by Ursula Tschorn | May 24, 2015
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...
by Ursula Tschorn | Jul 12, 2015
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...
by Ursula Tschorn | Jul 17, 2015
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...
by Ursula Tschorn | Jul 16, 2015
MAA short for Marketing Authorization Application
by Ursula Tschorn | Jul 14, 2015
Marketing Authorisation Holder (MAH)