Controlled Access Programme Portal Terms of Use
As part of the conditions of EU Marketing Authorisation of fenfluramine, the Marketing Authorization Holder is required to implement a controlled access programme (“CAP”). UCB Pharma Limited and its affiliates* (“UCB”, “we”, or “our”) have implemented this CAP portal to comply with such requirement. The CAP Portal is provided to you on the basis of these terms and conditions (“Terms of Use”). *Zogenix International Limited and its affiliates are now part of the UCB Group of Companies
The pharmaceutical product fenfluramine that is the object of the CAP (“CAP Product”) is available only upon prescription from a specialty doctor or qualified medical professional and may not be available in all countries. The CAP Product may also be subject to various regulatory requirements depending on the country of use. You should not construe anything on the CAP Portal as a means of promotion or advertisement for any product (including the CAP Product), or for the use of any product (including the CAP Product) that is not authorized by the laws and regulations of your country of residence.
Access and/or use of this CAP portal is subject to our Terms of Use and all applicable laws, statutes, and/or regulations.
Acceptance
The use of the CAP portal is governed by these Terms of Use. Users of the CAP portal (each a “User”, “you” or “your”) are only permitted to use the CAP upon their agreement, without limitation or qualification, to the following Terms of Use and subject to full compliance with applicable laws.
When referring to a particular audience (for example, healthcare professionals), the above definitions shall be interpreted to include only that specific subset of Users and excluding all other potential Users
Healthcare Professionals (HCPs)
This CAP portal does not, and is not intended to, provide medical advice or instruction on the appropriate use of the CAP Product.
Medical information on the CAP Portal is specifically intended for healthcare professionals (“HCPs”), who shall read the CAP educational content, certify performance of the training on important safety information and obtain an individual Prescriber ID. HCPs can access this specific section of the CAP portal by self-certifying their status as licensed doctors. When completing the steps required to generate the Prescriber ID, HCPs also have the option to register to the CAP portal in order to be able to expedite recovery of their Prescriber ID and CAP Certificate and to manage their account. This feature is optional, and we will provide this service to you if you wish us to do so, but you can manage your account (including withdrawing your registration) at any time.
HCPs may also obtain complete medical information of the CAP Product from the Patient Information Leaflet and Summary of Product Characteristics (SmPC), and we will also respond to inquiries from and provide information to healthcare professionals or specialty doctors in accordance with local regulations.
Patients and Caregivers
The CAP Portal includes a section dedicated to patients and caregivers with official documents approved the competent national regulatory authority (i.e. the Summary of Product Characteristics (SmPC) and Patient Information Leaflet) as well as a guide with general information on the CAP Product.
PATIENTS AND CAREVGIVERS SHOULD ALWAYS REFER TO THEIR PRESCRIBING PHISICIAN OR SPECIALTY DOCTOR FOR ANY INFORMATION ON THEIR MEDICAL CONDITION, A PATIENT-SPECIFIC TREATMENT ADVICE, OR POTENTIAL BENEFICIAL MEDICAL USES AND POSSIBLE ADVERSE EFFECTS OF A PARTICULAR PHARMACEUTICAL PRODUCT (INCLUDING THE CAP PRODUCT).
Use of Information
You may only access, download or use information from the CAP portal in line with its regulatory purpose and for your non-commercial use (including training and education). You may not distribute, modify, transmit, reuse, repost, or use any information available through the CAP portal for any other purposes, without our prior written authorization.
Except for the foregoing limited authorization, no license to or right in the information provided by us through the CAP portal is granted or conferred to you.
Intellectual Property Rights
The CAP Portal may also contain reference to our trademarks, patents, products, processes and other proprietary rights. In addition, the entire content of the CAP portal is protected by copyright. Any use, reproduction or copying of our trademarks, patents, products, copyright, processes and other proprietary rights without our prior written permission, is prohibited.
No license to or right in any of such trademarks, patents, products, copyright, processes and other proprietary rights is granted to or conferred upon you.
We reserve the right to take appropriate legal action for any illegal or unauthorized use of the CAP Portal or to prevent the unauthorized use of our intellectual property rights.
Scope and Purpose of CAP portal, Accuracy, Quality and Completeness of Information
THE CAP PORTAL IS DESIGNED TO PROVIDE GENERAL INFORMATION ABOUT THE CAP AND ITS IMPLEMENTATION IN EUROPE. While we use reasonable efforts to ensure that the information provided in the CAP portal is accurate and up to date, inaccuracies or typographical errors may still be possible.
We are under no contractual obligation, and assume no responsibility or liability, to ensure that the information available in the CAP portal is at all times accurate and complete. We make no warranties or representations as to the accuracy, quality or completeness of any information contained in the CAP portal or its possible use.
In addition, any information presented on the CAP portal as of a particular date may only be accurate as of such date and we disclaim any responsibility to update such information. In particular, information available through the CAP portal may become outdated due to medical and scientific developments. We cannot be held responsible for any action taken by Users that is based on information presented on the CAP portal.
Limitation of Liability
To the extent permitted by law, we shall have no liability for:
- All conditions, warranties and other terms which might otherwise be implied by statute, common law or the law of equity; and
- ANY DIRECT, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF YOUR ACCESS TO, USE OF OR INABILITY TO USE OR ACCESS THE WEBSITE, OR ANY ERRORS OR OMISSIONS IN ITS CONTENT, including, without limitation, any liability for (i) loss of income or revenue; (ii) loss of business; (iii) loss of profits or contracts; (iv) loss of anticipated savings; (v) loss of data; (vi) loss of goodwill; (vii) wasted management or office time; and (viii) for any other loss or damage org any kind, however arising and whether caused by tort (including negligence), breach of contract or otherwise, even if foreseeable.
The above provisions apply to all claims for damages, regardless of their legal cause, except for claims for damages in the event of (a) an injury to life, body or health, (b) fraudulently concealed defects or misrepresentation as to a fundamental matter, (c) an explicit assumption of a guarantee (in which case we shall be liable within the scope of the guarantee assumed), and (d) violations of applicable mandatory provisions of product liability laws.
The above provisions also apply in relation to the liability of an assignee and the personal liability of our employees, agents and statutory representatives.
Third Party Websites
The CAP portal may include hyperlinks to websites maintained or controlled by others. We are not responsible for and does not routinely screen, approve, review or endorse the contents of or use of any of the information, products or services that may be available at these websites.
Updates and Changes
We reserve the right to revise and update these Terms of Use at any time. Such changes and modifications will be made available to the User on the CAP portal and govern any further use of the CAP portal by the User. We encourage you to review these Terms of Use periodically to be informed on how to use the CAP portal.
Choice of Law
This Terms of Use are governed by the Republic of Ireland.
Contact Information
UCB (Pharma) Ireland Ltd.
United Drug House
Magna Drive
City West Road
Dublin D24
X0CT IRL - Co Dublin
Updated September 2024