Filing of Applications for Automatic Renewal Registration and Revalidation

To avoid any inconvenience with the importation, distribution or marketing of your products, please file your applications for Automatic Renewal Registration at the earliest possible time. The Center for Drug Regulation and Research would like to reiterate that as per the Implementing Rules and Regulations of Republic Act No. 9711, otherwise known as the "Food and Drug Administration Act of 2009," and Administrative Order No. 2005-0030, "Subject: Guidelines and Procedure for the Automatic Renewal of the Certificate of Product Registration Issued by the Bureau of Food and Drugs," applications for Automatic Renewal Registration may be filed as early as ninety (90) days before the expiration of the Certificate of Product Registration.

Likewise, pharmaceutical products granted conditional approval (i.e., one year validity) requesting revalidations are requested to submit their applications as soon as the documents/data required become available.

For your information and guidance.

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