Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...
In a decision issued this week, Roland v. Green, -- F.3d --, 2012 WL 898557 (5th Cir. Mar. 19, 2012), the U.S. Court of Appeals for the Fifth Circuit addressed an issue of first impression—the scope of the preclusion provision of the Securities Litigation Uniform Standards Act (“SLUSA”). Recognizing the current split among circuits, the court adopted the “tangentially related” test ...
The Powers Of CSST Inspectors ConfidentialityAgreements:The Importance Of Protecting Your Secrets; Your First Financial Institution. Various statutes impose obligations on employers to take the necessary measures to protect the health and safety of workers, including An Act respecting Occupational health and safety (R.S.Q., c. S‑2.1) (hereinafter referred to as the “AROHS”) ...
Class Action and Consumer Law: The Court of Appeal Excludes Non-Consumers from the Approved Class in an Authorized Class Action CONSUMER PROTECTION LAW AND THE CONSUMER PROTECTION ACT (“CPA”) APPLY FIRST AND FOREMOST TO ECONOMIC ACTIVITIES IN THE RETAIL SECTOR. EXPENDITURES ASSOCIATED WITH THIS SECTOR REPRESENT MORE THAN SIXTY-FIVE PERCENT OF ALL EXPENDITURES IN THE PROVINCE. IT IS ALSO AN AREA OF THE LAW WHICH FREQUENTLY COMES BEFORE THE COURTS ...
You are the general counsel of a public company and expect M&A activity to increase in the United States during 2012. Do you know if your company looks like a good target to potential acquirors? It is important to understand whether you could be a target before getting that first overture from an acquiror ...
E-DISTRIBUTION OF INSURANCE PRODUCTS: THE AMF WANTS YOUR INPUT!On February 24, 2012, the Autorité des marchés financiers (the “AMF”) published, on its website, a notice of consultation entitled Notice and Request and Comment on Internet Insurance Offerings in Québec (the “Notice”). This process follows the AMF’s analysis, initiated a few years ago, on the issues relating to e-distribution of insurance products ...
On 6 January 2012, Bank Indonesia issued Regulation No. 14/2/PBI/2012 on the Amendment to Bank Indonesia Regulation No. 11/11/PBI/2009 on Card-Based Payment Instrument Activities (“New Regulation”). The New Regulation is aimed at re-evaluating the role of credit cards as a means of payment and to promote consumer protection when using credit and debit cards as a method of payment. The New Regulation is also aimed at limiting the provision of loans through credit cards ...
Bank Indonesia has issued Regulation No. 13/25/PBI/2011 regarding The Precautionary Principle to Delegate Some Commercial Bank Work to Third Parties (“Regulation”). Under the Regulation, banks should be more selective in selecting outsourcing companies in order to maintain the level of service provided to customers ...
On 28 November 2012, the Capital Market – Financial Institutions Supervisory Board (Badan Pengawas Pasar Modal – Lembaga Keuangan or “BAPEPAM - LK”) issued a new regulation on Changes to Material Transactions and Main Business Activities, ie Decree of the Head of BAPEPAM-LK No. KEP-614/BL/2011 (“Regulation IX.E.2”) which revoked Decree of the Head of BAPEPAM-LK No. KEP-413/BL/2009 (“Previous Regulation”) on the same matter. Regulation IX.E ...
On December 20, 2011, President Barack Obama, Vice President Joe Biden, Deputy Defense Secretary Ashton B. Carter, and Army General Martin E. Dempsey, chairman of the Joint Chiefs of Staff, welcomed home the final group of United States troops from Iraq. After more than twenty years and two wars with Iraq, this long-awaited homecoming symbolized the end of an era for many ...
Among other matters, this law establishes the use limitation principle in the treatment of personal data. This law will supplement our legislation on this matter, in particular Law 19,628 on Data Protection. This law specifically focuses on the collection and treatment of personal data of an economic, financial, banking or commercial nature by data banks, distributors of personal records or personal data banks ...
The scope of additional hypothecs was examined by the Superior Court of September 6, 2011 in the case of Banque Nationale Du Canada v. Larouche. At issues in this case was whether the additional hypothec provision contained in the deed of hypothec granted by Mr ...
The Centers for Medicare and Medicaid Services (CMS) on February 16, 2012 proposed rules1 implementing Section 6402(a) of the Affordable Care Act,2 requiring persons to report and return Medicare overpayments by the later of 60 days after an overpayment is identified or the date any corresponding cost report is due. Twice in the past, CMS had proposed rules requiring the return of Medicare overpayments, but did not finalize the regulations ...
You are the general counsel of a public company, and your board and your CEO are considering the company’s strategic acquisition options. Your input is needed on the different forms that such a strategic transaction can take ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has begun the pilot phase of HIPAA privacy and security audits of health care providers, health insurers and health care clearinghouses (“covered entities”) to assess HIPAA compliance efforts. Up to 150 covered entities will be subject to the initial audits, to be conducted by KPMG, LLP, the OCR audit contractor ...
In its judgment of 19 January 2012 (case no. 08332/11), the Southern Central Administrative Court, decided that INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (the national authority for medicines and healthcare products), is obliged to issue a certificate of subsidisation of the price of a medicine even when the person requesting the issue of the certificate was not the person who applied for the subsidy ...
The United States Court of Appeals for the Fifth Circuit has confirmed that lower courts may use their discretion in choosing either of two methods - the "percentage method" or "lodestar method" - to calculate attorneys' fees in class action suits. The decision, in Union Asset Mgmt Holding A.G. v. Dell, Inc., 2012 WL 35249 (5th Cir. Feb. 7, 2012), affirmed a district court's use of the percentage method to calculate a $7.2 million fee award ...
In connection with the recent changes in legislation in the field of health, the Federal Commission for protection against health risks ("Cofepris") has taken various actions against the sale, distribution and advertising of the so-called "miracle products," which are distributed without scientific evidence to demonstrate its therapeutic properties ...
The Federal Trade Commission (FTC) recently announced its annual revisions to the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) jurisdictional thresholds. The revised thresholds will become effective 30 days after publication in the Federal Register and will apply to all transactions closing on or after such date. The new thresholds will remain in effect until the next annual adjustment, expected in the first quarter of 2013 ...
You’re the general counsel of a public company and your CEO calls you to tell you that he is interested in acquiring another public company. He’s already asking you how quickly this can get done and what the company needs to do. What are the first steps you should take? Board of Directors Generally, the CEO should call each of your board members individually to gauge their initial reaction toward the acquisition and schedule a special board meeting to discuss a potential transaction ...
Over the course of a few months spanning June to September 2011, a number of regulations were issued by the Business Competition Supervisory Commission (Komisi Pengawas Persaingan Usaha – “KPPU”) as implementing guidelines to several pertinent Articles in Law No. 5 of 1999 concerning Prohibition of Monopolistic Practices and Unfair Business Competition (“Anti-Monopoly Law”). These guidelines are: Guidelines for Monopolistic Practices (Regulation No ...
In order to provide extensive protection, especially for the distribution of drugs in Indonesia, BPOM has issued a new regulation which sets out the criteria and procedure for drug registration, ie BPOM Regulation No. HK.03.1.23.10.11.08481 of 2011 regarding The Criteria and Procedure For Drug Registration ...
Bank Indonesia (BI) issued a new Bank Indonesia Regulation No. 13/2011 on 30 September 2011 on Receipt of Export Earnings in Foreign Exchange and Withdrawal of Offshore Loans in Foreign Exchange. The new regulation will be effective as of 2 January 2012 ...
The Law on the Financial Services Authority (Otoritas Jasa Keuangan – “OJK”) was passed by the House of Representatives on 27 October 2011 and has been ratified by the President. The Law establishes the OJK as a new independent financial institution, which will take over several regulatory and supervisory authorities presently held by Bank Indonesia and the Capital Market and Financial Institution Supervisory Body (Bapepam-LK) ...
