FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the benefits and risks of Cinacalcet Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Cinacalcet Mylan?
English: This means that Cinacalcet Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU).
Maltese: Dan ifisser li Cinacalcet Mylan huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE).
English: Because Cinacalcet Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Cinacalcet Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The active substance in Cinacalcet Mylan, cinacalcet, works by increasing the sensitivity of the calciumsensing receptors on the parathyroid glands that regulate PTH secretion.
Maltese: Is-sustanza attiva f'Cinacalcet Mylan, cinacalcet, taħdem billi żżid is-sensittività tar-riċetturi li jħossu lkalċju fuq il-glandoli tal-paratirojde li jirregolaw is-sekrezzjoni ta' PTH.
English: Cinacalcet Mylan is a medicine used in adults and older patients to:
Maltese: Cinacalcet Mylan huwa mediċina li tintuża fl-adulti u l-pazjenti ikbar fl-età biex:
English: A risk management plan has been developed to ensure that Cinacalcet Mylan is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Cinacalcet Mylan jintuża bl-aktar mod sigur possibbli.
English: PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Cinacalcet Mylan.
Maltese: Il-livelli ta' PTH għandhom jiġu vvalutati tal-inqas 12-il siegħa wara d-dożaġġ u bejn ġimgħa u erba' ġimgħat wara kull aġġustament fid-doża ta' Cinacalcet Mylan.
English: Hyperparathyroidism is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to high levels of calcium in the blood, bone and joint pain and deformities of the arms and legs.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Cinacalcet Mylan wera li għandu kwalità komparabbli u huwa bijoekwivlenti għal Mimpara.
English: The Committee recommended that Cinacalcet Mylan be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Cinacalcet Mylan ikun approvat għall-użu fl-UE.
English: How has Cinacalcet Mylan been studied?
Maltese: Kif ġie studjat Cinacalcet Mylan?
English: The following deficiencies were identified:
Maltese: In-nuqqasijiet li ġejjin ġew identifikati:
English: Ammonaps is available as white oval tablets (500 mg) and as granules (940 mg/g).
Maltese: Ammonaps huwa disponibbli bħala pilloli ovali bojod (500 mg) u bħala granuli (940 mg/g).
English: Grounds for CHMP opinion Whereas
Maltese: Raġunijiet għal opinjoni tas-CHMP
English: Ammonaps is a centrally authorised product containing the active substance sodium phenylbutyrate.
Maltese: Ammonaps huwa prodott awtorizzat ċentralment li fih is-sustanza attiva sodium phenylbutyrate.
English: Dutasteride Actavis is a medicinal product containing the active substance dutasteride, a triple 5αreductase inhibitor.
Maltese: Dutasteride Actavis huwa prodott mediċinali li fih is-sustanza attiva dutasteride, inibitur 5a-reductase triplu.
English: SoliCol D3 20,000 IU tablets and SoliCol D3 50,000 IU tablets are medicinal products containing 20,000 or 50000 IU colecalciferol (vitamin D3 analogue) as active substance.
Maltese: SoliCol D3 20,000 pillola IU u SoliCol D3 50,000 pillola IU huma prodotti mediċinali li fihom 20,000 jew 50000 colecalciferol IU (vitamina D3 analoga) bħala sustanza attiva. SoliCol D3 ġie approvat fir-Renju Unit permezz ta' proċedura nazzjonali fit-18 ta' Diċembru 2015.
English: Lutinus (and associated names)
Maltese: Lutinus (u ismijiet assoċjati)
English: Pharmaceutics International Inc. (PII), located in Maryland, USA is listed as manufacturer in the marketing authorisation of four products authorised in the EU, including the centrally approved product Ammonaps and three nationally approved products: Lutinus, Dutasteride Actavis and SoliCol D3.
Maltese: (PII), li tinsab f'Maryland, fl-Istati Uniti hija elenkata bħala manifattur fl-awtorizzazzjoni għat-tqegħid fis-suq ta' erba' prodotti awtorizzati fl-UE, inkluż il-prodott Ammonaps approvat ċentralment u tliet prodotti approvati nazzjonalment: Lutinus, Dutasteride Actavis u SoliCol D3.
