Licence Renewed

Gardner, John. 1981. Licence Renewed. Bungay, Suffolk Book Club Associates. 

John Gardner, Licence Renewed (1981) 15. For Bond s equipment see 47 Bond s breakfast, 57 dinner with the villain, 87. 

Examples of geography at work include the American Dr. Autem doing his dirty work from Banbury Cross (Role of Honour), the supervillain Dr. Anton Murik plotting to attack America from his Scottish lair (Licence Renewed), and the revitalised SPECTRE basing itself in the Mississippi delta and Texas (For Special Services). 

It is often not appreciated how much work is required to ensure that the marketing authorisations are kept up to date through being renewed and amended as necessary. Similarly, it may not be realised that a simple variation to a product licence, such as a small change in the amormt of excipient, will require the submission of a variation document to the authorities. 

Sections 18-24 regarding applications for, and grant and renewal of, licences with section 19 requiring evidence for safety, efficacy and quality when determining an application. 

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. 

A Proforma for application for the licences, issue and renewal of licences, for sending memoranda under the Act. 

A licence shall specify the clinical indications that may be promoted and shall be for a limited period (5 years), which is renewable on application. 

Once a medicine is licenced for sale by one of the above procedures, its future regulatory life remains within that procedure. Licences have to be reviewed every 6 months for the first 2 years, then annually until 5 years, then renewed subsequently at 5-year intervals. The renewal of a licence is primarily the responsibility of the MAH but requires approval from the regulatory authority. This is the opportunity for MAHs to review, especially, the safety aspects to keep the licence in line with current clinical practice. Any major changes to licences must be made by variation of the original licence (safety, efficacy or quality, see below) and supported by data, which for a major indication, can be substantial. 

Each MA has to be renewed every 5 years. This is best done by indicating the minor changes that have occurred (e.g., updating analytical methods). As in the EC Directives, this will also be the time to update the leaflets on post-marketing surveillance issues. The Medicines Commission will also evaluate the legal status of every MA at the 5-year renewal date. Major changes (e.g., inactive ingredients, licence holder) have to be submitted for approval separately before implementation. 

Procedures that are put in place would provide for guidcmce for interested parties on the content and format of registration applications, as well as the circumstances under which an application for renewal, variation or extension will be required. It also has to detail from the onset the criteria on which licence applications will be evaluated. In effect, there should be issuance of guidelines on the procedure to be followed in order to help retain public confidence and respect. 

Regulations for the renewal of Registration Certificates for human use of pharmaceutical products were established by the CDMDR on 13 February 1997 and published in the Polish Pharmaceutical Journal. Renewal applications should be submitted for all products licenced before 1 January 1994 and those with expiry date of 31 December 1997. In the future applications for renewals should be made not later than six months before expiry date. Registration Certificates ending by 31 December 1997 were exempted from the rule. 

Renewals for product licences must be submitted to the licensing authority at lecist 2 months prior to the expiry of the licence. The following documents must be submitted ... 

Licences are issued for a 3-year period initially and renewed for another 5 years with an option for 10 years. 

The legal basis for the CTX scheme is given in SI 1995 No. 2808 The Medicines (Exemption from Licences) (Clinical Trials) Order, and SI 1995 No. 2809 The Medicines Exemption from Licences and Certificates) (Clinical Trials) Order. The MCA provides guidance notes on applications for clinical trial exemptions and clinical trial certificates. Special forms (MLA 164, 165,166, and 168), obtainable from the MCA, are provided for use by applicants in preparing a CTX application, notification of chcinge, and renewal. 

In December 1498 the news arrived of the discovery of Paria. The splendid ideas of the discoverer touching the beauty and wealth of that region were presently made known, and the spirit of maritime enterprise was revived with renewed vigour. Some of those who had sailed with the Admiral, and had benefited by his instruction and example, solicited and obtained from the Court licences to discover, at their own proper cost, the regions beyond what was already known, paying into the Treasury a fourth or fifth part of what they acquired. 

The regulatory body is to be provided with adequate authority, competence and financial and human resources. It shall be empowered to enforce legal requirements to issue, amend, renew, suspend or cancel licences or authorizations or to recommend such actions to the government. 

Applications for licences and for the renewal of licences is made on the approved form (FOD ASB1). 

A Public Enquiry, concerning the renewal of the plant licence, which was announced on 23rd December 1992 by a Press Release from the Prime Minister, referring to the handing-over... 

The specified time period during which an individual has to remain accident-free to be eligible for the bonus should be relatively short. Delayed rewards and penalties tend to be discounted, and are thus less effective in shaping behaviour than more immediate consequences. Periods as short as 1 month have been used in industry. In the cited California experiment, those drivers whose licences were coming up for renewal within 1 year after being informed of the incentive programme showed a greater reduction in accident rate than did people whose licences were not to be renewed until 2 or 3 years later (Harano and Hubert, 1974). 

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