Chapter 1
1.1 CE Marking The vast majority of the products that are engaged in commerce inside the European Economic Area (EEA) share a common characteristic, the conformity marking CE. The CE marking (which is the abbreviation of the French phrase (‘Conformité Européenne - European Conformity) indicates that the product baring it was designed, produced and inspected in a way that meets the requirements set by the European Union (EU) legislation . The CE mark has very strict image rules and it is placed on a visible place preferably on the product, and where this is not feasible on its packaging, manuals or other supporting documents.
Directive EEC/90/385, ANNEX 9
CE CONFORMITY MARKING
‘— The CE conformity marking shall consist of the
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The CE marking is proof that the manufacturer produces and merchandises the product in compliance with the EU legislation, and implies that he takes responsibility for the conformity of the product. Therefore it is the manufacturer’s duty to place the sign. The visual of the mark is specifically described in the EU law and must be affixed in a visibly way preferably on the product. Only the products that are required by the community’s harmonisation legislation should bare the mark, which should avert the affixing of other markings that can foment the functions of the CE marking .
1.2 The legal regime of notified bodies
1.2.1 The designation procedure The conformity assessment of the goods baring the CE marking can only be effective in a transnational level between the member states of the EU and EEA. Under the scope of the relevant EU Regulations and Directives each member-state, or any other state that has concluded a Mutual Recognition Agreement (MRAs) and Protocols to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products (PECAs), can delegate competent Authorities (notifying authorities ) with the duty to designate notified bodies, and further on be notified by the European Commission . For example in the UK the Medicines and Healthcare products Regulation Agency (MHRA) is the designating authority for NBs
Practitioners should check for Kitemarks and CE markings. Kitemarks are symbols that show products have been tested and meet the British Standard Institute requirements. CE markings show that products meet European standards as set out by the European Community.
Since 1996, the European Union's Trademark Regulation has allowed a single trademark registration enforceable in all members of the European Union.
The list also includes standards for different but related topics (like Information Security) when BCM is included only as a minor requirement for compliance. Standards that are issued by 3rd parties or professional groups will only be included if they are ratified by an accredited national standards body or accredited directly by a national accreditation service affiliated to the International Accreditation Forum (IAF).
When buying equipment I must always look for safety standard logos, such as the British Standards Institute, the European Union CE Mark or the Lion Mark.
According to the CE marking directives, every manufacturer or duly authorized representative of the manufacturer, based in any European country, is obligated to draw up a Declaration of Conformity. This is in compliance with the conformity assessment procedure. This declaration must be issued prior to the placement of products on the market in Europe.
Why does the European commission get involved with introducing such measures? For the most part it’s to protect certain aspects of the industry like personalised medicine. Personalised medicine or targeted therapy can be described as medical exemplary using molecular caricature technologies to tailor the right curative design for the right individual at the right time. (European Commission, 2010) There may be some challenges that face the current European pharmaceutical regulatory system that are likely to arise from development of anti-sense oligonucleotides for example, (Johnston et al. 2014) will companies be able to fund proper research into clinical trials in order to customize anti-sense oligonucleotides for boys suffering from Duchenne
The Trading Standards Institute enforces consumer related legislation as determined by central government. The variety of this legislation is vast and is always evolving. In view of this changing environment, the Trading Standards Institute is dedicated to engaging with central government and other proposals, displayed in their responses to the various consultations that concern consumer protection issues and/or the Trading Standards profession. (TSI 2010)
The euro zone which is officially called the "euro area" consists of 17 countries. In other words, it consists of countries which are also part of the European Union. The European Union consists of approximately 27 member states. For a country to be a member of the euro zone it is necessary for it to be a member of the European Union. A single currency was introduced as a result of European union reforms and the currency was named as the "Euro". Those countries which adopted the Euro as their currency by giving up their local currencies became the member states of the Euro Zones. These countries include: Austria, Belgium, Estonia, Cyprus, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, the Netherlands, Portugal, Slovakia, Slovenia, and Spain.
