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Consumer Goods/Pharmaceutical/Medical Sectors/e-Health

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MR-180 Health IT / eHealth in Europe

Summary
This report provides a snapshot of the European market for Health IT (HIT) and provides links to country specific reports on health IT.  The report reflects ample market opportunities, market data, demand, prospects as well as regulatory requirements, for U.S. HIT companies in the European market.  HIT in the context of this report embraces a broad scope of related terminology and subsectors such as eHealth, mHealth, Electronic Medical/Health Records (EMRs/EHRs), telemedicine, telecare, remote patient monitoring/care, connected health, digital health, health 2.0, welfare technology, health telematics etc.

MR-162 / EU Regulations on Food Supplements, Health Food, Herbal Medicines

Summary
The European Union has taken steps to harmonize the regulation of nutritional supplements, health foods and herbal medicines across the EU. Though some diverging regulations amongst Member States result in challenges for companies in the sector, the harmonization of EU rules overall provides an opportunity for US exporters entering the single market of 27 EU member states. This report provides an overview of the various pieces of legislation in this sector.

MR-153 / Exporting Textiles and Textile Products to the European Union - Frequently Asked Questions

Summary
This IMI answers the main questions faced by U.S. companies exporting textile and textile products to the EU. It covers issues such as the abolition of quotas in 2005, the effect of enlargement of the EU on the textile sector and provides a general overview of the documents required by exporters. It also examines the use of labeling in the EU as well as looking at other EU legislation which has a direct effect on the U.S. textile industry.

MR-136 / Authorization and Registration of Pharmaceuticals

Summary
Competencies in the pharmaceutical sector are shared between the Commission and Member States. Due to national budget responsibilities, two key issues, namely pricing and reimbursement levels, remain entirely with the Member States and can vary considerably. European Union-wide pharmaceutical legislation focuses on some aspects of marketing (e.g. packaging, labeling, and advertising), safety (e.g. pharmacovigilance inspections, Good Manufacturing Practices, and good clinical practices), transparency, and authorization procedures.

This report provides both an update on EU legislation of the sector and discusses an overview of issues affecting it, including the regulatory framework, EU enlargement, and competitiveness issues.

MR-125 / The EU's Globally Harmonized System of the Classification & Labeling of Chemicals

Summary
For companies involved in global trade, complying with different labeling requirements can be expensive, tricky, and often inefficient.

To address this problem, the United Nations adopted the “Globally Harmonised System of Classification and Labelling of Chemicals” (GHS) as a non-binding resolution. Recently, the European Commission proposed to implement the United Nation’s GHS system into law.

The Commission aims to time the GHS's entry into force as closely as possible to REACH to allow consistency of transitional arrangements of GHS and REACH. 

Our latest Market Research Report explains the European Union's Globally Harmonised System and provides advice on how companies can comply with the GHS's requirements.

MR-117 / E-commerce with the EU

Summary
This report will address the range of regulatory issues that should be taken into account by US companies wanting to do business with EU customers over the Internet. It consists of a series of paragraphs addressing various aspects of EU law that affects e-commerce. Please note that of necessity, this report is a high-level summary. In all cases, links are provided to Web addresses that provide more complete information. The summary below is intended as an aid only.

E-commerce is one of the most lightly regulated areas of the EU economy. The legal framework is relatively consistent across the EU; as a result, it should be a major motor of transatlantic trade.

MR-112 / EU Rules on Nutrition and Health Claims

Summary
In December 2006, the Council and the European Parliament adopted Regulation 1924/2006 on nutrition and health claims made on foods (published in Official Journal L 12 of January 18, 2007). This regulation goes into effect as of July 1, 2007 and sets EU-wide conditions for the use of nutrition claims such as "low fat" and health claims such as "helps lower cholesterol." The claims a food product can or cannot make will be based on nutrient profiles, i.e. appropriate ratios of salt, fat and sugar. These profiles will be developed within two years of the regulation entering into force, based on an opinion of the European Food Safety Authority (EFSA). The regulation is considered an important tool in the EU’s strategy to fight obesity.

