Gaois

Similar terms:

This is a static copy of data that is exported from IATE on an occasional basis. It should not be assumed that information provided about an entry here will always correspond to the current version of the entry in IATE. That current version can be checked by clicking on the link on the upper right hand side of each entry. More information »

2 results

  2. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency

    #688253

    IATE #3639990
    Clár um Iniúchadh Comhpháirteach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Chun cur chun feidhme reachtaíocht an Aontais maidir le dea‑chleachtas monaraíochta, cliniciúil agus dáileacháin, agus maidir leis na gníomhaíochtaí forfheidhmiúcháin comhfhreagracha, a choinneáil ar bun ar bhealach coibhéiseach comhchuibhithe, bunaítear leis an gcreat dlíthiúil nua, laistigh de EMA, Clár um Iniúchadh Comhpháirteach (JAP) chun a áirithiú go mbeidh cigireachtaí na mBallstát faoi réir iniúchtaí tráthrialta ag Ballstáit eile.' Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA"
    Gemeinsames Prüfprogramm
    de
    Joint Audit Programme | JAP
    en
    Definition programme established within EMA through which Member States’ inspectorates will be subject to regular audits conducted by other Member States Reference "Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006, COM(2023) 193"
    Comment In certain cases, shortcomings in Member States’ system of supervision and related enforcement activities could risk to substantially hinder the achievement of the objectives of this Regulation and those of revised Directive 2001/83/EC which could even lead to the emergence of risks to public health. To address these challenges, harmonised inspection standards should be ensured through the establishment of a joint audit programme within the Agency. This joint audit programme will also further harmonise the interpretation of good manufacturing and distribution practices on the basis of EU legislative requirements. Moreover, it will support further mutual recognition of inspection outcomes between Member States and with strategic partners. Within the joint audit programme, the competent authorities are subject to regular audits conducted by other Member States to maintain an equivalent and harmonised quality system and to ensure an appropriate implementation of relevant good manufacturing and distribution practices into national laws and equivalence with other EEA inspectorates.
    programme d'audit commun | PAC
    fr
    Definition "programme établi dans le cadre de l'Agence européenne des médicaments pour garantir que les inspections des États membres feront l'objet d'audits réguliers menés par d'autres États membres" Reference "COM-FR, d'après:proposition de règlement du Parlement européen et du Conseil établissant des procédures de l’Union pour l’autorisation et la surveillance des médicaments à usage humain et établissant des règles régissant l’Agence européenne des médicaments, modifiant le règlement (CE) nº 1394/2007 et le règlement (UE) nº 536/2014 et abrogeant le règlement (CE) nº 726/2004, le règlement (CE) nº 141/2000 et le règlement (CE) nº 1901/2006, COM(2023) 193 final"