SOCIAL QUESTIONS|health|pharmaceutical industry
- barrachas Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Comhthéacs 'Soláthrófar míniú lena n-áirítear an fhaisnéis seo a leanas ach gan a bheith teoranta di: ... (g) aon bharrachas san fhoirmliú chun neartúlacht íosta a ráthú ag deireadh na seilfré, mar aon le húdar leis...' 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"
- overage
- en
- Sainmhíniú "surplus quantity of active substance [ IATE:35093/EN ] used in the manufacturing of a medicinal product to compensate for degradation during manufacture or a product’s shelf life, or to extend shelf life" Tagairt "COM-Terminology Coordination, based on:European Medicines Agency. ICH Topic Q 8 (R2). Pharmaceutical Development. Step 5, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002872.pdf [6.1.2014]"