MR-106 / EU Packaging and Packaging Waste Directives

Summary
Directives 94/62/EC and 2004/12/EC harmonize EU Member States national measures regarding the design of packaging and the management of packaging waste. Their aim is to prevent and reduce the environmental impact of packaging. The directives contain provisions on the prevention, re-use of packaging and on the recovery and recycling of packaging waste. The directives cover all types of packaging (household, industrial and commercial), regardless of the packaging material used (paper, board, glass, plastic and metals).

MR-105/An Introduction to EU Medical Devices Legislation

Summary
As the European Union (EU) does not have a Food and Drugs Administration (FDA), the task of harmonizing and regulating medical devices is handled by the European Commission in close cooperation with member state health authorities.

 The purpose of the EU harmonization effort is to merge the differing national requirements into one law which can be applied throughout the European Union.

 Legislation adopted through this process covers implantable, non-implantable and in vitro diagnostics medical devices in three separate directives that provide manufacturers the basics to certify their compliance with EU-wide safety requirements.

 MR-87 / EU Franchising

Summary
This report covers the EC Directives that relate to Franchisors entering the market, namely, the exemptions to the EU’s general anti-trust law, the European Franchising Federation (EFF) and their ‘Code of Ethics’ that covers IPR protection and the relevant contacts for the individual Member State Franchising organizations. 

MR-82 / EU Food Contact Plastics

Summary
European Union (EU) legislation of materials and articles intended to come into contact with foodstuffs affects a broad number of products and packaging materials. Guidance for these materials was originally set out with the framework regulation of Council Directive 89/109/EEC on 21 December 1988, but has since been replaced by the 2004 Regulation 1935/2004/EC. The scope of the Directive included a wide range of items from ceramics to metals. Within this Framework Directive, a number of material-specific Directives were added to address issues unique to each material. In regard to plastics alone, there are at least five pieces of legislation regulating contact of other materials with foodstuffs.

To cut through the present system’s complexity, the Commission is currently drafting a single directive, a so-called plastics “Super Directive,” to address and consolidate all aspects of food contact legislation. In addition to replacing the Plastics Directive, the Super Directive will introduce a number of new elements. Among these are multilayer materials, a functional barrier concept, reinforced compliance procedures and imposed record keeping, as well as a “fat reduction factor” (FRF). The Commission intends to finalize the Super Directive by 2006 and put into force by 2007.

MR-76 / EU Pet Food Regulations

Summary
All pet food imported from the U.S. into the European Union has to meet EU requirements, relating mainly to health and labeling aspects. These requirements are generally harmonized throughout the 25 EU Member States but they are scattered over different pieces of EU legislation. A number of these requirements are likely to change in the near future as several legislative proposals are under discussion. This document is intended to provide a comprehensive guide on existing EU legislation and to provide an overview of proposals/issues that are currently debated and which may affect your future exports. 

MR-68 / The EU Eco-label

Summary
The European eco-label distinguishes environmentally friendly products and services. It is a voluntary scheme. Its symbol is a green flower. The flower can be found throughout the EU and Norway, Liechtenstein, and Iceland. The aim of the eco-label scheme is to encourage manufacturers to design products that have a reduced environmental impact throughout their life cycle, from manufacturing to disposal. It also aims to provide consumers with better information on the environmental performance of products and encourage them to buy green products.

 MR-55 / Traceability of Foodstuffs

Summary
Traceability of foodstuffs has become a priority for European consumers and Regulators in the last few years. EU Legislation has now totally integrated traceability requirements in its general framework. These requirements are mandatory for all European food operators since January 1, 2005.

 MR-24 / CE Marking of In Vitro Diagnostic Devices

Summary
This report advises U.S. industry of a new requirement to CE mark in vitro diagnostics (IVD) exported to the European Union and European Economic Area. The safety mark is mandatory as of December 8, 2003.