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The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
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 The Directive ceased to be in force on 31 May 2015 and was repealed by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and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 European emission standards are vehicle emission standards for exhaust emissions of new vehicles sold in the European Union and EEA member states and the UK. The standards are defined in a series of European Union directives staging the progressive introduction of increasingly stringent standards. Details of Euro 7, the final standard, will be announced in 2022 and probably come into force in 2025. The details of Euro 7 are likely to be influenced by European Green Deal targets to reduce carbon dioxide emissions.
The European Community number is a unique seven-digit identifier that was assigned to substances for regulatory purposes within the European Union by the European Commission. The EC Inventory comprises three individual inventories, EINECS, ELINCS and the NLP list.
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
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.
Directive 65/65/EEC1 was the first European pharmaceutical directive.
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.
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 the current system contained in the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC).
The European Union value-added tax is a value added tax on goods and services within the European Union (EU). The EU's institutions do not collect the tax, but EU member states are each required to adopt a value added tax that complies with the EU VAT code. Different rates of VAT apply in different EU member states, ranging from 17% in Luxembourg to 27% in Hungary. The total VAT collected by member states is used as part of the calculation to determine what each state contributes to the EU's budget.
Council Implementing Regulation (EU) No. 282/2011 was adopted by the Council of the European Union on 15 March 2011. This was mainly because the terms and wording of Directive 2006/112/EC have been inconclusive in some cases. The Regulation provided new implementing measures for the VAT Directive. Especially due to the amendment of the VAT Directive itself and the consistent case-law of the European Court of Justice, the former Implementing Regulation (EC) No. 1777/2005 had to be recast and clarified in certain aspects. This Implementing Regulation became effective on 1 July 2011 and does not have to be transported into national legislation of the individual member states of the European Union and thus is directly applicable.
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.