« back to GLOBAL TRANSPARENCY PAGE

Saudi Arabia
transparency obligations overview

Latest update: 22 October 2018 | Important Notes

Report Due Date

Disclosure period is annual/monthly

Authority

Saudi Food and Drug Authority

Who Must Report

Pharmaceutical companies, medical device companies and healthcare providers

Covered Recipients

Healthcare providers and healthcare institutions

Pharmaceutical Companies and Medical Device Companies

What is reported:

Reportable payments and transfers of value to HCPs must be reported. These include:

  • Consulting fees
  • Speaker fees
  • Training fees
  • Sponsorship of HCP to attend event (travel, lodging & registration)
  • Symposium or conference sponsorship (for HCI)
  • Research or educational grants (restricted & unrestricted)
  • Hospitality (meals and hospitality greater than SR 50* (~$13.33))
  • Gifts or entertainment
    • Gifts include promotional items (e.g. pens, prescription pads) or anything provided to HCPs/HCIs that doesn’t fit in other category
    • Any amounts paid to HCPs or HCIs greater than specified financial standards (SR 50)
    • Company should not report any tranfers of value less than SR 50 per payment unless the total annual aggregate is greater than SR 500
  • Scientific materials (e.g. books, journal articles or instruments)

*Amount permitted under Saudi Code of Pharmaceutical Promotional Practices

How to Report

Saudi Food and Drug Administration provides electronic forms

Important notes:
  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information reflects that most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. (In such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

Disclaimer:

The information contained in this website is for general information purposes only. The information is provided by MediSpend and, while we endeavor to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is, therefore, strictly at your own risk.

In no event will MediSpend be liable for any loss or damage including, without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this website.

Through this website you may be able to link to other websites which are not under the control of MediSpend. We have no control over the nature, content and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.

Every effort is made to keep the website up and running smoothly. However, MediSpend takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.