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...
by Ursula Tschorn | May 21, 2015
Global Ingredients Archiving System (GINAS) What is GINAS in relation to ISO 11238 GINAS and ISO 11238 specifically addresses the identification and exchange of regulated information on substances. GINAS supports all substance types described in the 11238 standard...