English: Lutinus is a vaginal tablet containing 100 mg progesterone, indicated for luteal support as part of treatment program for infertile women.
Maltese: Lutinus huwa pillola vaġinali li fiha 100 mg proġesteron, indikat għal appoġġ luteali bħala parti minn programm ta' kura għan-nisa infertili.
English: Dutasteride Actavis (and associated names)
Maltese: Dutasteride Actavis (u ismijiet assoċjati)
English: The additional risks due to non-compliance to GMP can potentially lead to potential cross-contamination with other drugs produced at the site, including hormones, cytotoxics and teratogens.
Maltese: Ir-riskji addizzjonali minħabba nuqqas ta' konformità mal-PTM jistgħu potenzjalment iwasslu għal kontaminazzjoni kroċjata potenzjali ma' mediċini oħrajn prodotti fis-sit, inklużi ormoni, ċitotossiċi u teratogens.
English: Dutasteride Actavis is indicated for the treatment of the benign prostatic hyperplasia and was first approved in the EU on 3 June 2015 via a decentralised procedure, with Denmark acting as Reference Member State.
Maltese: Dutasteride Actavis huwa indikat għall-kura ta' iperplasija beninna tal-prostata u ġie approvat għall-ewwel darba fl-UE fit-3 ta' Ġunju 2015 permezz ta' proċedura deċentralizzata, bid-Danimarka taġixxi bħala Stat Membru ta' Referenza.
English: • The CHMP reviewed the inspection report provided by the Supervisory Authority, the (co-) rapporteur's assessment reports and the available data presented by the MAHs in writing in response to questions addressed by the CHMP;
Maltese: • Is-CHMP irreveda r-rapport ta' spezzjoni pprovdut mill-Awtorità Superviżorja, ir-rapporti ta' valutazzjoni tal-(ko-)rapporteur u d-data disponibbli ppreżentata mill-MAHs bil-miktub bħala risposta għall-mistoqsijiet indirizzati mis-CHMP;
English: The sourcing of Lutinus from PII has stopped in 2014 and the manufacturing of the product fully switched to an alternative site registered in December 2013.
Maltese: Il-provvista ta' Lutinus minn PII waqfet fl-2014 u l-manifattura tal-prodott qalbet kompletament għal sit alternattiv li ġie rreġistrat f'Diċembru 2013.
English: • Major deficiencies relating to organisational data governance failures, sterilisation and depyrogenation processes, and insufficient control of aseptic operations to provide the required level of sterility assurance.
Maltese: • Nuqqasijiet maġġuri relatati ma' nuqqasijiet fil-governanza tad-data organizzattiva, proċessi ta' sterilizzazzjoni u depiroġenazzjoni, u kontroll insuffiċjenti ta' operazzjonijiet assetiċi li jipprovdu l-livell meħtieġ ta' assigurazzjoni ta' sterilità.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for medicinal products for which Pharmaceutics International Inc, Maryland, USA, is included in the marketing authorisation as manufacturing site;
Maltese: • Is-CHMP qies il-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal prodotti mediċinali li għalihom Pharmaceutics International Inc, f'Maryland, fl-Istati Uniti, hija inkluża flawtorizzazzjoni għat-tqegħid fis-suq bħala sit ta' manifattura;
English: • The CHMP considered the GMP compliance certificate for Pharmaceutics International Inc. issued by the MHRA on 15th June 2016 restricted to medicinal products considered critical to public health and valid until 30 June 2017; Ammonaps
Maltese: • Is-CHMP qies li ċ-ċertifikat ta' konformità mal-PTM għal Pharmaceutics International Inc. maħruġ mill-MHRA fil-15 ta' Ġunju 2016 limitat għall-prodotti mediċinali meqjusa bħala kritiċi għas-saħħa pubblika u validu sat-30 ta' Ġunju 2017;
English: • Critical deficiencies relating to the failure of organisational and technical measures to minimise the risk of cross-contamination between hazardous and non-hazardous products manufactured in the same manufacturing facilities using shared equipment, as well as failures of the quality unit to ensure the effective operation of the quality system;
Maltese: • Nuqqasijiet kritiċi relatati man-nuqqas ta' miżuri organizzattivi u tekniċi biex jitnaqqas ir-riskju ta' kontaminazzjoni kroċjata bejn prodotti perikolużi u prodotti mhux perikolużi manifatturati flistess faċilitajiet ta' manifattura bl-użu ta' tagħmir kondiviż, kif ukoll nuqqasijiet tal-unità talkwalità biex jiġi żgurat it-tħaddim effettiv tas-sistema tal-kwalità;
English: • The CHMP noted that batches of Lutinus from Pharmaceutics international Inc. are currently available on the EU market.
