News & Analysis as of

Exports Prescription Drugs

A&O Shearman

Drug shortages Belgian Royal Decree adopted which sets conditions for export authorisation

A&O Shearman on

The Royal Decree of 19 January 2023 (the Royal Decree) concerning the shortage of medicines (i) details the conditions under which a prior authorisation is required to export medicines aimed for the Belgian market to other EU...more

Smart & Biggar

Updates to Health Canada’s regulatory initiatives for 2022-2024, and amendments to Food and Drug Regulations (Exports and...

Smart & Biggar on

Update: Health Canada’s “ Forward Regulatory Plan: 2023-2025” no longer lists some of the below initiatives, including the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug...more

Smart & Biggar

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

Smart & Biggar on

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

Smart & Biggar

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

Smart & Biggar on

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

McDermott Will & Emery

Policy Outlook: How The 2020 Election Outcomes Will Impact Your Business - Health Policy

McDermott Will & Emery on

In this session, health law policy authorities discussed changes likely in 2021 in a Biden Administration and how these changes will impact business objectives and strategies for health industry stakeholders...more

McDermott Will & Emery

[Webinar] Policy Outlook: How The 2020 Election Outcomes Will Impact Your Business - November 5th, 12:00 pm - 2:15 pm EST

McDermott Will & Emery on

Are you prepared for the critical impacts of the US election outcome to you and your business in 2021 and beyond? Join McDermott’s lawyers and our policy and lobbying team for perspective on the effects of administration...more

McDermott Will & Emery

COVID-19 – Legal Implications for Pharmaceutical and Medical Device Companies in Germany

McDermott Will & Emery on

The impact of Coronavirus (COVID-19) on pharmaceutical and medical device companies has been unique as, not only have these businesses had to set up emergency management systems practically overnight in order to maintain...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

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

Hogan Lovells

Appealing a denial of a drug/medical device export certificate: FDA final guidance

Hogan Lovells on

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

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

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

McDermott Will & Emery

Overview – German Legal Regime Concerning Cannabis for Medical Use

McDermott Will & Emery on

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

Robins Kaplan LLP

Your Daily Dose of Financial News

Robins Kaplan LLP on

To no one’s surprise, the Fed followed through with its months of promises and raised its benchmark interest rate by 25 basis points yesterday. The FOMC also indicated that it’s planning to raise rates again in December....more

Jones Day

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

Jones Day on

The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more

Hogan Lovells

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

Hogan Lovells on

On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

Polsinelli

USTR Report Highlights Foreign Barriers to U.S. Exports

Polsinelli on

U.S. companies should review a recent USTR (United States Trade Representative) report providing insight into the various country-specific issues that may take center stage in future trade negotiations. Companies should then...more

Hogan Lovells

The Obama Administration Eases Sanctions Against Sudan

Hogan Lovells on

On January 13, 2017, the White House, the U.S. Department of Treasury ’s Office of Foreign Assets Control (OFAC) , and the U.S. Department of Commerce ’s Bureau of Industry and Security (BIS) announced a host of policy...more

Akin Gump Strauss Hauer & Feld LLP

OFAC Expands Iran-Related Authorizations for Medicine, Medical Devices and Agricultural Commodities

On December 23, 2016, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) issued a Final Rule amending the Iranian Transactions and Sanctions Regulations, 31 C.F.R. Part 560 (ITSR) to expand the...more

20 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide