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 | May 22, 2015
The FDA requires a “Stuctured Product Labeling” (SPL) for the registration of medicinal products. UNII Substances Unique Ingredient Identifier – a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance’s molecular...
by Ursula Tschorn | May 22, 2015
eSubscription is the process of registering medicinal products for marketing authorisation at the local authorities. eSubscription requires in current regulations in the US and Europe substantially different technologies, terminologies and vocabularies for...
