.12.2016.]
Maltese: [13: Proposta għal Regolament tal-Parlament Ewropew u tal-Kunsill li jadatta għadd ta' atti legali li jipprevedu l-użu tal-proċedura regolatorja bi skrutinju mal-Artikoli 290 u 291 tat-Trattat dwar il-Funzjonament tal-Unjoni Ewropea, COM(2016)799 final, datata l-14.12.2016.]
English: "Article 32a
Maltese: "Artikolu 32a
English: (c) in paragraph 3 the following point (m) is added:
Maltese: (c) fil-paragrafu 3 jiżdied il-punt (m) li ġej:
English: (i) advice provided by the Authority to potential applicants at pre-submission phase pursuant to Article 32a and 32c.
Maltese: (i) il-parir ipprovdut mill-Awtorità lill-applikanti potenzjali fil-fażi ta' qabel is-sottomissjoni skont l-Artikolu 32a u 32c.
English: [24: Communication from the Commission on the ECI "Ban glyphosate and protect people and the environment from toxic pesticides", C(2017) 8414 final.]
Maltese: Komunikazzjoni mill-Kummissjoni dwar l-ECI "Projbizzjoni tal-glifosat biex b'hekk in-nies u l-ambjent ikunu protetti mill-pestiċidi tossiċi", C(2017) 8414 final.]
English: "Article 25
Maltese: "Artikolu 25
English: [Heading……………………...…………] Diff./Non-diff.[44: Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.]
Maltese: ……] Diff./Mhux diff.[44:
English: Pre-submission meetings without PC 6.2 FTEs 176 dossiers & meetings 7 days/dossier 0.318 0.557 0.796
Maltese: Laqgħat ta' qabel is-sottomissjoni mingħajr PC 6,2 FTEs 176 dossier u laqgħa 7 ijiem/dossier 0,318 0,557 0,796
English: Preparatory work sharing with MSs grants/procurements 5.120 8.960 12.800 12.800 12.800 52.480
Maltese: Qsim ta' xogħol preparatorju ma' SM għotjiet/akkwisti 5,120 8,960 12,800 12,800 12,800 52,480
English: X The proposal is compatible with the current multiannual financial framework and may entail the use of special instruments as defined in Council Regulation (EU, Euratom) No 1311/2013.
Maltese: X Il-proposta hi kompatibbli mal-qafas finanzjarju pluriennali attwali u tista' tinvolvi l-użu ta' strumenti speċjali kif definit fir-Regolament tal-Kunsill (UE, Euratom) Nru 1311/2013.
English: Subtotal for specific objective No 2 6.000 10.500 15.000 15.000 15.000 61.500
Maltese: Subtotal għall-objettiv speċifiku Nru 2 6,000 10,500 15,000 15,000 15,000 61,500
English: Article 8
Maltese: Artikolu 8
English: Laboratory related audit can be performed by existing service SANTE.F "Health and Food audits and analysis".
Maltese: Awditu relatat mal-laboratorju jista' jsir mis-servizz eżistenti SANTE.F
English: Amendments to Regulation (EU) No 2015/2283 on novel foods
Maltese: Emendi għar-Regolament (UE) Nru 2015/2283 dwar ikel ġdid
English: Pre-submission meetings for all renewals with PC 4.3 FTEs 74applications 7 man-days+ 4 PC 0.220 0.385 0.550
Maltese: Laqgħat ta' qabel is-sottomissjoni għal kull tiġdid b'PC 4,3 FTEs 74applikazzjoni 7 jiem ta' xogħol+ 4 PC 0,220 0,385 0,550
English: (f) ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain.
Maltese: (f) l-iżgurar tal-iskambju xieraq ta' informazzjoni mal-partijiet interessati b'rabta mar-riskji assoċjati mal-katina agroalimentari.
