Get the free PSUR Repository user guide for MAH submissions - eSubmission
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17 April 2015 EMA/52449/2015 User Guidance for Marketing Authorization Holders (MAH's) for POUR Repository 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom Telephone +44 (0)20 3660
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How to fill out psur repository user guide
01
To fill out the PSUR repository user guide, you will first need to gather all the necessary information and documents related to the PSUR (Periodic Safety Update Report) that you are submitting.
02
Start by ensuring that you have access to the PSUR repository user guide. This guide will provide you with step-by-step instructions on how to navigate through the system and fill out the required fields.
03
Begin by logging into the PSUR repository using your credentials. If you do not have an account, you may need to register for one. Follow the instructions provided to create an account if necessary.
04
Once logged in, familiarize yourself with the layout and structure of the PSUR repository. This will help you navigate through the different sections and understand where to input the required information.
05
In the user guide, you will find detailed information on each field or section you need to complete. Follow these instructions carefully and ensure that you provide accurate and up-to-date information.
06
Take your time to review and fill out each section thoroughly. Double-check the information you provide to avoid any inaccuracies or missing details.
07
If you encounter any difficulties or have questions while filling out the PSUR repository user guide, refer to the user guide's troubleshooting section, or seek assistance from the appropriate authority or support team.
08
It is important to note that the PSUR repository user guide is intended for individuals or organizations responsible for submitting PSURs. Therefore, anyone involved in the reporting or regulatory compliance of PSURs will typically require access to and guidance from this user guide.
09
This may include professionals in the pharmaceutical or healthcare industry, regulatory authorities, and individuals responsible for pharmacovigilance and drug safety.
10
Ultimately, the PSUR repository user guide is designed to streamline the process of submitting PSURs and ensure that the required information is provided accurately and efficiently. Following the instructions in the user guide will ensure compliance with regulatory guidelines and help maintain the safety and effectiveness of pharmaceutical products.
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What is psur repository user guide?
The psur repository user guide provides instructions on how to submit Periodic Safety Update Reports (PSURs) to the repository.
Who is required to file psur repository user guide?
Marketing authorization holders are required to file the psur repository user guide.
How to fill out psur repository user guide?
The psur repository user guide must be filled out according to the instructions provided by the regulatory authorities.
What is the purpose of psur repository user guide?
The purpose of the psur repository user guide is to ensure that PSURs are submitted accurately and in a timely manner for regulatory review.
What information must be reported on psur repository user guide?
The psur repository user guide must include information on the drug's safety profile, adverse events, and any new safety information.
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