Maltese: • Is-CHMP innota li l-lottijiet ta' Lutinus minn Pharmaceutics international Inc. bħalissa huma disponibbli fis-suq tal-UE.
English: Nevertheless, the quality system at the manufacturing site is still significantly lacking in terms of change control and quality oversight.
Maltese: Madankollu, is-sistema tal-kwalità fis-sit tal-manifattura għadha nieqsa sew f'termini ta' kontroll tal-bidla u sorveljanza tal-kwalità.
English: This certificate of GMP compliance is valid until 30 June 2017.
Maltese: Dan iċ-ċertifikat ta' konformità mal-PTM huwa validu sat-30 ta' Ġunju 2017.
English: On 15th June 2016 the MHRA issued a GMP Statement of Non-Compliance (SNC) for PII, recommending a restriction of supply in the EU and the recall of the medicinal products manufactured at this site unless considered critical to public health.
Maltese: Fil-15 ta' Ġunju 2016 l-MHRA ħarġet Dikjarazzjoni ta' Nuqqas ta' Konformità (SNC) mal-PTM għal PII, fejn tirrakkomanda restrizzjoni tal-provvista fl-UE u l-ġbir lura tal-prodotti mediċinali manifatturati f'dan is-sit sakemm ma jitqisux kritiċi għas-saħħa pubblika.
English: The safety profile of Ammonaps in urea cycle disorders is well established.
Maltese: Il-profil tas-sigurtà ta' Ammonaps fid-disturbi taċ-ċiklu tal-urea huwa stabbilit sew.
English: The MHRA issued a corresponding certificate of GMP compliance for the site, limited to medicinal products confirmed by National Competent Authorities as being critical to public health.
Maltese: L-MHRA ħarġet ċertifikat korrispondenti ta' konformità mal-PTM għas-sit, limitat għall-prodotti mediċinali kkonfermati mill-Awtoritajiet Nazzjonali Kompetenti bħala kritiċi għas-saħħa pubblika.
English: • The CHMP noted that there are no batches of Dutasteride Actavis from Pharmaceutics international Inc. on the EU market.
Maltese: • Is-CHMP innota li fis-suq tal-UE ma hemm l-ebda lott ta' Dutasteride Actavis minn Pharmaceutics international Inc.
English: • The CHMP considers that in the absence of GMP compliance of the manufacturing site Pharmaceutics International Inc., the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC for Lutinus are incorrect.
Maltese: • Is-CHMP iqis li fin-nuqqas ta' konformità mal-PTM tas-sit ta' manifattura ta' Pharmaceutics International Inc., id-dettalji u d-dokumenti stipulati fl-Artikolu 8(3) tad-Direttiva 2001/83/KE għal Lutinus huma żbaljati.
English: • The CHMP considers that in the absence of GMP compliance of the manufacturing site Pharmaceutics International Inc., the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC for Dutasteride Actavis are incorrect.
Maltese: • Is-CHMP iqis li fin-nuqqas ta' konformità mal-PTM tas-sit ta' manifattura ta' Pharmaceutics International Inc., id-dettalji u d-dokumenti stipulati fl-Artikolu 8(3) tad-Direttiva 2001/83/KE għal Dutasteride Actavis huma żbaljati.
English: Although no reports of cross-contamination have been reported in the post-marketing setting, taking into account the target population, that is severely ill and the small patient population (as the prevalence of the condition is very low), the lack of such reports only provides a low degree of reassurance.
Maltese: Għalkemm ma ġie rrappurtat l-ebda każ ta' kontaminazzjoni kroċjata wara t-tqegħid fis-suq, b'kunsiderazzjoni talpopolazzjoni fil-mira, li huwa marid ħafna u l-popolazzjoni żgħira tal-pazjenti (peress li l-prevalenza talkundizzjoni hija baxxa ħafna), in-nuqqas ta' tali rapporti jipprovdi biss livell baxx ta' riassigurazzjoni.
