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Abstract

SPL: KEY REQUIREMENT FOR REGULATORY

Pawbake Ganesh R, Dhut Mayur O, Sayyed Sadik F and Chaudahari Sanjay R

In the world of globalization people gets each & every information on internet by the utilization of different website, with the use of daily med website peoples were aware about all information of particular drug product & it is possible with the concept of structure product labelling (SPL). SPL is the key requirement for the regulated market. By keeping in mind the awareness of people in the medicines or drugs, health level seven (HL7) members approved or introduced the concept of SPL that has been adopted by the U.S. Food and Drug Administration (FDA) as a mechanism for exchanging medication information. SPL is also used by the FDA for the submission of other regulatory information supporting product labeling, specifically for establishment registration and labeler information.


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