Get the free Psur Repository

The PSUR Repository serves as a centralized platform for Periodic Safety Update Reports (PSURs) and related documentation for regulatory authorities and pharmaceutical companies within the EU. It enables marketing authorization holders to submit all PSURs through a single channel, thereby improving the accessibility and assessment of safety information regarding authorized medicines. The repository became mandatory for all PSUR submissions in the EU as of June 13, 2016.

How to fill out psur repository

How to fill out psur repository

1. Gather necessary documentation related to the safety and efficacy of the product.
2. Identify the reporting period for the PSUR (Periodic Safety Update Report).
3. Collect and review all relevant adverse event data since the last report.
4. Analyze trends in adverse events and any emerging safety signals.
5. Summarize the benefits and risks of the product based on the new data.
6. Draft the PSUR, ensuring that it includes all required sections such as product information, safety data, and conclusions.
7. Review the draft for accuracy and completeness, incorporating feedback from relevant stakeholders.
8. Submit the finalized PSUR to the appropriate regulatory authorities.

Who needs psur repository?

1. Regulatory authorities who monitor medication safety and efficacy.
2. Pharmaceutical companies required to report on the safety of their products.
3. Healthcare professionals needing up-to-date information on the safety of medications.
4. Patients and the public who may be affected by the products being monitored.

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What is psur repository?

The PSUR (Periodic Safety Update Report) repository is a database that stores safety information about drugs, particularly post-marketing surveillance data used to monitor the safety of pharmaceutical products.

Who is required to file psur repository?

Pharmaceutical companies and organizations responsible for the marketing authorization of a drug are required to file PSURs.

How to fill out psur repository?

Filling out the PSUR repository typically involves collecting relevant safety data, reporting findings in a standardized format, and ensuring compliance with regulatory guidelines through a structured submission process.

What is the purpose of psur repository?

The purpose of the PSUR repository is to facilitate the ongoing monitoring of the safety and effectiveness of marketed drugs, ensuring that any risks are identified and managed appropriately.

What information must be reported on psur repository?

Information that must be reported includes data on adverse events, risk assessments, updates on the drug’s benefit-risk profile, and conclusions drawn from the data regarding safety.