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Pharmaceutical Industry › Exports › European Union

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 120

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Morgan Lewis

EU Imposes Authorization Requirements for COVID-19 Vaccine Exports

Morgan Lewis on

In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force...more

McDermott Will & Schulte

International News: COVID-19 Global Pandemic - May 2020

McDermott Will & Schulte 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

Hogan Lovells

The EU and various member states measures on Personal Protective Equipment in response to the COVID-19 outbreak

Hogan Lovells on

In response to the global outbreak of the COVID-19 virus, the EU and various member states have taken measures to ensure continuity of supply of personal protective equipment (PPE) and address shortages of healthcare...more

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

Skadden, Arps, Slate, Meagher & Flom LLP

Cross-Border Investigations Update - September 2019

Skadden, Arps, Slate, Meagher & Flom LLP on

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

McDermott Will & Schulte

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Schulte 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

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

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