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| home > pmps > autumn 2001 > compliance issues in the medicinal products supply chain - from manufacturer to pharmacy |
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Pharmaceutical Manufacturing and Packing Sourcer
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The Medicines Control Agency (MCA) regulates medicinal products for human use in the UK on behalf of the UK Licensing Authority, in accordance with The Medicines for Human Use (Marketing Authorisations and so on) Regulations 1994 (SI 1994/3144), and the Medicines Act and Regulations made under the Act. The legislation provides, inter alia, for a system of licences (authorisations), certificates and exemptions for the regulation and control of the manufacture, importation and distribution of medicinal products in the UK. The Licensing Authority is responsible for issuing licences and ensuring that licence holders comply with the provisions of their licences.
Council Directive 92/25/EEC places obligations on both regulator and distributor with respect to the wholesale distribution of medicinal products for human use. The necessity to exercise control over the distribution chain from manufacturer to supply to the consumer, in order to provide a guarantee that medicinal products are stored, transported and handled under suitable conditions, is emphasised in the third recital of the Directive.
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By John Taylor, Senior Inspector in the Standards Unit of the
Inspection and Enforcement Division at the Medicines Control Agency
John Taylor is a Senior Inspector in the Standards Unit of the Inspection and Enforcement Division of the Medicines Control Agency, where he is responsible for quality management systems. He joined the MCA in 1991 after working in the pharmaceutical industry for 24 years in quality control, quality assurance, research and development and regulatory affairs.
Following two years as a Medicines Inspector, John joined the Policy, Borderline and Standards group to develop the Medicines Inspectorate quality management system in order to obtain certification to ISO 9002. He has led the expansion of the system during recent years to cover other sections of the division and is a recognised authority on good
distribution practice of medicinal products and, in particular, on matters relating to cold-chain distribution. John is also a Chartered Chemist, a Fellow of the Royal Society of Chemistry, and a Member of the British Institute of Regulatory Affairs.
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