European Union rules/regulations

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. 

The CTD format has been incorporated into the E U regulations and is set out in the revised version of Annex I to directive 2001/82/EC, which was published as Commission Directive 2003/63/EC. It is also supported by detailed guidance in the Rules Governing Medicinal Products in the European Union, Volume 2B - Presentation and content of the dossier - CTD2001 edition. The relationship between the CTD format and the previous four-section format that was used in the E U is shown in Table 6.1. 

The Community procedure for establishing MRLs of veterinary medicines in foodstuffs of animal origin is set down in Council Regulation (EEC) No. 2377/90 as amended by Council Regulation (EC) No. 1308/1999. The regulations are supported by detailed guidance contained in The Rules Governing Medicinal Products in the European Union, Volume 8 - Maximum Residue Limits. 

Attempts to harmonize European pharmaceutical laws were accelerated in the 1980s. From 1985 onwards, a substantial number of European pharmaceutical directives have been adopted. This entire legislation has been published in the form of a nine-volume series entitled The Rules Governing Medicinal Products in the European Union (Table 4.11). These volumes form the basis of EU-wide regulation of virtually every aspect of pharmaceutical activity. 

The raft of rules, regulations, guidelines and procedures (both the European Union and ICH) governing the human medicinal products in the European Union can be found in the following five volumes published by the European Commission ... 

In the United States, the European Union, and many other countries, as has been mentioned earlier, there are regulations that control the use of biocides and other types of chemicals in industrial situations. Successful efforts to clean up rivers, improve working environments, and remove pollutants from being discharged cannot just be ignored or overridden. The cooling system operator often has a duty to review all water treatment chemicals, including biocides, prior to their potential use on-site. The owner may have rules in place over what biocides are or are not acceptable in the workplace. 

IV. PRODUCTION RULES ITALIAN AND EUROPEAN UNION REGULATIONS... 

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