Submitting reports

The oil company will also be required to periodically submit reports to the national oil company (NOG) or government, and to partners in the venture. These typically include ... 

Contractors/subcontractors shall prepare and submit reports of the work as required. This may include daily technical reports, invoices, or other documents. 

Secondly, stmctural features in dmg regulation in countries operating a federal system of government affect the ability of the DRA to monitor dmg distribution throughout the entire country. In Australia, authority over distribution channels is fully delegated to the individual states. As a result, the TGA does not have the authority to assess and control the dmg distribution situation for the whole country. In contrast, the Pharmaceutical Services Division in Malaysia appoints a deputy director of health in each of its 13 states with power to issue licences, carry out inspections and submit reports. Under this arrangement, command and control may be exercised and an official channel established for information flow between the federal and state governments. 

To report an error, practitioners may phone USP toll-free at 1-800-23ERROR. A voice-mail system allows a report to be left 24 hr a day, seven days a week. Callers may submit reports anonymously, or speak directly to one of USP health professional staff. Alternatively, a report may be submitted to USP in writing. Report forms (Fig. lA and B) may be obtained by calling USP directly or via an on-demand faxback system. Practitioners may also employ the form online on the USP website. 

To invite from the manufacturer or other person developing or proposing to market a drug in the United Kingdom, any reports they may think fit on the toxicity tests carried out on it to consider whether any further tests should be made and whether the drug should be submitted to clinical trials and to convey their advice to those who submitted reports. 

Taking into accoimt the safety and efficacy of each drug, and the purposes for which it is to be used, to consider whether it may be released for marketing, with or without precautions or restrictions on its use and to convey their advice to those who submitted reports. 

Pharmaceutical companies are now required to report all serious suspected ADRs to the CSM within 15 calendar days of receipt of the original information by the representative or other appropriate employee. Companies are also now obliged to submit reports received from all health professionals... 

Because of the problems that resulted from self-regulation, another law, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was approved in 2006. This law requires manufacturers, packers, or distributors of supplements to submit reports of serious adverse events to the FDA. Serious adverse events are defined as death, a life-threatening event, hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, or an adverse event that requires medical or surgical intervention to prevent such outcomes based on reasonable medical judgment. If this requirement were enforced, and consumers cooperated, these reports would make it possible to identify trends in adverse effects and would help to alert the public to safety issues. 

Safety reports Applicants are required to submit reports of any adverse experiences associated with the use of the product. Safety reports should also bring to the agency s attention any trends resulting from product use, even if they are expected and not very serious. Any correlation between manufacturing and quality problems and these trends should be presented in the safety and annual reports as well. 

Progress Report The progress report summarizing any actions (successful or unsuccessful, complete or in progress) since the last submitted report (14 months after initial Orphan-Drug Status or 12 months after the last Annual Report). If no action has been taken, a statement to that effect should be included. 

In the initial mixed zooplankton experiments, Long et al. (submitted) found that crustacean mesozooplankton, dominated by adult copepods A. tonsa and P. pelagicus, significantly suppressed colony formation. In other experiments, Long et al. (submitted) found that infochemical cues alone from the mesozooplankton A. tonsa alone suppressed colony formation. Long et al. (submitted) also observed that the colony suppression effect of A. tonsa was density dependent. In experiments with the microzooplankton Euplotes spp., Long et al. (submitted) reported that info-chemical cues from this ciliate enhanced P. globosa colony formation. 

In November 2006, the Government of the Russian Federation issued a decision requiring importing and exporting companies to submit reports on their trade in narcotic drugs, psychotropic substances and precursor chemicals and requiring manufacturers, producers and retailers to submit reports on the respective quantities produced, manufactured, supplied, sold and in stock. 

Accident Reports. Each subcontractor must submit reports on every losttime accident. The Construction Manager must participate in the investigation of major accidents and insure that reports on all accidents are promptly filed and kept as protection against potential future legal action. 

Note Submitted reports, such as References 5 and 7, are available upon request. 

Q. Who is required to submit reports on a monthly basis of each transaction conducted during the previous month involving ephedrine, pseudoephedrine and phenylpropanolamine products ... 

Submitting Reports of Clinical Studies on Food Ingredients... 

FDA representatives thus went through a minute deconstruction of Ay-erst s application. The company had submitted reports of eight controlled double-blind studies, involving 123 patients. Repeating criticisms articulated in... 

Like the AMA s Council on Drugs, the FDA initially found it difficult to convince physicians and hospital administrators to submit reports of adverse reactions. FDA officials resolved issues of data analysis that plagued the AMA by developing formal methods to codify and compare reports of adverse reactions. Agency officials soon recognized that too much data in a given case complicated... 

ISMP—Spain publishes information about submitted reports on their web site www.usal.es/ismp and includes safety recommendations designed to help reduce the probability of such errors recurring. The goal is to make this information readily available to healthcare professionals. 

Only the PMA applicant on record with the FDA may amend, supplement, or submit reports to their PMA, unless the PMA includes the original and not a copy of an appropriate letter of authorization from the applicant permitting another person to submit information on behalf of the applicant. 

For nuclear attacks, only designated observer units will submit reports to division NBCCs (NBC centers). All other units will be prepared to send the information, if requested. 

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