Marketing Authorization Transfer (MAT) Process in SFDA

Under the Saudi Food and Drug Authority (SFDA) regulations, the Marketing Authorization Transfer (MAT) from one Marketing Authorization Holder (MAH) to another is managed as a variation submission. This article provides an overview of SFDA requirements, eligibility criteria, and the MAT submission process. It is intended to serve as a helpful guide for pharmaceutical companies, applicants, and other stakeholders involved in managing MA transfers in Saudi Arabia.

Table of Content

• MAT Variation Type
• Eligibility
• When is an MA transfer required?
• Steps to transfer from one MAH to another
• Important-Considerations

MAT Variation Type

Transferring a Marketing Authorization to a new Marketing Authorization falls under a Type IB variation.

Type IB is a tell-wait-do procedure. The MAH must submit this variation to the authority before implementation, but it does not require official SFDA approval. However, the MAH must wait 60 working days to ensure the SFDA reviews and accepts the application before making the change. However, it is highly recommended to wait until SFDA grants approval before implementing the changes and importing the drug with the new artwork livery.

Read more: How to Submit an SFDA Variation Application?

Eligibility 

An MA transfer is applicable only when:

When is an MA transfer required? 

• Change of Marketing Authorization Holder (MAH)
• Company merger or acquisition
• Product ownership transfer
• Business restructuring

Steps to transfer from one MAH to another

A Marketing Authorization Transfer Variation is an administrative post-approval change that transfers the ownership of an authorized medicinal product from the current MAH to a different legal entity.

The transfer applies only to a change in the marketing authorization holder’s legal entity and does not constitute a new product registration.

The variation of marketing authorizations undergoes the following steps and processes:

• Online submission of the variation application and fees.
• Business validation: The application undergoes SFDA validation to ensure the information is accurate and to identify any additional document requirements.
• Timeline: If there are any discrepancies, SFDA may send it back to the applicant for justification and clarification, which must be responded to within the SFDA timeline frame i.e. 30 working days; otherwise, the application will be rejected.
• Assessment: One or more departments may review the variation application. If the MAH bundles other changes on the drug dossier, the evaluation will involve related departments and may extend the MAT approval timelines.
• Receive SFDA approval.
• Implement the transfer after SFDA acceptance.

Important Considerations

• All submitted information should be complete, accurate, and consistent with the approved dossier, with changes to the affected parts, if applicable such as product labeling.
• The new MAH is responsible for maintaining the product’s regulatory compliance after approval.

Since transferring a Marketing Authorization (MA) from one Marketing Authorization Holder (MAH) to another can be complex and time-consuming, our expert team is here to simplify it. With our professional support, you can minimize delays, ensure regulatory compliance, and complete the MA transfer more efficiently.

Please feel free to contact us if you have any questions regarding the Marketing Authorization transfer process.