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Manufacturers Pharmaceutical Industry Exports

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

Smart & Biggar

Amendments to Food and Drug Regulations (Exports), Natural Health Products Regulations (Labelling)

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The Federal Government has published the following proposed amending regulations in Part 1 of the Canada Gazette: - Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs): The amendments...more

McDermott Will & Emery

International News: COVID-19 Global Pandemic - May 2020

McDermott Will & Emery on

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

K2 Integrity

Deterring the Counterfeits: Finding an Antidote for Global Businesses

K2 Integrity on

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

McDermott Will & Emery

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Emery on

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

Hogan Lovells

EU SPC Manufacturing Waiver Now in Force

Hogan Lovells on

The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469).  The Waiver has been introduced with the stated aim of putting EU generic and...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - September 2018

ANTICORRUPTION DEVELOPMENTS - Petrobras Settles with U.S. Authorities Over Alleged FCPA Violations - On September 27, 2018, the U.S. Department of Justice (DOJ) and the Securities and Exchange Commission (SEC)...more

Hogan Lovells

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

Hogan Lovells on

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

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsleter

Welcome to the May 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month, on the anticorruption front, Avon Products, Inc. (“Avon”) agrees to pay USD $135 million to settle a...more

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