DEV SITE: Marken

Informed Compliance: Navigating the Complex Regulatory Challenges of Importing APIs

Alex — Fri, 20 Jan 2012 18:07:46 +0000

When you think of moving boxes from one place to another, it seems simple and some cases it is. When you are importing APIs under the interplay of FDA 21 CFR guidance, which could easily be 50 pound book and US Customs and Border Protection (CBP) agency 19 CFR regulations, it is not so easy.

I relate it to hiring a tax consultant. Yes, you can go through the forms and fill them out and file them. But you don’t. You hire a tax consultant who has the experience and understands the tax codes to afford you a larger tax return and ensure compliance. You hire them for experience, just as you would hire premium supply chain provider.

When I have a new API, my thoughts go beyond how to move the API, but what is the bigger picture. We need to analyze the documentation to understand what we are moving to see if it is categorized correctly as the stakes are getting higher. In 2009, U.S. imports of APIs and other pharmaceutical products totaled over $85 billion. Using lower cost suppliers in emerging markets has been the industry standard for sourcing APIs. Yet tariffs of up to 6.5% ad valorem can be imposed on items not considered to be for pharmaceutical use.

A list of HTS codes for APIs has been created as part of a tariff-elimination agreement between the US and 33 other countries. This list of roughly 10,000 products can be imported without duties being levied. However, in some cases, these products can be imported at a lower rate or duty free if they meet the criteria for the “K” special-rate-of-duty code. Provision K status is granted if the party importing the bulk API can show FDA that it qualifies for the designation.

Some of you from large companies have the luxury of brokers within your company to provide the importation experience you need. Medium and small sized pharma don’t have that expertise in house and need a resource for knowledge.

As we see a rise in biologics and everything gets more expensive, this 6.5% has an immense impact on your bottom line. This analysis is a gratis part of premium logistics service as our experience tells us to look deeper for cost savings for you.

Want more information? Check out my White Paper:
Securing Provision K Status For A Client’s API Helps To Expedite Shipping And Reduce U.S. Importation Costs

ABOUT DAN BELL
Director of Commercial Operations / Director Regulatory Compliance

Dan Bell, Director of Commercial Operation, has led Marken’s operations on the West Coast of the United States since he joined the company in 2003. He is a licensed US Customs Broker and a Certified Customs Specialist with 10+ years of combined education and practical experience in global life science supply chain solutions, with a focus on trade compliance aspects. His clients include pharmaceutical and medical device companies, Clinical Research Organizations, Central Labs and Contract Manufacturing Organizations.

Case Study: Provision K

Marken — Sat, 03 Dec 2011 22:06:59 +0000

Marken’s In-Depth Knowledge of Regulatory Requirements Pays Big Dividends for Clients

Challenge
A customer of Marken is bringing an Active Pharmaceutical Ingredient (API) into the US for testing and further manufacturing. They chose Marken as their supply chain/logistics solution provider because they needed to insure that their product was handled in an expeditious manner, particularly through the regulatory agencies as the product entered the United States from Europe.

Our client had been told that their product would incur an ad valorem duty of 6.5% of the entered value based on the original HTS classification or could possibly use a harmonized tariff classification for a “proto-type”, to try to get a duty free status. Although the USHTS Chapter 98 (special classification provision) for prototypes would be duty free this type of classification commonly results in cargo release delays and further document review by agencies.

Solution
Marken initiated full review of their product documentation and validation for CBP, FDA, and USDA prior to export. Upon reviewing the client’s documentation, Marken noticed that the CAS number (Chemical Abstract System) indicated in the MSDS (Material Safety Data Sheet) that that the API being brought to the United States actually was eligible for special tariff treatment. Marken was able to confirm that the product was indeed listed in the duty free special provision in the pharma-ceutical index of the US Tariff.

Working closely with United States customs, a licensed customs broker, and using our knowledge of import and trade compliance regulations, Marken was able to provide the client with all of the details necessary to achieve duty-free status and to avoid delays each time a product was being shipped. The FDA did suggest that the client submit an IFE (Import for Export) as the affirmation code of compliance (AOC). This AOC, which associated with the appropriate FDA product code, will notify FDA that this shipment is for further manufacturing.

Outcome
As result of Marken’s attention to detail and knowledge of Regulatory and Customs requirements for pharmaceutical products, Marken’s client will save ~$13,000 on this shipment of the API and any subsequent shipments entering the US under the same provisions and designation.

Marken Launches New Brand And Marketing Campaign

Marken — Fri, 30 Sep 2011 20:13:02 +0000

Coincides with new direction and reflects the ‘voice of the client’

New York, September 30. 2011 – Marken, a global leader in supporting clinical research logistics, announced the launch of a new global brand and advertising campaign to reflect the unique position that it holds in the pharmaceutical industry. The campaign will be introduced globally with the launch of its new website, www.marken.com , and will include its new brand and tagline: “Global Life Science Supply Chain Solutions”.

“The Marken name has been synonymous with reliability and impeccable customer service” said Wes Wheeler, Marken’s Chief Executive Officer. “This new branding and marketing campaign reflect the voice of our clients who trust Marken to provide supply chain solutions to the clinical and commercial segments of the pharmaceutical industry. This is especially relevant as we bring more pharmaceutical depots online according to our master plan.”

