Terms of Use

1. Acceptance of Terms

By accessing and using the website https://pharmalexica.com (the “Website”) and the EU Variation Fees Calculator (the “Calculator”), you agree to be bound by these Terms of Use and by our Privacy Policy.

If you do not agree with any part of these Terms of Use, you must refrain from using the Website and the Calculator.

These Terms constitute a legally binding agreement between you and the owner of PharmaLexica (the “Owner”, “we”, “us”).

2. Description of the Platform

PharmaLexica provides informational content related to pharmaceutical topics, including articles and downloadable PDF materials.

In addition, PharmaLexica provides access to the EU Variation Fees Calculator, a web-based tool that allows registered users to perform automated calculations of regulatory fees related to pharmaceutical variations, based on user-selected parameters and regulatory fee information made available by European regulatory authorities.

The Calculator is currently offered free of charge during a testing phase. We reserve the right to modify, suspend, restrict, or discontinue the Website or the Calculator, in whole or in part, at any time and without prior notice.

3. User Registration and Account

3.1 Registration and License Grant

Access to the Calculator requires the creation of a user account. Users agree to provide accurate and complete information during the registration process.

This license is granted solely to the registered user, is linked to the individual account, and may not be shared, assigned, transferred, or otherwise made available to third parties.

3.2 Account Security

Users are responsible for:

• Ensuring that their access credentials are kept secure and not disclosed to third parties
• Any use of the Calculator carried out through their account
• Promptly informing us if they become aware of any unauthorized access or security breach related to their account

3.3 Account Deletion

Users may request deletion of their account by contacting us at info@pharmalexica.com.

4. Data Accuracy, Calculations and Disclaimer of Liability

As the Calculator is based on regulatory fee information made available by European regulatory authorities, reasonable efforts are made to keep the calculation logic, information and data accurate and up to date. However, regulatory fee information may be subject to updates, revisions, or changes over time, and there may be a delay between such changes and their implementation within the Calculator.

We do not guarantee:

• The absolute accuracy or completeness of calculation results
• That regulatory fee information is always current at the time of calculation
• That all possible regulatory scenarios, exceptions, reductions, or specific cases are covered
• That calculated results correspond to final or official fees applied by regulatory authorities

Non-binding outputs: All calculations and outputs generated through the Calculator are non-binding, indicative and provided for reference purposes only. They do not constitute official determinations, regulatory interpretations or legally binding information.

PharmaLexica assumes no responsibility or liability for:

• Any inaccuracies, errors or incomplete results generated by the Calculator
• Differences between the calculated outputs and the fees ultimately applied by regulatory authorities
• Any financial or regulatory consequences resulting from reliance on the Calculator or its outputs
• Decisions, actions or regulatory submissions made based on information generated by the Calculator

Users remain responsible for independently verifying regulatory fee information with the relevant regulatory authorities or official sources prior to relying on such information for regulatory submissions or other decisions.

5. Informational Nature of Content and User Responsibility

PharmaLexica prepares its articles, downloadable PDF materials and newsletter contentwith due care and attention, aiming to provide accurate and reliable information on pharmaceutical topics.

However, all such contents are provided for informational purposes only and may not reflect the most recent developments or all possible interpretations.

Users acknowledge that:

• Official sources and communications from competent authorities remain the only authoritative and binding references
• Any information obtained through PharmaLexica should be independently verified against official sources before being relied upon
• Articles, PDF materials, newsletters and Calculator outputs are intended to support understanding and awareness, not to replace professional judgment or official guidance

6. Intellectual Property Rights

6.1 Ownership of Original Content

All original content available on PharmaLexica, including texts, articles, logos, software, calculation logic, databases and downloadable materials, is the exclusive property of the Owner and is protected by applicable intellectual property laws.

6.2 Third-Party Licensed Assets (Freepik)

Certain visual elements of the Website, including background graphics and icons, are used under license from third-party providers, including Freepik. Such materials remain the property of their respective owners and are used in accordance with the applicable license terms.

6.3 Restrictions and License

Except as expressly permitted, users are prohibited from:

• Reproducing, copying, distributing or redistributing any content made available on PharmaLexica
• Modifying, reverse engineering or creating derivative works based on the Website or the Calculator
• Using any content for commercial purposes without prior authorization from the relevant rights holder

A personal, limited, non-exclusive, non-transferable, and non-sublicensable license is granted to users to access and use the Calculator only, solely in accordance with these Terms of Use and for personal, non-commercial purposes.

7. User Conduct

Users agree not to:

• Attempt to gain unauthorized access to databases, data, systems, or technical resources related to the Website or the Calculator
• Use automated systems (including bots or scrapers) without authorization
• Share account credentials or access rights with third parties

8. Third-Party Links

The Website may contain links to third-party websites or services. We do not control and are not responsible for the content, policies, or practices of any third-party resources. Access to such resources is at the user’s own risk.

9. Privacy and Data Protection

The processing of personal data is governed by our Privacy Policy, available at:

https://pharmalexica.com/privacy-policy

By using PharmaLexica, users acknowledge and accept the terms described therein.

10. Changes to the Terms

We reserve the right to modify these Terms of Use at any time. Any changes will become effective upon publication on this page, with the “Last updated” date revised accordingly.

Continued use of the Website or the Calculator after such changes constitutes acceptance of the updated Terms.

11. Termination

We reserve the right to suspend or terminate access to the Calculator at any time, without prior notice, in the event of a violation of these Terms or for operational reasons.

Upon termination, all licenses granted to the user under these Terms shall immediately cease.

12. Governing Law and Jurisdiction

These Terms of Use shall be governed by and construed in accordance with applicable European Union law.

Any dispute arising out of or relating to these Terms or the use of PharmaLexica shall be subject to the jurisdiction of the competent courts, as determined in accordance with applicable European Union regulations.

13. Severability

If any provision of these Terms of Use is held to be invalid or unenforceable, the remaining provisions shall remain in full force and effect.

14. Contact Information

If you have any questions or concerns regarding these Terms of Use, please contact us at:

• Email: info@pharmalexica.com

15. Entire Agreement

These Terms of Use, together with the Privacy Policy, constitute the entire agreement between the user and PharmaLexica regarding the use of the Website and the Calculator and supersede any prior agreements or understandings.