National health authorities

In the years that followed, cooperation between national health authorities at European Union level was further encouraged. Directives 83/570/EEC [5] and 87/22/... 

The European system is based on cooperation between the national health authorities of the member states and the EMEA. The latter aets as a focal point of a network whieh eoordinates the seientific resources made available by the member states. This partnership between the EMEA, national health authorities, and the European Union institutions is erueial to the functioning of the European authorization procedures. 

Before submission of the dossier, the sponsor company contacts the CPMP or CVMP to annoimce its intention to submit a registration and to request the appointment of a rapporteur. If, as is usually the case, the sponsor has had contact with national health authorities, they may request that a particular CPMP or CVMP member be appointed as rapporteur. The CPMP/CVMP is not obliged to follow this request, but in many cases either the rapporteur or the corapporteur is the CPMP/ CVMP member requested. 

Private philanthropy occupies an important place in the past and present of global health. For example, the Rockefeller Foundation has made significant contributions to public health, and the Bill and Melinda Gates Foundation has made major investments in this regard over the past 15 years. While these contributions are welcome, they cannot and will not form the basis of concerted global public sector action to control an entire class of infectious diseases. Private philanthropy is, by definition, not accountable to the public in the way that action undertaken by the public sector is. It is neither fully transparent nor predictable, nor is it subject to the checks and balances that come from engaging in multilateral cooperation involving national health authorities that are accountable to their citizens. 

Most national health authorities now recommend increased potassium consumption, along with their advice to cut back on sodium. That s true for the U.S. Dietary Guidelines Advisory Committee the National Academy of Sciences Food and Nutrition Board the National Heart, Lung, and Blood Institute of the National Institutes of Health the American Heart Association Health Canada and the Australian Heart Foundation. The reason for this unanimity is simple the science just can t be denied. Potassium is a chemical element that helps to maintain normal functioning of muscles, the heart, and the nervous system. Potassium is a major regulator of blood pressure. 

The Decentralized Procedure is made on the basis of mutual recognition. Council Directive 93/39/EEC has been implemented in all member states in accordance with Directives 65/65/EEC and 75/319/ EEC. The sponsor makes a submission to the national health authority of one member state, with a request to assess the dossier for mutual recognition. Within 210 days, the so-called Reference Member State (RMS) must approve the application, prepare an assessment report, and agree on an SPC. The clock may be stopped to obtain further information during this time. 

The Ministry of Health (MOH) is the central national health authority for healthcare, health protection, curative spas, curative centres, health education and pharmacy care. The state secretary has a function as a vice-minister. The MOH consists of the office sections and departments that are responsible for different MOH activities. The MOH directly governs more than 350 hospitals, institutions and healthcare facilities. 

Pubhc awareness can be raised by the national health authorities, non governmental organizations notably professional medical societies, patients associations and foundations. Special alert days are very efficient. The use of audiovisual and printed media via TV programmes and press are indispensable for diffusing the information to the public and particularly individuals under risk. Finally education at any level at schools is the master goal of the strategic planning in this field. 

As a consequence of the new legislation for clinical trials, documentation on the quality and preclinical (i.e., toxicological) data of investigational medicinal products, including radiopharmaceuticals, needs to be submitted to obtain approval from the national health authorities in the member states prior to initiating a clinical study in humans. Furthermore, all clinical trials which started in the European Union after 1 May 2004 need to be recorded in the European EudraCT database (European Commission 2003 b). 

The manufacturer must carry out on-going real-time stability studies to substantiate the expiry date and the storage conditions previously projected. The data needed to confirm a tentative shelf-life must be submitted to the registration body. Other results of ongoing stability studies are verified in the course of GMP inspections. To ensure the quality and safety of products with particular reference to degradation, national health authorities should monitor the stability and quality of preparations on the market by means of a follow-up inspection and testing programme. 

Administrative measures of national health authorities should be directed towards the application of these standards in practice, and any new or amended national regulations for good manufacturing practice should at least meet their level. 

The Brazilian National Health Authorities (AgSncia Nacional de Vigilancia Sanitaria - ANVISA) has revoked the current stability guideline [22] and replaced it just 9 months later with a new document [23], which came into effect on 1 August 2005. 

The list will be decreased as a result of the implementation of new directives, such as the European Biocide Directive that will be fuUy implemented by 2010. The use of biocides in paper production is often further limited by national health authorities, e.g. FDA (USA) and BfR (Europe) for food packaging paper, as well as green label lists such as White Swan. A list of substances used to control microbiological growth on a paper machine is given below ... 

Medical handling in an emergency situation is normally divided into medical care on-site (more often for workers) and off-site (for workers and affected population). To organize the off-site medical response, it is recommended that a system of off-site mechcal assistance for radiation emergencies be established under the supervision of national health authorities, i.e.. Ministry for Public Health. The general structure of such a system is shown in Fig. 9.6. 

For food packaging applications, both additives and polymers need specific toxicological regulations from national health authorities. Because of severe requirements concerning safety, the demand for low-dust versions of additives is steadily increasing, to reduce to a minimum any contamination of human beings on handling. 

The follow-up of the meeting will include communicating its conclusions to national health authorities and to the public. Close contacts need to be made with the salt industry, to optimize the preparation, utilization and monitoring of iodized salt, and with the food industry, especially regarding the diets of pregnant and lactating women and of neonates. Most important, every effort should be made to advance international action and national policy strategies toward the eradication of IDD in Europe by the year 2000. 

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