To address the question as to how financially interlinked is Europe is to ask the extent to which what happens in one European country has a financial effect on another European country. Through this essay GDP will be used as the primary measure of the strength of an economy. Some may argue that this is not the sole measure: there are many other factors, which come into the strength of an economy such as unemployment, government spending and consumption. Furthermore the statistics surrounding GDP may themselves be inaccurate and hold distortions since it doesn’t take into account distribution of income and hidden economies such as the black market. However, it is easiest to look primarily at GDP and seek to examine the extent to which European economies’ GDP move in harness. This essay will also look at the reasons behind similarities and differences in individual European GDP movements and the efforts of European authorities to encourage Europe to be more financially interlinked.
Since the inception of the European Union, it has been plagued with numerous problems and currently it is facing in of the biggest problems right after dealing with an economy in recession to a point where Greece had to be bailed out. There is unrest like none other among the European Union member countries to withdrawing from the union led by the United Kingdom. This is in the wake of eastern European being buried in civil war as is the case with Ukraine and the war threatening to spill over to Poland. Its unending war with Russia is leading to the unrest worsening. The United Kingdom as the main driver of the European Union policy driver has been meddling in the affairs of Russia and Ukraine leading to Russia threatening to cut off its oil supply to Europe as it is the main producers and supply of oil to Europe.
In the aftermath of the 1957 Treaty , the European Economic Community (EEC) was established and customs barriers between the member states have been abolished. Member States throughout the Community, can “promote a harmonious development of economic activities, a continuous and balanced expansion, an increased stability, an accelerated raising of the standard of living and closer relations between them”. Therefore, in order for a common market to be established between Member States, the Community enacted some legislative provisions which aimed to a true harmonization of laws; incorporate different legal systems under a basic legal framework. The main issue arising is whether these legal provisions in accordance with the case law, ensured the free movement of goods within this market.
The authors Weedle and Clarke (2011); Appelbe et al. (2013) have synopsised the criteria which must be met in order to be eligible for the EU route of registration with regards the directive 2005/85/EC to practice in the ROI and subsequently the UK. Firstly the applicant must be a citizen of a member state within the EU/EEA. The applicant must then provide evidence of their qualification in pharmacy. The education/training prerequisites are outlined in Article 44 of the EU directive (Directive 2005/85/EC). If the criterion there is met then automatic recognition is permitted. Alternatively one must demonstrate a minimum of three uninterrupted years of the past five years in a regulated pharmaceutical discipline/area as mentioned in Article 45. This form of entry is as a result of acquired rights provision. This is for those who cannot comply with the above mentioned training requisite. This maybe as a result of the applicant possessing the qualification in pharmacy in a
The European Union (EU) is composed of twenty- eight European countries. Since its inception in the early 1990’s, the EU has moved major European countries towards economic cooperation. Lately, the fundamental and economical disparity of some of these countries, specifically Germany and France has caused dissent within the Union. The debate over fiscal policy, in particular, austerity implementation has left the two European powerhouses at odds on the best possible way to regain regional stability. This paper will seek to shed light on as to why these two countries have such differing views of austerity and to describe the issues that arise due to them.
To become “the most competitive and knowledge based economy by 2010” was the aim of the Lisbon Agenda set in the year 2000; an economic strategy designed to be implemented across Europe in order to address the challenges posed by an increasing globalised and evolving economy. (Rodrigues, 2009) It was launched as an intention to find a solution to the European Union’s stagnating growth rate which had been ‘structurally lower than that of its main economic partners’ particularly when in comparison to the United States through a set of new policy initiatives. (European Commission, 2010) The ambitious ten year reform programme included aims which targeted promoting the integration of social and economic policy, completing the internal market
With the effect of the Single European Act on 1st July 1987, the emergence of European Union (EU) as a common market has essentially been created. The benefits of this act are substantial to European firms, economies, and workers. It eliminates conflicting national regulations and trade barriers, as well as offering firms opportunity to sell their goods to all other EU members (Griffin & Pustay 2005).