English: XX 01 02 02 (AC, AL, END, INT and JED in the Delegations)
Maltese: XX 01 02 02 (AC, AL, END, INT u JED fid-Delegazzjonijiet)
English: IT support for data disclosure Licences/maintenance/storage/security 0.960 1.680 2.400 2.400 2.400 9.840
Maltese: Appoġġ tal-IT għad-divulgazzjoni ta' data Liċenzji/manutenzjoni/ħżin/sigurtà 0,960 1,680 2,400 2,400 2,400 9,840
English: Information systems
Maltese: Sistemi tal-informazzjoni
English: "Article 30
Maltese: "Artikolu 30
English: Fundamental rights
Maltese: Drittijiet fundamentali
English: (4) In Article 28, the following paragraph 4 is added:
Maltese: (4) Fl-Artikolu 28 jiżdied il-paragrafu 4 li ġej:
English: The proposal/initiative will entail reprogramming of the relevant heading in the multiannual financial framework.
Maltese: Il-proposta/l-inizjattiva se tirrikjedi programmazzjoni mill-ġdid tal-intestatura rilevanti fil-qafas finanzjarju pluriennali.
English: Amendments to Directive (EC) 2001/18/EC on the deliberate release into the environment of genetically modified organisms
Maltese: Emendi għad-Direttiva (KE) 2001/18/KE dwar ir-rilaxx intenzjonat fl-ambjent ta' organiżmi modifikati ġenetikament
English: Article 8b
Maltese: Artikolu 8b
English: Amendments to Regulation (EC) No 178/2002
Maltese: Emendi għar-Regolament (KE) Nru 178/2002
English: on miscellaneous revenue
Maltese: aġenziji eżekuttivi
English: Subtotal for specific objective No 3 9.592 16.785 23.979 23.979 23.979 98.314
Maltese: Subtotal għall-objettiv speċifiku Nru 3 9,592 16,785 23,979 23,979 23,979 98,314
English: (2) Regulation (EC) No 178/2002 defines "risk analysis" as a process consisting of three interconnected components: risk assessment, risk management and risk communication.
Maltese: (2) Ir-Regolament (KE) Nru 178/2002 jiddefinixxi "analiżi tar-riskju" bħala proċess li jikkonsisti fi tliet komponenti interkonnessi: stima tar-riskju, amministrazzjoni tar-riskju u komunikazzjoni tar-riskju.
English: Preparatory work sharing with MSs 6.9 FTEs 0.356 0.624 0.891
Maltese: Qsim ta' xogħol preparatorju ma' SM 6,9 FTEs 0,356 0,624 0,891
English: Review clause
Maltese: Klawżola ta' reviżjoni
English: [42: As referred to in Article 54(2)(a) or (b) of the Financial Regulation.]
Maltese: Kif imsemmi fl-Artikolu 54(2)(a) jew (b) tar-Regolament Finanzjarju.]
English: Alternatives considered:
Maltese: Alternattivi kkunsidrati:
English: "Article 15
Maltese: "Artikolu 15
English: 3 17.03 11 European Food Safety Authority Diff.
Maltese: 3 17.03 11 L-Awtorità Ewropea dwar is-Sigurtà fl-Ikel Diff. IVA LE LE LE
English: 10 01 05 02 (AC, END, INT - Direct research)
Maltese: 10 01 05 02 (AC, ENS, INT - Riċerka diretta)
English: 4) Strengthen risk communication between the Commission/EFSA /Members States and public /stakeholders.
Maltese: 4) Tisħiħ tal-komunikazzjoni tar-riskju bejn il-Kummissjoni/l-EFSA /l-Istati Membri u l-pubbliku /il-partijiet ikkonċernati.
English: The term of office of the members referred to in paragraph 1a(c) may be renewable only once.
Maltese: Il-mandat tal-membri msemmija fil-paragrafu 1a(c) jista' jiġġedded darba biss.",
English: 2) increase reliability, objectivity and independence of studies
Maltese: 2) iż-żieda tal-affidabbiltà, tal-oġġettività u tal-indipendenza tal-istudji
English: (c) information on the complete composition of a plant protection product.
Maltese: (c) l-informazzjoni dwar il-kompożizzjoni kompleta ta' prodott għall-protezzjoni tal-pjanti.";
English: "The number of members in each Scientific Panel within the maximum provided for in paragraph 5g.
Maltese: "In-numru ta' membri f'kull Bord Xjentifiku fi ħdan il-massimu previst fil-paragrafu 5g.";
English: Other simplification aspects include the harmonisation of the confidentiality rules across different sectors providing a similar baseline to all industry applicants in terms of predictability.
