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This document provides a comprehensive review of International Nonproprietary Names (INN) for biological and biotechnological substances, detailing policies, classifications, and challenges faced
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How to fill out INN Working Document 05.179
01
Gather the necessary information required for the INN Working Document 05.179.
02
Start with Section 1: Contact Information - Provide your name, position, organization, and contact details.
03
Move to Section 2: INN Details - Include the full name of the International Nonproprietary Name and its usage context.
04
Fill in Section 3: Supporting Data - Provide relevant research, literature references, or data that supports the use of the INN.
05
Complete Section 4: Signatures - Ensure that the document is signed by the appropriate authorities.
06
Review all sections for completeness and accuracy before submission.
07
Submit the form according to the specified guidelines, either electronically or by mail.
Who needs INN Working Document 05.179?
01
Pharmaceutical companies developing new drugs that require registration of an International Nonproprietary Name.
02
Regulatory agencies responsible for approving and managing drug names.
03
Healthcare professionals involved in prescribing or dispelling information about drugs.
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People Also Ask about
What exactly is an inn?
Inns are generally establishments or buildings where travelers can seek lodging, and usually, food and drink. Inns are typically located in the country or along a highway. Before the advent of motorized transportation, they also provided accommodation for horses.
Who international nonproprietary names INN for biological and biotechnological substances?
International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.
What does inn stand for?
International Nonproprietary Names (INN) identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property.
What is an example of an inn in pharma?
For example, amfetamine and oxacillin are INNs, whereas various salts of these compounds – e.g., amfetamine sulfate and oxacillin sodium – are modified INNs (INNM).
What is an INN document?
INN or TIN is a taxpayer identification number. International academics and researchers with an employment or service contract should request an individual taxpayer identification number at the tax office. To get your SNILS and INN, please submit to us the following documents at patapenia@sfeu.ru: ▪ Your passport.
What is the meaning of inn in EMA?
International non-proprietary name. The globally recognised name used to identify the active ingredient in a medicine. Abbreviated as INN.
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What is INN Working Document 05.179?
INN Working Document 05.179 is a guideline document that outlines the processes and requirements for the registration of International Nonproprietary Names (INNs) for pharmaceutical substances.
Who is required to file INN Working Document 05.179?
Pharmaceutical companies, researchers, and any organizations that are developing or marketing pharmaceutical substances need to file INN Working Document 05.179.
How to fill out INN Working Document 05.179?
To fill out INN Working Document 05.179, applicants must provide detailed information about the substance, including its chemical structure, therapeutic classification, and intended use, ensuring all sections are completed accurately.
What is the purpose of INN Working Document 05.179?
The purpose of INN Working Document 05.179 is to ensure that INNs are assigned and standardized globally, facilitating safe and effective communication regarding pharmaceuticals.
What information must be reported on INN Working Document 05.179?
The information to be reported includes the name of the substance, its chemical identity, pharmacological data, proposed indications, and any relevant safety data.
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