Licensing of new medicines

Eurther to this directive, the European Medicines Agency (EMEA) began, in 2001 [98], to outline a feasible risk assessment scheme, which was later published in a draft form in 2003 [50] in 2006 [51], the following five-step procedure was adopted, with a view to guaranteeing that possible long-term and low-level effects of the new substances are not overlooked this procedure is also used in the licensing of new compounds (including pharmaceuticals). 

In this section, a brief summary of the nature, frequency, and consequences of adverse drug reactions (ADRs) in two clinical situations is presented. There are ADRs experienced by healthy volunteers and patients participating in clinical studies with potential new medicines and those experienced by patients who are prescribed licensed medicines. A review of these two situations points to areas of success with the current practices for non-clinical safety pharmacology testing but also identifies some areas where further research might lead to new or better safety pharmacology tests. Prior to reviewing the literature, some... 

The other fundamental reason for organising clinical trials before a new medicine is licensed for widespread clinical use is that the effects of the medicine must be thoroughly assessed in patients with the illness that it is intended to treat. Because the response varies between individual patients and is affected by the situations in which the medicine is used, it is desirable to evaluate the medicine in groups of patients who represent a range of circumstances and to deduce from these trials the overall response. 

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... 

The Scottish Medicines Consortium (SMC) was established in 2001 with the remit to provide advice to NHS Boards and their Area Drug and Therapeutics Committees across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. The SMC process (full details of which are available on their website http //www.scottishmedicines.org.uk/) requires pharmaceutical companies to complete a new product submission form. The aim is to make a recommendation soon after the launch... 

And what can consumers or patients do Fear all medicines they come across No, counterfeit medicines are not invariably present in all pharmacies and hospitals. Consumers should learn to go back to their pharmacist or their doctor when they feel that the medicines they regularly takes seem to work differently, when a new medicine does not work as expected, or every time they experience a side effect. In most cases there will be no counterfeit medicine to blame. However, it is important that patients know what to do when they have a doubt about a medicine. Consumers should always purchase medicines from the officially licensed outlets as there is evidence that the incidence of counterfeits medicines is much lower in licensed outlets. 

Prior to the global consolidation of the pharmaceutical industry in the past decade, compulsory licenses had been routinely used in North America and Europe to facilitate the distribution of new (generic or not) medications. The use of generic medicines, in turn, has resulted in important economies for the public healthcare system, thereby contributing to its viability and the protection of public... 

There is no licensing or specific approval procedure for medical devices in New Zealand. Section 38 of the Medicines Act 1981, however, places restrictions on the sale of medical devices and details the powers of the Director-General of Health to request evidence on the safety of any device from the importer or manufacturer, and to recall any product from sale if necessary. Regulations 10 and 12 of the Medicines Regulations 1984 control the advertising and labelling of medical devices. 

The legislation requires the licensing of all premises in New Zealand used for the manufacturing, packing and labelling and wholesaling of medicines. Persons who hawk prescription, restricted or pharmacy-only medicines (i.e., medical representatives) must also be licensed. 

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