Licensing Authority

Specifications for hGH products are defined by the governmental licensing authorities, eg, the U.S. Pood and Dmg Administration. Draft monographs for hGH have been prepared by both the EnitedStates Pharmacopia and the European Pharmacopeia commissions and should be formally adopted by 1995. These specifications are suitable for biosynthetic hGH. The much less purified pituitary-derived hGH has virtually disappeared from commercial production. An international reference standard for pituitary-derived hGH (lot 80/505) has been used for caUbration, particularly for bioassay purposes. A highly purified biosynthetic hGH standard (lot 88/624) has been prepared and should be formally adopted by 1995, or before. 

AECB - Atomic Energy Control Board, the nuclear licensing authority in Canada. 

Compliance with the principles of GMP is one of the major factors considered by the Licensing Authority when examining an applicahon for a licence to manufacture under the Medicines Act (1968). Similar codes exist in the USA and other countries. 

Suspension of licensing authority for medical personnel from outside jurisdictions Authorization of other doctors to perform functions of medical examiner Access to Communications and Parking Relations Identification of public health officers, e.g., badges Dissemination of accurate information, rumor control, 1-800 numbers Establishment of command center Access to elected officials... 

Local clinical trial may be waived by the licensing authority in the interest of the public good, in which case data from preclinical studies are to be evaluated. TTie approval for import permission is given on Form 45 or 45A, clinical trial on Form 46 and/or 46A, and new bulk drug substance on Form 54a. 

The licensing authority is empowered imder Part VI of the Act to require copies of advertisements issued within the past 12 months to be submitted to it. There are also a number of enabling provisions under Part IV imder which regulations may be made to further control the advertising of medicines. 

Paragraph 7 requires that person to notify the licensing authority of any such suspected serious adverse reaction and to make available for inspection at all reasonable times the records referred to in the previous paragraph. 

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. 

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. 

The advantage of the CTX scheme was its speed, since a decision had to be made by the Licensing Authority within 35 days with the possibility of one 28-day extension to this period. The maximum time for determination of a CTX application was therefore 63 days. 

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. 

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. 

Promotional material must not include any reference to the Medicines Commission, the Committee on Safety of Medicines, the Medicines and Healthcare products Regulatory Agency, the Medicines Control Agency or the licensing authority, unless this is specifically required by the licensing authority. 

The company has a legal obligation to report all suspected serious ADRs occurring in the European Union to the Licensing Authority within 15 days of the receipt from any health professional. Serious and unexpected suspected ADRs are required to be reported from outside the EU within 15 days of receipt from health professionals. All other ADRs should be reported in the periodic safety updates. 

Although its mode of action is uncertain, two mechanisms, one involving interference with the production and/or utilization of polyamines and the other preventing the entry of inositol into the erythrocyte that contains the parasite, have been proposed. It is a compound with low safety margin since administration of as low as 10 mg/kg bw to cattle can cause death. By now, its withdrawal periods in edible animal products are under review by the licensing authorities and, in some cases, a 90-day withdrawal period may be required (4). 

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