News & Analysis as of

Healthcare Imports

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

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In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Bricker Graydon LLP

The Impact of Tariffs on Medical Equipment Manufacturing in Kentucky

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In our recent publication, “The Impact of Tariffs on the Insurance Industry,” we explored how the sweeping tariff policy announced by President Donald Trump is affecting various insurance sectors....more

Rivkin Radler LLP

ADA Joins Coalition Seeking Tariff Exemption for Medical and Dental Supplies

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The American Dental Association (ADA) has joined a coalition of other healthcare organizations in writing a letter to U.S. Trade Representative Jamieson Greer urging the Trump administration to exempt medical and dental...more

White & Case LLP

First International Procurement Instrument case relating to EU medical devices in China’s public procurement market. The key...

White & Case LLP on

On 14 January 2025, the European Commission ("Commission") published the findings of its first investigation under the EU's International Procurement Instrument ("IPI"). Findings of the investigation concludes that China...more

King & Spalding

The Trifecta: What to Expect from a Second Trump Administration and a Republican Congress

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Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more

Mintz - ML Strategies

2024 Post-Election Analysis

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Following a hotly contested election, Donald Trump is once again the president-elect and will return to the White House on January 20, 2025. He will do so with a dominant electoral college win, potentially a win of the...more

Akin Gump Strauss Hauer & Feld LLP

US Presidential Elections 2024—What is at Stake for Swiss Companies and Investors?

The November U.S. Presidential electoral campaign is in full swing. Since President Joe Biden ended his reelection bid and Vice President Kamala Harris secured the Democratic Party nomination, polls now show a tight race...more

Clark Hill PLC

The Learned Concierge - July 2024, Vol. 10

Clark Hill PLC on

The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

Jones Day on

The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

Smart & Biggar

U.S. FDA authorizes Florida plan to import drugs in bulk from Canada

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A proposed program by the state of Florida to import certain prescription drugs from Canada has received the approval of the United States Food and Drug Administration (FDA): FDA news release on January 5, 2024....more

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

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On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

Hogan Lovells

The Court of Justice clarifies the EU customs rules applicable to customs valuation

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The Court of Justice of the European Union (“Court”) just released its judgement in Case C-1/18 Oribalt Riga concerning the customs valuation methodologies applicable to generic medicines in the framework of consignment...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

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On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....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

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