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EU Article 29 Data Protection Working Party Releases Guidelines Stemming from Google Spain Case

Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent set of guidelines issued by the European Union’s Article 29 Data Protection Working Party outlining how EU Data Protection Authorities (DPAs) intend to implement the judgment of the Court of Justice of the European Union in Google Spain SL and Google Inc. … Continue Reading

New UK Pharmaceutical Packaging Warnings: Lucy in the Sky with Directions for Marketing Authorisation Holders

The UK Medicines and Healthcare Products Regulatory Agency has directed Marketing Authorisation Holders (MAHs) for medicines containing specified controlled drugs to update their Summary of Product Characteristics, patient information leaflets, and product labeling. These new warnings are designed to make it easier for the government to enforce a new law prohibiting driving under the influence … Continue Reading

Lessons for Life Sciences Companies With Global Operations that include Countries Sanctioned by the U.S.

On July 10, 2012, OFAC announced that Great Western Malting Co. ("Great Western"), a U.S. company, agreed to pay $1.35 million to settle apparent violations of the Cuban Assets Control Regulations. Great Western produces malt for the brewing, distilling and food markets. OFAC's settlement announcement indicates that Great Western's U.S.-based personnel provided back-office support for a foreign affiliate's sales of foreign-origin barley malt to Cuba. This case is noteworthy because the liability appears to be based solely on Great Western's facilitation of its foreign affiliates' sales of foreign products. This enforcement action is a warning to companies operating globally with business in the United States and in U.S.-sanctioned countries -- particularly U.S.-based companies whose foreign affiliates and subsidiaries conduct business in Cuba, Iran, Sudan, or Syria. Companies should consider whether they have sufficient internal controls in place to prevent inadvertent back-office support or other forms of facilitation of their related companies' sales in sanctioned countries.… Continue Reading
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