Terms of Use

The terms of use have to be accepted in order to gain access to clinical data. They provide detailed information on the access to the information in the clinical reports, and on the intended use of such information.

There are two terms of use, in line with the category of access to the published clinical data.

The general information purposes terms of use are for users accessing the published clinical data for general information and other non-commercial purposes, including non-commercial research purposes.

The academic and other non-commercial research purposes terms of use are for users accessing the published clinical data for academic and other non-commercial research purposes. They allow more access rights compared to the “general information purposes” terms of use, but require some additional procedural steps.

Prior to viewing or downloading every document users must re-confirm their acceptance of the terms of use.

 

Terms of Use for general information purposes

These Terms of Use ("Terms") govern the access and use of clinical data, as defined in chapter 3.  of the EMA policy on publication of clinical data, Policy 0070 ("Policy"), that are made available to Users via such Policy. By accepting these Terms and upon being granted access to the Clinical Reports, you agree to be bound by these Terms. Please read them carefully.

 

1. Definitions

In these Terms the terms below have the following meaning:

"EMA" means the European Medicines Agency.

"Clinical Reports” means the clinical overviews (module 2.5), the clinical summaries (module 2.7) and the clinical study reports (module 5, “CSR”), together with appendixes to the CSRs no. 16.1.1, 16.1.2 and 16.1.9 which are accessible via the EMA website as a result of the implementation of the Policy.

Applicant/MAH” means the natural or legal person(s) or organisation(s) that submitted the Clinical Reports to the EMA in the context of applications in support of centralised marketing authorisations/post-authorisation submissions under Regulation (EC) No 726/2004, as well as any person(s) or organisation(s) who own(s) copyright or other intellectual property rights in the Clinical Reports.

"User” means the natural or legal person or organisation who, having registered with the EMA website in connection with the implementation of the Policy, receives access to the Clinical Reports.

 

2. Access to the Clinical Reports under the Policy

The User acknowledges that the Clinical Reports are protected by copyright or other intellectual property rights of the Applicant/MAH and can be considered commercially valuable when used for commercial and regulatory purposes.

The User acknowledges that the Clinical Reports will be made available to the User on the EMA website in a “view-on-screen-only” mode, after completing the registration process. The User agrees that the User is not permitted to download, save, edit, photograph, print, distribute or transfer the Clinical Reports. The User agrees not to access the Clinical Reports using a method other than the interface provided by the EMA, or remove, bypass, circumvent, neutralise or modify any technological protection measures which apply to the Clinical Reports.

 

3. Use of the Clinical Reports

The User agrees to use the Clinical Reports according to these Terms and, in particular, that:

  1. The User may use the Clinical Reports for general information and other non-commercial purposes, including non-commercial research purposes, subject to these Terms.
  2. The User is not granted any intellectual property or other commercial rights in relation to the Clinical Reports other than as expressly set out in these Terms.

 

When using the Clinical Reports, the User shall:

  1. acknowledge that its source is the Applicant/MAH;
  2. not use it in a way that suggests that the Applicant/MAH endorses the User’s use of the Clinical Reports for any other purpose than general information and other non-commercial purposes, including non-commercial research purposes;
  3. ensure that the use of the Clinical Reports comply at all times with applicable law;
  4. not misrepresent the source of the Clinical Reports;
  5. not seek to re-identify the trial subjects or other individuals from the Clinical Reports in breach of applicable privacy laws.

The User may not:

  • use the Clinical Reports to support an application to obtain a marketing authorisation and any extensions or variations thereof for a product anywhere in the world;
  • share the User’s username, password or other account details with a third party or otherwise provide a third party with access to the User’s account;
  • make any unfair commercial use of the Clinical Reports.

If the User fails to accurately complete the registration process, comply with these conditions, or uses the Clinical Reports in breach of these Terms, the rights to access and use the Clinical Reports will be revoked.

 

4. Warranties and liability

Without prejudice to any obligation of the Applicants/MAHs in accordance with the Union legislation:

  • The EMA and the Applicant/MAH exclude all representations, warranties, obligations and liabilities in relation to the Clinical Reports as accessible via the EMA website to the maximum extent permitted by law;
  • Neither the EMA nor the Applicant/MAH are liable for any errors or omissions in the Clinical Reports as provided via the EMA website and shall not be liable for any loss, injury or damage of any kind caused by its use.
  • The Agency accepts no responsibility for the User’s compliance with the Terms.

 

5. Third party rights

The restrictions and conditions and the warranty and liability provisions of these Terms are also made for the benefit of any and all Applicants/MAHs and, accordingly, each such Applicant/MAH may in its own right enforce these Terms in accordance with the provisions of the Contracts (Rights of Third Parties) Act 1999.

