Licensing, Division of

Once the PDMA review is completed, the result is reported to the Evaluation and Licensing Division of MHLW. The report is then consulted to the Pharmaceutical Affairs Section of Pharmaceutical Affairs and Food Sanitation Council (PAFSC). Upon positive advise from PAFSC, the minister of MHLW grants the approval. 

The JP secretariat is part of the Evaluation and Licensing Division of the Pharmaceutical and Medical Safety Bureau of the Ministry. The secretariat works under the scientific and technical support of the National Institute of Health Sciences (NIHS). The Pharmaceutical and Medical Safety Bureau is a new... 

In the United Kingdom, the post-licensing division of the MHRA deals with all reclassification requests. By law, all medicines are P unless they meet the criteria for POM or GSL. Pack size restrictions for GSL products are listed in the Medicines (Sale or Supply) (Miscellaneous provisions) Regulations 1980. For all licensed medicines, legal status is ultimately determined by the MA. 

Another follow-up meeting is organized between the reviewers and the specialists, and a second review report is finalized. The report is transferred to the Evaluation and Licensing Division of the PFSB. After a careful reading, the report will be circulated to the Committee on New Drugs ofthePAFSC. 

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

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U. S. Atomic Energy Commission, Conditions and Limitations on the General License Provisions of 10 CFR 150-20, Rules and Regulations, May 1, 1964, Division of Materials Licensing,... 

Work performed under the auspices of the Office of Basic Energy Sciences, Division of Chemical Sciences, U.S. Department of Energy under contract number W-31-109-ENG-38. Accordingly the U.S. Government retains a nonexclusive royalty-free license to publish or reproduce the published form of this contribution or allow others to do so, for U.S. Government purposes. 

Syntex licensed norethindrone to Parke-Davis for development. Eventually, Parke-Davis decided not to market it because of fears about a possible boycott of their other products by groups who were opposed to birth control. Searle had no such concerns and brought its pill to the market in 1960 under the name Enovid. In the meantime, Syntex was forced to find another partner and finally settled on the Ortho division of Johnson Johnson. The norethindrone pill was first marketed in 1962 under the name Ortho-Novum. By 1965 the pill" was the most popular form of birth control. 

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