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Restart Medicines List ITB No. ITB2019/04TItem numberDESCRIPTIONMandatory item for bidders, Administration Restricted use with full documentation route specifications providedCold chain (28C) or Cool
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How to fill out international non-proprietary name

01
Step 1: Start by obtaining the necessary information about the drug or substance that requires an international non-proprietary name (INN). This includes the chemical structure, pharmacological information, and any other relevant data.
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Step 2: Research existing INNs to ensure that the proposed name is not already in use. This can be done by consulting official databases or contacting regulatory authorities.
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Step 3: Follow the guidelines set by the World Health Organization (WHO) in their INN system. These guidelines outline the format and conventions for naming pharmaceutical substances.
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Step 4: Prepare a submission dossier containing all the necessary documentation, including the proposed name, supporting data, and any additional information required by regulatory authorities.
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Step 5: Submit the dossier to the appropriate regulatory authority or organization responsible for INN assignment. This can vary depending on the country or region.
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Step 6: Await review and feedback from the regulatory authority. They may request additional information or clarification during the evaluation process.
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Step 7: If the proposed name is approved, it will be included in the official list of INNs and can be used for labeling, marketing, and international communication.
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Step 8: Ensure compliance with any ongoing reporting requirements or updates regarding the INN. Changes to the INN may require further submissions or notifications.

Who needs international non-proprietary name?

01
Pharmaceutical companies: International non-proprietary names (INNs) are used by pharmaceutical companies to identify and differentiate their products in the global market. It helps in promoting the safe and effective use of medications.
02
Regulatory authorities: Regulatory authorities use INNs to ensure the accurate identification, labeling, and registration of pharmaceutical substances. It helps in standardizing the naming process and avoiding confusion.
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Healthcare professionals: INNs provide a common language for healthcare professionals to communicate about specific drug substances. It allows for better understanding and exchange of information.
04
Patients and consumers: International non-proprietary names make it easier for patients and consumers to recognize and understand the active ingredients in medications. It promotes transparency and informed decision-making.
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International non-proprietary name (INN) is a unique identification system for pharmaceutical substances.
The manufacturers of pharmaceutical substances are required to file international non-proprietary names.
International non-proprietary names are typically filled out through an application process with the relevant regulatory authorities.
The purpose of international non-proprietary names is to provide a standardized and internationally recognized name for pharmaceutical substances.
The information reported on an international non-proprietary name typically includes the chemical structure and properties of the pharmaceutical substance.
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