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  • Submissions To The Psur Repository Using Ema Gateway

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Submissions to the PSUR Repository using EMA Gateway/Web Client Webinar training to existing Gateway users Presented by Kristiina Puusaari on 10 February 2015 An agency of the European Union Presenters.

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PSURs must be submitted every 6 months after product authorisation until 2 years after the initial placing on the EU market, yearly for the following 2 years, and at 3-year intervals thereafter.

Submission of the application Applicants should use the electronic common technical document (eCTD) format and submit the application through the eSubmission gateway or web client. If EMA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a deadline.

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.

PSURs must be submitted every 6 months after product authorisation until 2 years after the initial placing on the EU market, yearly for the following 2 years, and at 3-year intervals thereafter.

Frequency and timings of PSUR submissions A PSUR should be submitted at least every six months after authorisation until the placing on the market.

Marketing authorisation holders (MAHs) are legally required to submit PSURs, in line with Regulation (EU) No 1235/2010, Directive 2010/84/EU and Commission Implementing Regulation (EU) No 520/2012. Article 35 of the Commission Implementing Regulation describes the structure of PSURs.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232