News & Analysis as of

Disclosure Requirements European Union Pharmaceutical Industry

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

K&L Gates LLP

Brussels Regulatory Brief: March 2021

K&L Gates LLP on

ANTITRUST AND COMPETITION - The European Commission Opens a New Investigation in the Pharma Sector - On 4 March 2021, the European Commission (Commission) has opened a formal investigation into alleged misuses of patent...more

Jones Day

French Court Clarifies Surveillance Obligations

Jones Day on

The Situation: In a recent decision, the French Supreme Court clarified the surveillance obligations of notified bodies—independent entities accredited by an EU Member State's national health authority to determine whether a...more

Jones Day

France Simplifies Local Medical Device Regulations and Sets Precedent for Other Member States

Jones Day on

On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more

Hogan Lovells

France imposes an extra notification obligation on Class III and implantable medical devices manufacturers

Hogan Lovells on

On 13 December 2016, the French Decree 2016-1716[1] implementing the French Law 2016-41 modernising the French healthcare system[2] (“French Law 2016-41”) was adopted. This Decree provides important information concerning the...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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Soooooo . . . about that whole Brexit thing. A UK High Court has ruled that Britain’s EU withdrawal cannot move forward without the approval of Parliament, setting off more uncertainty and what’s expected to be a series of...more

Dechert LLP

The SPC Saga Continues

Dechert LLP on

The Court of Justice of the European Union (CJ) issued three judgments on grant of Supplementary Protection Certificates (SPCs) on 12 December 2013 in the cases: - C-493/12 Eli Lilly v HGS, - C- 443/12 Actavis v...more

King & Spalding

European Federation of Pharmaceutical Industries and Associations (EFPIA) Launches New Financial Relations Disclosure Code

King & Spalding on

Member Organizations Will Have Tracking and Reporting Obligations for Certain “Transfers of Value” to HCPs and HCOs - On July 2, 2013, the European Federation of Pharmaceutical Industries and Associations (EFPIA or “the...more

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