The National Procedure

Conceptually, this procedure for Community authorisations (also known as the centralised procedure) resembles a hybrid of the national procedure and the mutual recognition procedure, with the differences that first, the application is submitted to EMEA second, the dossier supporting the application undergoes a detailed assessment by the CHMP before approval in any Member State of the EU third, the applicant is provided with an opportunity to clarify any issues raised by any of the EU Member States fourth, the procedure naturally has an extended time frame but stUl with predetermined deadlines and finally, the applicant ends up with an approval or a refusal to market the product in all or any Member States of the EU. The centralised procedure is shown in Figure 17.2. 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

The institution of the new European licensing systems (centralised and de-centralilsed) in 1995 hcis brought about the most profound change in European pharmaceutical regulation since its inception. The scientific skills and the standards applied have undoubtedly risen, the leveling-off effect hcis been upwards rather than downwards. This is most evident in the new systems where the assessment reports are freely available, but it is edso likely to have affected the national procedures. Skills learned in the centralised procedure will also be applied to national applications. 

In line with Article 14 of Decree-Law No. 72/91 of February 8, as amended by Decree-Law No. 272/ 95 of October 23 the rules applying to variations to the terms of MAs of medicinal products authorised under the national procedure are hereby set out. This is made in agreement and harmony with the Community rules governing the same variations under the decentralised procedure. 

The initiation and management of multinational clinical trials in the EU therefore requires considerable coordination and effort. The centralized coordination of the national procedures is essential to make sense of the complexity, ensure consistency, and to avoid duplication of effort, thus saving time and money. Therefore, to transform the presently cumbersome disparate situation through the EU CT Directive into a single set... 

Since January 1995, in the EU there are two routes for authorizing medicinal products besides the national procedures ... 

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. 

The main purposes of the System of accreditation is to ensure reproducibility of measurements, harmonisation of rules and procedures of the National system of accreditation with guidelines of international organizations and national systems of different countries, creation of conditions for mutual recognition of the results of testing, calibration, attestation. 

The requirements to the test procedures, order and status of the approval are specified in international and national documents of western countries. 

In recent years, the three-level system of NDT experts certification, which corresponds to the EN 473, is being introduced m Ukraine The unified Rules of NDT Experts Certification will be introduced in the near future. This work is headed by the State Committee of Ukraine on Labour Safety), and with the aim of the most expedient transition to EN 473, the National Certification Committee of Ukraine on NDT was established by the initiative of US NDT TD. The Committee has the tasks of preparing the programs, procedures, questionnaires for carrying out the certification. It is a non-profit organisation which is in charge of the methodological issues of certification m the US NDT TD. 

Anyway, there have been two very hot topics in chemistry lately clay microwaves. Both have been shown to do remarkable things in preparative organic chemistry. And this article Strike has [58], has combined both to produce some stunning reductive ami-nations of ketones to final amine products. The procedure involves mixing naked ketone, the amine, some clay and some NaBH4 in a beaker and zapping it in the microwave for only a couple of minutes. That s it. The general procedure is as follows ... 

The terms green chemistry and environmentally benign synthesis have been coined to refer to procedures explicitly designed to minimize the for mation of byproducts that present disposal problems Both the National Science Foundation and the Envi ronmental Protection Agency have allocated a por tion of their grant budgets to encourage efforts m this vein... 

Several countries have developed their own standard test methods for cellular plastics, and the International Organization for Standards (ISO) Technical Committee on Plastics TC-61 has been developing international standards. Information concerning the test methods for any particular country or the ISO procedures can be obtained in the United States from the American National Standards Institute. The most complete set of test procedures for cellular plastics, and the most used of any in the world, is that developed by the ASTM these procedures are pubUshed in new editions each year (128). There have been several reviews of ASTM methods and others pertinent to cellular plastics (32,59,129—131). 

Each plant or laboratory should adopt definite rules and procedures for electrical iastahations and work. All iastahations should be ia accordance with the National Electrical Code (NEC) for the type of ha2ard, eg. Class I flammable gas or vapor Class II organic, metallic, or conductive dusts and Class III combustible fibers and the degree of process containment, eg. Division 1 open and Division 2 closed (67). Regardless of the flammabiUty of the materials ia the iastaHed operations, changes ia procedure involving use of such materials often occur, sometimes without concurrent alteration of the electrical iastaHation. 

This section covers only the tests that are essential on a completed motor, irrespective of the manufacturing procedure and stage quality checks. If ISO 9000 guidelines are assimilated, practised and enforced by a manufacturer so that a customer s trust is obtained, a final pre-despatch inspection by the customer may not be necessary. The customer, having gained confidence in the practices and Quality Assurance Systems of the manufacturer, may issue an authorization to the manufacturer to despatch the material under their own inspection certificate, rather than an inspection by the customer. We discuss below the test requirements procedure and the acceptance norms prescribed by various national and international standards for such machines and adopted by various manufacturers. 

Standard sampling instruments and procedures have been developed by OSHA with the assistance of the National Institute of Occupational Safety and Health (NIOSH). 

The mean time to failure of various instrumentation and equipment parts would be known from the manufacturer s data or the employer s experience with the parts, which then influence inspection and testing frequency and associated procedures. Also, applicable codes and standards—such as the National Board Inspection Code, or those from the American Society for Testing and Materials, American Petroleum Institute, National Fire Protection Association, American National Standards Institute, American Society of Mechanical Engineers, and other groups—provide information to help establish an effective testing and inspection frequency, as well as appropriate methodologies. 

The direct reduction of esters with diisobuty laluminum hydride in the presence of the Horner-Emmons reagent prepared from ethyl diethylphosphon-ofluoroacetate avoids the necessity to work with sensitive aldehydes in the olefi-nation procedure [72, 75] (equation 62) (Table 23). 

Certain commercial equipment, instruments, or materials are identified in this report to specify adequately the experimental procedure. Such identification does not imply recommendation or endorsement by the National Institute of Standards and Technology, nor does it imply that the materials or equipment identified are necessarily the best available for the purpose. 

Historically, it was pfrepd in a stamp mill by a procedure developed by the National Fireworks Co (Ref 1). This mill consisted of a solid block of granite in which 3 cup-shaped cavities had been cut. The stamps, which operated in the cavities, were fitted at their lower ends with cylindrical wooden blocks cut from a hornbeam tree. The blocks were replaced when worn... 

A further resolution of the higher oxidation states in aquatic systems occurred in 1978 when scientists at Argonne National Laboratory(20) and Oak Ridge National Laboratory(21) independently established the capability to identify Pu(V) as the oxidized form that exists in natural waters. Both methods are based upon preferential adsorption on finely divided solids. In the Argonne procedure, adapted from a Japanese method for determining Np(V)(22), Pu(IV) and Pu(VI) adsorb onto silicic acid while Pu(V) does not. The Argonne scientists also have shown that the oxidized form of plutonium in natural waters carries on CaC03 when it is formed by... 

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

---