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CESP Support is available Mon - Fri from 9:30 - 17:00 GMT
Phone: +353-1-634-3801
Email: cesp@hma.eu

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  • Home
  • Announcements
  • FAQs
  • General Information
  • Contacts
  • Terms & Conditions
  • Register

FAQs / Latest5


Categories
Latest 5 FAQs All Delivery Files eSubmissions General Security Setup Software Training Guides
How many characters can a username have?

A username is made up of the last name and first letter of the users first name.

This should not be more than 14 characters in length.

Brexit Update - 27th March 2019

Please find an update on the United Kingdom's withdrawal from the European Union ('Brexit') and how this relates to CESP.

Following the European Council meeting on 22 March 2019, the date for UK's withdrawal from the EU has been extended beyond 30 March 2019.

Based on the European Council decision, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood to be replaced by 12 April 2019 until further notice.

The decision makes clear that the UK remains a Member State for the duration of the extension and will retain access to CESP alongside other EU telematics systems.

Companies are advised to continue their preparedness for the UK’s withdrawal as per previous guidance.

 

MHRA Clinical Trial Submission Guidelines

If you are a first time CESP user and wish to setup up an Organisation/University or Trust to manage multiple users on the system, register here

If you are a standalone User and wish to upload for Non Commercial Use on your own behalf, register here

Once registered you will receive credentials to access the portal to your registered email address.

Please view the MHRA Clinical Trials Guidelines document here

General CESP Training is available to all registered users via our training menu once logged into the system. Training on demand videos are available and you can also sign up to our free online weekly live demonstrations. We encourage all users to attend training before using the system.

Glossary of Terms

CESP Common European Submission Portal
EDQM European Dictorate for the Quality of Medicines & Healthcare
GxP GxP is a general term for Good (Anything...) Practice quality guidelines and regulations.
PSUR Periodic Safety Update Report
CEP Certificate of Suitability to the monographs of the European Pharmacopoia 
OCABR Official Control Authority Batch Release 
CTA Clinical Trials Application
CAP  Centrally Authorised Products
CHMP Committee for Medicinal Products for Human Use 
PRAC Pharmacovigilance Risk Assessment Committee
CCC Clinical Competency Committee
WHO World Health Organisation
GMP Good Manufacturing Practices
MAs Marketing Authorisation
MP Manufacturing Procedure 
COEN Centre of Exceellence in Neurodegeneration 
NBOG Notified Body Operations Group
IVMP Immunological Veterinary Medicineal Products
MRP Mutual Recognition Procedure
DCP Decentralised Procedure
CP Centralised Procedure
eCTD Electronic Common Technical Document
NeeS Non-eCTD electronic Submissions for Human Medicinal Products
vNeeS Non-ectd electronic Submissions for Veterinary Medicinal Products
MAA Number Marketing Authorisation Application Number
RMS Reference Member State
CMS Concerned Member State
How to Contact CESP Support

Please contact CESP Support for any information in relation to CESP via the Online Support desk.   This is monitored daily (Monday-Friday).  We ask that once the issue has been resolved that the user closes the call. To Add a new support call select new support call, provide some brief details.  Please make sure to provide the Delivery file Number and submit the support call.                                                                                                                                                                                          

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