A B C D E G H I L M N O P R S T U X

ISO 11616

ISO 11616 International Standard “Health informatics — Identification of Medicinal Products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information”. ISO 11616 is intended to assist...

ISO TC 215

The ISO TC 215 is the International Organization for Standardization’s (ISO) Technical Committee (TC) on health informatics. TC 215 works on the standardisation of Health Information and Communications Technology (ICT), to allow for compatibility and...

Lot Distribution Report LDR

Lot Distribution Report LDR In US under 21 CFR 600.81, marketing authorisation applicants must submit to the Center for Drug Evaluation and Research (CDER), LDRs containing certain specified information every 6 months about the quantity of the product distributed...

MAA

MAA short for Marketing Authorization Application