European Union procedure

A new CEN European standard, EN 12874, was issued in 2001. It will be used by all European nations that belong to the European Union (EU) that are members of the Comite Enropeean de Normalisation (CEN), as well as other non-EU nations that are members of the CEN. It will supersede BS 7224 in England, FEB and BAM in Germany, and standards in use in other European countries. This is a very comprehensive standard covering types of flame arresters not covered in US, Canadian, and other standards. It contains test procedures for the following types of flame arresters ... 

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. 

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

Interest has been expressed in the possibility of using biomarker assays as a part of risk assessment for regulatory purposes, and some workers have suggested tiered testing procedures that follow this approach (see, for example, Handy et al. 2003). It is to be hoped that regulatory schemes, such as that of REACH (see European Union 2003), will be sufficiently flexible to incorporate new assays and testing strategies as the science advances. 

Five synthetic and five natural colorants were identified and quantified in lyo-philized dairy products and fatty foods using an automatic method based on solid phase extraction using a stationary phase followed by RP-HPLC C,g columns for the sequential retention of colorants and diode array detection. Lyophilization of the samples coupled with the separation procedure provided clean extracts despite the complexity of the food matrices and preserved the sample for at least 2 months without changes in colorant concentrations. The detection limits achieved for the colorants were found in a wide range from 0.03 to 75 pg/g of the lyophilized sample, according to the limits established by the European Union. ... 

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. 

Legislation and control procedures in the United Kingdom are increasingly being derived from regulations promulgated by the European Union (EU). 

Those activities are generally conducted during the course of official registration of a plant-protection product. Because, according to Council Directive 91/414/EEC, the registration procedures and evaluation criteria are currently harmonized between the member states of the European Union, the objective of this paper is to contribute to the discussion about a future Union-wide evaluation and assessment scheme for re-entry exposure. 

French and European Union legislation relating to the control of emissions in the workplace is examined, with particular reference to the rubber processing industry. Air sampling and analytical procedures used in the detection of nitrosamines formed in vulcanisation reactions are reviewed. 2 refs. 

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. 

Thus, as for the European Union, the requirements are based on accreditation, proficiency testing, the use of validated methods of analysis and, in addition, the formal requirement to use internal quality control procedures which comply with the Harmonised Guidelines. Although the EU and Codex Alimentarius Commission refer to different sets of accreditation standards, the ISO/IEC Guide 25 1990 and EN 45000 series of standards are similar in intent. It is only through these measures that international trade will be facilitated and the requirements to allow mutual recognition to be fulfilled will be achieved. 

European Commission. Notice to Applicants, Medicinal Products for Human Use, Procedures for Marketing Authorization, Volume 2A of The Rules Governing Medicinal Products in the European Union, EC, 1998. 

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. 

In early 2007, the EMEA reported the analysis of GMP deficiencies in its document entitled Good Manufacturing Practice An Analysis of Regulatory Inspection Findings in the Centralised Procedure. It detailed the deficiencies reported in 435 inspections of manufacturers of medicinal products and starting materials in the European Union and third countries in the period 1995 to 2005. Altogether there were 9465 deficiencies, of which 193 were critical (2%), 989 major (10%), and 8283 (88%) others. The top 20 deficiencies are presented in Table 10.1. 

The European system is based on cooperation between the national health authorities of the member states and the EMEA. The latter aets as a focal point of a network whieh eoordinates the seientific resources made available by the member states. This partnership between the EMEA, national health authorities, and the European Union institutions is erueial to the functioning of the European authorization procedures. 

Compliance with the GLP principles covers many aspects of accreditation to ISO 17025. The European Union has adopted the procedures for Good Laboratory Practice of the Organization for the Economic Cooperation and Development (OECD) and calls on member states to take all measures necessary to ensure that laboratories carrying out tests on chemical products comply with the GLP principles. The OECD s GLP principles are part of the Eiuopean Commission Directive 2004/10/EC (http //eur-lex. europa.eu). 

A separate application has to be made to cover the goods in each class. Across the European Union, each mark must be separately registered for the appropriate class or classes of goods in each individual country, either according to the applicable procedure or through the recent Commrmity trade mark registration system. 

Since the last edition of this book was published, a plethora of new updating information has become available on the internet. The sheer volume of this is such that it is beyond the reach of this chapter. Attempts to create a standard set of procedures and requirements in the new and enlarged European Union have certainly made progress although the pharmaceutical physician will have to consult the most recent regulations and guidelines if errors are to be avoided. Even such basic concepts as a suspected serious adverse reaction may vary between countries. 

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 ... 

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