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this proposal avoids such duplicative requirements.
din il-proposta tevita tali rekwiżiti duplikati.
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
general rules on avoidance of duplicative testing
ir-regoli ġenerali biex jiġu evitati testijiet idduplikati
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
it was set up as a neutral, non-binding and non-duplicative process.
hu tfassal bħala proċess newtrali, mhux vinkolanti u mhux duplikattiv.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
currently, for active substances included in more than one medicinal product, literature cases are reported in a duplicative way.
attwalment, għal sustanzi attivi inklużi f’iktar minn prodott mediċinali wieħed, il-każijiet tal-letteratura qed jiġu rrapportati doppji.
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
since there is no provision to group submissions and assessments by products or substances, this leads to duplicative submissions and assessments.
billi ma teżistix dispożizzjoni għas-sottomissjonijiet u l-evalwazzjonijiet tal-gruppi ta' prodotti jew ta' sustanzi, is-sottomissjonijiet u l-evalwazzjonijiet ta' sikwit jirrepetu rwieħhom.
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
at the same time, respondents perceived some reporting requirements as inconsistent and duplicative across legislation, excessively complex and not always fit for purpose.
fl-istess ħin, dawk li wieġbu qiesu ċertu obbligi ta’ rappurtar bħala inkonsistenti u dduplikati fil-leġiżlazzjoni, ferm kumplessi u mhumiex dejjem adattati għall-iskop tagħhom.
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplicative testing on vertebrate animals;
għal kull test jew studju li jinvolvi l-annimali vertebrati, ġustifikazzjoni tal-passi meħuda biex jiġi evitat l-ittestjar fuq l-annimali u l-ittestjar duplikattiv fuq annimali vertebrati;
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
for instance, many comments from both enterprises and public administrations were recorded on the frequency and duplicative character of reporting or statistical obligations and the level of detail required to comply with them;
biex insemmu xi każi, ħafna kummenti kemm mingħand intrapriżi u kemm minn amministrazzjonijiet pubbliċi kienu nnutati dwar il-frekwenza u d-duplikazzjonijiet fir-rapporti jew fl-obbligi tal-ġbir ta’ statistika u l-livell ta’ dettall mitlub biex wieħed jikkonforma magħhom;
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
by increasing the efficiency of the community pharmacovigilance system, the proposal will free up resource currently expended on meeting duplicative and complex administrative requirements and these resources can then be channelled into activities that directly promote and protect public health including better communications about the benefits and risks of medicines
billi tiżdied l-effiċjenza tas-sistema komunitarja tal-farmakoviġilanza, il-proposta għandha tillibera r-riżorsi li bħalissa qed jintużaw biex jilħqu r-rekwiżiti doppji u kumplessi u dawn ir-riżorsi mbagħad jistgħu jiġu rijallokati f’attivitajiet li jippromwovu u jipproteġu direttament is-saħħa pubblika inklużi komunikazzjonijiet aħjar dwar il-benefiċċji u r-riskji tal-mediċini.
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
the proposal takes a pragmatic approach in that it does not request for duplicative background information to be submitted to the commission but rather seeks to ensure that the existing technical background reports are made available for the public's information.
il-proposta tieħu approċċ pragmatiku għax ma titlobx li l-informazzjoni ta’ sfond duplikata tiġi ppreżentata lill-kummissjoni, iżda tfittex li tiżgura li r-rapporti ta’ sfond tekniċi eżistenti jsiru disponibbli għall-informazzjoni tal-pubbliku.
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
this efficient “two in one” approach is meant to avoid duplicative requirements, alleviate unnecessary burdens and concentrate the information investors need in one single document which is updated at least every year.
dan il-metodu effiċjenti ta’ "tnejn f’wieħed" hu maħsub sabiex jiġu evitati rekwiżiti doppji, biex jittaffew il-piżijiet bla bżonn u jikkonċentraw l-informazzjoni li l-investituri jkunu jeħtieġu f’dokument wieħed li jiġi aġġornat mill-inqas kull sena.
Last Update: 2017-04-06
Usage Frequency: 1
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current reporting rules apply equally to all medicinal products, irrespective of their known risks, are submitted to several authorities where a product is authorised in more than one member state, and lead to duplicative assessments as there is no provision to group assessments by products or substances.
ir-regoli attwali ta' rappurtar japplikaw ugwalment għall-prodotti kollha mediċinali, irrispettivament mir-riskji magħrufin tagħhom, jitressqu lil bosta awtoritajiet fejn prodott huwa awtorizzat f'aktar minn stat membru wieħed, u jwasslu għal evalwazzjonijiet duplikati billi ma jeżistux dispożizzjonijiet għal valutazzjonijiet ta' gruppi ta' prodotti jew sustanzi.
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
a lack of proactive and proportionate monitoring including a lack of risk management and structured data collection in the form of post authorisation safety studies and duplicative reporting rules for the industry and authorities relating to both 15-day, literature and periodic (psur) reporting of adrs;
nuqqas ta’ sorveljanza proattiva u proporzjonata ta' dejta ta' kwalità għolja inkluż nuqqas ta’ immaniġġjar tar-riskju u ġbir strutturat tad-dejta fil-forma ta’ studji dwar sikurezza ta' wara l-awtorizzazzjoni u regoli dwar rapportaġġ doppju għall-industrija u l-awtoritajiet relatat kemm mal-letteratura ta' 15-il jum kif ukoll ir-rapportaġġ perjodiku tar-reazzjonjiet issusspettati ħżiena (adrs).
Last Update: 2017-04-06
Usage Frequency: 1
Quality: