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 ...
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 ...
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 new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...
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 ...
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The Centers for Medicare and Medicaid Services (CMS) has delayed the start date for data collection of payments made to physicians and teaching hospitals by drug and device manufacturers and group purchasing organizations (GPOs). Under the Physician Payment Sunshine Act (the “Sunshine Act”), such payments were to have been recorded beginning on January 1, 2012 ...
On Monday December 19, 2011, the Department of Justice announced year-end results for False Claims Act (“FCA”) cases in fiscal year 2011. The results, summarized below, demonstrate a dramatic increase in FCA cases brought by the government and private whistleblowers. The pharmaceutical industry is the prime target at the moment, but companies with defense contracts, federal subsidies and loans, and government contracts more generally are on the enforcement radar ...
The role, and especially the liability, of corporate directors have evolved considerably over the last few decades. Obviously, the financial scandals of the 1990s are largely responsible for this change that began in the United Stated with the enactment of the Sarbanes-Oxley Act of 200, prompting Canadian authorities to follow suit with the adoption of more stringent securities regulations ...
