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Committee on Payments and Market Infrastructures Board of the International Organization of Securities CommissionsConsultative report Harmonization of critical OTC derivatives data elements (other
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01
Understand the purpose of harmonisation of critical OTC.
02
Gather all necessary information related to the OTC product.
03
Identify the critical elements that need to be harmonised.
04
Fill out the harmonisation form point by point, providing accurate information.
05
Double-check the filled-out form for any errors or missing details.
06
Submit the filled-out harmonisation form to the appropriate authority for review.
07
Follow up with the authority to ensure the harmonisation process is progressing smoothly.
08
Address any feedback or clarification requests from the authority promptly.
09
Once the harmonisation process is completed, keep a record of the approved harmonisation for future reference.

Who needs harmonisation of critical otc?

01
Manufacturers or distributors of OTC products.
02
Regulatory authorities responsible for ensuring the safety and quality of OTC products.
03
Healthcare professionals who prescribe or recommend OTC products to patients.
04
Consumers who rely on OTC products for self-medication or general wellness.
05
International organizations involved in regulating or standardizing OTC products across multiple countries.
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Harmonisation of critical OTC refers to the process of standardizing regulations and practices concerning over-the-counter (OTC) products that are deemed critical for public health and safety across different jurisdictions.
Entities involved in the manufacturing, distribution, or sale of critical OTC products are required to file harmonisation of critical OTC, including pharmaceutical companies and healthcare organizations.
To fill out harmonisation of critical OTC, one must gather required data, complete the relevant forms accurately, ensuring that all necessary information is included, and then submit them to the appropriate regulatory authority.
The purpose of harmonisation of critical OTC is to ensure consistency in the regulation of OTC products, improve safety and efficacy, facilitate trade, and enhance public health protection.
Information required includes product details, safety data, efficacy evidence, manufacturing processes, labeling information, and any relevant compliance documentation.
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