United Kingdom Control Agency

The AMFC Directive requires that food control laboratories should be accredited to the EN 45000 series of standards as supplemented by some of the OECD GLP principles. In the UK, government departments have nominated the United Kingdom Accreditation Service (UKAS) to carry out the accreditation of official food control laboratories for all the aspects prescribed in the Directive. However, as the accreditation agency will also be required to comply with the EN 45003 Standard and to carry out assessments in accordance with the EN 45002 Standard, all accreditation agencies that are members of the European Cooperation for Accreditation of Laboratories (EA) may be asked to carry out the accreditation of a food control laboratory within the UK. Similar procedures will be followed in the other Member States, all having or developing equivalent organisations to UKAS. Details of the UK requirements for food control laboratories are described later in this chapter. 

The applications for national authorisations are submitted to the national competent authority which, in the United Kingdom, is the Licensing Authority (LA), whose functions are discharged by the Medicines and Healthcare products Regulatory Agency (MHRA, previously Medicines Control Agency, MCA) of the Department of Health. The LA/MHRA are advised by the CSM, a multidisciplinary scientific body consisting of clinical, preclinical and pharmaceutical members well known for their expertise in their respective fields. Lay members are also included. 

A review of the case-control studies conducted by the National Cancer Institute, principally on non-Hodgkin s lymphomas, has not established a causal association between atrazine use and the occurrence of this disease (De Roos et al., 2003). This conclusion has also been reached in numerous authoritative reviews (USEPA, 2003a, b International Agency for Research on Cancer (IARC), 1999 United Kingdom (UK), 1996, 2000 Australian Pesticides and Veterinary Medicines Authority (APVMA, 2004). 

According to the mutual recognition approach, a company may first apply for approval in one EU member state, such as the Medicines Control Agency in the United Kingdom or the Agence du Medicament in France... 

MCA (2002), Best Practice Guidance on the Labeling and Packaging of Medicines, United Kingdom Medicines Control Agency, December 12, Her Majesty s Stationery Office, London. 

Regulatory bodies around the world have given approval for NIR methods for a variety of purposes. In June 1995, the Medicines Control Agency (MCA) granted approval to Glaxo Wellcome in the United Kingdom for a NIR method for the identification and assay of Zovirax (acyclovir) tablets. This is believed to be the first official approval for NIR granted by the MCA as an assay method for tablets. 

Without going into more detail it should be pointed out that the NIP mirrors, both in its organization and responsibilities, its counterpart in the European medicines control agencies (the Medicines Control Agency [MCA] in the United Kingdom, the Medical Product Agency [MPA] in Sweden, the medicines part of the National Board of Health in Denmark, etc.). 

Herbal products are regulated differently in countries other than the United States. For example, in the United Kingdom, any substance not granted a license as a medicinal product by the Medicines Control Agency is treated as a food, and cannot carry a health claim or medical advice on the label, although many do (Marwick, 1995). Canada is moving toward a system resembling that in the U.S. (Allen,... 

MCA Medicines Control Agency, United Kingdom now MHRA... 

A comprehensive table with the tests and quality control checks and their frequencies required in the United Kingdom is given in Highways Agency (2009b). 

It is worth discussing the workplace safety and health concept developed and implemented in the United Kingdom. Some of the Commonwealth countries, particularly Australia, have adopted this concept as well. The concept reduces the amount of regulation for safety and health details by the government. The concept relies on risk analysis and the hierarchy of controls (see Table 3-2) for companies, employers, and workers. It contrasts with the approach in the United States in which government agencies, such as... 

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