Legal status and documentation

INPADOC (International Patent Documentation Center) is the most comprehensive tttbliographic database of scientific and technological patent documents in the world. The stock encompasses more than 26 miUion patent documents, more than 59 miUion legal status data, and about 10 million patent famihes (January, 2003). The database contains more than 35 milhon patent citations from 71 patent-issuing organizations (European Patent Office, World Intellectual Property Organization (WlPO)) and is updated weekly with about 40 000 new citations. 

These notified bodies have introduced a type of certificate without any legal status the component certificate, which is marked by a U following the certificate number. This document acts as a working instrument for a simpler handling of components like conductor bushings, terminal blocks or inspection windows. The notified body issuing such a component certificate herewith declares the conformity with the relevant Harmonized European Norm and the relevant type tests. Other notified bodies accept this document without asking for renewed type tests. In this way, components can be handled in a very efficient... 

Many of the organic materials mentioned in this book are covered by trade bans and conservation treaties. Some countries are not signatories to CITES yet have their own trade bans. It is therefore not possible to give completely up-to-date lists, as these can quickly change. It is advisable that anyone seeking to purchase any of the organic materials first checks their status, and if necessary obtains the appropriate legal documents. 

The special status of petroleum under normal use means that limited attention is given to monitoring of petroleum levels in the workplace or the environment. It is usually only in the case of accidental spills, pipeline breaks, or seepage from storage tanks that well defined legal requirements are in place that require record keeping and documentation. As a result, it is usually hard to make precise connections between the original petroleum products and the types of TPH materials encountered at NPL sites. 

The Synoptic document collects all the substances used for the manufacturing of plastic materials which were notified to the European Commission and which have been evaluated or are currently being evaluated by the SCF. It includes the SCF evaluations and the legal status of these substances at EU level. 

The USP methods contained in the monographs are considered validated. The USP states ... users of analytical methods described in USP-NF are not required to validate the accuracy and reliability of these methods but merely verify their suitability for use. Recognizing the legal status of the USP and NF standards, it is essential, therefore, that proposals of new or revised compendial analytical procedures are supported by sufficient laboratory data to document their validity. The Code of Federal Regulations also recognizes that USP methods are validated. The section on laboratory records [8] states Laboratory records shall include completed data derived from all tests necessary to assure compliance with established specifications and standards,... and further states if the method employed is in the current revision of the United States Pharmacopeia [or] National Formulary... and the referenced method is not modified, a statement indicating the method and reference will suffice [8]. 

These documents are called guidelines although they eventually have legal status in the USA. The principles behind them should be considered and applied where the guideline is not directly applicable... 

From a legal perspective, safety and health professionals should be aware that there is a significant difference among and between the legal statuses of these individuals working at the job site. Independent contractors, as the name implies, work independently within a contractual relationship and contract, usually written, to perform specific work activities. Contractors are independent and usually paid by the job or activity. Contractors are responsible for their own workers compensation, insurance, wages, taxes, and other federal, state, and local requirements. Safety and health compliance at the worksite can be a provision within the written contact document. Safety and health professionals usually cannot discipline for failure to... 

Because each country has its own patent laws, the precise meaning of the bibhographic data and the legal significance of the pubUshed patent document vary from country to country. The Patent Cooperation Treaty (PCT) provides a recommended code to distinguish the various types of documents and to simplify storage and retrieval of patent data (2), but the code is implemented differentiy by different countries. For example, in the United States an A-document in 1995 was a patent in the Nethedands, an A-document was a pubUshed unexamined appHcation. It is essential to understand each country s system to interpret the status of its patent documents. 

Direct access to electronic documentation and records should not be offered to the inspector/investigator. If direct access is requested by the inspector/investigator, the legal department should be informed. The inspector/investigator is not an employee of the company and would have to be properly approved, involving authorization, suitable training, and competency to have access. Such access could also violate the security (e.g., closed system status) of the company s computer systems. Similarly, inspectors/investigators should not be permitted to connect their own computer systems to pharmaceutical or healthcare companies systems. 

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