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  1. #2776894

    Á aithint dó gur chuir Údarás Bia agus Drugaí SAM (‘FDA’) clabhsúr ar an measúnú ar 14 údarás de chuid Bhallstáit an Aontais Eorpaigh atá inniúil ar tháirgí tréidliachta (a bhfuil cúig údarás díobh sin inniúil ar tháirgí tréidliachta amháin, agus á chur san áireamh go bhfuil ceann amháin ar a laghad de na measúnuithe cumais sin ar na cúig údarás de chuid Bhallstáit an Aontais Eorpaigh fabhrach) i gcomhréir le mír II.A d’Fhoscríbhinn 4,

    Recognizing that the Food and Drug Administration (‘FDA’) has completed the assessment of 14 authorities of the Member States of the European Union (‘EU’) competent for veterinary products (of which five are competent for veterinary products only, and considering that at least one capability assessment of those five authorities of the EU Member States, is favorable) in accordance with paragraph II.A of Appendix 4,

    Decision No 2536/2023 of the Joint Sectoral Committee established under Article 14 of the United States – European Union amended Sectoral Annex for pharmaceutical good manufacturing practices (GMPs) (the ‘Annex’) on including veterinary products within the product coverage of the Annex of 11 May 2023 [2023/1044]

  2. #2783912

    I gcás an raoin feidhme a shonraítear in Airteagal 4 agus i bhFoscríbhinn 3 a ghabhann leis an Iarscríbhinn GMPanna, chinn an tAontas Eorpach go bhfuil an cumas, an acmhainneacht agus na nósanna imeachta i bhfeidhm ag Údarás Bia agus Drugaí SAM cigireachtaí a chur i gcrích ar GMPanna ar leibhéal atá coibhéiseach leis an Aontas Eorpach agus comhlíontacht GMPanna a fhorfheidhmiú agus, dá bhrí sin, cuirfear é le liosta na n-údarás aitheanta le haghaidh táirgí tréidliachta faoin Iarscríbhinn GMPanna.

    The European Union has determined that, for the product scope indicated in Article 4 and Appendix 3 to the GMPs Annex, the Food and Drug Administration of the United States of America has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU and enforce compliance with GMP and therefore, shall be added to the list of recognised authorities for veterinary products under the GMPs Annex.

    Notification to the Joint Sectoral Committee by the European Union under Article 7 of the Sectoral Annex on Pharmaceutical Good Manufacturing Practices (GMPs) of the Agreement on Mutual Recognition between the European Community and the United States of America