Maltese: Aspetti oħra tas-simplifikazzjoni jinkludu l-armonizzazzjoni tar-regoli dwar il-kunfidenzjalità fost setturi differenti li jipprovdu linja bażi simili lill-applikanti kollha mill-industrija f'termini ta' prevedibbiltà.
English: Article 39f
Maltese: Artikolu 39f
English: EFSA has in place and strictly monitors its rules on "independence" and "conflict of interest"; Control method(s) envisaged
Maltese: L-EFSA għandha r-regoli tagħha dwar "l-indipendenza" u "l-kunflitt ta' interess" fis-seħħ u tissorveljahom strettament; Metodu/i ta' kontroll previst(i)
English: "Article 23
Maltese: "Artikolu 23
English: Article 11
Maltese: Artikolu 11
English: (e) promote appropriate involvement of all interested parties; and,
Maltese: (e) il-promozzjoni tal-involviment xieraq tal-partijiet interessati kollha; u,
English: Regulation (EC) No 178/2002, Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1831/2003 and Regulation (EC) No 2065/2003 are currently included in the Commission's horizontal alignment legislative proposal adopted in 2016.
Maltese: Ir-Regolament (KE) Nru 178/2002, id-Direttiva 2001/18/KE, ir-Regolament (KE) Nru 1829/2003, ir-Regolament (KE) Nru 1831/2003 u r-Regolament (KE) Nru 2065/2003 bħalissa huma inklużi fil-proposta leġiżlattiva ta' allinjament orizzontali tal-Kummissjoni li ġiet adottata fl-2016.
English: Proposal/initiative of limited duration
Maltese: Proposta/inizjattiva ta' tul ta' żmien limitat
English: Officials (AST grades)
Maltese: Uffiċjali (Gradi AST)
English: Register of commissioned studies Development & run 0.160 0.280 0.400 0.400 0.400 1.640
Maltese: Reġistru ta' studji kummissjonati Żvilupp u tmexxija 0,160 0,280 0,400 0,400 0,400 1,640
English: XX 01 02 01 (AC, END, INT from the ‘global envelope')
Maltese: XX 01 02 01 (AC, ENS, INT mill-"pakkett globali')
English: Payments (2) 5.490 9.608 13.726 13.726 13.726 56.276
Maltese: Pagamenti (2) 5,490 9,608 13,726 13,726 13,726 56,276
English: "Article 12
Maltese: "Artikolu 12
English: That section shall be publicly available and easily accessible.
Maltese: Dik it-taqsima għandha tkun disponibbli pubblikament u aċċessibbli faċilment.
English: XX 01 05 02 (AC, END, INT - Indirect research)
Maltese: XX 01 05 02 (AC, ENS, INT - Riċerka indiretta)
English: Article 9
Maltese: Artikolu 9
English: "Article 20
Maltese: "Artikolu 20
English: Article 32c
Maltese: Artikolu 32c
English: For the adoption of standard data formats and software packages the following procedure shall be followed:
Maltese: Għall-adozzjoni ta' formats standard ta' data u ta' pakketti ta' softwer, għandha tiġi segwita l-proċedura li ġejja:
English: X The proposal/initiative does not provide for co-financing by third parties.
Maltese: X Il-proposta/L-inizjattiva ma tipprevedix kofinanzjament minn partijiet terzi.
English: 2022 Year
Maltese: 2022 Sena
English: (2) in Article 15, at the end of paragraph 1 the following sentence is added:
Maltese: (2) fl-Artikolu 15, fl-aħħar tal-paragrafu 1 tiżdied is-sentenza li ġejja:
English: SPECIFIC OBJECTIVE No 4 develop a more effective and transparent risk communication with the public in collaboration with Member States
Maltese: OBJETTIV SPEĊIFIKU Nru 4 l-iżvilupp ta' komunikazzjoni tar-riskju aktar effettiva u trasparenti mal-pubbliku b'kollaborazzjoni mal-Istati Membri
English: Function group III
Maltese: Grupp ta' funzjonijiet III
English: (1) in Article 6, the following paragraph 5 is added:
Maltese: (1) fl-Artikolu 6 jiżdied il-paragrafu 5 li ġej:
English: day cost= 1.152 0.221 0.387 0.553 0.553 0.553 2.267
Maltese: 21 Membru tal-bord 10 bordijiet x6laqgħat/sena Kost totali/jum= 1,152 0,221 0,387 0,553 0,553 0,553 2,267
English: Specify the indicators for monitoring implementation of the proposal/initiative.
