National authority designation

National authority responsible for monitoring the market means the national authority designated by the member state and required by it to check the conformity of product placed on the Community or national market with the applicable Community or national legislation ... 

The priorities and the program of activities of REMPEC are decided biennially by the contracting parties themselves, taking into consideration the recommendations and proposals made to them by REMPEC s Focal Points. These are the national authorities designated by their respective governments responsible for preparedness, response, and mutual assistance in cases of accidental marine pollution. 

States Parties are required to designate or establish a National Authority to ensure the effective implementation of the CWC. The National Authority makes the initial and subsequent annual declaration on chemical weapon stocks or facilities, coordinates and participates in the receipt of OPCW inspections of industrial and military sites, participates in assisting and protecting member states under threat or actual chemical attack, and promotes the peaceful use of chemicals. The National Authority is thus the focal point in a country s interaction with other countries and the OPCW. The Technical Secretariat of the OPCW helps in the provision of advice, assistance and capacity development of relevant skills and expertise in the staff of national authorities. The secretariat also hosts and coordinates regular meetings of the national authorities from all over the world. 

The RevCon confirmed the essential role of national legislation for the proper functioning of the Convention. It called on States Parties that had not already done so to, inter alia, designate a National Authority and inform the OPCW by the eighth regular session of the CSP (in October... 

In 1968 the IAEA with the participation of WHO conveyed a panel of experts to discuss the dosimetric requirements of radiotherapy centres. The panel recommended the setting up of dosimeter calibration centres (later called Secondary Standard Dosimetry Laboratories—SSDLs) in developing countries. In 1974 experts, mainly from the large national standard laboratories, discussed the concept of SSDLs and their role in metrology. An SSDL was defined as a laboratory designated by the competent national authority to undertake dosimetry calibrations. For the proper function of the SSDLs, the need for dose intercomparison and for coordination of the work of individual laboratories was recognised. This ultimately led to the establishment of the international lAEAAVHO Network of SSDLs. 

Under the EUs Mutual Recognition agreement, apphcant companies can achieve multistate clearance within Europe after just one member state approves their product. This decentralized approach enables apphcants to choose which national authority will handle preregistration documents and to designate where and when subsequent marketing authorization will be sought (specified countries versus the pan-European mandate). 

In addition, Article VII sets out obligations regarding the relationship between the State Party and the Organization for the Prohibition of Chemical Weapons. This includes the requirement to designate or establish a National Authority to serve as the national focal point for effective liaison with the Organization and other States Parties. 

Explicit consent to the import has been sought and received by the exporter through his designated national authority and the designated national authority... 

Each SIS performs one or more safely instrumented functions (SIF), by using some electrical, electronic, or programmable electronic technology. Design and operation must follow the requirements in lEC 61508 (1998) and lEC 61511 (2003), two standards that have been widely adopted by the national authorities for the oil and gas industry. lEC 61508 is a generic standard on SIS design and construction, while lEC 61511 addresses SIS applications in the process industries. 

Internal coordination at country level is affected by a MAP national focal point, while national authorities might also be designated as focal points to maintain liaison with individual components of the Plan. 

Competent authority shall mean any national or international regulatory body or authority designated or otherwise recognized as such for any purpose in connection with these Regulations. 

All information and documents given to or obtained by [the National Authority] pursuant to the Convention, this law or its implementing regulations shall be evaluated in order to establish whether they contain confidential information. Infonnation shall be considered confidential if it is so designated by the natural or legal person to whom it relates or from whom it has been received. It shall also be considered confidential if its disclosure could reasonably be expected to cause damage to the person it relates to or from whom it has been received or to the mechanisms for implementation of the Convention. 

This book does not specify minimum levels of performance to be achieved by individual barriers. National authorities may find it prudent to specify such performance levels in order to permit the timely design and development of certain engineered barriers. 

Use of a suitable standard report form allows the collection of information in a uniform way. The design of the report form is important. As the forms will usually be completed at site level it will assist site staff if they are only asked to give information which is likely to be readily available to them -social security numbers and other personnel information may be restricted, or held elsewhere. The penalty for using a format calling for answers that site staff cannot provide can be delays in the return of forms. Whatever detail is asked for, and whatever the final design of a report form, it will be helpful to require at least those answers to be given which are required by local or national authorities, when notifying them in turn. 

As with any device or material intended for use in medicine, medical adhesives cannot be sold for clinical use without regulatory clearance from the relevant national authority. This is to ensure, as far as possible, the safety of the product for the designated indication or indications. Different countries impose different requirements on products, which also depend on the nature of the device or material and its intended use. These frequently require extensive testing, both preclinically on animals and clinically in carefully controlled studies on humans, as well as the provision of other safety data. Because of the different regulations, products maybe found on sale in one country but restricted in others. 

Applicants should designate to the national authority a unique identifier for their product, at the latest, at the time of application for the first commercial approval. 

The national authority should, at the time of the first approval for commercialisation, notify the OECD BioTrack Product Database of the designated unique identifier, in order to enable access to the relevant information in the database for all subsequent applications for commercialisation in other countries. 

The unique identifier should include the applicant information of 2 or 3 alphanumeric digits (for example, the first 2 or 3 digits of the applicant organisation name), followed by a dash. Any new applicant that is not identified within the database shall not be permitted to use the existing codes listed in the applicant s code table within the database. The applicant shall inform the national authorities who will update the BioTrack Product Database, by including a new code that will be designed to identify the new applicant in the code table. 

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