English: • The CHMP considered the Statement of Non-Compliance with GMP for Pharmaceutics International Inc. issued by the MHRA on 15th June 2016 recommending a restriction of supply in the EU and the recall of the medicinal products manufactured at this site unless considered critical to public health;
Maltese: • Is-CHMP qies id-Dikjarazzjoni ta' Nuqqas ta' Konformità mal-PTM għal Pharmaceutics International Inc. maħruġa mill-MHRA fil-15 ta' Ġunju 2016 li tirrakkomanda restrizzjoni talprovvista fl-UE u l-ġbir lura tal-prodotti mediċinali manifatturati f'dan is-sit sakemm ma jitqisux bħala kritiċi għas-saħħa pubblika;
English: In February 2016, a joint inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) found critical and major deficiencies and concluded that PII was non-compliant with the legal requirements and/or the principles and guidelines of Good Manufacturing Practice (GMP) as provided for by Union law.
Maltese: Fi Frar 2016, spezzjoni konġunta mill-Aġenzija Regolatorja tal-Mediċini u l-Prodotti tas-Saħħa (MHRA) u l-Amministrazzjoni għall-Ikel u għall-Mediċini (FDA) tal-Istati Uniti sabet nuqqasijiet kritiċi u maġġuri u kkonkludiet li PII ma kinitx konformi mar-rekwiżiti legali u/jew il-prinċipji u l-linji gwida ta' Prattika Tajba ta' Manifattura (PTM) kif previst fid-dritt tal-Unjoni.
English: In addition to the above conclusions, the CHMP noted the recommendations from the Supervisory Authority in the statement of non-compliance with GMP of PII that all batches of Lutinus from Pharmaceutics Internationals Inc. should be recalled and the supply from this manufacturing site prohibited.
Maltese: Bħala konsegwenza, is-CHMP jirrakkomanda li l-awtorizzazzjoni għat-tqegħid fis-suq għal Lutinus (u ismijiet assoċjati) għandha tkun varjata biex Pharmaceutical International Inc. jitneħħa bħala sit ta' manifattura mill-awtorizzazzjonijiet ta' tqegħid fis-suq tagħhom.
English: Also, in view of the statement of non-compliance that was issued for Pharmaceutics International Inc. on 15 June 2016, the CHMP considered that the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC are incorrect and that the terms of the marketing authorisation of Lutinus (and associated names) should be varied to remove Pharmaceutics International Inc. as manufacturing site.
Maltese: Fid-dawl tad-dikjarazzjoni ta' nuqqas ta' konformità li nħarġet għal Pharmaceutics International Inc. fil15 ta' Ġunju 2016, is-CHMP qies li d-dettalji u d-dokumenti stipulati fl-Artikolu 8(3) tadDirettiva 2001/83/KE huma żbaljati u li t-termini tal-awtorizzazzjoni għat-tqegħid fis-suq ta' Dutasteride Actavis (u ismijiet assoċjati) għandhom ikunu varjati biex ineħħu lil Pharmaceutics International Inc. bħala sit ta' manifattura.
English: For the suspension of SoliCol D3 to be lifted, the marketing authorisation holder shall provide evidence that the manufacturing process complies with the requirements of Commission Directive 2003/94/EC (as amended) laying down the principles and guidelines of GMP as provided for in Article 8(3) of Directive 2001/83/EC.
Maltese: Biex is-sospensjoni ta' SoliCol D3 titneħħa, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jipprovdi evidenza li l-proċess ta' manifattura huwa konformi mar-rekwiżiti tad-Direttiva talKummissjoni 2003/94/KE (kif emendata) li tistabbilixxi l-prinċipji u l-linji ta' gwida tal-PTM kif stipulat fl-Artikolu 8(3) tad-Direttiva 2001/83/KE.
English: Dutasteride (and associated names)
Maltese: Dutasteride (u ismijiet assoċjati)
English: In view of the certificate of non-GMP compliance issued for Pharmaceutics International, Inc., the CHMP considered that the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC are incorrect and therefore, pursuant to Article 116 of Directive 2001/83/EC, the marketing authorisations of SoliCol D3 should be suspended.