Maltese: Speċifika l-indikaturi għall-monitoraġġ tal-implimentazzjoni tal-proposta/inizjattiva proposta.
English: "Article 16
Maltese: "Artikolu 16
English: Article 39d
Maltese: Artikolu 39d
English: Payments (3b) 19.512 34.145 48.779 48.779 48.779 199.994
Maltese: Pagamenti (3b) 19,512 34,145 48,779 48,779 48,779 199,994
English: (7) the following Articles 39a to 39g are inserted:
Maltese: (7) jiddaħħlu l-Artikoli 39a sa 39g li ġejjin:
English: [52: See Articles 11 and 17 of Council Regulation (EU, Euratom) No 1311/2013 laying down the multiannual financial framework for the years 2014-2020.]
Maltese: Ara l-Artikoli 11 u 17 tar-Regolament tal-Kunsill (UE, Euratom) Nru 1311/2013 li jistabbilixxi l-qafas finanzjarju pluriennali għas-snin 2014-2020.]
English: "Article 18
Maltese: "Artikolu 18
English: Member States were consulted in a meeting of the Expert Group on the General Food Law on 5 March 2018.
Maltese: L-Istati Membri ġew ikkonsultati f'laqgħa tal-Grupp ta' Esperti dwar il-Liġi Ġenerali dwar l-Ikel fil-5 ta' Marzu 2018.
English: Nature of the proposal/initiative
Maltese: 1.3. Natura tal-proposta/inizjattiva
English: Expected generated Union added value (ex-post)
Maltese: Valur miżjud tal-Unjoni li mistenni jiġi ġġenerat (ex post)
English: Function group I
Maltese: Grupp ta' funzjonijiet I
English: "Article 10
Maltese: "Artikolu 10
English: 2023 2024 esq. (see point 1.6)
Maltese: 2023 2024 esq.
English: ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE
Maltese: FINANZJARJU STMAT TAL-PROPOSTA/INIZJATTIVA
English: Article 39e
Maltese: Artikolu 39e
English: (a) the specification of impurity of the active substance and the related methods of analysis for impurities in the active substance as manufactured, except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant and the related methods of analysis for these impurities;
Maltese: (a) l-ispeċifikazzjoni tal-impurità tas-sustanza attiva u tal-metodi relatati ta' analiżi għall-impuritajiet fis-sustanza attiva kif immanifatturata, ħlief għall-impuritajiet li huma meqjusa li huma tossikoloġikament, ekotossikoloġikament jew ambjentalment rilevanti u l-metodi relatati ta' analiżi għal dawn l-impuritajiet;
English: Risk communication is defined as the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions amongst risk assessors, risk managers, consumers, feed and food businesses, the academic community, including the explanation of risk assessment findings and the basis of risk management decisions.
Maltese: Il-komunikazzjoni tar-riskju hi ddefinita bħala l-iskambju interattiv ta' informazzjoni u ta' opinjonijiet matul il-proċess sħiħ ta' analiżi tar-riskju fir-rigward ta' perikli u ta' riskji, fatturi relatati mar-riskju u l-perċezzjonijiet tar-riskju fost l-assessuri tar-riskju, l-amministraturi tar-riskju, il-konsumaturi, in-negozji tal-għalf u tal-ikel, il-komunità akkademika, inkluża l-ispjegazzjoni tas-sejbiet tal-istima tar-riskju u l-bażi tad-deċiżjonijiet tal-amministrazzjoni tar-riskju.
English: Function group II
Maltese: Grupp ta' funzjonijiet II
English: Article 32d
Maltese: Artikolu 32d
English: "(c) ensure public access to the application and any information supplied by the applicant, in accordance with Article 18.
