European approval procedures

Information regarding each of the products approved through the centralised procedure (European PubUc Assessment Report - EPAR) http //www.emea.eu. int/htms/human/epar/epar.htm... 

The main intense sweeteners currently permitted for use in the major markets of Europe and the United States are not natural and have had to go through a food additive approval procedure. Within the European Union, approval is controlled by the EU Commission, with the aim of achieving harmonisation across member states. The current system allows for temporary national approval (and this was the mechanism by which sucralose was approved in the United Kingdom). This in turn allows the other EU countries time to review the data and either approve or reject each product within a specified period. Within the European Union, approved sweeteners are assigned an E number and can also be assigned a maximum use level within a specific application (e.g. soft drinks). The maximum use levels for sweeteners in soft drinks in the European Union are given in Table 4.2. 

Ainsworth MA. New drags and European procedures of approval. The European Agency for Evaluation of Medicinal Products role. Ugeskr Laeger 2003 165 1648-9. 

The CP is the only EU approval procedure where a communication with the competent authority is requested before filing. Even though many national agencies are open for early advisory meetings, i.e., so-called scientific advice procedures, these are all voluntarily. Only for the CP has one to contact the European agency (EMEA) in advance. 

One thing we can mention here is the completely different legal frameworks of the American and European regulatory systems. For example, options, such as that open to the US approval authority, of suspending the application of stringent exhaust gas standards either in general terms of in respect of individual manufacturers, or, as in the case of the commercial-vehicle exhaust gas standards now proposed of permitting manufacturers to "offset these is not provided for either in the EEC s type approval procedure or in those of the individual Member States. 

Since this period and especially over the past 15 years, legislation on the placing of chemical plant protection products on the market has been continuously developing to cope with European regulations. Directive No. 91/414/CEE of July 15 1991 [4], later transcribed into French law, defines the guidelines of the market approval procedure for chemical plant protection products. The provisions related to the effect on the environment and on beneficial organisms, in particular bees and other pollinators came to special importance. 

Many rubber products, when exported to the member states of the European Union, must comply with the requirements of the relevant legislation approach. The EU Directives of New Approach and Directives of Sectoral Approach are legislative provisions that must especially be followed. Directives of New Approach confine the requirements to the protection of health, property and environment and the safety requirements. The Directives of New Approach lay down the uniform procedure of approval of conformity. Harmonised European standards, giving detailed specifications of the product, follow these Directives. Detailed requirements are given in the Directives of Sectoral Approach and they have to be interpreted individually. The essential concepts are explained and a review of the most important documents is presented. 

In Europe, inspections are conducted by member states on behalf of the European Union. For drugs approved under the centralized procedure, inspections are coordinated by the European Medicines Agency (EMEA refer to Sections 7.3 and 8.3). For countries that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S see Section 7.13), there is mutual recognition of inspections performed by members. 

To be able to EC mark a product, the manufacturer must undergo, for each product and type of valve, a conformity assessment comprising the EC type or design examination and the assurance of the production quality system. The manufacturer must also demonstrate the quality compliances of all sub-suppliers and ensure that all critical parts (or at least pressure-retaining parts) are fully traceable and accompanied by a material certificate. Procedures to certify conformity to PED are carried out by a notified body approved by the member states of the European Community. With completion of the assessment, the manufacturer may stamp the EC mark on the product. 

Unfortunately, sparteine is not marketed and approved for clinical use in many countries, including North America and the United Kingdom, and analytical reference compounds required for the GLC analytical procedure are not readily available. Accordingly, the use of sparteine for CYP2D6 phenotyping has had limited use outside a small number of mainly European investigators. 

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