On May 11, 2017, ANVISA formally published RDC-157/2017 that will serve as the regulations for their 3-Lot Pilot that is to take place in 2017. We’ve been expecting this new RDC around this time because they were required by the recent Law Number 13.410 of December 28, 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”). ANVISA also held a “public consultation” to allow the public to review and comment on an earlier draft of what is now RDC-157/2016 (see “ANVISA Reveals Draft Serialization Regulation and Asks For Comments”). The newly adopted RDC-157 is clearly intended to guide the pilot and then ANVISA intends to update it as part of their analysis of the pilot results. They will likely go through another public consultation before they make it a final regulation that all companies will need to follow. Bottom line, if you are not part of the 3-Lot Pilot, don’t start implementing a solution until Continue reading Brazil Publishes RDC-157 To Regulate 2017 3-Lot Pilot
Tag Archives: Pharma serialization
FDA Tea Leaves: Are They About To Delay The November Deadline?
I don’t have any hard evidence, but there are some interesting things out there that just might point to a coming delay in the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline for drug manufacturer serialization and electronic transaction data exchange. Let’s call them “tea leaves”, and let me attempt to “read” them. They might turn out to be meaningless, so don’t take any action based on such speculation. And if you know something more, or interpret something differently, leave a message.
During the Cold War the U.S. government and the press attempted to figure out what was going on in the Soviet Union by paying attention to who was standing next to whom during military parades. Our exercise might seem a little like that. Continue reading FDA Tea Leaves: Are They About To Delay The November Deadline?
InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance
As you are already well aware, the FDA is long overdue to publish four different guidance documents covering various aspects of the Drug Supply Chain Security Act (DSCSA), as mandated by Congress (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”). At least two of those guidance documents would affect how companies should expect to comply with the serialization deadline on November 27, 2017.
If the FDA doesn’t publish on or before that date, does that mean you don’t need to comply on time? Can you just sit back and wait for the FDA to post those guidance documents someday? I don’t think so. Here’s why. Continue reading InBrief: Why The DSCSA Will Be Enforced Even Without FDA Guidance
Can Anyone Buy Non-Serialized Drugs After 11-27-2019?
Well over a year ago, my good friend Kevan MacKenzie, Director, Serialization Technology with McKesson, pointed out a really interesting discrepancy contained in the Drug Supply Chain Security Act (DSCSA) regarding the sale of non-serialized drugs. I’ve been meaning to write about it since then. The topic finally bubbled up to the top on my list.
What Kevan pointed out is that there are two sections of the DSCSA that contain slightly conflicting requirements. This leaves companies Continue reading Can Anyone Buy Non-Serialized Drugs After 11-27-2019?
Sponsored: Pharma Traceability
Pharmaceutical serialization and traceability laws continue to be developed all over the world. In any one market, it takes several years to progress from the initial stirrings to the publication of full, workable regulations. As we have seen, several countries have had to take a few steps back, make adjustments and then move forward again (see “Brazil Gets Rational With Their New Pharma Traceability Law” and “China’s Retreat From Pharma Serialization: Will This Become A Global Trend?”). In fact, I think those countries that do, will end up with a much better approach.
What that means to you is Continue reading Sponsored: Pharma Traceability
The Russia Serialization Pilot Guideline
The Russia Ministry of Health (MoH) is conducting a serialization and tracing pilot with a number of supply chain members between February 1, 2017 and December 31, 2017 (see “Russia Begins Its Pharma Supply Chain Pilot”). The MoH is due to publish an assessment of the pilot by next February 1st.
Two weeks ago the Russian Minister of Health, Veroníka Skvortsova, signed the guidelines document for the pilot. The 42-page document appears to be written as a pilot setup document, as opposed to Continue reading The Russia Serialization Pilot Guideline
Sponsored: The Season For Label Redesign
With the approach of pharma serialization deadlines all around the world, this is the season for label redesign. The addition of new unique identifiers in 2D barcodes and human readable forms—often without removing existing linear barcodes—requires knowledge of the pharma labeling regulations in the target markets as well as artwork skills (see “DSCSA: Label Artwork Heartaches”). The problem is, serialization doesn’t apply to just one product, it applies to all prescription drugs marketed in the target market. That threatens to cause Continue reading Sponsored: The Season For Label Redesign
Sponsored: Brand Protection: The ‘No Brainer’ Value, Beyond Compliance
Pharma companies are spending a boat-load of money to put serial numbers on their drug packages and homogeneous cases, and collecting aggregation data for the wholesale distributors. And in every one of those companies, their leadership is asking, “What can we do to get some value, beyond compliance, from our investments? Can we sell someone some data? Can we get some new business advantage? Can we get some new insight into our processes or into the operation of the supply chain?” Continue reading Sponsored: Brand Protection: The ‘No Brainer’ Value, Beyond Compliance
