SOCIAL QUESTIONS|health|pharmaceutical industry
- anailís baisceanna Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Comhthéacs 'I ndáil le hanailísí baisceanna, soláthrófar tuairisc ar na baisceanna agus torthaí anailísí baisceanna le haghaidh na substainte/substaintí luibhe agus na hullmhóide/n‑ullmhóidí luibhe i gcás inarb infheidhme, lena n‑áirítear le haghaidh na substaintí pharmacopoeia sin.' Tagairt "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
- batch analysis | batch analyses
- en
- Sainmhíniú analysis of a batch of a medicinal product for human use or of a veterinary medicinal product Tagairt "COM-Terminology Coordination, based on: Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures"
- Nóta Analysis may concern the active substance, excipients, or any other material (reagents, etc.) used in the manufacturing or packaging.