National authority

Where conformity assessment involves intervention of third party, that task is normally carried out by the notified body. The pressure equipment directive enables in addition the national authorities to authorise in their territory user inspectorates for the carrying out of conformity assessment procedures which relate to product verification. These inspectorates shall act exclusively on behalf of the group of which they are part. The placing on the market and putting into service of equipment which has undergone such assessment is however limited to the territory of the authorising Member State and to those Member States which have also proceeded to such authorisation. The equipment concerned shall therefore not bear the CE-marking. 

Evaluation of applications for drug marketing authorisations made either directly to the national authority or indirectly via the centralised procedure to the EMEA... 

The regulations also address the need to ensure that drug information provided by pharmaceutical firms is truthful, balanced, and accurately communicated. As such, it must be consistent with the indications for use and the established performance and limitations. In Europe, the directives do not impose a specific requirement to review advertising or promotional material before it is released. Acceptable standards may be achieved via voluntary codes of practice and self-regulation. However, national authorities must monitor such material and should have the power to act where the need arises. In the U S, the F DA must vet advertising and promotional material before it is released. 

In-process quality control is the control exercised over starting materials and intermediates. Its importance stems from the opportunities that it provides for the examination of a product at the stages in its manufacture at which testing is most likely to provide the most meaningful information. The WHO Requirements and national authorities stipulate many in-process controls but manufacturers often perform tests in excess of those stipulated, especially sterility tests (Chapter 23) as, by so doing, they obtain assurance that production is proceeding normally and that the final product is likely to be satisfactory. Examples of in-process control abound but three of different types should suffice. 

While delegation of regulatory authority is found in all types of government, it is most far-reaching in countries with a federal system. Usually, full authority is delegated from the federal or central level to the states. If this is not properly coordinated, there will be problems of accountability. Such arrangements can also affect the national authority s... 

In 1975 the World Health Organization produced a guideline for the establishment, maintenance and distribution of chemical reference substances (WHO 1975). This document was intended to foster collaboration and harmonization of approval for the provision of reference substances by national authorities and organizations responsible for reference substances collections. This guideline was revised in 1982 (WHO 1982) and a further revision was completed more recently (WHO 1999) to take into account progress in pharmaceutical analysis. The latest guidehne defines both primary chemical reference substance and secondary chemical reference substance as follows ... 

A national authorization may be granted providing that the a.i. has been included in the positive Community list of a.i. (Annex I to the Directive), and the uniform principles for evaluation are applied, as defined in Annex VI to the Directive. 

This safety check is in the first approach a check the responsible manufacturer or importer has to do in his own responsibility. In a second approach, it is to some extent also a check which is done by the competent authorities, especially the European Chemicals Agency (ECHA) and the national authorities. 

None of the solutions mentioned in the above lines will be forthcoming from any invisible hand , nor can it be decided by one state as a corrective measure against market failures, because national authorities lack the capacity to impose regulations beyond their national borders. The way forward should be along the lines of an international agreement between countries, promoted and guaranteed by international bodies such as the WHO and the World Trade Organization (WTO). 

The system requires a level of confidence by the various regulators in the individual tests used in all the other countries of the Community, which in the short time is unlikely to be achieved. National authorities cannot be expected to accept materials on the basis of tests they do not know, nor understand, and which are conducted in foreingn laboratories. Currently they do not accept tests to their own national Standards from other countries. 

The mutual recognition procedure is an alternative means by which a marketing authorization may be sought. It is open to all drug types except products of biotechnology. Briefly, if this procedure is adopted by a sponsor, then the sponsor applies for a marketing licence not to the EMEA, but to a specific national regulatory authority (chosen by the sponsor). The national authority then has 210 days to assess the application. 

If adopted by the national authority in question, the sponsor can seek marketing licences in other countries on that basis. For this bilateral phase, other states in which marketing authorization are sought have 60 days in which to review the application. The theory, of course, is that no substantive difficulty should arise at this stage, as all countries are working to the same set of standards as laid down in The Rules Governing Medicinal Products in the European Union . 

Previous production of pentachlorophenol, as well as the bleaching process in pulp and paper mills, has been shown to be a major source. Changes in industrial processes have resulted in a reduction of PCDD/PCDFs concentration in products. Whereas in the past the chemical industry and, to a lesser extent, the pulp and paper industry were considered to be the main sources of PCDD/PCDFs (and also the cause of many of today s contaminated sites in several industrialized countries), today s dioxin input is mainly due to thermal processes. There is still a considerable focus on waste incineration but, owing to requirements for dioxin reduction in stack gases set by several national authorities, the importance of this category has declined during the last years. Examples can be seen especially in the European emission inventories... 

