How do I submit to PSUR?
How do I submit to PSUR?
PSUR submissions to the Repository are made using the eSubmission Gateway/Web Client with the use of an XML delivery file. The delivery files are used to provide required metadata allowing the EMA to process the submissions. You can find the link to the tool to create the delivery file here.
How often is a PSUR submitted?
PSUR Submission Cycle For most newly authorised products, PSURs should be submitted every 6 months until initial placing on the market.
What is the timeline for submission of PSUR?
the timeline for the submission of ad hoc PSURs requested by competent authorities will normally be specified in the request, otherwise the ad hoc PSURs should be submitted within 90 calendar days of the data lock point.
Who is responsible for submitting PSUR?
The Marketing Authorization Holder is responsible for the submission of the PSURs for his products [Article 107b DIR] [Article 28 (2) of the REG].
What is the full form of PSUR?
The periodic safety update report for marketed drugs (PSUR) was designed to be a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product.
What is PV PSUR?
A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an update of the worldwide safety experience of a medicinal product to regulatory authorities at defined time points post-authorisation.
What does PSUR stand for?
periodic safety update report for marketed drugs
The periodic safety update report for marketed drugs (PSUR) was designed to be a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product.
What is a Pader?
A PADER is a type of aggregate safety report required to be submitted by a sponsor or marketing authorization holder (MAH) to the US Food and Drug Administration (FDA) after obtaining marketing authorization approval.
What is PV DLP?
The data lock point (DLP) is defined as the cut-off date for data to be included in a PSUR. After obtaining the marketing authorisation for a medicinal product, the MAH is requested to inform the Agency of their choice of birth date (EBD or IBD) and of the chosen first data lock point (1st DLP).
What is data lock point in PV?
The data lock point (DLP) is defined as the cut-off date for data to be included in a PSUR. It may be set according to the European birth date (EBD) or international birth date (IBD) of the medicinal product.
What is the difference between PSUR and PMCF?
The PSUR should include: Conclusions of risk-benefit determination. Main findings of your Post Market Clinical Follow Up (PMCF) Sales volume of the device.
What is E2B in pharmacovigilance?
by Pharmacovigilance Team on Mon, Dec 04, 2017. The International Conference on Harmonisation (ICH) has defined E2B as the international standard for transmitting medicine adverse event reports. The ICH E2B document includes message standards required for effective transmission of individual case safety reports (ICSR).
How is a PSUR submission made in esubmission?
PSUR submissions to the Repository are made using the eSubmission Gateway/Web Client with the use of an XML delivery file. The delivery files are used to provide required metadata allowing the EMA to process the submissions. You can find the link to the tool to create the delivery file here.
What do you need to know about the PSUR process?
PSUR procedure type Marketing Authorisation type of the products concerned Addressees Submission requirements Reference document(s) File name to be used when submitting to EMA PSUR Assessment of substances contained in 1 or several centrally authorised product(s)
When is the deadline for non-EU single assessment PSUR?
MAHs should please note that if you have submission deadline for non-EU single assessment PSUR on Friday, 19th July, you may wish to submit the PSUR prior to the submission deadline to avoid the downtime.
Can a Mah be submitted to the PSUR repository?
EMA regulatory Post- Authorisation Guidance . 2. The submission Process The MAHs are required to include a delivery file in the submission package. The use of the PSUR Repository is thmandatory since 13 June 2016 and the submission of PSURs directly to National Competent Authorities is no longer accepted .