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The HMA website includes a link to a hosted platform designed to enable authorised users to submit electronic submissions electronically to participating Member State Regulators through a central hub (the ‘Portal’). Use of the Portal is governed by the following Terms and Conditions.
The CESP Group grants access to the portal in order to allow authorised users participate and submit electronic submissions subject to these Terms and Conditions. All users of the Portal agree that access to the Portal is only to facilitate the submission of applications through the Portal. Each user agrees to take all reasonable and prudent steps not to allow any other person learn or use the information provided by the CESP Group to access the Portal except the CESP customer support staff as necessary.
Nothing in these Terms and Conditions will limit the CESP Group liability for death or personal injury caused by its negligence, fraud or for any other type of liability that cannot be limited by law. The CESP Group, its employees, subcontractors, licensors and agents will not be responsible to any named user or company or any other third party for any loss, however arising, from the use of, or reliance on this information, including but not limited to miscommunications or any errors. The CESP Group, its employees, subcontractors, licensors, and agents will not be liable for any special, incidental, indirect or consequential damages of any kind, or for any loss of use, data or profits, however those damages may arise and even if the parties had been informed of the possibility of the same. The Portal is provided "as is" without warranty of any kind, either expressed or implied, to the extent permitted by law. A named user or company should not presume that the information displayed is error-free or that it will be suitable for any particular purpose. The CESP Group does not guarantee or represent that the content and/or facilities available or accessible via the Portal will always be accurate, complete or current or that access to the Portal will be uninterrupted. The CESP Group assumes no responsibility for errors or omissions in any publications and services, or other documents, which may be referenced in, or linked to, the Portal. The CESP Group may at any time revise these Terms and Conditions by posting a revised version of these Terms and Conditions on the Portal and all users and companies agree to be bound by all such revisions from the date they are posted.
Though the CESP Group makes every reasonable effort to check and test material at all stages of production, it is always wise for the company to run an anti-virus program on all material downloaded from the Internet. The CESP Group cannot and does not accept any responsibility for any loss, disruption or damage to data or computer systems which may occur whilst using material derived from using the Portal.
It is required to upload submissions in a zip file format through the CESP system. Only zip files with a .zip extension will be accepted by the system. Our users use a variety of zip software but the most common packages used to create .zip files are:
The information received from authorised users is held by the CESP Group however The CESP Group is not responsible for the privacy practices at any other site. The CESP Registration team may provide authorised Company Administrator details to users if required to facilitate registration on the system. If the CESP Group does so, it will only be as the law permits, to
Confidentiality and security
The CESP Group has a legal duty to protect the confidentiality of user information. The CESP Group takes every precaution to protect any information submitted via the Portal, in accordance with legislation. Any technical information logged by the CESP Group will be used only by the CESP Group, and only for statistical and other administrative purposes. Any data, which the CESP Participants use in their offices, is protected in accordance with their local standards and not the responsibility of the CESP Group.
Collection and use of Technical information:
Technical details in connection with visits to this Portal are logged to provide support, statistical, audit and security governance purposes. Technical details logged are confined to the following items:
It is the policy of the CESP Group never to disclose such technical Information in respect of individual Portal visitors to any third party, unless obliged to disclose such information by a rule of law.
You should note that technical details, which we cannot associate with any identifiable individual, do not constitute "personal data" for the purposes of the Data Protection Act, 1988 and the Data Protection (Amendment) Act, 2003.
To use the Portal: The company must first complete the CESP Portal Registration Form and nominate one or more "Company Administrator/s". Upon receipt of a signed letter, the CESP Group will verify the company administrators and on successful verification grant the company administrator access and administration rights over the designated company.
The company administrator is from that time forward responsible for the setup and administration of standard users on the portal. The CESP group will not setup or administrate users on the system with the exception of Company Administrators.
Non Commercial Use
To use the Portal: Non Commercial Named Users must first complete the CESP Portal Registration Form. The CESP Group will request a signed letter and upon receipt of this letter will verify the named user. Upon successful verification grant the named user access to the Portal for their own personal use.
The named user from that time forward will act as an individual Non Commercial User on the Portal and will only use the Portal for their own personal user for Non Commercial Submissions, Clinical Trials or Research Cases. The named user will not be allowed to merge or join their account to any Company account. In the case that this become a requirement for a Non Commercial Named User their account will be revoked and a new company user account must be requested from the relevant Company Administrator.
Please be advised that unprocessed registrations will be deleted if not processed within three months, this applies to all registration types within the system. New Non Commercial Named User registrations will only be processed when the requested letter is completed and uploaded in PDF format to the CESP Portal. New Company registrations will only be processed when the requested information is completed and uploaded on letter headed paper in PDF format to the CESP Portal.
The Portal may contain links to other sites, mainly those of other regulatory agencies and other third parties. The CESP Group is not responsible for the privacy practices within any of these other sites. The CESP Group encourages the authorised users to be aware of this when using these links to leave the Portal and to read the privacy statements on other websites which collect personally identifiable information. This privacy statement applies solely to information collected on the Portal.
The CESP Group shall provide support in respect of the Portal to all authorised users during normal working hours on Monday to Friday other than bank holidays or privilege days. Contact details for accessing CESP Group support are available on the Portal
All support calls should be logged through the online support system available to all registered users of the system.
Business hours are:
Monday to Friday, 09:30hrs to 17:00hrs (GMT)
Main contact details
Email Address: firstname.lastname@example.org
BY ACCEPTING THESE TERMS AND CONDITIONS, THE NAMED USER OR COMPANY ACKNOWLEDGES THAT IT HAS READ THE TERMS AND CONDITIONS, UNDERSTOOD THEM AND AGREES TO BE BOUND BY THEM.