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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 28 EU member states. This report provides an overview of the various pieces of legislation in this sector.
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.
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-117 / E-commerce with the EU
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.
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.