European Union guidelines

Netherlands drug regulation now follow European Union rules. For example, GMP inspection is based on the 1983 European Union guidelines for GMP. Since 1 January 1995, a European procedure for registration has operated in the Netherlands. Now two types of trade licences exist a European licence and a national licence. Products with a European licence may be sold throughout the whole European Union, while the national licences are only valid for the country in which the licence was issued by means of the national registration procedure. 

Several countries (Cyprus, Estonia, Venezuela and Zimbabwe) have adopted the WHO GMP guidelines (25) as their statutory GMP standards. Australia has its own GMP guidelines. Malaysia uses the GMP guidelines of the ASEAN (26). The Netherlands has adopted the European Union guidelines on GMP inspection (27). The majority of the countries have also developed SOPs for their inspectors, as indicated in Table 7.1. Australia, Cuba, Cyprus, Malaysia, Uganda and Venezuela have not developed guidelines for GDP. 

The Rules Governing Medicinal Products in the European Union. Guidelines on the Quality, Safety and Efficacy of Medicinal Products for Human Use. Clinical Investigation of Chiral Active Substances, Pharmaceutical Press, London (1991). 

The Rules Governing Medicinal Products in the European Union Guidelines on Medicinal Products for Human Use, 3. 

Side-effects or the concern about side-effects listed in patient information leaflets can also be a barrier to patient compliance. What patients perceive is the probability of a side-effect listed and what the terminology used actually means is often at variance. According to European Union guidelines, the terms recommended to convey the likelihood of side-effects are as listed in Table 8.2, but most patients tend to overestimate the risks, leading to non-compliance. This is why it is important to explain the risks in the pharmacy. 

EUROPEAN UNION GUIDELINE FOR TESTING OF CHEMICALS UNDER THE REGISTRATION,... 

EUROPEAN UNION GUIDELINE EOR TESTING OE CHEMICALS UNDER THE REACH 253... 

U.S. Code of Federal Regulations, Title 21, Part 211.68 European Union Directive 91/356/EEC, Annex 11 Australian Code of CMP, Medicinal Products, Part 1, Section 9 European Union Guidelines on Good Distribution Practice 94/C 63/03... 

Food coloring is restricted by law to prevent misuse that may lead to deception of consumers related to reduced value or usability. For this purpose, the European Union implemented food colorant guidelines in 1994 based on the understanding that food coloration presents a technological need. While European Parliament and Council Directive 94/36/EC lists colors and their uses in food, the European Commission Directive 95/45/EC contains specific purity criteria for colors in foodstuffs, e.g., a maximal lead content of 20 ppm. " ... 

A system of classification is given in the Classification, Packaging and Labelling of Dangerous Substances, Regulations, 1984 (United Kingdom), which is based on European Union (EU) guidelines for example ... 

The rapid dissolution class boundary is defined in terms of the in vitro dissolution being greater than 85% in 30 min in 900 mL aqueous media at pH 1, 4.5, and 6.8, using USP Apparatus I (100 rpm) or Apparatus II [50 rpm (revolutions/min)] [104]. A similar guideline has been introduced in the European Union [105]. Examples of molecules from the various four classes are presented in Fig. 2.9 [102,104]. 

Increasingly, guidelines resulting from political decision process of the European Union influence national markets and global competition. In order to have an influence on behalf of the interests of the plastics industry, the Association of Plastics Producing Industries, (VKE), is reported to wish to intensify its communication with European political institutions. The VKE sees the discussion about the EU book on the environmental problems relating to PVC as particularly controversial, and does not consider that it takes important points of view sufficiently into account. The treatment of the PVC theme, is examined as an example of so-called europisation of the work of associations. (Article translated from Kunststoffe 91 (2001) 4, pp.26-27). 

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