United Kingdom Licensing

New products introduced following a major apphcation for a product licence from the United Kingdom Licensing Authority may be priced at the discretion of the company on entering the market. This will have to take account of costs of research and development and the competition in the marketplace. 

Chinuka An electrochemical process for making titanium metal directly from a titaniferous raw material such as rutile. The rutile is mixed with carbon and heated to above 1400°C in a vacuum, producing titanium oxycar-bide. This is electrorefined using a molten sodium/potassium chloride eutectic as the electrolyte. Developed by D. Fray and S. Jiao in Cambridge, United Kingdom. Licensed to White Mountain Titanium Corp, Chinuka... 

Carrousel An unconventional aerobic treatment system for sewage and industrial effluents, providing efficient oxygenation, mixing, and quiescent flow in an elliptical aeration channel fitted with baffles. Developed in The Netherlands by DHV Raagevend Ingenieursbureau B.V., and licensed in the United Kingdom by Esmil. 

When the real problems with benoxaprofen emerged, however, they were more serious It was apparently killing elderly patients with hepatic disorders, inducing massive photosensitivity, and causing oncholysis (separation of the nail plate from the bed) in about 15% of patients. It seems probable that at least 70 elderly patients died, and many more people suf-fered. ° Shortly after its well-publicized entry into the U.S. market, the manufacturer of benoxaprofen voluntarily withdrew its product as it caused fatal cholestatic hepatitis. " This action immediately followed news of suspension of the license to sell benoxaprofen in the United Kingdom. ... 

The EEC had already in place the Coim-cil Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products. Many of the requirements under Coimcil Directive 65/65/EEC had already formed part of the Medicines Act. When Directives 75/318/EEC and 75/319/EEC were adopted by the Council of Ministers on 20 May 1975, they only supplemented and amended the original Directive 65/65/EEC. Therefore, when the United Kingdom joined the EEC in 1973, the provisions of these two new Directives did not substantially affect the licensing system that operated in the United... 

Because of the rising future demands and delays in licensing, the Minister of Health announced on 11 March 1987 that he had commissioned a study of the control of medicines in the United Kingdom. The terms of reference were ... 

The thalidomide disaster was to provide the impetus to the introduction, for the first time in most non-US countries (including those in Western Europe), of regulatory control of drugs to be marketed for clinical use. In the United Kingdom the result was the Medicines Act 1968 and the establishment of the Licensing Authority. 

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. 

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. 

Reboxetine is a pure noradrenaline reuptake inhibitor that is licensed as an antidepressant in the United Kingdom. Reboxetine has established efficacy based on placebo-controlled studies both in the short and the long term. Previous noradrenaline reuptake inhibitors, such as desipramine, nortriptyline, and maprotiline, have been relatively selective for noradrenaline compared... 

In the early 1990 s, the Committee on Safety of Medicines of the United Kingdom concluded that the risks of treatment with triazolam at the licensed doses (0.25 and 0.125 mg) outweighed the benefits. The United Kingdom and a few other countries banned triazolam primarily because of persistent reports of adverse reactions. As of 1992, France, Spain, and New Zealand suspended the 0.25-mg dose of triazolam but allowed continued marketing of the 0.125-mg dose, whereas Canada and Japan lowered the recommended starting dose for nonelderly insomniacs to 0.125 mg. 

In the United Kingdom one of the chemicals monitored regularly is the coccidiostat nicarbazin, which is not licensed for use in laying hens and, therefore, any positive samples create cause for concern. The results of surveillance of the incidence of nicarbazin in eggs during the period 1996-1997 are presented in Table 13.22. 

Traditionally, ethanol has been made from ethylene by sulfation followed by hydrolysis of the ethyl sulfate so produced. This type of process has the disadvantages of severe corrosion problems, the requirement for sulfuric acid reconcentration, and loss of yield caused by ethyl ether formation. Recently a successful direct catalytic hydration of ethylene has been accomplished on a commercial scale. This process, developed by Veba-Chemie in Germany, uses a fixed bed catalytic reaction system. Although direct hydration plants have been operated by Shell Chemical and Texas Eastman, Veba claims technical and economic superiority because of new catalyst developments. Because of its economic superiority, it is now replacing the sulfuric acid based process and has been licensed to British Petroleum in the United Kingdom, Publicker Industries in the United States, and others. By including ethanol dehydrogenation facilities, Veba claims that acetaldehyde can be produced indirectly from ethylene by this combined process at costs competitive with the catalytic oxidation of ethylene. 

Accdg to Marshall (Ref 2), Carlsonites were the first Amm perchlorate expls submitted to HM Inspectors of Explosives. Some of the mixts were r eported favorably, but no license was ever issued in the United Kingdom for these expls Refs l)DanieI(1902), 116 2)Marshall, Dictionary(1920), 20 3)Giua, Trattato 6(1959), 401... 

Qll Although low-dose aspirin can be safely used for prevention of intravascular coagulation, it is not currently licensed in the United Kingdom for prevention of travel-related DVT. 

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