A study of the perceived trustworthiness of different sources of information about food safety was reported in the Eurobarometer (1998). It indicated the trust in consumer associations was the highest, followed by national authorities. Overall, sources of information about food safety were least trusted from producers, companies, and market venders. Following is the percentage of respondents perceiving each of the information sources as completely trustworthy ... 

We have a U.S. sytem which could satisfactorily resolve the conflict. I propose that we take the approach of permitting confidentiality claims for the identity of an existing substance, if they can be justified to the national authority, such as a ministry of the environment, which will consider whether confidentiality reasons are sufficient to merit excepting that item from inventory requirements. 

The national authority which is processing the information for EINECS could refuse the claim, in which case the firm must either allow for disclosure or use available remedies to appeal — or not use the material within the EEC in order to preserve confidential status elsewhere. Or the national authority could accept confidentiality, and could insist that it be told immediately upon public disclosure (or patent issuance disclosure) of the material s existence. 

In general, the registration process in the EU allows one to either apply to an overall medicines authority or to an individual national authority. Either of these steps is supposed to lead to mutual recognition by all the individual members. 

Purity criteria are published by JECFA as well as by national authorities. The JECFA specifications33 may be endorsed by the Codex Alimentarius as advisory specifications which means that they are equivalent to a Codex Alimentarius standard. In the EU a directive laying down special criteria of purity for sweeteners for use in foodstuffs with subsequent amendments sets the purity standards,31 while in the USA criteria may be listed in conjunction with the approval. Normally a monograph of the Food Chemicals Codex34 is considered the applicable basis for assessment of purity. 

Food additives in general and sweeteners in particular are extensively tested for their safety before approvals are granted. Safety studies follow some general guidelines and rules, but are specifically adapted to the properties of the single products. For the common intense sweeteners the acceptable daily intake levels as allocated by international agencies and national authorities are in most cases fully sufficient to cover common food habits. 

The use of food additives is restricted in all European countries by national order concerning food additives, only those antioxidants specially mentioned are allowed to be used. The antioxidants may only be used with the foods mentioned and in the amounts specified. The veterinary service and national food agencies or other national authorities have supervisory powers. 

National Authorization Procedure To obtain marketing authorization in a country, the application must be submitted to the Competent Authority of that... 

Abridged National Authorization Procedure This procedure is for generics, and there is no necessity to provide preclinical or clinical results. However, evidence of bioavailability and bioequivalence and GMP manufacturing compliance has to be submitted. If the applicant has an abridged approval from a member state, the Mutual Recognition Procedure can be used. 

Within the frame of the EMEA, members of the CPMP and CVMP act independently of their nominating member state. The scientific committees are aided by a network of about 2300 European experts, nominated by the appropriate national authorities of the member states on the basis of proven experienee in the assessment of medicinal products. Experts may serve on working parties or expert groups of the CPMP or CVMP. 

This working party considers safety-related issues at the request of the CPMP and national authorities, resulting in the harmonization of the summary of produet eharae-teristics and package leaflets of marketed products. Regular videoeonferenees are held with the U.S. Food and Drug Administration (FDA) to discuss issues of mutual interest. A pilot project has been started for the electronic transmission of individual case safety reports with a restricted number of participants from national authorities and marketing authorization holders. 

A sponsor company or a national authority may make referrals to the EMEA imder Article 10 of Directive 75/319/EEC, in order to harmonize the summary of product characteristics in all member states for products previously approved rmder national legislation. 

Similarly, where there are public health concerns as a result of pharmacovigilance data, nationally authorized products or products authorized by the mutual recognition procedure may be referred rmder Articles 12 or 15 of Directive 75/319/EEC. The CPMP/CVMP gives an opinion on variation, suspension, or withdrawal of the marketing authorization in such cases. 

This directive is concerned with the authorisation and the placing on the market of biocidal products. It attempts to establish a list of active substances that may be used in biocidal products within the EC. In order to assess which substances should be included in the list, a system of registration, authorisation and periodic evaluation is legislated with this Directive. Once approved, active substances will be incorporated into Annex I of the directive. The system of registration is created for active substances, which pose a low riskfor humans, animals and the environment and will be incorporated in Annex lA. In Annex I B so called basic substances such as are listed. For products of higher concern, usually not an active substance, an authorisation system is established, that includes the formulation of dossiers on these products which need to be submitted to the respective national authority. In Annex I B... 

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