Maltese: L-ebda manifattur alternattiv mhuwa rreġistrat fl-awtorizzazzjoni għat-tqegħid fis-suq ta' SoliCol D3. Fid-dawl taċ-ċertifikat ta' nuqqas ta' konformità mal-PTM maħruġ għal Pharmaceutics International, Inc., is-CHMP qies li d-dettalji u d-dokumenti stipulati fl-Artikolu 8(3) tad-Direttiva 2001/83/KE huma żbaljati u għalhekk, skont l-Artikolu 116 tad-Direttiva 2001/83/KE, l-awtorizzazzjonijiet għat-tqegħid fis-suq ta' SoliCol D3 għandhom jiġu sospiżi.
English: • The CHMP considers that at present, the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC are incorrect.
Maltese: • Is-CHMP iqis li fil-preżent, id-dettalji u d-dokumenti previsti fl-Artikolu 8(3) tadDirettiva 2001/83/KE huma żbaljati.
English: The statement of noncompliance with GMP of PII clarifies that marketing authorisation holders are requested to contact the relevant National Competent Authority (NCA) to verify whether their products are considered medically critical to public health in their territory.
Maltese: tikkjarifika li d-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huma mitluba jikkuntattjaw l-Awtorità Nazzjonali Kompetenti (NCA) relevanti biex jivverifikaw jekk il-prodotti tagħhom humex ikkonsidrati medikament kritiċi għas-saħħa pubblika fit-territorju tagħhom.
English: The MAH should provide evidence by 30 June 2017 that the manufacturing process complies with the requirements of Commission Directive 2003/94/EC (as amended) laying down the principles and guidelines of GMP as provided for in Article 8(3) of Directive 2001/83/EC, as this is a condition to the marketing authorisation.
Maltese: Sat-30 ta' Ġunju 2017, l-MAH għandu jipprovdi evidenza li l-proċess ta' manifattura huwa konformi mar-rekwiżiti tad-Direttiva tal-Kummissjoni 2003/94/KE (kif emendata) li tistabbilixxi l-prinċipji u l-linji gwida tal-PTM kif stipulat fl-Artikolu 8(3) tad-Direttiva 2001/83/KE, peress li din hija kundizzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq.
English: Given the absence of reports of cross-contamination and taking into consideration the criticality of the product and the improvements in manufacturing which has reduced the risk of cross-contamination to low, it is recommended that the supply of Ammonaps from PII is maintained for the patient population for whom no other treatment option is available.
Maltese: Minħabba n-nuqqas ta' rapporti ta' kontaminazzjoni kroċjata u b'kunsiderazzjoni ta' kemm huwa kritiku lprodott u t-titjib fil-manifattura li naqqas sew ir-riskju ta' kontaminazzjoni kroċjata, huwa rrakkomandat li l-provvista ta' Ammonaps minn PII jinżamm għall-popolazzjoni tal-pazjenti li għaliha l-ebda għażla oħra ta' kura mhija disponibbli.
English: • There is no alternative manufacturing site registered in the marketing authorisation for SoliCol D3 and the CHMP noted that no batches of SoliCol D3 are currently available on the EU market;
Maltese: • Ma hemm l-ebda sit ta' manifattura alternattiv irreġistrat fl-awtorizzazzjoni għat-tqegħid fissuq għal SoliCol D3 u s-CHMP innota li l-ebda lott ta' SoliCol D3 mhuwa attwalment disponibbli fis-suq tal-UE;
English: This product was approved in the EU via a decentralised procedure including all 28 Member States, with Sweden acting as reference Member State.
Maltese: Dan il-prodott ġie approvat fl-UE permezz ta' proċedura deċentralizzata li tinkludi t-28 Stat Membru kollha, bl-Iżvezja taġixxi bħala Stat Membru ta' referenza.
English: For the suspension of SoliCol D3 to be lifted, the marketing authorisation holder(s) shall provide evidence that the manufacturing process complies with the requirements of Commission Directive 2003/94/EC laying down the principles and guidelines of GMP as provided for in Article 8(3) of Directive 2001/83/EC.
