It is the responsibility of the product license holder to ensure the quality, safety and efficacy of the product before the submission, as well as the preparation of the dossier in the right eCTD format. This responsibility lasts even after the approval and as long as the product is licensed to be placed in the Qatari market. The local agent is the one responsible for the product in Qatar and he is the only authorized body to deal with MOPH as per Qatari law. However, PDCD has the right to communicate directly with the product license holder in certain cases. The product license holder should inform PDCD through his local agent with any variation on the product, as well as any emerged safety signal, as soon as possible.
Any local Qatari organization has the right to register itself as an agent for pharmaceutical companies after fulfilling MOPH requirements. The local agent should ensure the registration of the product license holder; known as marketing authorization holder in most cases (MAH), as well as the manufacturing sites before submission of any product application as per MOPH requirements.
This document has been developed to assist applicants in the preparation and submission of the documents required for re-registration (renewal) of the already registered pharmaceutical products to the “Pharmacy & Drug Control Department – MOPH, Qatar “.