Authorized Representative in Jordan
Foreign companies planning to market products in Jordan may need a local representative or agent to support regulatory submissions and communication with the relevant authority. The exact role depends on the product and its regulatory route, so the appointment should be confirmed for the specific product before the application begins.
For pharmaceutical products, the Jordan Food and Drug Administration (JFDA) workflow identifies a local company legally responsible for placing the product on the Jordanian market. It requests the local agent’s details and contacts responsible for registration and communication with JFDA.
Appointing a representative does not itself authorize a product for sale. The product must follow the applicable JFDA review and authorization process. JFDA’s current guidance describes submission and lifecycle procedures, including renewals and variations for human medicinal products.
What a local representative may do
The representative’s responsibilities should be set out in writing and aligned with the applicable regulatory process. Depending on the appointment, they may:
- Provide local company and contact details for the application.
- Coordinate submission documents and regulatory correspondence.
- Act as a local point of contact for the authority.
- Help manage responses to authority questions.
- Support applicable post-approval submissions.
- Coordinate local pharmacovigilance contacts where required for the product and route.
For pharmaceutical applications, JFDA’s workflow asks for the local company’s agent details and identifies contacts responsible for the registration process and communication with JFDA.
The responsibilities of a local representative can vary by product category. For medical devices, manufacturers can review the Jordan medical device registration requirements to understand the local authorized representative requirement and the documents needed for registration.
Typical appointment and support process
- Discuss your product and plans. Share the product details, current approvals and intended activities in Jordan.
- Confirm the applicable route. OMC reviews the information and identifies the local representation requirements to verify for your case.
- Agree the service scope. We confirm the representative arrangement, responsibilities, documents and fees before appointment.
- Prepare the appointment documents. OMC helps coordinate the mandate and local company information required for the agreed route.
- Coordinate the application. We support document preparation, submission coordination and regulatory follow-up.
- Support ongoing requirements. If included in the agreed service, we help coordinate applicable renewals, variations and ongoing communications.
Information to prepare
To assess the representation requirements, manufacturers should be ready to provide:
- Product name, type and intended use.
- Manufacturer and marketing authorization holder details.
- Current approvals and registration status in other markets.
- Proposed Jordanian importer or commercial partner details, if known.
- Available product dossier and labeling.
- Details of the local support required, such as appointment, submission coordination or post-approval support.
JFDA may request additional information according to the product and application type. Its current guidance should be checked before submission.
Fees and pricing
Please check the official JFDA website and Jordan Trade Portal before relying on any fee amount or submitting an application. Official fees and requirements may change.
JFDA/government charges are separate from OMC’s private service fees. The Jordan Trade Portal lists examples of pharmaceutical application charges, including JOD 100 for registration of a medicine with a similar registered product and JOD 1,000 for registration of a new medicine. It also lists separate evaluation charges for certain studies and analyses. These are pharmaceutical application charges—not Authorized Representative fees—and do not represent the total cost for every application.
OMC’s service fee depends on the agreed representation and regulatory support scope. We provide a quotation after reviewing the product and requested services.
How OMC Medical helps
OMC Medical helps manufacturers plan and coordinate local representation in Jordan. We work with you to understand the product, confirm the appropriate representation arrangement and define the regulatory support required before the appointment is made.
Our support can include:
- Initial requirements review: We review the product and your market-entry plans to identify the relevant regulatory route and local representation needs.
- Representative arrangement: We help determine the appropriate local representative structure and coordinate the appointment process for the agreed scope.
- Appointment documentation: We support preparation and review of the authorization, mandate and company information required for the applicable process.
- Regulatory document coordination: We help organize the application documents and identify missing or inconsistent information before submission.
- Submission support: We coordinate the regulatory submission process with the appointed local contact and help track correspondence.
- JFDA communication support: We help manage questions, requests for clarification and follow-up actions during the review.
- Post-approval coordination: Where included in the agreed scope, we support applicable renewals, variations and other lifecycle submissions.
- Ongoing contact and handover support: We help maintain clear communication between the manufacturer and local representative, including when responsibilities or representation arrangements need to change.
The exact services depend on the product, the applicable route and the agreed mandate. Before work begins, OMC confirms the scope, responsibilities, documents required and service fee with the client.
OMC Medical also provides regulatory support for different product categories. Manufacturers can review our regulatory services for medical devices, pharmaceuticals and cosmetics to identify services relevant to their market-entry plans.
Ready to get started?
OMC Medical can review your product and market-entry plans, clarify the local representation support you need, and provide a service proposal for Jordan.
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Frequently Asked Questions
Yes. According to OMC Medical’s Jordan medical device registration guidance, foreign manufacturers must appoint a local authorized representative to submit the application. Requirements should be confirmed for the specific device and current JFDA process.
Depending on the applicable regulatory route and agreed appointment, responsibilities may include coordinating registration documents, communicating with the relevant authority, supporting responses to regulatory questions and coordinating applicable post-approval submissions.
The documents depend on the product category and application type. Manufacturers may need product details, manufacturer information, existing approvals, a product dossier, labeling and applicable authorization documents. Additional documents may be requested by JFDA.
No. Appointing a representative does not automatically authorize a product for sale. The product must complete the applicable registration, review and approval process before it can be marketed where authorization is required.
The cost depends on the product category, the responsibilities involved and the regulatory support required. Government registration fees are separate from private representative and consulting fees. OMC Medical can provide a service quotation after reviewing the product and requested scope.
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