European Commission compliance requirements

Harmonised standards are technical specifications adopted by one of the European standards organisations following a mandate issued by the European Commission on which Member States were consulted. When published by the Commission in the Official Journal of the European Communities, the hamionised standards give presumption of confomiity to the essential requirements they specify. This means that manufacturers applying these standards do not have to demonstrate the compliance of the manufactured products with the relevant requirements of the directive. 

Within the European Union, the European Commission (EC) has codified the GLP requirements for medicinal products in the Introduction and General Principles chapter of Directive 2003/63/EC [31]. Within this document it is stated that nonclinical (pharmacotoxicological) studies must be carried out in conformity with the provisions related to GLP laid down in Council Directives 87/18/EEC3 on the harmonization of regulations and administrative provisions relating to the application of the principles of GLP and the verification of their application for tests in chemical substances and 88/320/EEC4 (corrigenda 1, 2, and 3) on the inspection and verification of GLP [32,33], The OECD principles have been adopted by the European Union and published, in their revised form, in the appendix to Directive 2004/10/EC [32], The GLP Web site of the EC contains detailed reference information and links for member state GLP compliance [34],... 

Directive 2001/20 required that compliance with GMP guidelines was introduced into the national laws of all MS and (see European Commission Directive 2003/94/EC). GMP inspections have long been standard for all companies at the time of a MA application, but there had previously been no such requirement for IMPs. This gap has now been closed. 

AFL occurrence and concentration data, submitted from 22 EU Member States for the EFSA risk assessment requested by the EC in 2006, were available for this evaluation. In the EU, methods of analysis for the official control (enforcement, defence and referee purposes) of the levels of AFL and other mycotoxins in foodstuffs have to fulfil the analytical requirements laid down in Annex II of Commission Regulation EC No. 401/2006 (European Commission, 2006). These include, among others, criteria for laboratory blanks, recovery and precision and specify that the analytical result corrected for recovery shall be used for controlling compliance. Some details of the EU methodology can be found in European Food Safety Authority (2007). 

The European Commission mandates the creation of standards to support the essential requirements (ERs) of the directives. A standard is considered harmonized at the time of announcement which is published in the Official Journal of the European Communities (OJEC). Compliance with the harmonized standards will, in most cases, ensure a product s conformity with the essential requirements of the directives. Adherence to European harmonized standards is the only proven and universally accepted method of showing conformity with the ERs of the directives (Figure 3-1). Properly applying standards produces a presumption of conformity. ... 

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. 

Figure 4.124 Compliance of GC-MS/MS with the required EU PCDD/PCDF maximum levels for butter, eggs, meat and fat in pg/g fat and % difference to the GC-HRMS method (European Commission, 2006 Kotz ef al., 2011).

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