United Kingdom granting

In the past, a limited number of reference materials have been explicitly developed for ocean science (as discussed in Chapter 2) salinity, ocean C02, and DOC. Although salinity reference materials are available on a commercial basis from Ocean Scientific International Ltd. in the United Kingdom, the others are presently supported through grants from the U.S. National Science Foundation. The widespread use of such materials and their success in enhancing the scientific return on ocean studies is clear, and it is essential that such materials remain available. 

The granting of a product licence in the United Kingdom, or its equivalent in other countries, is a dividing line that places firm constraints on what studies can and cannot be done in the pre- and post-marketing periods. Because it would be medically and ethically unacceptable to permit doctors (investigators) to use an unapproved drug in unrestricted circumstances, it is essentially impossible to conduct clinical trials... 

The proposed review of PLRs was already considered necessary by the United Kingdom but became a requirement when it joined the European Union. It was to correspond to the requirements under Directives 65/65/EEC and 75/318/EEC of the European Community that required that, throughout the Community, proprietary medicinal products granted licences before 22 November 1976 should be reviewed by 20 May 1990. All Member States of the European Community were similarly required to review the quality, safety and efficacy of products on their market. 

Where a clinical trial was proposed with a marketed product then the CTMP scheme could be used. This was a streamlined process based on the fact that there were no quality issues with a product that had already been granted a marketing authorisation. The applicant submitted a copy of the trial protocol, provided information on the investigators and, depending on whether or not the applicant was the MAH, information on the procedures for reporting adverse drug reactions. It was only possible to use this procedure for UK marketed products. It did not apply to unauthorised products manufactured specifically for trial or to products, which were licensed only in countries other than the United Kingdom. 

I. P. Grant (1), Mathematical Institute, University of Oxford, Oxford 0X1 3LB, United Kingdom... 

D. Grant, Capillary Gas Chromatography (1995), John Wiley Sons (United Kingdom). An introduction to specialized GC. 

Sucralose is not metabolised by mammalian species and is poorly absorbed by the body. JECFA has assigned an ADI of 15 mg/kg bw. Sucralose was approved in the United States in April 1998 for use in a variety of food applications, including soft drinks. In August 1999, this approval was extended to full-category GMP approval. In the United Kingdom, it was granted a temporary approval on 15 March 2002 (UK Statutory Instrument 379). In 2004, sucralose was added to the EU list of permitted sweeteners. 

The name of the degree-granting university is the minimum requirement for an acceptable citation. You should also include the city and state or city and country. Use the two-letter postal abbreviations for states. Spell out names of countries unless they have standard abbreviations, such as U.K. for United Kingdom. 

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. 

The United Kingdom joined the European Community (EC) in 1973, but the data requirements for granting MAs has, as the implementation of the Medicines Act (1968), been in accordance with EC Directive 65/65 and the subsequent Directive 75/318, which elaborated on the requirements for preclinical testing, pharmaceutical quality and manufacture. Both these Directives and the Medicines Act (1968) envisaged that MAs issued on the basis of these requirements would be valid for five years and subject to review and/or renewal. 

At the start of product licensing in the United Kingdom in 1971, products already on the market were granted Product Licences of Right (PLRs), which were subject to review. Between 1971 and 1982,22 376 lapsed or were revoked or suspended, and 598 had been converted to full product licenses. The Committee of Review of Medicines was deemed to have completed its work in 1991 and was disestablished on 31 March 1992. 

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