Medicinal products for paediatric use This law aims to ensure that medicines for children are fully adapted to their particular needs. It lays down specific obligations on the pharmaceutical industry, accompanying these with rewards and incentives. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on products for paediatric use and amending Regulation (EEC) No 1768/92, Directives 2001/20/EC […]
Transparency of decisions regulating prices and the reimbursement of medicinal products in EU countries Directive 89/105/EEC on the transparency of measures regulating the prices of medicines for human use and their inclusion in the scope of national health insurance systems It aims to ensure that any measures taken by EU countries to set the prices of and to reimburse medicinal products are transparent. To achieve […]
EU rules on the authorisation, import and production of medicines for humans Medicines for human use must satisfy strict authorisation procedures to prove they meet high quality and safety standards. Different national provisions must also be removed to ensure they are available throughout the European Union (EU). Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code […]
Supplementary protection certificates for medicines and plant protection products Regulation (EC) No 1610/96 — supplementary protection certificate for plant protection products Regulation (EC) No 469/2009 — supplementary protection certificate for pharmaceutical products Purpose They provide additional protection for specific patented pharmaceutical and plant protection products that have been approved for sale. Amending Regulation (EU) 2019/933 introduced a manufacturing waiver to the protection given by a […]
European standardisation Regulation (EU) No 1025/2012 on European standardisation It aims to modernise and improve standardisation, which plays a leading role in the EU’s Single Market by outlining how: the EU standards-setting process operates; and the various organisations involved in this process (both at EU and national level) work together. It seeks to simplify and adapt the legislative framework to reflect the latest developments and […]
Ensuring safe personal protective equipment for users Regulation (EU) 2016/425 — safe personal protective equipment It lays down requirements for the design and manufacture of personal protective equipment* (PPE). These aim to ensure the health and safety of users and to allow the equipment to be sold and used throughout the European Union (EU). It replaces earlier legislation (Council Directive 89/686/EEC). Key Points Personal protective […]
Commercialisation of radio equipment Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC. SThis is a European Union law that sets out rules for putting radio equipment on the EU’s internal market. It is a […]
Safety of pressure vessel equipment and material Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment This European Union law lays down essential safety requirements for pressure equipment and assemblies (such as boilers, pressure cookers, fire extinguishers, heat exchangers […]
Ensuring lift safety European Union (EU) law on the sale and putting into service of lifts and safety components for lifts has two key aims: i) to allow lifts and their safety components to be sold throughout the EU market; and ii) to ensure a high level of safety for lift users and maintenance staff. Directive 2014/33/EU of the European Parliament and of the Council […]
Appliances burning gaseous fuels Regulation (EU) 2016/426 on appliances burning gaseous fuels It modifies and updates rules set out in earlier legislation (Directive 2009/142/EC). It establishes the rules for the placing on the market and putting into service of appliances burning gaseous fuels and their fittings. It provides access to the European Union (EU) market for the appliances and fittings covered as far as their […]
Equipment used in potentially explosive atmospheres (ATEX) The European Union has adopted a law on the sale and putting into service of equipment and protective systems intended for use in potentially explosive atmospheres (ATEX). Such atmospheres occur when a mixture of air, gases, vapours, mists or dusts combine in a way that can ignite under certain operating conditions. Directive 2014/34/EU of the European Parliament and […]
Construction products Regulation (EU) No 305/2011 — harmonised conditions for the marketing of construction products It aims to make the single market work better and improve the free movement of construction products* in the EU, by laying down uniform rules for the marketing of these products and by providing a common technical language to assess the performance of construction products. In this way the regulation […]
The EU’s Internal Market Information System (IMI) Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System It lays down rules on the use of the Internal Market Information (IMI) system for administrative cooperation including the processing and exchange of personal data of EU citizens between EU countries’ competent authorities and the European Commission. Key Points The IMI system is a secure […]
Mutual recognition of goods Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another EU country It aims to strengthen the internal market by improving the application of the mutual recognition principle* in the field of goods and removing unjustified barriers to trade. It does so by: defining the principle’s rights and obligations for national authorities and businesses when goods are sold […]
Rapid Intervention Mechanism Regulation (EC) No 2679/98 on the functioning of the free movement of goods among EU countries It establishes rules that help to ensure the free movement of goods and prevent physical obstacles to trade (e.g. border blockades, demonstrations/strikes, or attacks on trucks) through enabling the sharing of information on these obstacles between all European Union (EU) countries. Key Points This regulation is […]
EU approval and market surveillance measures for motor vehicles and their trailers Regulation (EU) 2018/858 — approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles The regulation sets out EU-wide rules on technical requirements and procedures to ensure that new types of motor vehicles and their trailers conform to EU-approved requirements on […]
Standards of quality and safety of organs intended for transplantation The therapeutic use of organs poses certain risks which should be limited by a judicial framework covering all stages of the process from donation to transplantation. The safety and quality of organs should be guaranteed, as should the protection of donors and recipients through the competent authorities. Directive 2010/53/EU of the European Parliament and of […]