Maltese: "(c) tiżgura aċċess pubbliku għall-applikazzjoni u kwalunkwe informazzjoni fornita mill-applikant, b'konformità mal-Artikolu 18.";
English: Strengthened analysis of social science survey analysis 0.500 0.875 1.250 1.250 1.250 5.125
Maltese: Analiżi msaħħa tal-analiżi tal-istħarriġ tax-xjenza soċjali 0,500 0,875 1,250 1,250 1,250 5,125
English: Article 39c
Maltese: Artikolu 39c
English: TOTAL COST 19.512 34.145 48.779 48.779 48.779 199.994
Maltese: KOST TOTALI 19,512 34,145 48,779 48,779 48,779 199,994
English: Article 32b
Maltese: Artikolu 32b
English: (b) the competent authority shall assess the confidentiality request submitted by the notifier/applicant.
Maltese: (b) l-awtorità kompetenti għandha tivvaluta t-talba ta' kunfidenzjalità sottomessa min-notifikatur/mill-applikant.
English: Recent debates raised concerns on transparency and independence of industry-generated studies and data.
Maltese: Id-dibattiti riċenti qajmu tħassib dwar it-trasparenza u l-indipendenza ta' studji u ta' data ġġenerati mill-industrija.
English: for [body] <EFSA.> Commitments =1+1a +3a 25.002 43.753 62.505 62.505 62.505 256.270
Maltese: għall-[korp] <EFSA.> Impenji =1+1a +3a 25,002 43,753 62,505 62,505 62,505 256,270
English: An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State, (the rapporteur Member State), together with a summary and a complete dossier as provided for in Article 8(1) and (2) of this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation.
Maltese: L-applikazzjoni għall-approvazzjoni ta' sustanza attiva jew għal emenda għall-kundizzjonijiet ta' approvazzjoni għandha titressaq mill-produttur tas-sustanza attiva lill-Istat Membru, (l-Istat Membru relatur), flimkien ma' sommarju u ma' dossier komplet kif previst fl-Artikolu 8(1) u (2) ta' dan ir-Regolament jew flimkien ma' ġustifikazzjoni motivata xjentifikament għalfejn ma ġewx previsti ċerti partijiet minn dawk id-dossiers, fejn jintwera li s-sustanza attiva tissodisfa l-kriterji ta' approvazzjoni previsti fl-Artikolu 4 dan ir-Regolament.
English: Article 39g
Maltese: Artikolu 39g
English: Member States may nominate nationals of other Member States.
Maltese: L-Istati Membri jistgħu jinnominaw ċittadini ta' Stati Membri oħra.
English: The EFSA also regularly fine-tunes and strengthens its strict policies on independence, transparency and openness.
Maltese: L-EFSA tirfina u ssaħħaħ b'mod regolari wkoll il-politiki stretti tagħha dwar l-indipendenza, it-trasparenza u l-aċċess miftuħ.
English: Acting in accordance with the ordinary legislative procedure,
Maltese: Waqt li jaġixxu skont il-proċedura leġiżlattiva ordinarja,
English: Title 1: Staff expenditure Commitments (1) 5.490 9.608 13.726 13.726 13.726 56.276
Maltese: Titolu 1: Nefqa għall-persunal Impenji (1) 5,490 9,608 13,726 13,726 13,726 56,276
English: OUTPUTS
Maltese: BAŻI
English: Targeted changes are proposed to align the composition of the Management Board of EFSA and the procedure for the external evaluation of EFSA to the Common Approach set out in the annex to the 2012 inter-institutional joint statement on Union decentralised agencies.
Maltese: Huma proposti tibidliet immirati biex il-kompożizzjoni tal-Bord ta' Ġestjoni tal-EFSA u l-proċedura għall-evalwazzjoni esterna tal-EFSA jiġu allinjati mal-Approċċ Komuni stabbilit fl-anness tad-dikjarazzjoni konġunta interistituzzjonali tal-2012 dwar l-aġenziji deċentralizzati tal-Unjoni.
English: [16: Commission Staff Working Document, Synopsis Report, SWD(2018)97, [dated 11.04.2018].]
Maltese: Dokument ta' Ħidma tal-Persunal tal-Kummissjoni, Rapport fil-Qosor, SWD(2018)97, [datat il-11.
