News & Analysis as of

Exports Imports Pharmaceutical Industry

WilmerHale

President Trump Announces Three New Section 232 Investigations After Suspending Reciprocal Tariffs, Excluding Certain Electronics,...

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The Trump Administration has formally launched three separate national security investigations under Section 232 of the Trade Expansion Act of 1962 including on: 1) imports of semiconductors (including downstream electronic...more

Jones Day

Mexican Government Releases "Plan México"

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The Mexican government recently launched the Mexico Plan (Plan México), a six-year strategy in collaboration with the federal government and the private sector intended to promote economic growth in Mexico....more

Vicente LLP

What is the Process for Federal Psilocybin Registration?

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We’re fielding an increasing number of questions these days from companies and organizations about registering with the U.S. Drug Enforcement Administration (DEA) to handle psilocybin and psilocin in various ways. In light of...more

Wiley Rein LLP

[Webinar] National Security Concerns in International Supply Chains: New Laws, Policies, and Funding - April 13th, 2:00 pm - 3:00...

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The United States, China, and multiple nations are implementing new laws, policies, and funding to address supply chain security. Such changes may greatly impact international trade flows and compliance requirements for...more

Smart & Biggar

U.S. rule permitting import of drugs from Canada prompts Health Canada to release Interim Order prohibiting exports that may risk...

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UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Hogan Lovells

UK post-Brexit regulation of medicines from 1 January 2021

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The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published a raft of guidance on how various aspects of the UK regulatory regime for medicines will operate in England, Wales and Scotland (together Great...more

McDermott Will & Schulte

International News: COVID-19 Global Pandemic - May 2020

The Legal Impact in Europe on Pharmaceutical and Medical Device Companies - The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across Europe. ...more

Bradley Arant Boult Cummings LLP

Trade Agreements and COVID-19: A Changing Relationship

Since the start of this year, trade relations with China, previously marked by an escalating trade war, have reached a major inflection point. Recently, on March 12, the U.S. reacted to the growing COVID-19 pandemic by...more

K2 Integrity

Deterring the Counterfeits: Finding an Antidote for Global Businesses

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When thinking of counterfeit products, minds may wander to a person on the street selling near-authentic looking bags, sunglasses, and watches, for a fraction of the price of what would be paid at a store. But what if there...more

Robins Kaplan LLP

Financial Daily Dose 2.6.2020 | Top Story: Feds Probing Google’s Ad Business Over Antitrust Concerns

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More detail is emerging on the DOJ’s ongoing antitrust probe into Google, with recent attention to the company’s online ad tools suggesting the topic has become “a major focus of the investigation,” with special focus on “how...more

Herbert Smith Freehills Kramer

USMCA: Implications for Biologics and Innovation

On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more

Robins Kaplan LLP

Financial Daily Dose 1.17.2020 | Top Story: Senate Passes USMCA by Wide Margin to Update NAFTA

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While there’s plenty of other business afoot in D.C. these days, it also happens to have been a pretty big week for trade deals. A day after Phase One with China was inked, the Senate overwhelmingly approved a revised...more

Robins Kaplan LLP

Financial Daily Dose 12.10.2019 | Top Story: Remembering Influential Former Fed Chair Paul Volcker

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Some remembrances upon the passing of influential former Fed Chair Paul Volcker, a force in American economic policy for nearly 60 years who led “the Federal Reserve’s brute-force campaign to subdue inflation in the late...more

Skadden, Arps, Slate, Meagher & Flom LLP

Cross-Border Investigations Update - September 2019

This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more

Robins Kaplan LLP

Financial Daily Dose 9.20.2019 | Top Story: Fintech startup Stripe Inc. hits $35 billion valuation in latest funding round

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Fintech firm Stripe Inc., which “allows internet companies and online marketplaces to accept credit cards for their goods and services and pay out money to the people and firms that sell on their platforms,” just wrapped a...more

Robins Kaplan LLP

Financial Daily Dose 8.27.2019 | Top Story: OK Judge Hits Johnson & Johnson With $572 Million Fine in Opioid Trial

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A bad day for J&J in Oklahoma at the close of the state’s trial against Johnson & Johnson means that the company’s on the hook for upwards of $572 million for its role in the opioid crisis that’s decimated swaths of the...more

Akerman LLP - Health Law Rx

Florida Board of Pharmacy Initiates Work on International Export Pharmacy Permit Application and Rules

International export pharmacies took another step forward towards a separate, distinct licensure in Florida as the Florida Board of Pharmacy held a specially called Rules Sub-Committee Meeting on June 27, 2019, to address the...more

McDermott Will & Schulte

European SPC Manufacturing Waiver Goes into Force

Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

Robins Kaplan LLP

Financial Daily Dose 7.1.2019 | Top Story: US and China Pledge to Resume Trade Talks

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The US and China agreed to resume trade talks after a  7-week hiatus, “averting for now an escalation of their multibillion-dollar tariff war that has roiled global markets and threatened the future of the world’s two largest...more

McDermott Will & Schulte

Overview – German Legal Regime Concerning Cannabis for Medical Use

The German Constitutional Court and the German Highest Federal Administrative Court first introduced the concept of legal pharmaceutical-grade cannabis in 1999 and 2005, and the German legal regime has since made significant...more

Hogan Lovells

AFTA NAFTA: USMCA and the path forward

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On 30 September, after an intensive, last-minute flurry of negotiations, Canada joined the United States and Mexico in a new trilateral agreement to replace the original North American Free Trade Agreement (NAFTA 1.0). ...more

Ladas & Parry LLP

USMCA – New Agreement as to The Modernization of NAFTA Comes with Key Changes Regarding U.S. IP Rights

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Late on September 30, an agreement (USMCA) was reached between the United States, Mexico and Canada which modernizes the 24 year old North American Free Trade Agreement (NAFTA)....more

Holland & Knight LLP

Boletín Mensual de Comercio Internacional: Enero - Información con Énfasis en la Regulación Comercial y de Arbitraje Internacional

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Durante el mes de Enero destacan los siguientes temas: Acceso, Compras, Propiedad Intelectual, Comercio, Inversión, Solución de Diferencias, Competencia, Subvenciones, Arbitraje Inversión....more

Hogan Lovells

Obama Administration Issues Changes to Iran Sanctions Regulations That Benefit Exporters of Medicine, Medical Devices and...

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On December 23, 2016, the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”) published a number of changes to the Iranian Transactions and Sanctions Regulations (“ITSR,” 31 C.F.R. Part 560) that expanded the...more

Skadden, Arps, Slate, Meagher & Flom LLP

"OFAC and BIS Implement Additional Amendments in Support of Cuba Policy Shift"

On October 14, 2016, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Department of Commerce’s Bureau of Industry and Security (BIS) announced further amendments to ease U.S. sanctions and...more

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