On July 25, 2016, China Food and Drug Administration (“CFDA”) published the latest "Measures for the Administration of Drug Registration (revised draft)” (“Latest Revised Draft”) for public comments1 ...
On June 25th, 2016, Law No. 20,930 that establishes the environmental conservation right was published in the Official Gazzette. The purpose of this law is to create a mechanism to simplify and promote the participation of private parties in the conservation of the environment, as a complement to the work done by the State in these matters. This right has its origin in Comparative Law ...
The Health Care Arbitral Tribunal (Arbitral Tribunal) has pronounced a decision on a dispute between an independent medical specialist and a Medical Specialist Company (MSC) for the first time since the introduction of the comprehensive rates on 1 January 2015. Although neither party has terminated the existing (membership) agreement between them, the Arbitral Tribunal is of the opinion that termination of membership and deregistration of the specialist from the members' register are justified ...
The Environmental Evaluation Service (SEIA) has published the “Guide for Determination of the Ecological Flow for Hydropower Plants”.The objective of the Guide is to establish uniform criteria for determining the environmental flow regime in hydropower plant projects that are evaluated by the SEIA. The Guide incorporates the use of hydrological criteria, valuation of ecosystem services and anthropic uses, while also taking into account the particular project’s specific characteristics ...
On May 10, 2016, the Québec Court of Appeal1 confirmed a Superior Court decision allowing an application for authorization of treatment and placement to a patient. The application had been brought by the Douglas Mental Health University Institute, commonly known as the Douglas, or the Douglas hospital ...
In a unanimous decision rendered on May 16, 2016,1 the Québec Court of Appeal confirmed that the delivery of ophthalmic lenses purchased online from suppliers who are not members of the Ordre des optométristes (Order of Optometrists) (?Order?), or the Ordre des opticiens d?ordonnances (Order of Dispensing Opticians), does not violate the Optometry Act 2(?OA?) or, by necessary extension, the Dispensing Opticians Act ...
Article 81 of the Food Safety Law of the PRC (the “Food Safety Law”), revised in 2015, stipulates that the product formulas for infant formula milk powder shall be registered with the food and drug administration under the State Council ...
1. What Is the Size of the Market and What Are Current Trends in Switzerland? Life Sciences is one of the most dynamic and most rapidly growing sectors in Switzerland with respect to both the industrial and the academic dimension. In 2013, the total financing volume amassed by Swiss biotech companies more than doubled compared to the previous year’s figure, reaching USD 325 million, which amounts to an increase of 112% ...
Recently the “guideline for the supervision and regulation of the nutritional composition of foodstuff and its advertisement (“the guideline”) was published by the Undersecretary of Health.The guideline´s main objective is to, “guide the process of supervision and regulation of foodstuff”, taking into consideration the upcoming implementation of Decree No. 13 (June 27, 2016), which modifies the Health Regulations for Food Products ...
Today, Wednesday, June 1st, the Framework Law for the Management of Waste, Extended Liability of the Producer and Promotion of Recycling No. 20,920 (the “Law”) was published.PurposeThe Law seeks to reduce the generation of waste and encourage its reuse, recycling and other types of recovery ...
Today, Wednesday, June 1st, the Framework Law for the Management of Waste, Extended Liability of the Producer and Promotion of Recycling No. 20,920 (the “Law”) was published.PurposeThe Law seeks to reduce the generation of waste and encourage its reuse, recycling and other types of recovery ...
As the overall level of convergence between industries in the business world keeps increasing, it is only logical for the related legal aspects to follow suit every step of the way ...
On May 12th, EPA issued two rules that will significantly impact the oil and gas industry nationally. The first rule, an outgrowth of the President’s Climate Action Plan, establishes new source performance standards (“NSPS”) to curb emissions of methane, as well as volatile organic compounds (“VOCs”), from new natural gas and oil well sites and from new natural gas production gathering and boosting stations, processing plants, and transmission compressor stations ...
The Climate Action and Low Carbon Development Act 2015 (the Act) was signed into law on 10 December 2015. The Act comprises of a framework designed to achieve a low carbon, climate resilient, and environmentally sustainable economy by 2050. The Act provides for two statutory plans which will guide policy in relation to greenhouse gas emission reduction and climate change adaption. The plans are: 1) National Mitigation Plan; and 2) National Adaption Framework (NAF) ...
1 Which legislation sets out the regulatory framework for the marketing, authorisation and pricing of pharmaceutical products, including generic drugs? Which bodies are entrusted with enforcing these rules? The relevant legislation includes the following: • Law on Medicines 1996;
On April 19, 2016 Association of European Business (hereinafter – “AEB”) and the Russian Federal Antimonopoly Service (hereinafter – the “FAS”) presented the Code of Good Practice in the Pharmaceuticals Industry (hereinafter – the “Code”). The full text of the Code (both in Russian and English) is available at the official web-site of the antimonopoly authority (http://fas.gov.ru/documents/documentdetails.html?id=14513). Below is short outline of the Code. 1 ...
On April 18, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued revised guidance regarding exclusions imposed under section 1128(b)(7) of the Social Security Act ...
Responding to a Supreme Court mandate, the Environmental Protection Agency (“EPA” or “the Agency”) yesterday published a final supplemental finding that it is necessary and appropriate to regulate hazardous air pollutants emitted from coal- and oil-fired power plants under Section 112 of the Clean Air Act. 81 Fed. Reg. 24,420.Read the full alert ...
Entities that file disclosures with the Securities and Exchange Commission (“SEC”) should be aware of recent actions by regulators and shareholders questioning the sufficiency of opinion statements made in environmental-related disclosures. Most recently, on March 31, 2016, the SEC announced a settlement with Navistar International Corp ...
Important notification of four new guidelines for the compilation of mandatory codes of practice, which are binding in terms of the Mine Health and Safety Act 29 of 1996 (“the MHSA”).Kindly take note that on Friday, 5 February 2016, notices were published in Government Gazette No ...
The FDA’s Proposals on the Revision of the Nutrition and Supplement Facts Labels In early 2014, first lady Michelle Obama announced upcoming changes to the FDA’s Nutrition Facts label, and in March 2014, the FDA issued a proposed rule on the revision of Nutrition and Supplement Facts labels “to assist consumers in maintaining healthy dietary practices ...
On January 4th, 2016, the President of the Republic introduced a series of amendments to the bill of law that, “modifies the Health Code in order to regulate generic bioequivalent pharmaceutical products and prevent the vertical integration of pharmaceutical laboratories and pharmacies”, – Bill No. 9914-11- (“Pharmaceutical Bill II”) ...
Increased deal activity is likely in Australia's health and aged care sector in 2016, driven by:• investment interest from China• Australian players targeting outbound opportunities through joint ventures and partnerships; and• consolidation in the aged and home care services areas.Rapidly ageing populations across our region are driving demand for high quality health care, especially in countries such as China and Japan ...
Are you ready to disclose? All Transfers of Value (ToV) from 2015 must be disclosed publicly via the Irish Pharmaceutical Healthcare Association (IPHA) central reporting system by 1 July 2016. This relates to all ToVs that were made by pharmaceutical companies to Healthcare Providers (HCPs) and Healthcare Organisations (HCOs) in connection with the development and sale of prescription only medicinal products for human use ...
The High Court has delivered judgment in the case of Minch v The Commissioner of Environmental Information (CEI) (16 February 2016) concerning the scope of access to environmental information ...
