Showing posts with label NDC. Show all posts
Showing posts with label NDC. Show all posts

Wednesday, June 24, 2015

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. 

Monday, May 11, 2015

The ANVISA Unique Medicine Identifier (IUM) on Drug Packages - Dirk Rodgers

Last week Dirk wrote about the DSCSA Product Identifier on Drug Packages in the United States.  Last month he wrote about shipping container/transport package identification under the Brazil National Medicine Control System (SNCM) (see “ANVISA And The SSCC Controversy”).  In this article Dirk takes a look at drug package identifiers under the SNCM as regulated by the National Agency of Sanitary Surveillance (ANVISA).  Dirk is a member of the GS1 Healthcare group - Contact GS1 Healthcare for more information.

An excerpt from Dirk's article:
"Under the SNCM, manufacturers must apply a Unique Medicine Identifier (IUM) to all drug packages imported or sold into the Brazilian supply chain and trace them through the supply chain by December 11, 2016.  By December 11 of 2015, manufacturers must apply the IUM to the packages of at least three lots of drugs and trace them to the dispensing points.  And you thought compliance with the DSCSA was going to be hard to achieve!

Monday, May 4, 2015

The DSCSA Product Identifier On Drug Packages - Dirk Rodgers

According to the Drug Supply Chain Security Act (DSCSA), manufacturers must apply a new “Product Identifier” on all of their prescription drug products by November 27, 2017 (Repackagers by that date in 2018).  The DSCSA Product Identifier is defined this way:
“PRODUCT IDENTIFIER.—
The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.”  (Section 581[14])

Monday, April 27, 2015

Identification Of Pharma Cases In The U.S. - Dirk Rodgers

Article from Dirk Rodgers - "Last week I discussed controversy over the use of GS1’s Serial Shipping Container Code (SSCC) in the Brazil pharma supply chain to meet regulatory requirements imposed by ANVISA. But there are different controversies, or at least potential confusion, in the U.S. pharma supply chain surrounding case labels, and some of those are relate to the SSCC and its use. 
A case product identification label is the label a manufacturer usually places on each homogeneous case at case-packing time to identify what is inside the corrugated box. A “homogenous case” is a case that contains units from a single NDC and all units are from a single packaging lot. The product identification label should not be confused with a shipping/logistics label, which, if it exists, is applied at the time of shipment and contains information about the destination.
Typically, cases that are shipped from a higher-volume manufacturer to a larger wholesale distributor will be placed onto a pallet. The pallet often has cases of multiple products, and even different homogeneous cases of the same product can contain different lot numbers. You can sometimes even find a Non-homogeneous case mixed in with the homogeneous cases. Further, cases on the same pallet can actually be fulfilling different purchase orders submitted by the buyer. All of these variations complicate the job of the receiving clerk." - Read full article at RxTrace.com