European Economic Area countries

The current CP application fee is 232,000 Euros for a single strength associated with one pharmaceutical form. Although the fees are high and the Committee on Human Medicinal Products review is extremely thorough, if successful the centralized procedure leads to an authorization that is valid in all European Economic Area countries, and for this reason is attractive to companies that have a presence in only one or a few European countries. 

In this chapter, the regulatory requirements relating to data on development pharmaceutics and process validation will be discussed. The discussion will be limited to Marketing Authorization Applications (MAAs) for the European Economic Area and many central and eastern European countries. 

The Management Board is made up of two repre-sentativesfrom each member state, from the European Parliament and from the European Commission. Representatives of Iceland and Norway, who are members of the European Economic Area (EEA) but not of the EU, also attend meetings of the Board. As of January 1, 2000, these countries formally joined the EMEA. The Management Board appoints the Executive Director, and approves the budget and work... 

Directives are issued by the European Commission and the Council, and are binding as to their objectives and results. MS are obligated to transpose Directives into national law, with prescribed timelines for doing so. In the case of medicines regulation, this happens not only in the 25 countries of the EU but also, on a voluntary basis, in the additional countries of the European economic area (EEA) (Norway, Liechtenstein and Iceland) and even, to some extent, in Switzerland. 

The Directive covers all current 15 EU Member States (MS) and European Economic Area (EEA) members (Norway, Iceland, and Liechtenstein) i.e., 18 countries populated by 382 million citizens and coincidentally by the deadline date of May 1, 2004, will be joined by a further 10 new members of close to 75 million persons bringing the total to about 457 million citizens (5). This is already by far the largest pharmaceutical market in the world by population and this position will by 2004 be further consolidated. 

The Strategy has been prepared with the help of an extensive consultation process from 2002 to 2004, which included all EU Member States, candidate countries, the European Parliament, European Economic Area (EEA) States (Norway and Iceland),... 

New chemical notification schemes vary considerably between countries, but many base the studies for full notification on the OECD minimum pre-maiketing set of data (MPD) the EC, certain EFTA countries, Australia and the imminent Canadian scheme (See Table 34.1). Only a few studies additional to the EC Base Set are needed fw full notification in Austria and Switzerland. Chemical control legislation in Scandinavia is in the iwocess of being changed, in order to achieve the intended harmonization by 1 January 1995 of chemical control legislation between the EC and 6 of the EFTA countries under the new European Economic Area (EEA). The EC notification scheme will have been updated by then, under the Seventh Amendment Council Directive 92/32/EEC [12], which was brought into force by 31 October 1993. Thus the current Finnish new chemicals notification scheme will be modified to confoim exactly to that of Council Directive 92 2/EEC as from 31 October 1993, and the proposed notification schemes for Norway and Sweden will also have to be in harmony with the EC. 

The Declaration of Helsinki has considerable influence in the field of ethics in biomedical research and forms the basis of GCP and subsequent legislation in European Economic Area (EEA) countries. The latest EU GCP Directive (2005/28/EC) has specified the use of the 1996 version of the Declaration. 

The CE mark (Fig. 13.2) is not a quality mark, but an indication given by the manufacturer or importer that the product or system meets the legal safety requirements of the European Commission and can therefore be presumed safe to use. The mark is applied by the manufacturer after carrying out the appropriate tests to ensure compliance with the relevant safety standards. The CE mark gives the manufacturer the right to sell the product in all the countries of the European Economic Area. All electrical products used by electrical contractors after 1 January 1997 must bear the CE mark. 

Only gloves with CE markings should be used at work, at least in the countries of the European Union. Since July 1, 1995, only PPE with CE (European Community conformity) markings can be distributed inside the European Economic Area. This mark guarantees that the product fiilfills the essential requirements of directive 89/686/EEC. It also implies that all PPE (categories II-III), except those which are meant against minimal risk only (category I) must be type examined by a notified body before the CE mark can be affixed on the PPE. The Department of Physics at the FIOH is such a notified body. The user of the PPE is also entitled to receive information about the PPE, its classification as a PPE, and about the tests it... 

A prescription is a request from a prescriber (usually a doctor) to a pharmacist to dispense a medicine in the stated amount, strength and method of use. Each country has its own medicines law which will define the exact requirements of a prescription. However, there is a standard data set used with the European Economic Area (European Union plus Lichtenstein, Norway and Switzerland) as given in Table 2.1. 

In 1994 the European Union Member States and the countries of the European Free Trade Association (EFTA) (except Switzerland) joined to become the European Economic Area (EEA). 

Eighth Data Protection Principle. Personal data shall not be transferred to a country or territory outside the European Economic Area unless that country or territory ensures an adequate level of protection for the rights and freedoms of data subjects in relation to the processing of personal data. 

With regard to the common European market, the European Economic Community (EEC) has undertaken numerous activities concerned with materials and material information systems. In one demonstration program for material databases eleven such databases from various countries in the EEC are being cooperatively developed with joint standards for terminology, data presentation, database access, and the user interface of search commands, aids, and menus. For the materials class of plastics, Polymat was selected to participate in this cooperative work. Interesting developments occur from which the users of central material databases in the entire EEC area can benefit. 

Artiges, A. Quality and Safety of Plasma Products Control Authority Batch Release Within the Countries of the European Union and Economic Area, Proceedings of EPFA-EAPPI, Sep 29-30, 1998, 108-110. 

The formulation of water quality standards is an extremely sensitive area of pollution control. It is one in which there is a tendency for political decisions to hold almost as much weight as scientific judgements. The approach to standard setting varies from one country to another and this has led to innumerable problems, particularly when international co-operation is required. This is well illustrated by the years of argument and discussion which have arisen in an attempt to reach agreement over the European Economic Communities (EEC) Dangerous Substances Directive and the Directive on Quality of Water for Human Consumption. 

Clay materials used in the brick industries are currently monitored to control air and groundwater pollution. Some areas suffer from severe pollution by emission of fluorine to the atmosphere and its subsequent transport into the groundwater since clay may contain 200 to 1200 mg kg of F. As an example, the brick and ceramic industry is responsible for 50 /o of the total fluoride emission in The Netherlands. The emissions are calculated from the difference in the F content of the clay and the final product (brick). In some cases, raw materials are rejected if the fluoride contents are too high which cause an economic concern. As a consequence, many European countries have implemented regulations for the maximum authorised amount in gaseous emission of F from brick industries, which strongly stresses the need for the control of the quality of measurements using representative CRMs. 

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