When should I submit PSUR?
When should I submit PSUR?
PSUR Submission Cycle For most newly authorised products, PSURs should be submitted every 6 months until initial placing on the market. Following placing on the market they are submitted: every 6 months for the first 2 years; annually for the subsequent 2 years; and.
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.
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 a Psusa procedure?
EMA carries out PSUSA procedures to assess PSURs of medicines containing the same active substances or combinations, even if they are subject to different marketing authorisations and are authorised in different EU Member States.
What is difference between PSUR and Pbrer?
The new PSUR (which is still officially and confusingly called a PSUR but is unofficially called a PBRER) came into effect in the EU in January 2013 and is based on ICH E2C. It is an analytical document covering “all available data” – both interval data and cumulative data.
What is the difference between PSUR and DSUR?
The DSUR is the pre-marketing equivalent of the post-marketing Periodic Safety Update Report (PSUR). It covers drugs, biological, vaccines and combo products. It is a stand-alone document that is not just a data dump but is an analytical document.
What is difference between Psur and Pbrer?
What is the difference between Psur and DSUR?
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 frequency of Pader submission?
PADER submission starts once marketing authorization approval is received for a medicinal product by the sponsor. Quarterly and annual PADERs should be submitted within 30 and 60 days of data lock point, respectively.
What is a positive Dechallenge?
A dechallenge is positive when after removal of the drug the adverse event subsides or disappears. A dechallenge is negative when the event persists even after removal of the drug i.e. a causal relationship is unlikely. Rechallenge. The point at which a drug is given again to a patient after its previous withdrawal.
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.
Where can I submit a PSUR for medicinal products?
PSURs should be submitted through PSUR portal using MHRA Submissions. You can be given access to MHRA Submissions by a company administrator in your organisation. You should continue to submit one PSUR covering your medicinal products with the same active substance or combination of active substances according to the EURD list.
When do psurs need to be sent to Ris?
PSURs should be submitted according to special MAIL. Following submission of PSURs an acknowledgement letter is sent, if it is not received within 14 days then submitting authority should contact the Regulatory Information Service (RIS) to ensure the application. The following are the requirements of Frequency of PSUR reporting:
When to submit periodic safety update reports ( psurs )?
They shall be submitted by marketing authorisation holders at defined time points during the post-authorisation phase. The legal requirements for submission of PSURs are established in the Regulation (EC) No 726/2004 and the Directive 2001/83/EC.
