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European Commission Seeking Comments On Draft Text Laying Out The Safety Features To Appear On Pharmaceutical Packaging

On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human...more

Africa Update - August 2015 #3

Leading the News - Libya: On August 13th, the latest round of the United Nations (U.N.)-facilitated Libyan political dialogue concluded in Geneva, Switzerland. According to the U.N. Support Mission in Libya...more

China's Medical Device Market: New Policies, Higher Stakes

The recent introduction of the Regulations on the Supervision and Administration of Medical Devices (also known as State Council Order 650) has created significant impact in the medical device industry in China. The changes...more

Privacy Tuesday – August 2015: Three Bytes for End of Summer

It’s Privacy Tuesday again – and summer is winding down. Here are three bytes of privacy/security information to start your week...more

Orthofix Deferred Prosecution Agreement Extended for Two Months

In a recently-filed status report, the DOJ and medical device manufacturer Orthofix revealed that the company’s Deferred Prosecution Agreement (DPA) will be extended by two months. The DPA was due to expire on July 17, 2015,...more

Africa Update - August 2015 #2

Leading the News: Burundi - On August 6th, United Nations (U.N.) Secretary-General Ban Ki-moon urged Burundian President Pierre Nkurunziza to resume the political dialogue that was suspended last month and...more

EMBA Medical’s Hourglass™ Device Awarded CE Certificate

EMBA Medical Ltd., headquartered in Dublin, Ireland, recently announced that it has received CE certification for its Hourglass™ Peripheral Embolization Plug as a Class IIb medical device....more

European Competition Law Newsletter – August 2015

Continuing an EU-wide trend, yet another trade association has been fined in the UK for cartel activities. This time it was a medical professionals’ association. The message is clear; trade associations of all types need to...more

Health Alert (Australia) - August 10, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Victoria 3 August 2015 - AB v McKimm & Anor [2015] VCC 987 The County Court of Victoria granted an...more

DOJ Appoints Compliance Counsel to Provide Advice in FCPA Investigations

The U.S. Department of Justice (DOJ) is creating a new compliance counsel position in the Criminal Division’s Fraud Section to scrutinize the compliance programs of companies under investigation for possible Foreign Corrupt...more

China FDA Solicits Comments on Resolving the Backlog of Drug Applications

The China Food and Drug Administration (“CFDA”) recently published a draft circular to address the backlog of drug applications. The Circular Regarding Several Draft Policy Opinions to Accelerate the Resolution of the Backlog...more

Mead Johnson: Baby Formula and Bribes

Last week, the SEC announced a settlement of an FCPA enforcement action for $12 million against Mead Johnson Nutrition for payment of bribes in China to health care professionals at state-owned hospitals. Mead Johnson’s...more

Mead Johnson Nutrition Settles SEC FCPA Charges for $12 Million

On July 28, Mead Johnson Nutrition Co. (“Mead”), an infant formula maker, agreed to pay $12.03 million to settle civil FCPA charges with the SEC. The SEC alleged that a majority-owned subsidiary in China used discounts given...more

Health Alert (Australia) - August 3, 2015

In This Issue: - Judgments; Legislation; and Reports - Excerpt from Judgments: Victoria. 29 July 2015 - Inquest into the death of Jeffrey John McCarty The Victorian Coroner has investigated the death of...more

Health Alert (Australia) - July 27, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Australia. Fair Work Commission. 23 July 2015 - Foley v Melbourne Health [2015] FWC 4821 The Fair Work Commission has...more

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more

Health Alert (Australia) - July 20, 2015

In This Issue: New South Wales (NSW). 14 July 2015 - Ping Yuan v Da Yong Chen [2015] NSWSC 932 The New South Wales Supreme Court has made a declaration allowing an unconscious man's wife to consent to the...more

Africa Update - July 2015 #2

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from Leading the...more

Medicinal Product Regulation and Product Liability in Australia: Overview

The Therapeutic Goods Act 1989 (Cth)(TG Act): - Provides a national framework for the regulation of medicinal products. - Provides a national system to control the quality, safety, efficacy and timely availability...more

Health Alert (Australia) - July 6, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Victoria. 26 June 2015 - Northern Health v Kuipers [2015] VSCA 172 - The Victorian Supreme Court has allowed an appeal...more

Africa Update - July 2015

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from...more

Health Alert (Australia) - June 29, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Australian Capital Territory (ACT). Medical Board of Australia v Hocking [2015] ACAT 44 - The ACT Civil and...more

Real Guidance (Finally) On the Compliance Oversight Role of Boards

New guidance for boards of directors on what it means to have “reasonable oversight” for the implementation and effectiveness of corporate compliance programs could signal the beginning of a global trend towards more—and more...more

Health Alert (Australia) - June 15, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: New South Wales. O'Sullivan v Medical Council of New South Wales [2015] NSWCATAD 113 The New South Wales Civil and...more

Kyiv Tax Newsletter (Ukrainian)

Cancellation of the Military Tax on Currency Exchange Transactions - On 12 May 2015 the Verkhovna Rada of Ukraine adopted the Law of Ukraine “On Amendments to the Tax Code of Ukraine in Respect of the Military Tax” which...more

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