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Get the free Harmonisation status for Excipient monographs (PDG)

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Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) according to Regulation (EU) No. 2020/878 Trade name :101292 LAsparagine monohydrate, Ph. Eur.Revision date : Print date :04/11/2022
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How to fill out harmonisation status for excipient

01
Step 1: Identify the excipient in question and gather all necessary information such as composition, intended use, and safety data.
02
Step 2: Check regulatory guidelines to determine if harmonisation status is required for the excipient.
03
Step 3: Fill out the harmonisation status form with accurate and comprehensive information.
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Step 4: Submit the completed form to the relevant regulatory authorities for review and approval.
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Step 5: Monitor for any feedback or further requirements from the authorities and make any necessary adjustments to the form.

Who needs harmonisation status for excipient?

01
Pharmaceutical companies
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Excipient manufacturers
03
Regulatory authorities
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The harmonisation status for excipient refers to the process of aligning specifications, standards, and regulations for pharmaceutical excipients to ensure safety, quality, and efficacy across different regions.
Manufacturers and suppliers of excipients are required to file the harmonisation status to demonstrate compliance with relevant standards and regulations.
To fill out the harmonisation status for excipient, companies must provide detailed information about the excipient, including its specifications, regulatory compliance, and any relevant test results.
The purpose of harmonisation status for excipient is to ensure that all excipients meet consistent quality standards, facilitating safe and effective pharmaceutical products across different markets.
Information that must be reported includes the excipient's name, supplier details, compliance with pharmacopeial standards, and results from stability and quality testing.
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