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Overview of Regulatory Scenario on Switch Mechanism for Over The Counter class in European Countries, and Assessing its Effectiveness on Self-Care Management

Gaurav Agnihotri, Sonal Shidhore, Abhijit Chile, Vijay Patil, Deepak Pandurang Belsare

Abstract


Short term self-medication has tremendous power in lowering the burden of medical practitioners. Responsible self-care allows everyone to maintain their healthcare status with limited involvement in obtaining guidance from other health care practitioners such as pharmacists, etc. Although most of the EU countries have adopted to formal procedure of switch to change the class from Rx to OTC category, still there are chances to harmonize the mechanism of switch process by means of rationalizing factors getting impacted due to diverse regulatory environment in each of those countries/markets. Assessing complexities in existing situation will help identify solutions for future to mitigate and lower the risks associated with regulatory diversifications. Giant markets like US, Australia, New Zealand, China, etc., have implemented categorization of drugs as prescription drugs and non-prescription drugs, the one which is recognized as, ‘Over The Counter’. And because of which these markets could provide patients speedy recovery by means of elevating standards of self-care management.

 

Keywords: Self-medication, over the counter (OTC), switch mechanism, regulatory environment 

 

Gaurav Agnihotri, Sonal Shidhore, Abhijit Chile et al. Overview of Regulatory Scenario on Switch Mechanism for Over The Counter class in European Countries, and Assessing its Effectiveness on Self-Care Management. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(2): 17–23p.


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