Marken’s new purpose-built depots will form a ‘Pharmaceutical Services Network’ which will support the conduct of clinical trials in remote locations. Each depot will be able to store and distribute clinical trial supplies, aggregate and store frozen research specimens for batch shipment to central laboratories and to provide secure GMP compliant facilities to support more than 6000 investigator sites in over 100 countries.

The new brand and campaign was announced at its first global sales and operations meeting on the eve of the Marken-sponsored IQPC Cold Chain Conference in Philadelphia. In her opening remarks, Ariette van Strien, SVP Commercial Operations, stated: “Our new campaign: ‘Marken makes it happen’, reflects what we have heard from our clients. We are proud of our reputation in the industry and will continue to provide reliability, innovation and regulatory expertise to our clients.”

About Marken
Founded in 1980, Marken is focused on supporting life science companies by managing their supply chain through the entire clinical trial lifecycle. Marken integrates Depot and Logistics services into solutions that extend the reach of clinical trials to even the most remote treatment naïve geographies. As the leading supply chain solutions company managing global collection, transportation, storage and distribution of specimens and clinical trial supplies, Marken supports the clinical supply chain to over 6000 investigator sites in excess of 100 countries.

CONTACT: Elan Josielewski, info@marken.com, +1-347-855-3526, www.marken.com

Click here to download this Press Release.

UN General Assembly in New York

Marken — Fri, 23 Sep 2011 05:49:57 +0000

Traffic Changes, High Security as Diplomats Head to United Nations

The city’s got the whole world in its hands this week, with leaders in town for the UN General Assembly and the Clinton Global Initiative and to visit the 9/11 memorial. Throw in security checkpoints from the terror alert still in effect at bridges and tunnels and in lower Manhattan, and it’s traffic chaos.

New Yorkers should prepare for gridlock, heightened security and plenty of protesters as the United Nations General Assembly gets underway.

Dozens of world leaders, including President Barack Obama and Iranian President Mahmoud Ahmadinejad will be in town for the meetings, which are expected to be rife with controversy over the Middle East.

The Coast Guard says it is enforcing security zones on the East River during the United Nations General Assembly.

Among other things, it will restrict vessel traffic near the U.N. Headquarters.

The added measures started Monday. They’ll continue through Sept. 27.

Police have already locked down the area surrounding the United Nations. Stone barricades line the streets. Expect First Avenue to be shut down near the UN. Certain side streets are subject to closures.

The fun begins about 5 p.m. on Monday with the arrival of President Obama at Kennedy Airport. He’ll then chopper to Wall St. before heading up the FDR Drive to his home for the next two nights, the Waldorf-Astoria, which takes up the block between Park and Lexington Aves., from 49th to 50th Sts. On Monday night, the President will attend a fund-raiser starting around 7 p.m. to 7:30 p.m. on the upper East Side (avoid Madison and Fifth Aves. in the 60s and 70s). The Yankees play a 1 p.m. game on Monday; when the game lets out about 4 p.m., the NYPD will begin to freeze the FDR below 63rd St. Giants fans also start heading to the Meadowlands for a game at 8:30 p.m.

Tuesday, the President attends meetings at the UN and Waldorf-Astoria between 9 a.m. and 4 p.m. before a fund-raiser at Gotham Hall, Broadway at 36th St. Expect freezes on all avenues east of Madison as Obama travels between the UN and the Waldorf multiple times and again (east of Sixth Ave.) when he visits Gotham Hall.

UN closures and freezes all week include the FDR below 63rd St., First Ave. from 42nd to 48th Sts., 43rd to 47th Sts. between First and Third Aves., and 42nd and 50th Sts. east of Seventh Ave.

Wednesday, with Thursday a close second! Wednesday is the first day of the UN General Debate, where President Obama joins 31 other leaders. You also have a 1 p.m. Yankees game, a gala at the New York Public Library and Obama at the Clinton Global Initiative. Thursday is when the Iranian leader addresses the UN and will likely draw tens of thousands of protesters. I suggest driving to Secaucus Junction, leaving your car in the parking lot nearby and hopping on a train into Penn Station in Manhattan. Monday evening’s rush hour is no bargain either, as the President arrives from the east and Giants fans head west.

FDR Drive Embargo

Starting 12:01AM Monday, September 19th through 10:00PM, Friday, September 23:

FDR Drive between Whitehall Street and Willis Avenue Bridge/RFK Bridge.

Additional Embargo: Starting 12:01AM Monday:

· 7th Avenue between 54th Street and 51st Street
· 7th Avenue between 42nd Street and 35th Street
· 54th, 37th, and 36th Streets between 7th Avenue and 6th Avenue
· 53rd Street between 5th Avenue and Park Avenue
· Park Avenue (Including Viaduct) between 48th Street and 42nd Street
· Lexington Avenue between 48th Street and 41st Street

Yin-Lin Seow Sample 5

Alex — Tue, 13 Sep 2011 03:18:22 +0000

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Yin-Lin Seow Sample 4

Alex — Tue, 13 Sep 2011 03:15:37 +0000

Yin-Lin Seow Sample 3

Alex — Tue, 13 Sep 2011 03:15:16 +0000

Yin-Lin Seow Sample 2

Alex — Tue, 13 Sep 2011 03:14:48 +0000

Yin-Lin Seow Sample 1

Alex — Tue, 13 Sep 2011 03:13:57 +0000

Don Riach Sample 5

Alex — Tue, 13 Sep 2011 03:10:50 +0000