National requirements

Comparative evaluation of international and national requirements both in the part of the volume and frequence of calibration procedures and examination of devices for ultrasonic and radiographic testing was accomplished. This review showed that procedures specified in national documents on testing and documents of EAL coincide very much. 

For many years, the method of obtaining foreign patent protection corresponding to a U.S. patent appHcation was to file separate, individual patent apphcations in selected foreign countries. Each of the appHcations had to be written to conform with the national requirements of the country in which it was filed. 

The differences with the existing automotive quality system requirements need careful examination. There are additions, deletions, and movements that users of QS-9000 Third Edition, AVSQ 94, EAQF 94, and VDA 6.1 1998 need to be aware of, as they affect not only supplier quality systems but the internal and external auditing practices. As the national requirements are not similarly structured comparisons are impossible to illustrate in a single table. Readers are therefore advised to compare specific text in each to discover the actual differences. The source of the requirements is depicted in the tables that follow. A dash (-) indicates that there is no matching requirement. 

There is no national requirement limiting NO emissions from the FCC flue gas, but several state and regional agencies have imposed limits on their release. These emissions are directly proportional to... 

O Tuberculosis (TB) is the most prevalent communicable infectious disease on earth and remains out of control in many developing nations. These nations require medical and financial assistance from developed nations in order to control the spread of tuberculosis globally. 

The Convention Number 50 of the European Treaty Series of the Council of Europe gives the European Pharmacopoeia legal recognition to provide harmonized specifications for medicinal substances or pharmaceutical preparations within the member states. Within the signatory countries, existing national requirements may be superceded as the EP standards are implemented (2). 

In the field of immunization, for example, an exceptionally low probability of a serious or lethal reaction seems to have become the latest national requirement. Smallpox vaccination was routine for almost all children several decades ago and considered extremely safe. Now many regard it as a dangerous procedure because of the possibility of disastrous results - severe complications or even death - in as few as one case in a million. 

Companies with experience in working systematically with substitution are in many cases actively promoting the inclusion of the principle in legislation. This is, for instance, seen in comments from companies to the European Commission during the REACH consultation in July 2003. Notably, companies with lengthy experience from national requirements embracing the substitution principle praise the legislative instrument, and promote its use in REACH. 

This "new" approach has been in use for many years in most European countries. Originally, each country had their own national requirements. Then, based on the work done by the lEC (International Electrochemical Commission), standards were harmonized through the work of CENEEEC (Comity Europ en de Normalisation Electrotechnique). Harmonized standards, published as European Standards (EN), have to be adopted by the participating countries as national standards. Some of the countries which have already adopted these are Belgium, Erance, Germany, and the United Kingdom. 

The active pesticide chemical is often less that 1% of the material applied these estimates do not include chemicals used to dissolve or carry the active pesticide chemical. Determining the amount used is difficult because there is no national requirement to report pesticide use. Commercial agriculture uses approximately 60%... 

The corresponding secretariats may have to add information essential to the understanding of the implementation of the texts (e.g., the description of an analytical procedure or of reagents that do not exist in the pharmacopeia) and a translation is added by the European and Japanese Pharmacopoeias. The style may be adapted to that of the pharmacopeia concerned or global style may be used. A pharmacopeia can add text, either to amplify some of the requirements with additional information or because national requirements and compendial policy dictate that the addition is necessary. However, there must be a clear indication that this additional information is not part of the harmonized document. This will avoid additional text being included after the harmonization process is completed, but will allow interested parties to review a complete text. The three pharmacopeias endeavor to publish the drafts simultaneously or as close together as possible. 

FAO United Nations Requirements of Vitamin A, Thiainine, Ribojfavin and Niacin Report of a Joint FAO-Who Expert Group, FAG United Nations, Geneva, Switzerland, 1967. http ZMwwfda.gov/ (United States Food and Drug Association). 

German national requirements for the certification of floor covering materials. 

The power supplies for all computer equipment must meet both the manufacturers requirements and safety national requirements for wiring, grounding, and radiation. 

Safety requirements vary from state to state and from country to country. All local and national requirements need to be checked and taken into account... 

A number of scientific bodies have quality programs or quality assessment services. These programs should be seen as an aid or external assistance and should never replace national requirements for internal quality control. 

Time constraints imposed by transport of test material to the test site that may involve permits from either the CDC or USDA, or other national requirements when test material or the contract laboratory is located outside of the United States. 

Records should be retained for at least three years unless another time frame is specified in national requirements. 

In the EEC, applications or notifications for clinical trials have to be lodged with the individual national authorities. A common procedure or even mutual recognition of clinical trial certificates does not exist. A list of the different national requirements is provided in "The Rules Governing Medicinal Products in the European Communities" Volume III, Annex 1. A discussion paper (III/ 3044/91) released in 1991 by the EEC Division for Pharmaceuticals (DG III) addresses various issues on the harmonization of approval of clinical trials and may eventually lead to common, non-binding recommendations. 

National Requirements for Registration of Medicinal Products Following EU Centralised Procedure ... 

Pharmaceutical regulation in the United Kingdom (UIQ has, since accession in 1973 to the European Union (EU), followed the requirements of the many directives that have been agreed in this field. Most of the pharmaceutical legislation now introduced in the UK emanates from the EU. Nevertheless, some specifically national laws still apply, and many national practices and procedures which have evolved over the yeeu s are specific to the UK. This chapter is intended to provide an overview of those key national requirements which are of particular relevcince to the pharmaceutical industry. The author has had personal experience of many of the practices, procedures, and regulations discussed nevertheless the reader is advised to consult the official texts and if necessary seek specific advice in the interpretation of current requirements. 

In the previous sub-section, we saw that c/////-elimi nation requires the two groups that are to be eliminated to be anti-periplanar to each other. If there is a deviation from this angle then a different mechanism is observed. 

Its implementation is easy in small countries due to centralization of management and ease of surveillance of this new form of accreditation by a national accreditation body. Due to the long-standing establishment of validation of food microbiological methods in some countries, the beginning of validation of water microbiological methods, and establishment of European standards for the validation of food microbiological test methods (Microval project), the flexible-scope type of accreditation must be adapted to certain national requirements, but could prove less complex than the standard requirements. 

Name of ethics committee/IRB (if applicable by local and/or national requirements) and details of contact person on the ethics committee/IRB (if applicable by local and/or national requirements)... 

Product registered or licensed in accordance with national requirements. 

---