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

RxTrace.com: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015

Dirk Rodgers of rxtrace.com writes "It’s August and that means it is time to check in on the progress toward full serialization of drugs in the U.S. supply chain.  This is an annual look I’ve been doing for five years now.  For my previous essays, see:

• “Estimated Rise In Serialized Drugs In The U.S. Supply Chain”;
• “Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2011“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013“;
• “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014”.

In each essay I produced a graph of my own personal estimate of the likely rise in the percentage of drugs that I thought would result, based on the deadlines that were in place at the time.  Of course, things changed last year because the Drug Supply Chain Security Act had preempted the California Pedigree law the previous November, so last year I made a new estimate that took into consideration the DSCSA dates.

What GTIN would you use under this co-marketing scenario?

I saw this conversation on Linked In and felt that it was worthy to repost here for preserving...
Here’s the scenario:

A large multi-national manufactures and packages pharmaceutical finished goods. One presentation of these finished goods are sold in the US through a Partner (co-marketing arrangement). The Artwork and GTIN (NDC) of the product is that of the Partner. However the manufacturing authorization holder (MAH) is the large multi-national brand owner. With Serialization according to the DSCSA, should the GTIN remain that of the Partner? Or, would it need to revert to the MAH?
My belief is that it would not change – remain that of the Partner. Curious if you have come across this and if so, what approach you would take. 

Why serialization is vital for pharmaceutical product integrity in the cold chain

Read entire article at the Cold Chain View blog.

More than ever before, drug security is an important issue in ensuring the integrity of medicines and vaccines reaching patients. The industry needs to demonstrate that we care for patients, and are putting all necessary measures in place to ensure that medicines are safe to be taken.

That means knowing the entire journey of a medicine through the supply chain, and having fully automated documentation about the conditions on its journey. One of the ways in which this can be addressed in the cold supply chain is through serialization. A key driver for implementing serialization will be global compliance requirements coming into play. The USA introduced the Drug Supply Chain Security Act at the end of 2013, which will require the availability of information at individual package level about where a drug has been in the supply chain.

FDA Warns of Bogus Botox - Case for SAP ATTP?

Counterfeit Botox may have been distributed to doctors' offices and medical clinics across the United States, the U.S. Food and Drug Administration warns.

The bogus Botox -- which is considered unsafe and should not be used -- was sold by an unlicensed supplier not authorized to ship or distribute drug products in the United States, the FDA said in a news release.

Packaging similarities between the fakes and the FDA-approved Botox, which is made by Allergan (100 units/vial), could cause health care professionals to mistake one for the other.

Approved Botox displays the active ingredient as "OnabotulinumtoxinA" on the outer carton and vial, the FDA said.

The outer carton of the counterfeit version says the active ingredient is "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA," according to the agency.

The FDA said the counterfeit product also can be identified in other ways. For instance, the vial is missing the lot number.

Read full article here : http://mobile.philly.com/health/?wss=/philly/health&id=300685841