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)
- Payments made via third parties (Source: FAQ)
- Transfers of value made within national territory of Saudi Arabia AND abroad (Source: FAQ)
- Samples (Source: FAQ)
*Amount permitted under Saudi Code of Pharmaceutical Promotional Practices
- If less than 50 SR OR
- If less than 500 SR per year
- Please note: these thresholds will be reviewed and updated by the supervising authority based on the experiences of the implementation phase (Source: FAQ, see Resources)
Where to report: eServices platform provided by SFDA
- 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 provided reflects the 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 case it is based on codes of conduct, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of the association that follows that code.
- Including a jurisdiction in the Legislative Watch does not guarantee that jurisdiction is available for reporting via the MediSpend Transparency Reporting Solution.
- Reporting date normally means the date the transfers of value need to be published. The deadline for e.g. submission/sending the complete information to the authority could be before that date, for example to give HCPs and/or HCOs and/or the authority/association who publishes the information, the possibility to check the data the pharmaceutical companies/medical device companies are going to disclose.
- The information does not take into consideration (unless explicitly mentioned):
- 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)
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