Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #664637

    IATE #3592473
    eisíontas a bhaineann le táirgí Reference "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    product-related impurity
    en
    Definition molecular variant of the desired product (e.g. precursors, certain degradation products arising during manufacture and/or storage) which does not have properties comparable to those of the desired product with respect to activity, efficacy, and safety Reference "European Medicines Agency (EMA). 'ICH Topic Q 6 B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Step 5. NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS (CPMP/ICH/365/96)' (21.1.2021)"
  2. ENVIRONMENT|environmental policy|climate change policy|emission trading|EU Emissions Trading Scheme

    #682883

    IATE #3534338
    leibhéal gníomhaíochta stairiúil táirgí Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    produktbezogene historische Aktivitätsrate
    de
    product-related historical activity level
    en
    Definition "median, for each product for which a product benchmark has been determined as referred to in Annex I to Regulation (EU) 2019/331, of annual historical production of that product in the installation concerned during the baseline period " Reference COM-Terminology Coordination, based on: COM-Internal document: CLIMA-2023-00633 (emission allowances)
    niveau d’activité historique relatif au produit
    fr