License variations

Renewal every 3 years No licensing fees Renewal every 2 years Licensing application fee of British pounds 11,600 in 1998 Licensing variation fee of British pounds 195 in 1998... 

Once a product has been approved through the CP, all further regulatory activities, such as license variations, labeling changes, new indications and so on must be CP submissions. 

The PIL and the label of the drug container itself are as precisely regulated as the SmPC. Changes in any of these documents have to be approved by the RA (see license variations below). 

Most of the work of the national regulatory authorities concern license variations, line extensions and license renewals. The application will follow the same approval procedure in which the original authorization was obtained. As many products currently licensed have been licensed through national procedures, before the mutual recognition or CP were available, many of the applications are still undergoing the national approval process in each MS separately. 

License variations are divided into three main categories termed Type I variation , Type II variation and extensions . The main changes introduced by the new legislation are... 

Another variation is the catalytic oxidation of toluene with ammonia to produce benzonitrile. Such a process has been developed and is offered for license by Nippon Shokubai Kagaku Kogyo Company. Their plant is in Himeji, Japan. 

Invented by H. E. Benson in 1952 and then developed with J. H. Field at the U.S. Bureau of Mines. First licensed by the Benfield Corporation of Pittsburgh, subsequently acquired by the Union Carbide Corporation, and now licensed by UOP. The current UOP version includes new solution activators and incorporates zeolites or membrane processes for complete separation of acid gases and minimal loss of product gases. More than 650 plants were operating in 1996. Variations include the Benfield HiPure process and the Benfield LoHeat process. See also Carsol, CATACARB, Giammarco-Vetrocoke, HiPure. 

Takahax A variation of the Stretford process for removing hydrogen sulfide from gas streams, in which naphthaquinone sulfonic acid is used in place of anthraquinone disulfonic acid. Four variants have been devised types A and B use ammonia as the alkali, types C and D use sodium hydroxide or carbonate. Developed by the Tokyo Gas Company and licensed in the United States by Ford Baken and Davis, Dallas, TX. Many plants are operating in Japan. 

Under section 6 of the Medicines Act 1968, the Licensing Authority (LA) is the authority responsible for the grant, renewal, variation, suspension and revocation of licences and certificates. In 1971, the LA was constituted of a body of Ministers consisting of the Secretary of State for Social Services, the Secretary of State for Scotland, the Secretary of State for Wales, the Minister of Health and Social Services for Northern Ireland, the Minister of Agriculture, Fisheries and Food and the Minister of Agriculture in Northern Ireland. 

These sub-dew point processes can increase the overall Claus plant sulfur recovery to up to 99%, as limited by equilibrium conversion and sulfur vapor pressure losses. Elf Aquitaine s Sulfreen process, Amoco s cold bed adsorption (CBA) process, and the Mineral and Chemical Resource Company (MCRC) process licensed by Delta Hudson are all variations on the cold bed sub-dew point process. 

Figure 11 Variation of the energy width of the hydrogen atom against the applied field for different plasma screening. Reprinted with permission (license number 2041490042669) from [178].

Clauspol [Claus polyethylene glycol] A variation on the Claus process for removing hydrogen sulfide from gas streams, in which the tail gases are scrubbed with polyethylene glycol to remove residual sulfur dioxide. Clauspol 1500 is a modification of this. Developed by the Institut Franqais du Petrole. Forty-eight units had been licensed by 2000. See IFP. 

Energx A process for making LLDPE (linear low-density polyethylene). Developed by Eastman Chemical in the 1990s and used at its plant in Longview, TX. Licensed to Chevron Chemical in 1999 for use at its plant in Baytown, TX. By 2002, licenses had been granted in Europe, North America, and Asia. A variation, Energx-DCX, uses a supported catalyst (Sylopol DCX) made by W.R. Grace. The polyethylene products have the trade name Hifor. 

There are three basic arguments in favor of a merger or acquisition. First is a variation on the argument for doing more licensing and joint ventures—that no company, not even a big one like Merck, can expect to do everything itself or have a monopoly on great ideas. Even joint ventures aren t a solution, experts like Columbia professor Frank... 

Quality control for herbal medicaments that are sold as dietary supplements in most countries is poor (113,114). Thus, considerable variations in the contents of active ingredients have been reported, with lot-to-lot variations of up to 1000% (115). In most countries, the sale and supply of herbal remedies is to a large extent uncontrolled and unregulated most herbal remedies are sold as unlicensed food supplements and their safety, efficacy, and quality have therefore not been assessed by licensing authorities. Adulteration and contamination of herbal remedies with other plant material and conventional drugs have been documented (25,116) (Table 1). 

Under the Medicines Act, the licensing system for MAs, Manufacturer s, and Wholesale Dealer s Licences, and for Clinical Trial Certificates, allows the opportunity for an applicant or licence holder to appeal against an unfavourable recommendation or decision, right up to the High Court if necessary, although that has rarely happened. Nevertheless, appeals to the appropriate advisory committee such as the Committee on Safety of Medicines, and to the Medicines Commission, are commonplace in the process leading to grant of an MA. Appeals may also arise in connection with the suspension, revocation, or compulsory variation of MAs or certificates. Manufacturer s Licences and Wholesale Dealer s Licences are rarely subject of the need for such appeal action. 

The Medicines Act Information Letter is a bimonthly updating service on matters relating to the licensing and control of medicines, and is published on alternate months. MAIL regularly provides statistics on MCA assessment and licensing times for MAs and variations, and also includes a list of contact points. 

Cover letter - which clearly states the product license numbers involved, the reason for the change, for example if it has been requested or is as a result of harmonization and whether the application is national or a mutual recognition variation. 

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