Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #682036

    IATE #3502674
    baisc ar scála táirgeachta Reference Téarmeolaithe COM-GA
    ga
    baisc ar scála tionsclaíoch Reference "Rialachán Cur Chun Feidhme (AE) 2021/17 ón gCoimisiún an 8 Eanáir 2021 lena mbunaítear liosta modhnuithe nach n-éilíonn measúnú i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle (Téacs atá ábhartha maidir le LEE)Téacs atá ábhartha maidir leis an LEE"
    ga
    táirgeadh na mbaisceanna scála Reference "Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle an 11 Nollaig 2018 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE (Téacs atá ábhartha maidir le LEE)Téacs atá ábhartha maidir leis an LEE"
    ga
    Charge im industriellen Maßstab | Herstellungscharge
    de
    Definition Charge der Größe, die bei der routinemäßigen Vermarktung eines Produkts hergestellt wird Reference "COM-DE gestützt auf: EMA. CPMP & CVMP. 'NOTE FOR GUIDANCE ON PROCESS VALIDATION'"
    production scale batch | production batch | industrial scale batch
    en
    Definition batch of the size which will be produced during the routine marketing of a product Reference "COM-Terminology Coordination, based on:EMA. CPMP & CVMP. 'NOTE FOR GUIDANCE ON PROCESS VALIDATION' (23.4.2025)"
    Comment Data on production scale batches may not always be available prior to granting marketing authorisation.
    lot à l'échelle de production | lot à l’échelle industrielle
    fr
    Definition lot dont la taille est la même que celle des lots produits lors de la commercialisation Reference "COM-FR, d’après: Comité des spécialités pharmaceutiques (CSP) et comité des médicaments à usage vétérinaire (CVMP), Note for Guidance on Process Validation (17.12.2024), EMA, 2001"