Déanfaidh monaróirí córas bainistithe riosca a dhoiciméadú, a bhunú, a chur chun feidhme agus a choinneáil faoi mar a thuairiscítear i Roinn 3 d'Iarscríbhinn I.
Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.
Bunóidh monaróirí córas bainistithe riosca agus déanfaidh siad é a dhoiciméadú, a chur chun feidhme agus a chothabháil.
Manufacturers shall establish, implement, document and maintain a risk management system.
Déanfaidh monaróirí córas bainistithe riosca a bhunú, a dhoiciméadú, a chur chun feidhme agus a choinneáil mar a thuairiscítear i Roinn 3 d'Iarscríbhinn I.
Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.
Bunóidh monaróirí córas bainistithe riosca agus déanfaidh siad é a dhoiciméadú, a chur chun feidhme agus a chothabháil.
Manufacturers shall establish, implement, document and maintain a risk management system.
·na dúshláin a bhaineann le heangach sábháilteachta mhargadh an Aontais Eorpaigh, agus an córas bainistithe riosca atá i bhfeidhm i SAM;
·the challenges of the EU market safety net and the recent developments in the risk management system in force in the US;
·na dúshláin a bhaineann le heangach sábháilteachta mhargadh an Aontais Eorpaigh, agus an córas bainistithe riosca atá i bhfeidhm i SAM;
·the challenges of the EU market safety net and the recent developments in the risk management system in force in the US;
·na dúshláin a bhaineann le heangach sábháilteachta mhargadh an Aontais Eorpaigh, agus an córas bainistithe riosca atá i bhfeidhm i SAM;
·the challenges of the EU market safety net and the recent developments in the risk management system in force in the US;
Áiritheoidh EIT go mbeidh córas bainistithe riosca i bhfeidhm ag PENanna i gcás nach bhfuil comhpháirtithe áirithe in ann seasamh lena gcuid gealltanas tosaigh.
EIT will ensure that KICs have a risk management system in place for cases where some partners are not able to meet their original commitments.
Áiritheoidh EIT go mbeidh córas bainistithe riosca i bhfeidhm ag PENanna i gcásanna nach bhfuil comhpháirtithe áirithe in ann seasamh lena gcuid gealltanas tosaigh.
The EIT shall ensure that the KICs have a risk management system in place for cases where some partners are not able to meet their original commitments.
Thug an t-aeriompróir dá aire go n-úsáideann sé tacar uirlisí bogearraí chun na sonraí sábháilteachta, cáilíochta agus bainistithe riosca a chomhtháthú, lena n-áirítear an córas bainistithe riosca tuirse.
The air carrier noted that it uses a set of software tools in order to integrate the safety, quality, and risk management data, including the fatigue risk management system.
Cé gur cheart d'údaráis chustaim faisnéis áirithe a roinnt le húdaráis chustaim eile agus an córas bainistithe riosca custaim á úsáid acu de réir reachtaíocht chustaim an Aontais, ba cheart do na húdaráis inniúla dá dtagraítear in Airteagal 8 de Rialachán (CE) Uimh. 1236/2005 faisnéis áirithe a roinnt le húdaráis inniúla eile i gcomhréir le hAirteagal 11 den Rialachán sin.
While customs authorities should share certain information with other customs authorities using the customs risk management system according to Union customs legislation, the competent authorities referred to in Article 8 of Regulation (EC) No 1236/2005 should share certain information with other competent authorities in accordance with Article 11 of that Regulation.
Chomh maith leis sin, d'fhonn na rioscaí a íoslaghdú nó cosc a chur ar theagmhais a bhaineann le feistí, ba cheart do na monaróirí córas bainistithe riosca a bhunú agus córas le teagmhais agus le gníomhartha ceartaitheacha um shábháilteacht allamuigh a thuairisciú.
In addition, in order to minimize risks or prevent incidents related to devices, manufacturers should establish a system for risk management and a system for reporting of incidents and field safety corrective actions.
Ba cheart an córas bainistithe riosca a ailíniú go cúramach leis an bpróiseas meastóireachta feidhmíochta ar an bhfeiste agus ba cheart é sin a léiriú ann, lena n-áirítear na rioscaí cliniciúla nach mór aghaidh a thabhairt orthu mar chuid de staidéir feidhmíochta, den mheastóireacht feidhmíochta agus den mheasúnú leantach feidhmíochta iarmhargaidh.
The risk management system should be carefully aligned with and reflected in the performance evaluation process for the device, including the clinical risks to be addressed as part of performance studies, performance evaluation and post-market performance follow-up.
an oibleagáid córas bainistithe riosca a oibriú, amhail dá bhforáiltear in Airteagal 14a agus in Airteagal 21(2) den Rialachán seo i gcomhar le hAirteagal 104(3) de Threoir 2001/83/CE agus Airteagal 34(2) de Rialachán (CE) Uimh. 1901/2006;
the obligation to operate a risk management system as provided for in Article 14a and Article 21(2) of this Regulation in conjunction with Article 104(3) of Directive 2001/83/EC and Article 34(2) of Regulation (EC) No 1901/2006;
Cé gur cheart d'údaráis chustaim faisnéis áirithe a roinnt le húdaráis chustaim eile agus an córas bainistithe riosca custaim á úsáid acu i gcomhréir le reachtaíocht chustaim an Aontais, ba cheart do na húdaráis inniúla dá dtagraítear sa Rialachán seo faisnéis áirithe a roinnt le húdaráis inniúla eile.
While customs authorities should share certain information with other customs authorities using the customs risk management system in accordance with Union customs legislation, the competent authorities referred to in this Regulation should share certain information with other competent authorities.
Déanfaidh gach Páirtí córas bainistithe riosca maidir le rialuithe custaim a ghlacadh nó a chothabháil d’fhonn dóchúlacht agus tionchar teagmhais a chosc, teagmhas a chuirfeadh cosc ar chur i bhfeidhm ceart na reachtaíochta custaim, a chuirfeadh as do leas airgeadais na bpáirtithe agus a chuirfeadh slándáil agus sábháilteacht na bPáirtithe agus a gcónaitheoirí, sláinte an duine, sláinte ainmhithe nó plandaí, an comhshaol nó a thomhaltóirí i mbaol.
Each Party shall adopt or maintain a risk management system for customs controls with a view to reducing the likelihood and the impact of an event which would prevent the correct application of customs legislation, compromise the financial interest of the Parties or pose a threat to the security and safety of the Parties and their residents, to human, animal or plant health, to the environment or to consumers.
De mhaolú ar an gcéad fhomhír, féadfaidh CIM lena dtionscnaítear iasachtaí a bheith neamhiata ar choinníoll go bhfuil an BCIM atá á bhainistiú aige in ann a léiriú d’údaráis inniúla Bhallstát baile an BCIM go bhfuil córas bainistithe riosca leachtachta an CIM comhoiriúnach lena straitéis infheistíochta agus lena bheartas fuascailte.
By way of derogation from the first subparagraph, a loan-originating AIF may be open-ended provided that the AIFM that manages it is able to demonstrate to the competent authorities of the home Member State of the AIFM that the AIF’s liquidity risk management system is compatible with its investment strategy and redemption policy.