English: [Heading………………………………] Diff./non-diff. from EFTA countries from candidate countries from third countries within the meaning of Article 21(2)(b) of the Financial Regulation
Maltese: ……] Diff./mhux diff. minn pajjiżi tal-EFTA minn pajjiżi kandidati minn pajjiżi terzi skont it-tifsira tal-Artikolu 21(2)(b) tar-Regolament Finanzjarju
English: Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY
Maltese: Proposta/inizjattiva b'effett minn [JJ/XX]SSSS sa [JJ/XX]SSSS
English: Article 39b
Maltese: Artikolu 39b
English: [4: https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_en ]
Maltese: [4: https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-chain_mt ]
English: Synopsis report
Maltese: Rapport fil-qosor
English: Transparency of industry studies
Maltese: Trasparenza tal-istudji tal-industrija
English: The stakeholders that took part represented a variety of sectors: trade and business associations (39.22 %), companies and groups (14.38 %), NGOs (13.07 %), professional associations (8.5 %), national/regional authorities (8.5 %), governmental agencies (5.23 %), research institutes (3.92 %), public bodies (1.96 %), professional consultancies (1.96 %), think-tanks (1.31 %), law firms (0.65 %), EU Institutions (0.65 %), and other (0.65 %).
Maltese: Il-partijiet ikkonċernati li ħadu sehem irrappreżentaw varjetà ta' setturi: l-assoċjazzjonijiet tal-kummerċ u tan-negozju (39,22 %), il-kumpaniji u l-gruppi (14,38 %), l-NGOs (13,07 %), l-assoċjazzjonijiet professjonali (8,5 %), l-awtoritajiet nazzjonali/reġjonali (8,5 %), l-aġenziji governattivi (5,23 %), l-istituti ta' riċerka (3,92 %), il-korpi pubbliċi (1,96 %), il-konsulenzi professjonali (1,96 %), il-gruppi ta' riflessjoni (1,31 %), id-ditti legali (0,65 %), l-istituzzjonijiet tal-UE (0,65 %) u oħrajn (0,65 %).
English: For respondents from the stakeholder group, these percentages were 47.7 %, 21.6 % and 9.2 %, respectively.
Maltese: Għar-rispondenti mill-grupp ta' partijiet ikkonċernati, dawn il-perċentwali kienu 47,7 %, 21,6 % u 9,2 %, rispettivament.
English: Risk Communication
Maltese: Komunikazzjoni tar-Riskju
English: However, 27.7 % of citizen replies and 26.1 % of stakeholder replies disagree or strongly disagree with this statement.
Maltese: Madankollu, 27,7 % tat-tweġibiet taċ-ċittadini u 26,1 % tat-tweġibiet tal-partijiet ikkonċernati ma jaqblux jew ma jaqblux bis-sħiħ ma' din id-dikjarazzjoni.
English: This was followed by an open public consultation (OPC), targeting citizens and stakeholders, open from 23 January 2018 to 20 March 2018.
Maltese: Din kienet segwita minn konsultazzjoni pubblika miftuħa (OPC, open public consultation), immirata lejn iċ-ċittadini u l-partijiet ikkonċernati u miftuħa mit-23 ta' Jannar 2018 sal-20 ta' Marzu 2018.
English: Sustainability of the risk assessment system and involvement of MS
Maltese: Sostenibbiltà tas-sistema tal-valutazzjoni tar-riskju u involviment tal-Istati Membri
English: Need to ensure the protection of confidential data and personal data.
Maltese: Il-ħtieġa li tiġi żgurata l-protezzjoni ta' data kunfidenzjali u ta' data personali.
English: Citizens and stakeholders had the opportunity to provide feedback on a Commission roadmap from 20 December 2017 to 17 January 2018.
Maltese: Iċ-ċittadini u l-partijiet ikkonċernati kellhom l-opportunità li jipprovdu feedback dwar pjan direzzjonali tal-Kummissjoni mill-20 ta' Diċembru 2017 sas-17 ta' Jannar 2018.
English: Scientific independence and excellence of experts are cornerstones of the EU risk assessment system.
Maltese: L-indipendenza xjentifika u l-eċċellenza tal-esperti huma s-sisien tas-sistema ta' valutazzjoni tar-riskju tal-UE.
English: Safeguarding confidentiality and intellectual property rights is fundamental in order to avoid hampering innovation and competitiveness.
Maltese: Is-salvagwardja tal-kunfidenzjalità u tad-drittijiet tal-proprjetà intellettwali hija fundamentali sabiex jiġu evitati l-ostakli għall-innovazzjoni u għall-kompetittività.