Regulatory license

In Vivo Rx Europe. Norwalk, CT. Windhover Information Inc. Monthly. Online publication. Publication from the European point-of-view. Covers public and private companies with emphasis on strategic issues affecting European executives in business development, marketing and sales, R D, regulatory, licensing, and finance. 

No cost estimates were included for plant regulatory licensing permits. 

Manual of standard operating procedures and policies. Regulatory- License applications complete review and issuance of action letters. SOPP 8405. Center for Biologies Evaluation and Research, Eood and Drug Administration Rockville MD, 2003. 

There is no formally established consensus on what constitutes "validation" of codes or at least consensus on the validation process. However, there are general principles commonly used for code validation which reflect an agreed international practices. Code verification is required to review and accept the code source coding relative to the code description provided by supplier. In general, industry sponsored codes have been subjected to stringent verification procedures as a consequence of the regulatory licensing process. 

Clarification ofTMIMction Plan Requirements Report No. NUREG-0737, U.S. Nuclear Regulatory Commission, Division of licensing, Washington, D.C.,Nov. 1980. 

There are no PSA requirements for licensing the current generation of nuclear power plants, i (PRA to the NRC) has been a tool for regulatory decisions b]... 

Regulatory programs tliat promote prevention through mechanisms such as codes, licenses, and permits... 

The Food and Drug Administration (FDA) also accept submissions prepared according to the CTD format. However, they have not directly incorporated the CTD format into US regulatory requirements, which are detailed in Title 21 CFR, Part 514.50 in the case of a New Drug Application (NDA), or Title 21 CFR Part 601.2 (a) in the case of a Biologies License Application (BLA). Rather, they have introduced the CTD format via Guidance for Industry documents. The correlation between the requirements in 21 CFR Part 514.50 and the CTD format is shown in Table 6.2. 

This rule varies from state to state. Some materials are exempt from Nuclear Regulatory Commission or State licensing requirements. Most institutions already have an institutional license which would specify the safety officer. It would be well for the clinical chemistry laboratory to check with this individual before beginning to use radioactive materials. If there is no license, many manufacturers of isotope materials will assist the laboratory in obtaining the proper license. 

Regulatory functions include licensing of persons, premises and practices, inspection of pharmaceutical establishments, product assessment and registration, QC, control of dmg promotion and advertising and monitoring of ADR. 

This section briefly summarizes the licensing system in each of the 10 countries, focusing on the power the dmg regulatory authorities in each country have over pharmaceutical facilities the sources of that power and the licensing process. 

The lack of human resources is a major constraint for dmg regulatory authorities in all 10 countries, and the licensing function is no exception. Some countries have sought to... 

Human resources management systems for inspection differ among countries. In Australia, the same group of personnel is responsible both for licensing of manufacturers and for GMP inspection. In Cypms, Tunisia, Venezuela and Zimbabwe, GMP inspectors also carry out other dmg regulatory functions. One of the results of such an arrangement is that the different functions must compete for the employees time. Cuba, Estonia and Tunisia employ both full-lime and part-time inspectors for both functions. Other countries have full-time employees only. 

The Australian TGA is by far the largest in terms of the number of staff Venezuela and the Netherlands rank second and third, respectively. Cypms has the smallest number of registration staff—two pharmacists and three administrative staff—who are also responsible for licensing and GMP inspection. Of all the dmg regulatory authorities, only those of Australia, Cypms and Tunisia have more administrative staff than professional staff The dmg regulatory authorities of Estonia, Uganda and Zimbabwe do not employ administrative staff for the registration unit, and it is not clear whether administrative matters are handled by the professionals. 

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