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The presence of the logo on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA); goods sold elsewhere may also carry the mark.
The Dangerous Substances Directive was one of the main European Union laws concerning chemical safety, until its full replacement by the new regulation CLP Regulation (2008), starting in 2016. It was made under Article 100 of the Treaty of Rome. By agreement, it is also applicable in the EEA, and compliance with the directive will ensure compliance with the relevant Swiss laws. The Directive ceased to be in force on 31 May 2015 and was repealed by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
In the European Economic Area, a supplementary protection certificate (SPC) is a sui generis intellectual property (IP) right that extends the duration of certain rights associated with a patent. It enters into force after expiry of a patent upon which it is based. This type of right is available for various regulated, biologically active agents, namely human or veterinary medicaments and plant protection products. Supplementary protection certificates were introduced to encourage innovation by compensating for the long time needed to obtain regulatory approval of these products.
The Undertakings for Collective Investment in Transferable Securities Directive (UCITS) 2009/65/EC is a consolidated EU directive that allows collective investment schemes to operate freely throughout the EU on the basis of a single authorisation from one member state. EU member states are entitled to have additional regulatory requirements for the benefit of investors.
The European Pharmacopoeia is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. It is a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use.
Government procurement or public procurement is undertaken by the public authorities of the European Union (EU) and its member states in order to award contracts for public works and for the purchase of goods and services in accordance with principles derived from the Treaties of the European Union. Such procurement represents 13.6% of EU GDP as of March 2023, and has been the subject of increasing European regulation since the 1970s because of its importance to the European single market.
EudraLex is the collection of rules and regulations governing medicinal products in the European Union.
Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Union sought to bring the benefits of innovative pharmaceuticals to patients across Europe by introducing the mutual recognition, by Member States, of their respective national marketing authorisations.
Directive 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Union sought to bring the benefits of innovative pharmaceuticals to patients across Europe by introducing the mutual recognition, by Member States, of their respective national marketing authorisations.
Council of the European Communities Directive 93/41/EEC of 14 June 1993 repealed Directive 87/22/EEC on the approximation of national measures relating to the marketing of high-technology medicinal products, as this directive had been superseded by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (5) and by Council Directive 88/182/EEC of 22 March 1988 amending Directive 83/189/EEC laying down a procedure for the provision of information in the field of technical standards and regulations (6).
The Clinical Trials Directive is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonise the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.
The Good Clinical Practice Directive lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
The European Directive on Traditional Herbal Medicinal Products (THMPD), formally the Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, was established by the European Parliament and Council on 31 March 2004 to provide a simplified regulatory approval process for traditional herbal medicines in the European Union (EU). Previously, there was no formal EU wide authorisation procedure, so each EU member state regulated these types of products at the national level.
As of 2009, the European Union had issued two units of measurement directives. In 1971, it issued Directive 71/354/EEC, which required EU member states to standardise on the International System of Units (SI) rather than use a variety of CGS and MKS units then in use. The second, which replaced the first, was Directive 80/181/EEC, enacted in 1979 and later amended several times, which issued a number of derogations to the United Kingdom and Ireland based on the former directive.
The CLP Regulation is a European Union regulation from 2008, which aligns the European Union system of classification, labelling and packaging of chemical substances and mixtures to the Globally Harmonised System (GHS). It is expected to facilitate global trade and the harmonised communication of hazard information of chemicals and to promote regulatory efficiency. It complements the 2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation and replaces an older system contained in the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC).
The Dangerous Preparations Directive was a European Union directive in the field of occupational safety and health and consumer protection that came into force in 30 July 1999. It complemented the Dangerous Substances Directive (67/548/EEC) and replaced a previous Dangerous Preparations Directive (88/379/EEC). The European Court of Justice had ruled in 1985 that Dangerous Substances Directive (67/548/EEC) applies only to pure substances, not preparations. It was repealed on 1 June 2015, as part of the European Union's adoption of Globally Harmonized System of Classification and Labelling of Chemicals, as part of CLP Regulation.
European hazard symbols for chemicals are pictograms defined by the European Union for labelling chemical packaging and containers. They are standardised currently by the CLP/GHS classification.
European company law is the part of European Union law which concerns the formation, operation and insolvency of companies in the European Union. The EU creates minimum standards for companies throughout the EU, and has its own corporate forms. All member states continue to operate separate companies acts, which are amended from time to time to comply with EU Directives and Regulations. There is, however, also the option of businesses to incorporate as a Societas Europaea (SE), which allows a company to operate across all member states.
References
- ↑ "EUR-Lex - 32001L0083 - EN". Official Journal L 311. 28 November 2001. pp. 67–128. Archived from the original on 25 January 2022. Retrieved 2022-02-26.