Noise emission by equipment used outdoors The European Union is creating a single framework to control noise emitted by equipment used outdoors. Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors. [See amending acts]. Summary This framework […]
Measuring instruments This Directive ensures the free movement of measuring instruments in the internal market. It guarantees, through the use of CE marking, a high level of confidence through essential specifications which are applicable in all Member States. Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments. Summary Scope. The directive applies to the measuring instruments defined […]
Electrical equipment designed for use within certain voltage limits The rules relating to low-voltage electrical equipment in the Member States often differ, thus impeding the free movement of this of equipment. This Directive therefore aims at further harmonisation of the safety requirements with which this equipment must comply in order to move freely in the internal market. Directive 2006/95/EC of the European Parliament and of […]
Classification, packaging and labeling of chemicals and their mixtures The European Union (EU) is adapting its system for the classification of chemical substances and mixtures to the United Nations Globally Harmonised System (GHS). Under this international system, chemical substances and mixtures are classified according to their hazardous properties, and the pictogram and other notices which must appear on the label are determined. The rules introduced […]
A renewed vision for the pharmaceutical sector The pharmaceutical sector must adapt in order to take advantage of globalisation and innovations in the field of science. In this perspective, it is important to define the outlines of an effective Community framework with a view to making progress towards the single market, taking on the opportunities associated with globalisation and enabling access to medicines for European […]
The completion of the internal market by 31 December 1992 as contemplated under the Single European Act amendments to the treaties required a new method of technical harmonisation of standards. Prior to that, technical standards had been spelled out in detail, which resulted in very slow progress in the harmonisation of standards. Under the new approach, general rules were established for particular sectors or types […]
Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC. Summary The objective of this Regulation is to improve the free movement of goods in the Community. It establishes rules and procedures which should be […]
Toys There have been EU directives on safety standards for toys since the early days of the EU. Toys are products which are designed or intended, whether or not exclusively, for use by children under fourteen years of age. A list of products which may be used by children but are not considered as toys is available in Annex I of this Directive. The directives […]
The directive on machinery lays out the essential health and safety requirements relating to the design and construction of machinery placed on the market within the EU. The directive applies to the following: Machinery; Interchangeable equipment; Safety components; Chains, ropes and webbing; Removable mechanical transmission devices partly completed machinery. Before placing machinery on the market, the manufacturer must ensure that its meets the essential health […]
EU common standards medical equipment. EU directive provides for harmonisation of safety in relation to active inplantable medical devices. They may be placed on the market provided the devices meet essential criteria as set out in the directive and lawfully bear the CE Mark. They must be permitted on to the market in any state. States are to publish standards implementing the harmonised standards., equipment […]
The EU ecolabel is regulated by a 2010 Regulation. The label may be awarded to services and products which have lower environmental impact that comparable products in their group. The criteria are based on scientific data referable to the whole of the product’s life, from product development to disposal. The label may be awarded to goods and services distributed, consumed and used through the EU […]
An EU directive from 2009 provides for eco-design requirements for energy-related products. It does not apply to vehicles for persons or goods. Eco-design parameters relate to different stages of the product lifecycle including raw material selection and use, manufacture, package, transport and distribution, installation and maintenance, use, end of life. In each phase the following aspects of the product must be assessed. Predicted consumption of […]
À 2007 directive provides the deregulation of pack size at both EU and national levels. The purpose is to give greater flexibility to consumer product industries. It covers foodstuffs and also other packaged products. Provisions prescribing mandatory nominal quantities for pre-packaged goods are prohibited. States in which mandatory nominal quantities are prescribed for butter, milk, dried pasture and coffee were entitled to retain the restrictions […]
Cosmetics. EU legislation on cosmetics dates back almost 50 years. Cosmetic products are substances intended to be placed in contact with various external parts of the human body or with teeth and the mucus membrane of the oral cavity, with a view exclusively or mainly to cleansing, perfuming, change in their appearance or correcting body odours and/or protecting them or keeping them in good condition. […]
EU directives on packaging and labelling of dangerous substances date back over 50 years. Under the first directive substances means chemical elements and their compounds in their natural state or as produced in industry. Preparations mean mixtures or solutions of substances. Dangerous substances are classified in categories, defined in the directive according to the degree of hazard and risk and the nature of the risks. […]
EU directive applies to the labeling of materials in footwear including parts sold separately. Footwear must bear certain information. At least one of the footwear item must bear the information relating to the upper lining and in sole sock measure of footwear article. The information must be conveyed by way of certain pictograms or text set out in the directive. It must relate to the […]