Showing posts with label Regulations. Show all posts
Showing posts with label Regulations. Show all posts

Saturday, October 8, 2016

NNIT Announces Partnership with SAP to collaborate on IDMP

"NNIT collaborates with SAP to deliver leading IT software and services for identification of medicinal products (IDMP) tailored to improve the reporting and tracking of product safety."
COPENHAGEN, Denmark, Oct. 5, 2016 (GLOBE NEWSWIRE) -- NNIT, a global provider of IT services and consultancy, today announced a worldwide partnership with SAP SE, the market leader in enterprise application software, to market leading solutions supporting regulatory compliance for Identification of Medicinal Products (IDMP) within the pharmaceutical industry.
The European Medicines Agency (EMA) is implementing five new standards developed by the International Organization for Standardization (ISO). Pharmaceutical companies will be required to submit data on medicines to EMA in accordance with common global formats and terminologies. The penultimate goal as defined by the EMA is to improve overall patient safety.
Committed to support these new regulatory requirements, NNIT will introduce tailored, innovative solutions intended to secure successful IDMP compliance within the authority timelines. Read full Globe Newswire article here

Monday, April 20, 2015

ANVISA And The SSCC Controversy - By Dirk Rodgers


GS1’s Serial Shipping Container Code, or SSCC, has been around a long time, but the logistics identifier has recently taken center-stage in a number of controversies related to meeting several country-specific pharma traceability regulations. I’ll cover these controversies in multiple essays—in this one, Brazil. 
This controversy started when ANVISA, the pharma regulator in Brazil, indicated in their regulations that they expected companies to mark every “transport package” entering their supply chain with a unique identification code so that each serialized unit inside can be associated with it (the aggregation requirement).
The problem is, a homogeneous case of product can be both a “standard grouping” of the product and a transport package. GS1 recommends that “standard groupings” of product be marked with its own GS1 Global Trade Item Number, or GTIN. Read the full article at RxTrace.com - Author Dirk Rodgers