SOCIAL QUESTIONS|health|pharmaceutical industry
- eisíontas a bhaineann le táirgí Tagairt "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
- Sainmhíniú 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 Tagairt "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)"