 

6. Governing law

These Terms and any dispute or claim arising out of or in connection with them or their subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales.

 

7. Jurisdiction

The courts of England and Wales shall have non-exclusive jurisdiction to settle any dispute or claim arising out of or in connection with these Terms or their subject matter or formation (including non- contractual disputes or claims).

 

Terms of Use for academic and other non-commercial research purposes

These Terms of Use ("Terms”) govern the access and use for academic and other non-commercial research purposes of clinical data, as defined in chapter 3. of the EMA policy on publication of clinical data, Policy 0070 ("Policy”), that are made available to Users via such Policy. By accepting these Terms and upon being granted access to the Clinical Reports, you agree to be bound by these Terms. Please read them carefully.

 

1. Definitions

In these Terms the terms below have the following meaning:

"EMA” means the European Medicines Agency.

"Clinical Reports” means the clinical overviews (module 2.5), the clinical summaries (module 2.7) and the clinical study reports (module 5, “CSR”), together with appendixes to the CSRs no. 16.1.1, 16.1.2 and 16.1.9 which are accessible via the EMA website as a result of the implementation of the Policy.

Applicant/MAH” means the natural or legal person(s) or organisation(s) that submitted the Clinical Reports to the EMA in the context of applications in support of centralised marketing authorisations/post-authorisation submissions under Regulation (EC) No 726/2004, as well as any person(s) or organisation(s) who own(s) copyright or other intellectual property rights in the Clinical Reports.

"User” means the natural or legal person or organisation who, having registered with the EMA’s website in connection with the implementation of the Policy, receives in electronic format a copy of the Clinical Reports.

 

2. Access to the Clinical Reports under the Policy

The User acknowledges that the Clinical Reports are protected by copyright or other intellectual property rights of the Applicant/MAH and can be considered commercially valuable when used for commercial and regulatory purposes.

The User acknowledges that the Clinical Reports will be made available to the User in electronic format for academic and other non-commercial research purposes. Before being granted access to the Clinical Reports in electronic format, the User shall provide the EMA with:

  • An e-mail address,
  • A place of address in the European Union; in the event that the User does not have a place of address in the European Union and wishes to avail itself of the services of a third party resident or domiciled in the European Union, such third party shall be considered User for the purposes of these Terms and shall comply with all the terms hereof,
  • Elements concerning the identity of the user (i.e. name, date of birth, passport or ID card number, expiry date of the document; for juridical persons, the affiliation and position within the organisation of the user should also be provided).

 

3. Use of the Clinical Reports

The User agrees to use the Clinical Reports according to these Terms and, in particular, that:

  1. The User may use the Clinical Reports solely for academic and other non-commercial research purposes, subject to these Terms.
  2. The User is not granted any intellectual property or other commercial rights in relation to the Clinical Reports other than as expressly set out in these Terms.

The User may not:

  • use the Clinical Reports to support an application to obtain a marketing authorisation and any extensions or variations thereof for a product anywhere in the world;
  • share the User’s username, password or other account details with a third party or otherwise provide a third party with access to the User’s account;
  • make any unfair commercial use of the Clinical Reports;
  • seek to re-identify the trial subjects or other individuals from the Clinical Reports in breach of applicable privacy laws.

For the avoidance of doubt, the User is permitted to download, save and print the Clinical Reports, subject to these Terms.

If the User fails to accurately complete the registration process, comply with these conditions, or uses the Clinical Reports in breach of these Terms, the rights to access and use the Clinical Reports will be revoked.

 

4. Warranties and liability

Without prejudice to any obligation of the Applicants/MAHs in accordance with the Union legislation:

  • The EMA and the Applicant/MAH exclude all representations, warranties, obligations and liabilities in relation to the Clinical Reports as made accessible to the Users to the maximum extent permitted by law;
  • Neither the EMA nor the Applicant/MAH are liable for any errors or omissions in the Clinical Reports as made accessible to the Users and shall not be liable for any loss, injury or damage of any kind caused by its use.
  • The Agency accepts no responsibility for the User’s compliance with the Terms.

 

5. Third party rights

The restrictions and conditions and the warranty and liability provisions of these Terms are also made for the benefit of any and all Applicants/MAHs and, accordingly, each such Applicant/MAH may in its own right enforce these Terms in accordance with the provisions of the Contracts (Rights of Third Parties) Act 1999.

 

6. Governing law

These Terms and any dispute or claim arising out of or in connection with them or their subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales.

 

7. Jurisdiction

The courts of England and Wales shall have non-exclusive jurisdiction to settle any dispute or claim arising out of or in connection with these Terms or their subject matter or formation (including non- contractual disputes or claims).