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  • 09. April 2021

    Fda Us Agent Agreement

    The agreement between the U.S. agent company between the company and Pragmatic remains valid for 12 months from the date of payment. Unless there is an extension, this is the period indicated. Email us to drugs@fdaagents.com and describe your activity (manufacturer, labeler, testing lab, etc.) and describe your medications (OTC, sunscreen, disinfectant, etc.). We can then provide you with more detailed information about the process. Information about the U.S. agent of a foreign company is transmitted electronically through the FDA Unified Registration and Listing System (FURLS) and is part of the operation registration process. Each foreign establishment can name only one U.S. agent. The foreign establishment may also designate its U.S. agent as its official correspondent, but it is not obliged to do so. The foreign company should provide the name, address, telephone and fax numbers and email address of the U.S. agent.

    Professionals focus on a core business and use other professionals to manage related functions. If you are a broker, use a forwarder; If you are an importer, use a customs broker. Similarly, using a professional company as an agent of the U.S. FDA, an agent who is responsible for serving as a necessary communication liaison between your customers and members and the U.S. Food and Drug Administration, helps ensure full compliance with the new rules. Pragmatic acts as a U.S. agent for companies to facilitate communication between the U.S. Food and Drug Administration (FDA) and is only responsible for transmitting information received from the FDA to the company, unless there is a specific service agreement. The new term and the requirement of a „U.S.

    agent“ is very specific in the new rules and does not apply to agents that you may already have for customs or other purposes. It is a new term for a person or company with very different responsibilities and responsibilities. This is the FDA`s contact in the event of an emergency or a potential terrorist threat. The identified U.S. agent must complete an automated process to confirm that he has agreed to act as a U.S. agent. The automated process sends an e-mail verification request to the U.S. agent. They are asked to confirm their consent to act as a representative/liaison officer on behalf of the foreign establishment.

    If the U.S. agent refuses to give consent (or does not respond within 10 business days), the official correspondent/owner of the foreign establishment is notified and must appoint a new U.S. agent to comply with the regulatory supervisory obligation. Any foreign branch involved in the manufacture, preparation, multiplication, composition or processing of a device imported into the United States must identify an American agent (USA).


    Verfasst von Stefan Oberhauser

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