Maltese: Biex is-sospensjoni ta' SoliCol D3 titneħħa, id-detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq għandu/għandhom jipprovdi/jipprovdu evidenza li l-proċess ta' manifattura huwa konformi marrekwiżiti tad-Direttiva tal-Kummissjoni 2003/94/KE li tistabbilixxi l-prinċipji u l-linji ta' gwida tal-PTM kif stipulat fl-Artikolu 8(3) tad-Direttiva 2001/83/KE.
English: The non-compliance with good manufacturing practice presents a degree of unquantifiable risk which cannot be detected reliably through postmarketing data; hence the lack of any significant concerns cannot provide sufficient reassurance over the safety of the batches manufactured at PII.
Maltese: In-nuqqas ta' konformità ma' prattika tajba ta' manifattura jippreżenta livell ta' riskju mhux kwantifikabbli li ma jistax jiġi identifikat b'mod affidabbli permezz ta' data ta' wara ttqegħid fis-suq; għalhekk in-nuqqas ta' kwalunkwe tħassib sinifikanti ma jistax jipprovdi biżżejjed riassigurazzjoni dwar is-sigurtà tal-lottijiet manifatturati f'PII.
English: • Lutinus is currently manufactured at an alternative manufacturing site registered in their marketing authorisation;
Maltese: • Lutinus qiegħed jiġi manifatturat f'sit ta' manifattura alternattiv irreġistrat fl-awtorizzazzjoni għat-tqegħid fis-suq tagħhom;
English: It is indicated to treat the patients who have urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
Maltese: Għandu jintuża biex jikkura l-pazjenti li għandhom disturbi fiċ-ċiklu tal-urea (UCDs), li jinvolvu nuqqasijiet ta' carbamylphosphate synthetase, ornithine transcarbamylase jew argininosuccinate synthetase.
English: On 17 June 2016, the European Commission (EC) initiated a referral procedure under Article 31 of Directive 2001/83/EC, and requested the Agency to assess the potential impact of the deficiencies on the quality, safety and the benefit risk balance of the medicinal products which have been authorised by the European Commission and the Member States.
Maltese: Fis-17 ta' Ġunju 2016, il-Kummissjoni Ewropea (KE) tat bidu għal proċedura ta' referenza skont lArtikolu 31 tad-Direttiva 2001/83/KE, u talbet lill-Aġenzija tivvaluta l-impatt potenzjali tan-nuqqasijiet fuq il-kwalità, is-sigurtà u l-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti mediċinali li ġew awtorizzati mill-Kummissjoni Ewropea u mill-Istati Membri.
English: However the non-compliance with good manufacturing practice presents a degree of unquantifiable risk which cannot be detected reliably through post-marketing data, hence the lack of any significant concerns cannot provide sufficient reassurance over the safety of the batches manufactured at PII.
Maltese: Madankollu, in-nuqqas ta' konformità ma' prattika tajba ta' manifattura jippreżenta livell ta' riskju mhux kwantifikabbli li ma jistax jiġi identifikat b'mod affidabbli permezz ta' data ta' wara ttqegħid fis-suq, għalhekk in-nuqqas ta' kwalunkwe tħassib sinifikanti ma jistax jipprovdi biżżejjed riassigurazzjoni dwar is-sigurtà tal-lottijiet manifatturati f'PII.
English: These measures include the use of assistance from experienced external specialists specialised in Quality management and an enhanced control of the batch documents by the Qualified Person at the EEA site responsible for batch release.
Maltese: Dawn il-miżuri jinkludu l-użu ta' assistenza minn speċjalisti esterni esperjenzati li huma speċjalizzati fil-Ġestjoni tal-kwalità u kontroll imtejjeb tad-dokumenti tal-lottijiet mill-Persuna Kwalifikata fis-sit talEEA li hija responsabbli għall-ħruġ tal-lott.
English: A detailed assessment of cumulative safety data on Lutinus up to 31 May 2016 was also performed which did not raise any significant safety concerns related to GMP non-compliance.
Maltese: Twettqet ukoll valutazzjoni dettaljata ta' data kumulattiva dwar is-sigurtà ta' Lutinus sal31 ta' Mejju 2016 li ma qajmet l-ebda tħassib sinifikanti dwar is-sigurtà relatat man-nuqqas ta' konformità mal-PTM.